inside - paactpaact.help/uploads/22faaebpaactspring2016.pdf · the past decade has brought many...

INSIDE:Focal Therapy for Early Stage Prostate Cancer On the Horizon - Individualized Biomarker Driven Therapy in Castrate Resistant Prostate Cancer (CRPC)Some Current Clinical Trials – in the Emerging Field of BiomarkersMy Journey as a Prostate Cancer Physician: Surgeon – to Patient – to Consultant

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VOLUME 32, NUMBER 1 • SPRING 2016 FOUNDER: LLOYD J. NEY, SR. FOUNDED 1984

PROSTATE CANCER COMMUNICATION

AR-V7 blood testing now available for mCRPC patients. See page 3

2 Prostate Cancer Communication / Spring 2016 • www.paactusa.org

Published Quarterly by: PAACT, Inc.Prostate Advocates Aiding Choices in Treatments

11555 Jadon Ct NESparta, MI 49345-8155

President/CEO —Richard H. Profit Jr.V.P. of Advocacy & Education — Jan Manarite

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EDITOR:Articles authored by other than the editor may not fully reflect

the views of the corporation but are printed with the understanding that the patient has the right to make his own interpretation of the

efficacy of the information provided.

In an effort to conserve space and be able to insert as much material as possible in the newsletter, references from various articles are intentionally

omitted. If you would like to obtain those references, please contact PAACT, we keep all of the original articles and the references used on file.

Life Without Prostate Cancer:Imagine The Possibilities!

President/CEO Richard H. Profit, Jr.

V.P. of Education & Advocacy Jan Manarite

Board of Directors: Saleem Durvesh, Executive

Marketing DirectorEdwin Kuberski, Treasurer

Janet Ney, DirectorJanette Ney, Director

Anthony Staicer, Director

Honorary Board Members: Newt Dilley

A.W. (Bud) Irish Fred Lee, Sr. MD Russell Osbun Art Schlefstein

Medical Advisory Board:V. Elayne Arterbery, M.D.

Robert A. Badalament, M.D.Duke K. Bahn, M.D.Israel Barken, M.D.

E. Roy Berger, M.D., F.A.C.P.Douglas O. Chinn, M.D.Michael J. Dattoli, M.D.Fernand Labrie, M.D.Gary E. Leach, M.D.

Robert Leibowitz, M.D.Mark A. Moyad, M.D., M.P.H.

Charles E. Myers, Jr., M.D.Gary Onik, M.D.

Haakon Ragde, M.D.Oliver Sartor, M.D.

Stephen B. Strum, M.D., F.A.C.P.Ashutosh (Ash) K. Tewari, M.D., M.CH.

Donald L. Trump, M.D.Steven Tucker, M.D., F.A.C.P., F.A.M.S.

PROSTATE CANCER COMMUNICATION

CONTACT US

TABLE OF CONTENTSContact Us ........................................................................................... 2

On the Horizon - Individualized Biomarker Driven Therapy in Castrate Resistant Prostate Cancer (CRPC) By Shahrooz Eshaghian, MD FACP .......................................................... 3

About Compassionate Use/Expanded Access Through FDA By Jan Manarite, VP of Advocacy & Education ........................................ 4

Some Current Clinical Trials – in the Emerging Field of Biomarkers By Jan Manarite, VP of Advocacy & Education ........................................ 5

My Journey as a Prostate Cancer Physician: Surgeon – to Patient – to Consultant By Larry L Bans, MD .............................................................................. 6

Focal Therapy for Early Stage Prostate Cancer Brief Overview, and Focal Cryotherapy Experience at PIOA By Duke K. Bahn, MD ............................................................................ 7

What the Heck Has Been Going On In My World – Part 72 By Mark A Moyad, MD, MPH ................................................................ 12

Newly Diagnosed Prostate Cancer - PAACT’s Step by Step Online Tool By Jan Manarite, VP of Advocacy & Education ...................................... 20

www.PAACT.HELP – Something for Everyone By Jan Manarite, VP of Advocacy & Education ...................................... 21

Acknowledgements ........................................................................... 22

Contributions .................................................................................... 23

PAACT Membership Form .................................................................... 24

Bayer is a supporting sponsor for the

educational content for this edition of PAACT’s Prostate

Cancer Communication newsletter.

• Rick Profit – President/CEO Headquarters, MI

• Jan Manarite – Vice President of Advocacy & Education Home Office, FL

• John Mullineaux – Volunteer Home Office, PA

(844) PAACT 4U PAACT’s Free Helpline

8:00 am – 5:00 pm EST, M-F

www.paactusa.org • Spring 2016 / Prostate Cancer Communication 3

ON THE HORIZON - INDIVIDUALIZED BIOMARKER DRIVEN THERAPY IN CASTRATE

RESISTANT PROSTATE CANCER (CRPC)Shahrooz Eshaghian, MD FACP • Compassionate Oncology Medical Group Clinical Instructor UCLA School

of Medicine • Attending Physician, Division of Hematology & Oncology at Cedars Sinai Medical Center [email protected]

The past decade has brought many advances for the treatment of CRPC, or MCRPC (metastatic CRPC). This includes the remarkable approval of at least 5 novel treatment options for these patients, who are on hormone therapy, with progressing disease. In previous years, we have called them hormone refractory (or androgen independent) prostate cancer patients:

• Novel anti-androgens: Abiraterone acetate (Zytiga) & Enzalutamide (Xtandi)• Second line chemotherapy: Cabazitaxel (Jevtana)• Immunotherapy: Sipuleucel-T (Provenge) • Radiopharmaceutical therapy: Radium-223 (Xofigo)

Although these agents have improved the progression free survival & overall survival in CRPC patients, the disease unfortunately still remains incurable. So, what does the future hold for patients that have progressed past these novel lines of therapies?

‘Novel’ – a term in medicine used to describe something “new, different, or unusual.”

Attending conferences & meetings and exploring various clinical journals & NCCN guidelines, the one common answer usually is – enrollment in a clinical trial. Although, we fully support enrollment in clinical trials, as a medical oncologist for almost a decade, I have seen that such a route is not always an option or desire for patients. Understandable information on trials is also difficult for patients to find. (However, please see PAACT’s corresponding article on current clinical trials using biomarkers – Page 5 of this issue.) Still, if a trial isn’t a reasonable option, what else is left for an oncologist and patient to do? One answer that I have found in our clinic is individualized biomarker driven oncology treatment based on novel molecular tests that may help guide a personalized decision. Below, I will briefly discuss and review a few such options that can be offered to patients.

One option would include, assessing for alterations in the expression of the androgen receptor (AR). It has been demonstrated that splice variant AR-V7 predicts a likely low response rate to androgen pathway therapies (REF). Additionally, such a finding might even imply the transition to a distinct new

more aggressive histology, which is now termed: intermediate atypical carcinoma (IAC). Prior to this new classification, tumors were traditionally classified as adenocarcinoma or small cell cancer. Although no standard therapy has yet to be established for the treatment of IAC tumors, it would not be unreasonable to consider treatment with chemotherapy (possibly a platinum based chemotherapy regimen) – instead of pursuing additional anti-androgen treatment options.

FROM PAACT: NOTE - The AR-V7 blood test recently became available for mCRPC (metastatic castrate-resistant PC) patients - only through Johns Hopkins. MCRPC patients should ask and make sure they are

eligible for the AR-V7 blood test. They should also ask about cost, insurance, turnaround time, and how to get their blood drawn locally to be sent to Johns Hopkins. Contact Katie Beierl at Johns Hopkins - [email protected]. For more detailed information, call PAACT at (844) PAACT 4U.

Additionally, an image guided biopsy (usually bone or lymph node) can be pursued with the help of a skilled radiologist. The tissue sample can then be tested for a possible novel targeted pathway. For many patients, this would also be their first biopsy since being diagnosed with prostate cancer – sometimes many decades ago and the pathology of a patient’s tumor now can certainly be different than it was at the time of their original diagnosis.

An example of testing for a novel pathway would be assessing for BRCA1 and/or BRCA2 mutations that tend to predict a more aggressive phenotype of disease; but, one that might demonstrate response to novel poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors. Although these mutations are rare (estimate <5% of MCRPC patients will harbor a BRCA1 or 2 mutation), such a finding can lead to a novel approach of therapy with a possible prolong response to treatment.

There are various labs that can offer such personalized genomic analysis. A reputable lab we have come to rely on in our clinic (COMG) to analyze a comprehensive genomic profile for our patients is: FoundationOne (www.foundationone.com). Please visit their website for more information and details about their various testing options. This test is normally covered by most insurance carriers and has a turnaround time of 2 weeks.

(844) PAACT 4U PAACT’s Free Helpline

8:00 am – 5:00 pm EST, M-F


Finally, more and more serum liquid biopsies are becoming commercially available in the clinic and might one day replace the need for invasive biopsies. These liquid biopsies can possibly also identify a potentially novel targeted signal pathway, which can lead to the utilization of an individualized treatment plan. Again there are various labs that offer such services and one that we have become most familiar with has been the Guardant360 (www.guardanthealth.com). Again, please visit their website for additional information and testing options. This test is also usually covered by most insurance plans and has a turnaround time of approximately 1 week.

As most readers like to end with a real life case example, I will briefly review a recent case example at Compassionate Oncology Medical Group (COMG) utilizing such methods:

Case Report - JM: 66-year-old male with no significant medical problems.

• 2001: Diagnosed at age 50 with Gleason 3+4 prostate adenocarcinoma, PSA 2.9. He underwent radical prostatectomy. PSA was 0 post-operatively and surgical margins were free of cancer.

• 2004: Biochemical (PSA) recurrence and underwent salvage radiation therapy followed by androgen deprivation therapy (hormone therapy).

• 2006: Castrate resistant & established care at COMG with Dr. Bob Leibowitz. By 2009 had progressive bone metastasis & was treated with Dr. Bob’s three-prong therapy including: Taxotere/Emcyt /Carboplatin (TEC) x5-cycles + Triple Hormone Blockade x9-months.

• 2011-15: Zytiga (2011-12), Xtandi (2012-13), Jevtana x21-cycles (2013-15). Briefly treated with Cometriq and then did not qualify for any clinical trials. He deferred Xofigo given rapidly rising PSA (194) & CTC (158) with progressing & symptomatic (painful) bone metastasis.

• 2015: Bone biopsy done & sent to FoundationOne that demonstrated BRCA -2 positivity. Some extensive paperwork granted compassionate approval through FDA (read more below) of Lynparza (olaparib) and he has been on oral Lynparza daily since October 2015. Since then, bone pain has resolved and PSA (94) & CTC (1) are decreasing, and follow up is continuing. He continues to work daily and lives an active lifestyle.

In conclusion, the future continues to hopefully look more promising for patients with MCRPC and more personalized therapies are likely in the landscape for a select group of patients.

This article is not meant to be an endorsement for any one test or lab and is meant to serve as a review for the reader, which will hopefully start a conversation with their own personal oncologist &/or physician about what individualized biomarker driven therapies might be available for them, like the AR-V7 blood test, and BRCA 1 or 2 – if ever needed. If I can be of any assistance, please feel free to contact me via phone (310)229-3555 or email ([email protected]).

REF: Antonarakis E., et al: AR-V7 and Resistance to Enzalutamide and Abiraterone in Prostate Cancer. NEJM 2014; 371:1028-1038

ABOUT COMPASSIONATE USE / EXPANDED ACCESS

THROUGH FDAJan Manarite, VP of Advocacy & Education

The Expanded Access program through the FDA has more than one section or approach. One of those sections is for an individual patient to receive an individual drug, called IND (single patient investigational new drug.) There is a fair amount of time and paperwork required to work through this IND program, so an advocate may be helpful.

Per the FDA website, these are a few of the things that must apply for a patient to be eligible for Compassionate Use with IND:

“Participation

• The patient and his or her licensed physician must both be willing to participate.

• The patient must:- Have a serious or immediately life-threatening disease

or condition;- Have no comparable or satisfactory alternative therapy

to diagnose, monitor, or treat the disease or condition; and

- Be unable to obtain the investigational drug under another IND or to participate in a clinical trial.”

For more information on the process for Expanded Access or IND call the FDA’s Office of Health and

Constituent Affairs at (301) 796-8460 or email [email protected]

Lynparza (olaparib) is not currently available commercially for prostate cancer in the U.S. There is

presently one clinical trial in Europe - See page 5.*Trial info is constantly changing.

Check www.ClinicalTrials.gov for latest info.


SOME CURRENT CLINICAL TRIALS – IN THE EMERGING FIELD OF BIOMARKERS

Jan Manarite • VP of Advocacy & Education

Clinical trials are constantly changing. But to offer our readers some current options that might be worth researching, here is what I found for clinical trials using BRCA testing, or AR-V7 testing – both of which are mentioned in Dr Eshaghian’s article on page 3.

SEE TIPS FOR PATIENTS & CAREGIVERS ON CLINICAL TRIALS - PAGE 6.

CURRENT TRIALS IN PROSTATE CANCER, USING BRCA 1 OR BRCA 2 TESTING *Note – ask trial site how they are doing BRCA testing. Are they offering in trial? Or does it need to be done beforehand? Are they using the blood test or the pathology test?

1) A Phase II Study of the Chk1/2 Inhibitor (LY2606368) in BRCA1/2 Mutation Cancers, Including Metastatic Castrate-Resistant Prostate Cancer Phase 2, NO Placebo

Basic Eligibility Criteria:• Must be on hormone therapy, with cancer progressing• Must have soft tissue mets that can be biopsied (lymph

node, lung, bladder, etc)• Must have had prior Xtandi OR Zytiga (for 1 month or more)• No limit to the number of prior therapies (For full eligibility criteria, check with contacts below)

Location: Bethesda, MD (NIH) Contacts – Anna Couvillon, CRNP, (301) 443-6211, [email protected] or Cynthia Boyle, R.N, (301) 496-0932, [email protected]

2) Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and BRCA Mutations Phase 1/2, NO Placebo

Basic Eligibility Criteria:• Must be metastatic with at least 1 standard treatment for

metastatic cancer• Must be willing to undergo tumor biopsies• At least 4 weeks since surgery, radiation, or chemo (For full eligibility criteria, check with contact below)

Location: Bethesda, MD (NIH) Contact: Melanie M. Herrin (301) 402-5640, [email protected]

3) TOPARP: A Phase II Trial of Olaparib [Lynparza] in Patients With Advanced Castration Resistant Prostate Cancer (TOPARP) Phase 2, NO Placebo

Basic Eligibility Criteria:• On hormone therapy, or previous orchiectomy• CTC blood test of 5 or more• Previous Taxane chemotherapy – 1 or 2 cycles• At least 4 weeks since chemotherapy (For full eligibility criteria, check with contact below)

Location: United Kingdom – London and Sutton, Surrey Contact: TOPARP Trial Manager, 020 8722 4156, [email protected]

CURRENT TRIALS IN PROSTATE CANCER, USING AR-V7 BLOOD TESTING*Note – AR-V7 blood testing is only available through Johns Hopkins, and for mCRPC patients. For more information about how to obtain AR-V7 testing through a local laboratory (your blood must be shipped to Johns Hopkins), please contact Katie Beierl, [email protected]. Or ask the trial site how they are doing their AR-V7 blood testing.

1) Biomarker-Driven Therapy with Nivolumab [Opdivo] and Ipilimumab [Yervoy] Treating Patients with Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7 (STARVE-PC) Phase 2 - NO placebo

Basic Eligibility Criteria:• On hormone therapy, with progressing disease• Two or more bone metastases• At least 4 weeks since radiation or major surgery• At least 4 weeks since use of antiandrogens (For full eligibility criteria, check with contact below)

Location: Baltimore, MD Contact: Rana Harb, MS, (443) 287-6662, [email protected]

2) Niclosamide and Enzalutamide [Xtandi] in Treating Patients With AR Splice Variant [7]-Positive, Castration-Resistant, Metastatic Prostate Cancer Phase 1 - NO placebo

Basic Eligibility Criteria:• On hormone therapy, with progressing disease• Must be metastatic• Must have taken, and failed abiraterone (Zytiga) (For full eligibility criteria, check with contact below)

Location: Seattle, WA Contact: Michael Schweizer, (206) 288-6252, [email protected]


3) A Study of Galeterone Compared to Enzalutamide [Xtandi] In Men Expressing Androgen Receptor Splice Variant-7 (AR-V7) Metastatic CRPC (ARMOR3-SV) (galeterone and enzalutamide are 2nd line hormonal therapy given as pills) Phase 3 - NO placebo

Basic Eligibility Criteria:• Castration-resistant PC (PSA rising on hormone therapy)• Metastatic (positive bone scan or CT scan)• No previous Zytiga or Xtandi• No previous chemo for CRPC• AR-V7 blood test must be positive – you will be offered the

blood test to see if you qualify. (For full eligibility criteria, check with contact below)

Locations: 23 US states + Canada and Europe Contact: Kerry Horgan, [email protected]

TIPS FOR PATIENTS & CAREGIVERS – CLINICAL TRIALS:Think of a clinical trial as another treatment choice. Therefore, weigh the Risks and Benefits with your doctors and nurses, just like any other treatment.

Here are some things to consider & ask: • How long is the enrollment paperwork & process for this

trial? (it’s usually 3-4 weeks) How does that affect your current cancer situation? What is your PSA Doubling Time (PSADT), for example?

• Can you do anything (as a patient or caregiver) to speed up the paperwork and enrollment process? Ask to speak directly to the clinical trial nurse, who is usually a different nurse than your regular nurses. Develop a relationship with them, and hand them any medical records they may not have.

• How much testing is involved? Is the patient willing to do the testing?

• Is there any travel or cost involved? Is the patient willing to travel? (There is usually no cost for a trial, but ask – there are always a few exceptions.)

Remember, clinical trials are voluntary and you can pull out of a clinical trial any time you want.

MY JOURNEY AS A PROSTATE CANCER PHYSICIAN: SURGEON – TO PATIENT – TO CONSULTANT

Larry L Bans, MD • www.psa.md • (602) 426-9772 • Phoenix, AZ

When I started medical school at Cornell University I had no idea what direction my career would take. I was most interested in internal medicine and pathology but as I rotated on the various specialty services my interest in surgery, and in particular urology, flourished. When I decided on urology as my career path, prostate cancer was certainly not as major of an issue as it has become today.

This was prior to the PSA era, and as the majority of patients being diagnosed with prostate cancer were already advanced and often incurable, and treatment choices were more limited. As is well known today, the advent of PSA testing and improved prostate biopsy techniques have changed all that for the better.

I consider myself very fortunate to have had my urologic training at Indiana University Medical Center under the tutelage of Dr. John Donohue and the superb staff that he assembled. When I completed my residency, prostate cancer was rapidly becoming one of the foremost issues in urology. At that time I considered a career in academic urology

specializing in pediatric urology but ultimately, working with adults trumped that interest, and I set out for a career in private practice in Phoenix, Arizona. The year was 1983.

I was fortunate to become the fourth member of Urology Associates, Ltd. and to have the opportunity to be able to learn from, and work with, three very special and talented physicians. I started out in a very busy practice and enjoyed the diversity of general urology. Through the years urologic oncology surfaced as my main area of interest and expertise and I gradually developed a large practice significantly devoted to prostate cancer. With the advent of PSA, nerve sparing radical prostatectomy surgery, and brachytherapy, my practice rapidly evolved into one that was heavily weighted with prostate patients, including my own patients, and referrals.

Ironically, as my prostate practice increased, so too, did my own PSA blood test. I was 50 years old, had no family history of prostate cancer or any other cancers, and I had no symptoms. Despite my hopes that the PSA increase was not due to cancer, I ultimately decided one day to ask one of my associates to perform a biopsy on me. The procedure


was just before a long holiday weekend and I was on call. I didn’t expect to find out the pathology results until the next week, but in a very surreal experience, I walked into the office over the weekend and passed by the fax machine. There, in a dark quiet room, all alone, I saw my positive biopsy report on the printer. Although I won’t go into full details of my treatment choice in this particular article, I will say that this experience gave me a deeper understanding into the emotions tied to a cancer diagnosis, the weight of a treatment decision, and the need for impartial consultations. As you might expect, this began to alter some of my desires and viewpoints as a clinician working with patients and caregivers.

After my successful treatment for prostate cancer, I returned to my general urology practice but didn’t feel fulfilled continuing on that path. Within a year I decided to leave the group after practicing for 20 years, and sub- specialize in prostate exclusively. It was a risky, but ultimately very rewarding choice. The majority of my practice focused on prostate cancer, and a large multi-national cancer care company recruited me to help set up their inter-disciplinary prostate cancer program. It was highly successful and helped to solidify my dedication to helping patients and families with prostate cancer.

In 2012, I joined 21st Century Oncology of Arizona and continued to evolve my practice by bringing in an associate

also dedicated to prostate care. In 2015 I was honored to accept their offer to become Director of Prostate Cancer Care for Arizona, and since that time I have dedicated my full-time practice to working exclusively with prostate cancer patients.

In accepting this position I had to decide how my role could be best adapted to the task. After much deliberation, I decided to redefine my role to one of an unbiased, pure, prostate cancer consultant, and

as such, I stopped performing surgery to instead counsel patients only in regards to their options. By doing so, without financial or other incentives to direct patients along any specific path, I became an impartial consultant focused exclusively on prostate cancer.

This is a great honor and privilege to me, and it has become a most rewarding and gratifying position. It has allowed me the opportunity to utilize my passion and expertise in the field to assist patients who have a prostate cancer diagnosis, or related issues, with their often difficult decision making in regards to potential treatment options. I remain deeply grateful to all those who have trained, assisted and helped me with my knowledge in the field. Above all, I remain thankful for the trust and confidence that my patients have afforded me in this journey. I enthusiastically look forward to my continued passion and service to those who have been afflicted with prostate cancer, a disease in which we have seen so many significant therapeutic advances in my short career.

FOCAL THERAPY FOR EARLY STAGE PROSTATE CANCER - BRIEF OVERVIEW, AND FOCAL

CRYOTHERAPY EXPERIENCE AT PIOADuke K. Bahn, MD • Prostate Institute of America (www.PIOA.ORG)

• Ventura, California (805) 585-3082 or (888) 234-0004

INTRODUCTION: The progression of clinically localized prostate cancer is usually slower than other cancers, and has confounded the development of a national consensus regarding the optimal treatment for the disease. In addition, most of the observers believe that screening with PSA can result in the over-treatment of prostate cancer. However, the justification for PSA

screening and treatment is still accepted by most experts due to the estimated 27,540 death from this disease last year in the United States. Although some prostate cancers are aggressive, the relatively slow growing nature of clinically localized prostate cancer has refuted the current established treatment options for the disease. This argument is supported by the fact that about one third men over 50 years of age will display incidental prostate cancer at autopsy, but only 10 – 16% will develop invasive prostate cancer during their life time, and only 2.5% will die from it.

Current treatment options for prostate cancer (PC) are either active surveillance or radical intervention treating the entire prostate (surgery, radiation, and others). Radical therapy may maximize the cancer control, but with a certain degree of sexual and urinary complications which may seriously affect quality of life. Active surveillance will not impact a patient’s sexual and urinary function, but it can carry the psychological burden of missing the window of opportunity for cure for some men.

This article reviews many forms of novel approaches that are called “focal therapy” or “subtotal therapy”. The goal of this approach is not only to achieve the same level of cancer control as seen in radical therapy, but also to maintain few or no complications in a selected group of men who have early stage organ- confined disease.

After much deliberation, I

decided to redefine my role to one of

an unbiased, pure, prostate cancer consultant….


DEFINITION OF FOCAL THERAPY:Focal therapy is a generic term for destroying the tumors only by treating a portion of the prostate, and leaving the prostate gland intact. There is no consensus of opinion on the method of focal therapy. Some researchers treated only areas of known cancer while others have tried to treat the entire one half of the prostate that showed tumor involvement. There was also an attempt to treat the entire gland excluding the neurovascular bundles. Therefore, some advocate the term “subtotal therapy” instead of “focal therapy”. But “focal therapy” is the most common term, now spanning over a decade of research.

The advantages of focal therapy include:1. It is a minimally invasive procedure using highly accurate

imaging to target and destroy only the cancerous tissue within the prostate.

2. The side effects (mainly urinary and sexual dysfunctions) are far less frequent and severe than other conventional therapies.

3. If it fails, other currently available treatment options remain viable. In other words, it will not burn the bridge behind you.

4. It usually performed as an out-patient basis, if not an overnight hospital stay.

5. Recuperation from the procedure is mostly uneventful and quick.

The disadvantages of focal therapy include: 1. It is not widely available. The patient may need to travel to

find an expert.2. Parts of the procedure may not be covered by insurance for

some men. The patient should ask about cost, insurance, etc.

TARGETED FOCAL (SUBTOTAL) CRYOABLATIONFocal (subtotal) cryotherapy is defined as the less than complete ablation of the prostate gland with freezing or ice.

A known tumor site (lobe) is aggressively treated, but the contralateral (opposite side) lobe of prostate tissue and surrounding structures are spared. This method offers targeted local cancer control, while preserving urinary continence and sexual potency for most. (See Table 1)

In the PSA era, many cancers are detected at an early organ contained stage, and may be confined in one lobe of the prostate. As many as 35% of clinically localized prostate cancers are unifocal and may be candidates for focal therapy. A tumor less than 0.5cc is used as a criterion for low-volume disease; this may not require any type of intervention. Others argue that even tumors smaller than 0.5 cc may be clinically

aggressive and may require intervention. It is indeed a burden to identify the proper candidates for focal therapy.

PATIENT SELECTION FOR FOCAL CRYOABLATION:Optimal patient selection criteria are not clearly defined nor agreed upon within the urology field. However, it is essential that the patient have unifocal (1 focus lesion) or unilateral (1 side of gland) prostate cancer. We perform a color Doppler transrectal ultrasound and staging biopsy (in addition to the initial extended blind biopsy that usually was already performed by the patient’s physician). Some centers advocate more invasive saturation biopsy to confirm the known tumor site but more importantly to reconfirm the absence of any additional tumor in the other lobe. If an unexpected clinically significant cancer is found in the other lobe by repeated biopsy, the patient is excluded as a candidate for focal therapy. In general, low-risk prostate cancers are preferred but moderate to high-risk cancers in men with medical co-morbidities can also be considered. Only unilaterality, not pre-operative PSA level or tumor differentiation (Gleason grade), are the defining issue. Men with extracapsular extension or seminal vesicle invasion can also have focal therapy.

Focal cryotherapy can also be offered as a salvage therapy (failure after any type of organ preserving treatment, such as radiation, cryotherapy, HIFU, and photodynamic therapy) as long as the recurrent disease is unilateral in location.

METHODS:The cryoablation procedure uses extremely cold temperature (ice) to ablate the tissue. The third generation technology uses argon gas for cooling and helium for warming. It consists of two freeze and thaw cycles after the placement of a urethral warming device. Under general anesthesia or spinal block, cryoprobes are placed percutaneously under ultrasound guidance at strategic locations to be frozen. If seminal vesicle invasion is present, it would also be frozen by placing one of the probes in the lumen of the seminal vesicle. Usually 2-4 cryoprobes are used, depending on the size of the lesion and the size of the prostate. (See Figure 1) A single probe may be placed in the contralateral lobe close to the urethra and external sphincter in case heating is necessary to protect these organs (simultaneous heating and cooling). This can be a useful technique if the prostate gland volume is small. This combination of aggressive freezing at targeted locations within the prostate while maintaining the integrity of the urethra, external sphincter, and contralateral lobe, including the neurovascular bundle, is the premise of focal cryoablation.

Cryotherapy is an outpatient based procedure performed as same day surgery. However, if the patient visits from long distance he will have overnight observation in the hospital and discharged following day with a Foley catheter in place. The catheter is usually removed in 3-5 days. (See Figure 1)

As a follow up PSA levels should be checked once every three months for one year and every six months thereafter. Biopsy is encouraged at one year, two years, five years, and anytime there is a PSA elevating trend.

Dr Bahn has been targeting PC with color Doppler ultrasound for almost 2 decades.


RESULTS:Based on multiple publications in the literature (See Table 1.), the overall oncologic outcome of focal cryoablation therapy is encouraging. We recently published focal cryotherapy data for clinically unilateral, low-intermediate risk prostate cancer in 73 men with a median follow up of 3.7 years (1-8.5 years). Complete follow up was available in 70 patients. No patient died or developed metastasis. Pre-cryotherapy PSA was 5.9 ng/ml and Gleason score was 6 (n=30) and 7 (n=43). More patients had Gleason 7 (Intermediate risk) than Gleason 6 (Low risk) cancers. Post-cryotherapy mean PSA was 1.6 ng/ml (70% reduction). Of 48 patients undergoing post-cryotherapy biopsy, 36 (75%) had negative biopsies and 12 had positive biopsy for cancer. Reviewing the 12 cases with positive biopsies, 11 cancers were seen in untreated lobe and one in the treated lobe. Complete urinary continence and potency sufficient for intercourse were documented in 100% and 86% of patients, respectively. Matched-pair comparison of focal cryotherapy and robot assisted laparoscopic prostatectomy revealed similar oncologic outcome, defined as needing salvage treatment.

DISCUSSION:Appropriate patient selection and standardized follow-up protocols remain controversial issues in focal therapy for

prostate cancer. In our opinion, image visibility of prostate cancer is extremely important for proper patient selection, precise cancer mapping that allows accurate therapeutic targeting. We believe the encouraging oncologic outcomes (cancer responses) of our study were a result of accurate TRUS-based sextant and color Doppler targeted biopsy and mapping.

Follow-up biopsies in the treated side confirmed no evidence of cancer in 98% (47 of 48). Ohori et al reported that the index (primary) lesion typically accounts for 80% of the tumor bulk, with the remaining 20% comprising smaller secondary lesions. Removing or destroying the index tumor might eliminate the possibility of distant metastasis in the future and overall tumor burden by 90%.

Similarly, Villers et al. reported that 80% incidental cancers were <0.5 ml. In our series, the follow-up systemic biopsies from the untreated, contralateral, previously negative lobe revealed newly diagnosed cancers in 11 patients: most were small volume Gleason 6, but two were Gleason 7 = 3+4 and one was Gleason 7 = 4+3. However, 8 of 11 patients elected to undergo active surveillance for these newly diagnosed relatively low risk cancers. Consequently, only 4 (5.7%) of 70 patients

FIGURE 1 -


TABLE 1 - FOCAL CRYO PUBLICATIONS

underwent salvage treatment. Three patients chose focal cryotherapy and one had radiation therapy. In matched-pair radical prostatectomy series, 6 patients (8.8%) underwent salvage therapy.

Given the potential for cancer mutifocality (more than 1 tumor) and/or bilaterality (both sides of prostate), as well as potential under-diagnosis at the entry biopsy, follow-up biopsies for the untreated lobe are mandatory.

Following focal cryoablation, current PSA criteria have a limited role in predicting local recurrence in the treated lobe or progression in the untreated lobe. It is noteworthy that in our series, even patients with biopsy-proven recurrence had well controlled PSA levels (range: 0 – 1.5ng/ml). In other words, our mandatory post-cryotherapy biopsies revealed cancer before a significant PSA rise. Interestingly, percent decrease of PSA from pre to post-cryotherapy was 70%. Since untreated tissue remained in the contralateral lobe, this 70% PSA decrease after hemi-ablation seems a reasonable benchmark to indicate successful ablation of the index lesion, based on prior data that the index cancer accounts for 80% of entire cancer volume in a given patients.

A major limitation of our study includes the fact that 22 patients (33%) refused follow-up biopsy, mainly due to their negligible post-treatment PSA level (<1 ng/ml).

CONCLUSION:Imaging visibility on scanning is necessary to achieve precise cancer mapping. Focal cryotherapy represents a modification of the whole gland approach and appears to offer acceptable oncologic effectiveness with reduced treatment related adverse events. The risk of incomplete eradication of cancer is likely to be small in appropriately selected men. It is precisely those types of patients who are presently confounded by the choice between active surveillance and a more complex whole-gland treatment. There are other competing technologies that can be applied to focal or subtotal therapy. Some of them are not ready for clinical use, but are intriguing. The most important component in any focal therapy is the precise imaging. Without clear identification of the tumor, its location and stage of the disease, focal therapy can be a blind approach with potential for suboptimal outcome.

Other Competing Focal Ablation Technologies

HIGH INTENSITY FOCUSED ULTRASOUND (HIFU)In HIFU, ultrasound beam is focused at a small fixed point to create high power that produces heat ranging from 80 to 100 degrees C. It is proven to be lethal temperatures that will create tissue ablation. It has been applied towards organ-confined, localized prostate cancer treatment as a primary treatment or as salvage therapy (after failed any organ preserving therapy, such as radiation, cryoablation, etc). Recently the help of MRI

Author Onik Bahn Lambert Ellis *Ward

n=No of Patients (n=48) (n=73) (n=25) (n=60) (n=1160)

Average age n/a 64 68 69 68

Average Follow up Years 4.5 3.7 2.3 1.3 1.8

Gleason: No. of patients (%) n/a 6: 30 (41)

7: 43 (59)6: 13 (52)7: 12 (48)

<7: 47 (78) 7: 12 (20)

>7:1 (2)

<7: 844 (74) 7: 240 (21)

>7: 64 (6)

Clinical Stage: No. of patients (%) n/a

T1c: 41 (56)T2a: 31 (43)

T2b: 1 (1)T1c: 25 (100) T2a: 55 (92)

T2b: 5 (8)T2a: 1013 (87)T2b: 147 (13)

Stable PSA (%) 94 85 85 80.4 75

Incontinence (%) 0 0 0 3.6 1.6

Potency Maintained (%) 90 86 71 71 58

*Data from COLD registry


scan is applied to enhance the targeting the cancer in addition to the ultrasound imaging. It is a quite popular procedure in Europe and Asia. This technology just received the FDA clearance, although patients should still ask about insurance coverage and costs.

HIFU is performed as an outpatient procedure, usually under spinal anesthesia. Real-time ultrasound imaging guidance and/or magnetic resonance guidance is used to position the probe and to monitor the procedure. Pulses of HIFU are directed at the targeted section of the prostate, inducing tumor necrosis.

A few published outcome data show fairly good cancer control and acceptable rates of complications. The study populations in the studies are all small and all had short follow up. One study reported the treatment failure (defined as any positive biopsy and/or need for salvage therapy prompted by rising PSA levels) was observed in 42%. Other studies reported the rates of positive biopsy at 12 months were in the range of 8-23%. The sexual and urinary dysfunction rates are fairly low (< 10%).

FOCAL BRACHYTHERAPY: LOW-DOSE RATE (LDR) AND HIGH-DOSE RATE (HDR)LDR brachytherapy is typically used to treat the entire prostate by implanting permanent radioactive seeds that allow the delivery of high dose radiation to the prostate while limiting the collateral damages. The use of whole-gland brachytherapy for localized prostate cancer has been well established. Focal LDR brachytherapy is to target the cancerous area only in the prostate while sparing the rest of the prostate tissue. It will further reduce the radiation toxicity related complication. It usually performed under transrectal ultrasound guide.

HDR brachytherapy (temporary placement of radioactive material in the prostate) can be also used as a focal therapy modality. There is only limited information in the literature related to the clinical outcome of focal brachytherapy, either as LDR or HDR.

FOCAL LASER ABLATIONLaser-induced thermal ablation therapy is a percutaneous tumor-ablation technique that utilizes high-power lasers placed interstitially in the tumor to deliver therapy. Multiple laser fibers can be placed into the cancerous mass to rapidly heat the area. Modern system utilizes small, compact, high-powered laser diode systems with actively cooled applicators to help keep tissue from charring during procedures. Usually, three-dimensional ultrasound is used to guide a laser to the target area which has been confirmed as a cancerous tissue by ultrasound or MR/ultrasound fusion images. The reported outcome studies in the literature are scanty. One report of 12 patient experiences showed 67% cancer free rate at 6 months biopsy.

PHOTODYNAMIC THERAPY (PDT) OR VASCULAR-TARGETED PHOTODYNAMIC THERAPY (VPD)This technique describes the destruction of a target tissue via the administration of an inactive, light sensitive agent (photosensitizer) and the local application of light in the presence of oxygen. The photosensitizer absorbs a laser light and transfers this energy to the tissues, creating cell destruction. One recently developed photosensitizer has a tendency of staying within the tumor vascular network. Due to this reason, when PDT is applied, extensive vascular damage is created that leads to tissue necrosis. It is referred to “Vascular-Targeted PDT.” One small study of 13 patients who had salvage VPD reported 8/13 biopsies negative at

6 months. Two patients experienced urethro-rectal fistulae. This therapy is not approved for prostate cancer in the US, but there are a few clinical trial sites.

NANOKNIFENanoKnife technology is known as an Irreversible Electroporation. Instead of using extreme heat or cold, the NanoKnife system uses electrical currents to treat the tumors. The device known as the NanoKnife passes an electrical current through the tumor. The expected electric injury is a creation of permanent nano-meter sized very small holes (pores) in the tumor cells, leading to the death of the cells. Ultrasound or other imaging techniques such as CT or MRI is used to focus the electric current precisely on the tumor. One study in the literature reported about 75% disease free survival at 10 years.

SUGGESTED READING1. Bahn DK, et al: Focal prostate cryoablation: Initial results show cancer

control and potency preservation. J of Endourology. Vol 20, No 9, p688-692, Sept. 2006

2. Onik G, et al: “Male lumpectomy”:focal therapy for prostate cancer using cryoablation. Urology. 2007 Dec;70 (suppl):16-21

3. Jones JS. Et al: Focal or subtotal therapy for early stage prostate cancer. Current treatment options in oncology. Springer, Boston. Vol 8, No 3, June 2007

4. Gillett MD et al: Tissue ablation technologies for localized prostate cancer. Mayo Clin Proc Dec 2004;79(12):1546-1555

5. Polascik TJ et al: Focal therapy for prostate cancer. Current opinion in urology 2008, 18:269-274

6. Lambert EH et al: Focal cryosurgery: Encouraging health outcomes for unifocal prostate cancer. Urology. 69(6), 1117-1120

7. Bahn DK et al: Focal cryoablation of prostate: A review. The ScientificWorld Journal (2008) 8, 486-491

8. Nguyen H, Bryan BS et al: Focal cryotherapy in the treatment of localized prostate cancer. Cancer Control 2013, Vol 20, No 3

9. Bahn DK, de Castro Abreu A, et. al: Focal cryotherapy for clinically unilateral, low-intermediate risk prostate cancer in 73 men with a median follow-up of 3.7 years. European Journal of Urology 2012:62 (1):55-63

10. Babaian RJ, Donnelly B, Bahn DK, et al.: Best practice statement on cryosurgery for the treatment of localized prostate cancer. J Urol. 2008;180(5):1993-2004

11. De Castro Abreu A, Bahn DK, et al: Salvage focal and salvage total cryoablation for locally recurrent prostate cancer after primary radiation therapy. BJUI 2013:112, 298-307

12. Tong W, G Cohen, et al: Focal low-dose rate brachytherapy for the treatment of prostate cancer. Dovepress, April 2013

“Although HIFU recently received FDA

clearance, patients should still ask about

insurance coverage

and costs.”


WHAT THE HECK HAS BEEN GOING ON IN MY WORLD - PART 72!Mark A. Moyad, MD, MPH • (University of Michigan and all around nice guy-

just ask the people he pays off to say that on a regular basis)

Note: A total of 72 times in a row (and for 17+ years!) I have written and volunteered and worked my GLUTEUS to the MAXIMUS for this newsletter. I have yet to receive any financial compensation or personalized timeless gifts such as a PAACT I-phone that would remind me to turn in my article every 3-months, because I always forget and then the members of PAACT yell and scream at me, throw things at my house and spray paint my car with the words “truancy” and send me countless emails (okay all of that was a lie except the part about the countless emails).

I WANT TO THANK YOU AGAIN FOR CONTINUING TO MAKE “THE SUPPLEMENT HANDBOOK” –my semi-new book a best seller. YEAH!! THANK YOU!!! Second, if you have not picked up a copy please get one on Amazon.com (the very cheapest place to procure a copy) to support my “Michigan Football Clothing Fund.” Every 3 months I need to buy one new item of Michigan clothing and unless you purchase my book I might have to actually wear a shirt, hat or pants that does NOT carry the M GO BLUE LOGO and that would be an outright terrible, awful tragedy.

330) You do NOT need to exercise to lose weight/waist but you do need to cut back on calories!(Reference: Pontzer H, et al. Constrained total energy expenditure and metabolic adaptation to physical activity in adult humans. Current Biology 2016;26:1-8).

BOTTOM LINE“Americans trying to lose weight won’t get the results they desire by slogging through extra miles on the treadmill - they’ll need to cut calories to do it.” Ouch! This comment by one of the researchers from a new study is AWESOME! Researchers found that above a moderate exercise activity level the total energy expended plateaued, and they found that the percentage of body fat was related to the amount of energy expended (aka as you lose weight the body tries to hold on tight to the rest of the weight you have) and they found that the greater the intensity of the exercise the lower the amount of total energy expended (aka just because you move a lot more does not mean your body will lose a lot more weight because after a while it fights to hang on to the weight you have left). Now that I have depressed myself and so many others reading this please enjoy the rest of the article while eating a small (not large) hamburger.

WHAT ELSE DO I NEED TO KNOW?Exercise appears to attract most of the attention as the best way to lose weight/waist! FALSE! FALSE! FALSE! Also known as FALSE TO THE THIRD POWER! Many people gain weight with exercise or hit a threshold, so cutting calories is

arguably the best way to lose waist or weight as you age (aka “get older” or “become more seasoned” or “getting closer to having the big person behind the deli counter finally call your number,” etc.).

After following 332 adults in 5 countries including suburbanites in the U.S., urban residents in Jamaica, an agrarian group in Ghana, a township of South Africa and island residents of Seychelles off the coast of East Africa. Although, I have to admit I didn’t know where that last country was located, probably because I was too busy trying to get the attention of this girl in high-school geography, who in the end went to prom with someone else, so in reality I’m the victim of being geographically challenged because of a high school classmate. This is also the primary reason I never could become a full time cartographer. However, I do watch the weather channel and love a good rental car map!

Anyway, I digress so these researchers found that “total energy expenditure increases with physical activity at low activity levels but plateaus at higher activity levels.” So, there appears to be a limit to how many calories you actually burn by being more physically active! What?! Wow! So the over 27 Billion spent on gym memberships PER YEAR in the U.S. is a waste (that is B with a Billion - man I am in the wrong occupation)? No, but I do think that many folks including a plethora (love that word) of doctors think exercise is the key to losing weight. What someone eats and drinks and in what quantity is arguably as important if not more important than exercise, and simply being active beyond a certain limit does not make much of a difference. Why I ask? Good question Moyad.

These are theories but one thought is that human bodies of very active people may simply be more efficient and utilize less energy to keep things moving or operating. For example, when we exercise, over time the heart muscle gets so much stronger that it can pump just as much blood throughout the body at rest when the heart rate is low compared to when it was higher under the same circumstances (at rest for example). So, the heart becomes more efficient with exercise. Still, whatever the reason it has been known for a long time that the body can easily adjust how much energy it utilizes to keep the body itself functioning. For example, in very extreme situations like starvation (kind of like when I am trying to make deadline for this newsletter and I never get time to eat - thanks PAACT), low calorie diets or exhaustive exercise routines… metabolism can slow down dramatically to potentially conserve energy. It is also well known that as


a person exercises more, they consume more calories and in many cases more than they were consuming before they started exercising. I like to use myself as an example because I am somewhat of an egomaniac/narcissistic person and the last time I ran a marathon a few years ago I gained weight! I was eating everything in sight during my training. I could not get enough food in me and I was starving all the time.

So, perhaps the message about exercise has been wrong all along. Instead of looking at exercise as a key to weight loss it should probably be perceived as the greatest overall drug ever invented (next to Del Taco’s 59 cent baby bean burrito with green sauce), but not for weight/waist loss.

Now let me show you word-for-word below the final highlights of the study from the authors:“1. We measured total energy expenditure and physical activity

in a large adult sample.2. Above moderate activity levels, total energy expenditure

plateaued.3. Body fat percentage was positively related to total energy

expenditure.4. Activity intensity was inversely related to total energy

expenditure.”

I love one of the conclusions of this great research, which states that this study “COMPLEMENTS OTHER RESEARCH SHOWING THAT DIET MAY BE MORE IMPORTANT THAN EXERCISE WHEN IT COMES TO LOSING AND MAINTAINING WEIGHT.” OMG! OMG! This is amazing! SO THE BOTTOM LINE FROM THE ONGOING MESSAGE is that if you really want to lose weight then CONSUME LESS CALORIES. In other words, eat less and maybe move more or NOT!

331) Countless Antioxidant dietary supplements to boost exercise? No thanks!(Reference: Merry TL, Ristow M. Do antioxidant supplements interfere with skeletal muscle adaptation to exercise training? J Physiol 2016 released early on-line)

BOTTOM LINE “The evidence presented in this review suggests that antioxidants have the potential to suppress some exercise training adaptations and provides little evidence to suggest any positive effects, therefore we tend to reject the use of such supplements during training.” (Dr. Troy Merry - University of Auckland Co-author of this manuscript). This is a SAD statement from a person with the last name “Merry” (how ironic) but in reality it is very compelling, honest and probably accurate for many (not all) supplements to enhance the effects of exercise.

WHAT ELSE DO I NEED TO KNOW?Several years ago a research group from Europe and the U.S. published a controversial paper that suggested antioxidant supplements blunt or reduce the benefits of exercise! One of those researchers has continued to garner more data and stands by this theory and for the most part I agree with this person!

This new review article is interesting and focuses on studies that focused on oxidative stress but obviously they could not cover every supplement theorized to help exercise such as flavonoids or resveratrol or beet root juice…. These authors found that using supplements such as vitamin C and E could actually reduce the normal skeletal muscle adaptation mechanisms. In other words, muscle may be highly dependent on intrinsic oxidative stress signals to cause it to adapt and improve, and supplements could reduce that stress and the signals that normally go to muscle tissue to tell your body that you are actually working out.

These authors do admit that the jury is still out and still needs many answers but in the meantime since these studies have found that the benefit does not clearly outweigh the risk at this time they are not recommending supplements for exercise enhancement.

So, what to do in the meantime? I have said it many times before but let me tell you what I tell elite (like me) and not so elite athletes (like my brothers) about what is really needed for a good exercise routine. First, caffeine is crucial and a few sips of coffee before, during and/or after a workout could improve performance and reduce muscle fatigue. Also, the body needs fluids, especially water and electrolytes such as sodium, potassium or magnesium… that you can get from a sports drink or better yet food like a Roma tomato and/or protein powder. Finally, if there’s terrible pain during a major once in a blue moon workout don’t suffer in non-silence, taking an Aleve or ibuprofen once in a while after a major workout can keep you pain free the next day. I probably pop one every month or every few months. I could go on here but in the meantime when you work out the body needs to experience some stress so it can learn how to better deal with it in the future. If you take too many supplements it can desensitize the natural mechanisms already in your body to help it help you! Man that was profound! Let me take a second to appreciate how profound that last statement was….okay I’m over it and let’s move on!

332) Coffee wins again and this time in the famous PSA screening study! MAN, this PSA screening study is beginning to tell us a lot of good stuff about lifestyle changes to improve your everyday life!(Reference:Loftfield E, et al. Association of coffee consumption with overall and cause-specific mortality in a large US prospective cohort study. Am J Epidemiol 2015;182:1010-1022)

BOTTOM LINECoffee could reduce the risk of dying from all-causes from the PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) trial. This U.S. PSA screening trial also found a benefit with coffee intake and many chronic diseases. Could coffee be the new fountain of youth? I don’t know but this recent study is GROUNDS (get it!) for a new look at this issue!

WHAT ELSE DO I NEED TO KNOW?Okay, I realize I covered this subject in the last PAACT issue and I like to be redundant and I like to be redundant. More prospective observational screening studies are needed to continue to examine the association between coffee intake and


the risk of all-cause mortality and here comes a new and great study.Remember the PLCO (kind of like “remember the Alamo” but with prostates, etc.)?! Yes, the U.S. PSA screening study that served as one of the primary reasons that the U.S. Preventive Services Task Force (USPSTF) does not recommend PSA screening. What is always interesting in a large study, controversial or not, and regardless of what side one takes is that there is always a story behind the headlines that gets completely missed and here’s another headline story that received no headlines! Again, the PLCO was also an outstanding observational prospective study of lifestyle changes - an amazing study. This study also found that men have significantly less nocturia (get up less at night) if they exercise regularly and also a reduced risk of colorectal cancer from dietary fiber and now this!

Participants were identified from 90,317 baseline cancer-free individuals of the PLCO and 8718 deaths occurred during the observation period (1998-2009). Coffee intake was based on a self-reported baseline dietary questionnaire. A significant (p<0.0001) reduction in all-cause mortality (DEATH FROM ALL CAUSES) occurred for coffee drinkers versus non-drinkers. Caffeinated and decaffeinated coffee showed similar benefits with 2-3 cups a day demonstrating similar benefits to higher intakes. Benefits were also noted or inverse for mortality from heart disease, chronic respiratory diseases, diabetes, pneumonia and influenza, and intentional self-harm, but not cancer. Yet, we know many other studies suggest an anti-cancer impact. Coffee intake could reduce mortality by reducing inflammation, improving lung function, insulin sensitivity and reducing depression.

Now, is it the coffee drinker that has other healthy behaviors and genetics that really provides the advantage or does coffee itself provide the advantage? WHO CARES!!! Coffee is awesome and whether it is the coffee or the person drinking the coffee it has become clear that coffee appears in moderation (even just 1-2 cups a day) to provide some health benefits that we are only now beginning to appreciate!

333) Vitamin D supplements in higher dosages could increase your risk of falls?!!! What?? I thought more was better! (Reference: Bischoff-Ferrari HA, et al. Monthly high-dose vitamin D treatment for the prevention of functional decline. JAMA Intern Med 2016; released early on-line)

BOTTOM LINEVitamin D in high doses could increase the risk of falls. General population screening for 25-OH vitamin D blood levels or the vitamin D blood test is not supported at this time.

What else do I need to know?Vitamin D deficiency has been associated with many unhealthy conditions including poor physical performance. So, researchers decided to conduct a major study to determine the impact of high-dose monthly vitamin D on

functional decline. Participants (200 of them, 33% men and 67% women) were 70 years and older with a previous fall. Average age was 78 years and 58% were vitamin D deficient (<20 ng/ml) at baseline. Three study doses were used in this 1-year, double-blind, randomized clinical trial: low-dose control receiving 24,000 IU of vitamin D monthly (800 IU/day), 60,000 IU monthly dose (2000 IU/day), and 24,000 IU plus 300 ug calcifediol (type of vitamin D) group.

After 1-year there were no differences in functional decline between groups. The incidence of falls differed significantly among groups with higher incidences in the 60,000 IU group and 24,000 IU plus calcifediol versus 24,000 IU (66% versus 48%; p=0.05). Seniors reaching the highest quartile of vitamin D blood levels (44.7-98.9 ng/ml) at 12-month follow-up had a 5.5 fold significantly higher chance of falling compared to the lowest quartile (21.3-30.3 ng/ml of 25-OH vitamin D (p<0.001). Monthly doses of vitamin D effectively raise the blood level of vitamin D, but it had no effect on lower extremity function and was correlated with an increased risk of falls at the higher dosage. OUCH!!!

Less is more! Until someone is able to prove that consuming more vitamin D is CLEARLY better for you we need to remain conservative (I don’t mean Ted Cruz conservative or Bernie Sanders conservative but Moyad and medically conservative…PS for anyone that likes Cruz or Sanders I was just making a point and not a political statement, in fact I will be voting for Coach Jim Harbaugh for President, so what the heck do I know. Again if you want to yell at me or hurt me in any fashion I now live in Grand Rapids, Michigan and my name is Richard Profit).

The problem with vitamin D blood testing is that it has yet to demonstrate universal value or benefits for screening. And, 25-OH vitamin D (what is measured with the blood test) could just be a negative acute phase reactant. So, it’s possible that it’s not the vitamin D that’s making patients healthier, but healthy patients tend to have higher vitamin D levels compared to non-healthy patients. And, since vitamin D is arguably a hormone (not a vitamin) then why do some want to believe that high dosages are better for you. The history of hormone use in medicine is more is NOT better and greater dosages come with a major catch. So, let’s be careful with this one and wait for more clinical trials because we don’t need another selenium or vitamin E in urology!

Think of a healthy body like a beautiful lawn that you fertilize on a regular basis (Oh man this is getting weird - I wonder where Moyad is going with this one). If you give no fertilizer it has a tough time looking and operating normally, but if you give too much fertilizer it can kill or injure the lawn, so it needs not too much or not too little because both situations have consequences. WOW!! THAT WAS PROFOUND AND VERY CUTTING (get it!) EDGE!

334) BREAKING NEWS!!! FDA grants Olaparib (also known as “Lynparza” from the company AstraZeneca)


breakthrough designation status in men with mCRPC or metastatic Castrate Resistant Prostate Cancer.” Doesn’t mean FDA approved for prostate cancer but does mean accelerated review of this drug and it probably means that for men running out of options there may soon be a new option to talk about with your doc.(Reference:FDA 2016 and Mateo J, et al. DNA-repair defects and olaparib in metastatic prostate cancer. N Engl J Med 2015;373:1697-1708)

BOTTOM LINEOlaparib is the world’s first drug specifically approved for the treatment of patients with BRCA mutations (mutations that increase the risk of breast and/or ovarian cancer) so for example it is already being given to some ovarian cancer patients. A preliminary study suggested it could also help some men with advanced prostate cancer with this genetic mutation that have tried just about everything, which is why the FDA gave it a status that it will give it more attention. Of course as long as the research continues to be promising. What this does is open up the discussion of genetic testing for your tumor (now that’s a large can of worms that we’ll cover in more detail at a later time, but touch upon it briefly now).

WHAT ELSE DO I NEED TO KNOW?LET’S GO BACK IN TIME A LITTLE (I would like to go back to 5th grade where I told the teacher I had a crush on her and she punished me for saying it…what the hell was I thinking - you’re not supposed to tell a teacher that even if you are thinking that right? Well, I was honest and look what it got me!). Now, let’s go back to around December 19, 2014 when the U.S. FDA approved an ORAL DRUG CALLED “Lynparza” (also known as “olaparib”) for women with ADVANCED OVARIAN cancer caused by a mutated BRCA gene, and who have already had other treatments. It became the first drug of its kind to be approved because it’s also known as a “PARP inhibitor,” - it essentially specifically targets or has efficacy in tumors that have this gene mutation. PARP inhibitors also work by blocking the action of an enzyme that helps repair DNA. So, in certain women with ovarian cancer that have this mutation it could cause some cancer cell death. The FDA approved this drug because of a small trial of 137 women where all of the women received Lynparza and more than a third or 34% had a partial or complete reduction (objective response rate) of their tumor for an average of almost 8 months. This FDA approval was a bit of a surprise because earlier in this same year an FDA advisory committee voted against the accelerated approval of this drug. However, the committee was looking at a different situation on how to prevent the recurrence of ovarian cancer. So, the FDA received more data on women with BRCA mutation and those that received 3 or more chemotherapy treatments and probably because of its specificity and lack of great treatment options for advanced disease the FDA said “YES”!

NOW WITH THAT AS BACKGROUND LET’S FAST FORWARD TO NOW! What is going on with this drug that most people in the prostate cancer world have never heard of at all! There was a phase II trial called “TOPARP-A” that showed that Lynparza had some effect in most men with BRCA2 mutations or ATM aberrations (specific genetic defects). In other words, in this trial of 50 patients with metastatic CRPC whose disease had progressed after 1 or 2 chemotherapy treatments, were given 400 mg twice daily and 16 of the 49 patients who could be evaluated had a response to treatment. A response was defined as a decrease of at least 30% in tumor size, a reduction of at least 50% in PSA or a reduction in the circulating tumor cell count from 5 or more cells per 7.5 ml of blood to less than 5. A total of 12 patients showed a response to olaparib/Lynparza for more than 6 months. Genetic analysis from tumor biopsies showed that 16 of 49 patients had mutations in DNA repair genes including BRCA1/2. And, of these 16 patients, 14 or 88% SHOWED A RESPONSE TO OLAPARIB. This included all 7 patients with BRCA2 mutation and 4 out of 5 patients with ATM (ataxia telangiectasia mutated) changes. Men with these mutations could account for 25-30% of all sporadic CRPC cancers. So, if men have a genetic test of their tumor and they have these mutations it’s possible they could benefit!!!

So, what’s the catch? The drug is not FDA approved at this moment, but it may still be accessible because it was already FDA approved for ovarian cancer treatment. There are men getting genetically tested and some are BRCA2 positive so stay tuned and talk to your doctor about this and soon we’ll see if this is a winner! There are a number of genetic testing tumor companies out there and they’re not cheap so do your homework before submitting anything. One company, for example, is FoundationOne in Cambridge, MA (www.foundationone.com), but there are many, many others. I don’t work with any of these companies, in other words, I have never benefitted financially from any of these companies but I do follow them and call them often because I have no life and because I want to be a part of any breaking news so I can pass it on to you. Cost could be a catch (always check on insurance and out of pocket pricing) and these companies can find genetic defects, but it doesn’t guarantee that even if you have a mutation there’s a drug that can benefit you or will halt the growth of prostate cancer. So, are there any other catches with this drug right now? YES! Anemia and fatigue (and many others too long to name otherwise I would sound like one of those pharmaceutical commercials that list everything that could go wrong with a drug because of the legal quagmire we are immersed in today, etc.) were some of the more common side effects. This drug is not the easiest to take, but at least there’s preliminary research/data for the folks that potentially qualify so it’s getting very interesting!

335) Aspirin continues to gain attention as a way to potentially reduce the risk of prostate cancer returning or progressing, but don’t take it unless you QUALIFY for it. I will give you a web site to help in the discussion with your doctor.(Reference: www.cvriskcalculator.com and Moyad The Supplement Handbook and Allard CB, et al.J Clin Oncol 2016;34:suppl 2S; abstract 306 and Osborn VW, et al. Tumori 2015; released early on-line)

For more information on Lynparza (olaparib) see pages 3-5


BOTTOM LINEGo to www.cvriskcalculator.com and it will help you decide if you are a candidate for taking a baby aspirin (or even a statin) based on your cardiovascular risk. Then take your printed results to the doctor that you trust with your health and have a discussion.

WHAT ELSE DO I NEED TO KNOW?Here is a web site for you: www.cvriskcalculator.com. It is one of the best ever invented in my lifetime (now that is a dramatic statement but it’s true). It can calculate your 10-year risk of heart disease or stroke. KEEP IN MIND THAT THIS CALCULATOR ASSUMES YOU HAVE NEVER HAD A PREVIOUS HEART ATTACK OR STROKE.

Aspirin and/or statins for example are hot when it comes to prostate cancer. There continues to be ongoing evidence that it can have a role potentially in reducing the risk of certain cancers and perhaps even prostate cancer returning. However, aspirin or statins can come with serious side effects and you should never take them if otherwise healthy unless the BENEFIT OUTWEIGHS THE RISK! One way to figure out if the benefit outweighs the risk is to go to: www.cvriskcalculator.com.

And, here is the only information that you need to provide:• AGE?• GENDER?• RACE?• TOTAL CHOLESTEROL?• HDL CHOLESTEROL?• SYSTOLIC CHOLESTEROL?• DIASTOLIC BLOOD PRESSURE?• ARE YOU BEING TREATED FOR HIGH BLOOD PRESSURE?• DO YOU HAVE DIABETES?• ARE YOU A SMOKER?

This is the only information you need to share with your doctor to figure out if the benefits of taking aspirin for example outweigh the negatives (increased risk of ulcers and internal bleeding, etc.). For example, when I type in all my answers to their questions it says the following “2% 10-year risk of heart disease or stroke” and it also tells me “On the basis of your age and risk for heart disease or stroke, the USPSTF guidelines suggest you would not benefit from starting aspirin.” And, it also says I would not qualify for taking a statin but this is for me and not necessarily you. As your numbers and age increases, then the percentage risk of heart disease and stroke increases and the chances you might need aspirin, for example, increases. HOW AWESOME IS THIS CALCULATOR BASED ON THE LATEST CLINICAL RESEARCH!!!???? THIS IS RHETORICAL…OF COURSE IT IS AWESOME….Kind of like the LATEST STAR WARS movie. If you haven’t seen it you must because it’s amazing!

Anyhew….is that a word? Aspirin continues to look interesting every week in the cancer world. For example, a recent study from New York found a potentially significant reduction in the risk in prostate cancer returning after treatment and a

reduced risk of metastatic prostate cancer in African American men. It gets even more interesting with recent research. In 2016 at the ASCO GU meeting arguably the study that received the most media attention was a large observational study that found men who take aspirin on a regular basis have a lower risk of dying from prostate cancer! WHAT!!!??? This is one of the first studies to look at aspirin and the risk of lethal cancer. The researchers looked at data of 22,071 men in the Physicians’ Health Study (a HAAAAARVARD based study---notice how I said “Harvard”) and after 27 years of follow-up a total of 3193 men were diagnosed with prostate cancer and 403 of these men developed lethal prostate cancer (metastatic disease or death from prostate cancer). Researchers then adjusted the data for differences in age, race, BMI, and smoking status and men without prostate cancer that took more than 3 aspirin tablets per week had a 24% lower risk of developing lethal prostate cancer. And, among men with prostate cancer, regular aspirin use after diagnosis was actually associated with a 39% lower risk of dying from prostate cancer, but use of aspirin before being diagnosed with prostate cancer didn’t appear to have much of a benefit. So, the researchers think that aspirin could prevent the progression of prostate cancer to metastases, so it may help to prevent prostate cancer from spreading to the bones. The reason this is a potentially very accurate and powerful study from the HAARVARD girls and boys is because the Physicians Health Study (PHS) started in 1982 to determine the benefits and risks of aspirin and beta-carotene supplements in the primary prevention of cardiovascular and cancer. And, 30 YEARS (yes 30 years) and over 400 published research articles later the study is still going on! The original randomized trial ended in 1995 but researchers continue to follow the study subjects with annual questionnaires. Oh and by the way the men in the trial took buffered aspirin every other day (325 mg of Bufferin every other day actually), which showed a reduction in the risk of a first heart attack, but an increased risk of ulcers and the need for a transfusion which again is another reason you need to spend time analyzing the benefits versus the risks! Oh and by the way - beta carotene supplements did NADA (nothing!).

336) Alkaline versus Acidic diets etc. Is it true that acidic things encourage cancer growth and alkaline things in the diet for example kill cancer? (Cancer myth #4345).(Reference: Moyad past books and articles and 30 years of experience)

BOTTOM LINEThe body likes to remain in a very tight pH range and different body compartments are slightly more acidic or basic and do not like to change their pH. In other words, the goal is not to mess with the pH of the body unless absolutely necessary because it can mess with you. Read on please.

WHAT ELSE DO I NEED TO KNOW?I believe, like my friend Snuffy Myers, MD (I will make this the last time I address this issue in detail, but let’s just put this to bed so you can understand the full argument), why it makes no sense to drastically change your pH through diet to fight cancer, but does make plenty of cents for some people that make money off of cancer patients that want so dearly to believe this sales pitch.


Alkaline water or the purchase of an alkaline water system can be very, very, very costly (100s to 1000s of dollars over the short- and long-term) and it is generally safe and arguably as healthy as tap water, and if any type of water has any ounce of anti-cancer activity it is tap water more than any other. However, the problem is that one of alkaline waters primary selling points (in my experience) to patients concerned about cancer (diagnosed or not) is the claim, without clinical evidence, that cancer apparently cannot survive in an alkaline environment, but thrives in an acidic environment. I will explain why this cannot make sense, but believing this inaccuracy could cost a patient many cents.

Some parts of the body that are more acidic - do they have a higher risk for cancer? No, and in fact the most acidic part of the body is the normal functioning stomach at an average pH of 2-3 (highly acidic). And, the pH of the small and large intestines are primarily alkaline or become more alkaline along the length of each separate intestinal tract (small and large). If cancer thrives in an acidic environment then the stomach would be the most common site where cancers would survive and thrive, and arguably the largest source of cancer deaths. However, one of the most common cancers in women and men and one of the top causes of cancer deaths in the past and present is colorectal cancer (alkaline or almost neutral pH area), while stomach cancer is a rare cause of overall cancer deaths and in fact is currently at an almost 100-year low in the U.S. in terms of age-adjusted cancer deaths in women and men.

And, with or without cancer the pH of the colon is approximately the same, which is why testing the pH of the colon or any other part of the body directly cannot detect cancer or even establish the stage or prognosis of cancer. How about the esophagus or the tube that allows food and drink to reach your stomach after you swallow? If acid from the stomach escapes upward and chronically touches the esophagus, over time it causes long-term inflammation and changes the cells of the esophagus, which can increase the risk of esophageal cancer, but there are approximately four times as many deaths yearly from colorectal cancer compared to esophageal cancer. However, if I wanted to push the pro-alkaline anti-cancer agenda I would just focus on the small intestine (not the large intestine) where it is alkaline and an uncommon site of cancer and then mention acid striking the esophagus as a cancer risk factor (despite obesity and smoking also being major risk factors as with many other cancers), and not mention the rest of the body (of course), but again this would provide a twisted picture if one was not told about the entire gastrointestinal tract and overall cancer rates and deaths.

So, in reality, just using the entire gastrointestinal tract (esophagus thru colon) as an objective example - cancer can actually start, thrive and can be quite common or not common in an alkaline, neutral, or acidic environment and the gastrointestinal tract is a classic example of this observation (as is the rest of the body). And, whatever the

pH of any part of the mouth to the rectum (basic, neutral or acidic) it is so tightly regulated (like the rest of the internal body) and does not like to change dramatically (more on this later) or else there are serious health consequences. So, why would I want to try and change the pH of any part of the body when it functions optimally at its current pH and cancer grows in acidic or alkaline environments?

What would happen if humans could actually change the pH of a specific area of the body with some kind of dietary supplement or prescription drug? Would this prevent, cause or treat cancer or other diseases? As was mentioned earlier the esophagus does not like to be exposed to a highly acidic environment, but what about medication altering pH medications? There are only a small number of pills that patients utilize regularly that can cause a dramatic alkaline pH change in a specific part of the body. For example, if someone ingests acid reflux medications (proton pump inhibitors or PPIs) chronically then it removes the ability of the stomach to produce acid, then what happens when it becomes more alkaline or even less acidic? Long-term use of these drugs increases the risk of nutrient deficiencies, serious and in some cases life-threatening intestinal infections, pneumonia, bone loss and fractures, and there is some preliminary new evidence that suggests they could increase the risk of cardiovascular disease. Thus, the human body does not like to have any of its normal functioning parts change their inherent pH dramatically unless a medical condition requires an immediate need for this to occur. For example, for a serious case of acid reflux or ulcer risk due to a bacterium (H. pylori) treatment is to administer a combination drug regimen to eliminate the bacterium to reduce the risk of ulcer or gastric cancer. Some “experts” tout drinking alkaline water to reduce body acidity in the gastrointestinal tract and even in the blood but obviously trying to dramatically change the pH of the gastrointestinal tract (to a more alkaline state) or any part of the body can increase the risk of numerous problems or other unintended problems. So, even if you can temporarily change the stomach pH to more basic with a highly (not slightly basic but highly basic) alkaline drinking water source, pH 8.8 for example, the potential to denature critical enzymes for health could occur similar to what is observed with high potency acid reflux drugs. Why would one want to do this?

What would happen if humans could change the pH of the blood or cells of the body? The blood is slightly basic between 7.35 and 7.45, and the area right outside of human cells is also slightly basic, while the pH inside the cells is almost neutral to slightly acidic (pH of 6.8-7.0). In all of these areas of the body (head-to-toe) the pH is so tightly regulated that any tiny shift toward more basic or a more acidic environment could result in a life-threatening emergency. If the blood or cells in the body were to increase their pH (more alkaline) or reduce their pH (more acidic) significantly it would be a medical emergency. Severe body acidosis (too much acid) can cause shock and even death, but so can severe alkalosis (too alkaline), and this is why the body again does not like a shift in pH that is too high or low - it likes to be exactly where it was intended in terms of its


tight pH range to maintain life and normal body functions. It is like the thermostat of the body or a house maintaining a temperature balance or narrow range for comfort and if the barometer is not working well and allows the temperature to go too high (fever) or too low (hypothermia) then again it is a life-threatening emergency. So, why would someone want to do anything that risked changing the body pH dramatically - I wouldn’t want to do this!!!!!!! No way!

What happens when a person ingests food or beverages that vary in pH? Can that dramatically change the pH of the body? This is virtually impossible as mentioned before because the body doesn’t like to leave its pH or temperature comfort zone, because this can be a medical emergency. In fact, almost anything that one eats or drinks enters the stomach and becomes normally bathed in an acidic environment, then it’s transferred to the small intestine, where it becomes slightly basic in pH, and eventually is absorbed into the blood. Although water is absorbed in the small and large intestine, the end result is the pH of that ingested water also becomes slightly neutral to basic because it becomes part of the fluid of the cells or the blood. So, why would I drink a fluid that is slightly basic or acidic when it just ends up changing the pH of the internal body little to nothing and it was reviewed earlier what can happen when trying to change the pH dramatically of any body part (such as the stomach with acid reflux drugs). Coffee and caffeine are slightly acidic and are being studied for their anti-cancer and anti-disease effects. Most fruits and especially vegetables including the type that receive arguably the most research for cancer prevention, the cruciferous vegetables (broccoli, Brussels sprouts, cabbage, cauliflower, garden cress…) are basically all acidic. And, this is true of many healthy foods (salmon…) so why aren’t these foods associated with an increase rather than a decrease in cancer?

What about pills to prevent and treat cancer or other diseases?

Aspirin (acetylsalicylic acid) is acidic and appears to have the ability to prevent numerous cancers including colorectal cancer and it’s one of the only true anti-cancer pills ever discovered that could also be heart healthy. Metformin hydrochloride (HCL) is being studied to prevent breast, prostate and many others cancers and it prevents type 2 diabetes, and diabetes itself increases the risk of cancer, but the drug metformin HCL is slightly acidic. Many of the most effective drugs are neutral or slightly acidic or basic (nothing dramatic). And, what about vitamin C supplements, which are arguably one of the most acidic dietary supplements ever invented - hence its other name “ascorbic acid.” In fact, when health care professionals have difficulty with a less acidic stomach and need to create a temporary acidic environment to increase the digestion and absorption of another supplement or drug (like ketoconazole, etc.) then vitamin C is added to that pill regimen. For example, vitamin C is recommended with iron supplements or present in most prenatal vitamins to increase the absorption of iron. And, what about vitamin C and cancer? Obviously it has not been linked to an increased risk of cancer, but to no change in cancer risk or a potential

reduction in cancer risk. So, some of the most popular supplements and/or effective drugs are slightly acidic and they do not cause or encourage cancer growth but could prevent it and may even slow its progression (in the case of aspirin and metformin for example).

Now what about the one compartment of the body that has not been discussed, which alkaline diet enthusiasts utilize as evidence - the urinary tract? Some that advocate alkaline water usage argue that this is where their water really exerts its health effects. One of the only places in the human body that has a slightly larger pH range than the rest is the urinary tract or urine itself, because it’s one of the primary disposal areas of the body that needs a little more pH latitude in order to keep the whole body itself tightly pH regulated (remember the thermostat of the house example). This is a somewhat similar reason as to why humans sweat because it allows the internal body to stay tightly temperature regulated to function normally, while the urinary tract allows the internal body to stay tightly pH regulated. So, humans need some latitude (not a lot) in the urinary tract, but this also receives a lot of embellishment by some alkaline water enthusiasts. A large pH shift in the urine is a marker for something already wrong with the human body and usually not a cause of some disease process, but a consequence of the disease process somewhere else. Think of dirty ashtrays as the place where people dump their cigarettes pieces - the ashtrays are not the cause of the problem or cancer, but a consequence of the real carcinogen (tobacco) being used by humans. And, for example, some individuals with metabolic syndrome (higher-risk for diabetes, cardiovascular disease, cancer…) could have a lower urinary pH as a consequence of this medical situation. Excessive weight gain can also dramatically shift the urinary pH as can serious urinary tract infections. Otherwise, the pH of the urine is actually tightly regulated but just not as tightly regulated as the rest of the human body. A more alkaline pH favors some types of kidney stones for example, and more acidic urine increases the risk of other types of kidney stones. A normal urine pH is from approximately 5.0-8.0 and if too high (kidney failure) or too low (diabetic ketoacidosis) it can indicate a disease process or medical emergency. One of the only consistent solutions to help prevent kidney stone recurrence with almost every type of stone is to consume adequate fluids or increase fluid intake daily especially water (for urine output of 2-2.5 L/day). And, most of the studies showing the ability to reduce kidney stones, including the longest randomized trial of diet to prevent recurrent kidney stones encouraged greater fluid intake or regular water (not alkaline) consumption or one with reduced calcium and sodium similar to most U.S. tap waters. And, if greater fluid intake could result in a lower risk of any cancer, and the data is mixed, it is bladder cancer where water in one of the largest U.S. prospective studies (Health Professionals Follow-up Study, 47,909 participants over 10 years) demonstrated a reduced risk of bladder cancer, which appeared to be primarily from municipal sources or tap water. Although, the risk reduction was attenuated when participants were followed an additional 12 more years (total of 22 years), but


it is still an interesting observation. This is yet another one of the countless reasons I recommend plain water or tap water. If patients have a private well water source they should have it tested regularly for arsenic amounts because high levels of arsenic from these sources have been associated with an increased risk of bladder cancer, which is another reason to consume tap water (virtually zero or almost undetectable levels). The recent disaster in Flint is a good example of how water can impact your life in a negative way if something goes terribly wrong with it, but the Flint, MI water situation was obviously a rare event but still it’s a tragedy and another reason why clean water that isn’t extremely acidic or basic (or contaminated or altered in any major way) should be the goal of every town or city. Every year I look at the latest report of water analyzed from the city drinking water supply and it’s clean and not extreme and I am happy with it. I encourage you to take a look at your water supply annual testing report which is supposed to be available to every person in the U.S.

Has there been any other interesting research on the subject? After a 1-year (equivalent to 30-years in humans) exposure to alkaline water old rats (6- or 12-week old) had significantly lower body weights than the control, and the authors wrote “dull and patchy fur seen in some of the test animals suggests a systemic toxic or metabolic response to alkaline drinking water” (Reference: Merne ME, Syrjanen KJ, Syrjanen SM. Systemic and local effects of long-term exposure to alkaline drinking water in rats. Int J Exp Pathol 2001;82:213-219). The rats with the lowest body weights from the alkaline water were the age of 6 weeks. Interestingly, in human studies severe pH alterations in children can lead to growth stunting or reduction (Reference: Chan JC. Acid-base disorders and the kidney. Adv Pediatr 1983;30:401-471.). This is not to imply that alkaline drinking water is unsafe at all, but again suggests that the human body pH is tightly regulated for a reason and anything (disease, environmental hazard…) that chronically changes that pH could cause a health problem. Yet, that was just a laboratory study. It is also interesting that a recent report of severe alkaline drinking water contamination of a town near Bonn, Germany in North Rhine-Westphalia might provide more insight (Reference: Lendowski L, Farber H, Holy A, Darius A, Ehrich B, Wippermann C, et al. Accidental contamination of a German town’s drinking water with sodium hydroxide. Int J Hyg Environ Health 2015;218:366-369.). The town was exposed to a concentrated sodium hydroxide solution that washed into the drinking water at a pumping station, which increased the pH of the water to 12 (highly basic). The residents that were in contact briefly with this water had an immediate toxicity (contact dermatitis over the entire body exposed to the water, gastrointestinal side effects-inflammation of mouth...), and this was immediately and fortunately recognized and resolved because otherwise it could have been a large public health problem.

It is interesting that tap water in the U.S. generally falls between 6.5 to 8.5, which is slightly acidic, neutral, or slightly alkaline (U.S. EPA. Accessed on January 15, 2016 at: http://safewater.supportportal.com/link/portal/23002/23015/Article/22806/

What-is-the-federal-standard-for-pH-in-drinking-water), which is just like the different areas of the human body (nothing extreme). Again, the human body needs to remain in a tight pH range to survive and function and any slight increase in acidity or alkalinity in the body signals the activation of three major lines of defense by the human body to save it from disaster, starting immediately with the blood buffers, followed soon by the respiratory system’s control of carbon dioxide, and finally the kidney excretion of the excess acid or base. Thus, whatever one eats, drinks, or ingests in terms of pills or potions, or even when a disease occurs (including cancer) it will fight to remain in a narrow pH zone to survive and thrive (not too basic and not too acidic). And it is not the acidity or alkalinity of products that prevents cancer, nor the acidity or alkalinity of the body that prevents cancer, but extreme pH is a consequence (along for the ride) of the disease process and not the cause of it.

So, here is the bottom line. It is far more cost effective to spend time and money on reducing the known major cancer risk factors or those that can reduce the risk of cancer recurrence such as eliminating tobacco, reducing obesity, exercising more, improving diet/eating less, or even decreasing ultraviolet light exposure makes more sense than spending more cents and large sums of money on other methods that might sound logical at first, but when one peels back the layers of this argument there is no real evidence and no real convincing argument, but only a distraction from what really matters in the fight against cancer.

THAT’S ALL FOLKS…. See you in the SUMMER, when I will write about many other serious issues and give timeless advice in the next newsletter, such: as why it is never good to give your email to anyone to buy ANYTHING anymore because all these companies do is constantly send you questionnaires to rate their service whether it’s an airline, car rental, clothing, books, food, etc.…I receive 10 questionnaires or surveys a day via email telling me to just take a few minutes to rate their service, but if I take a few minutes to rate the service of every service related industry I spend money on I would be filling out surveys as a full-time job so now “I’M MAD AND I’M not going to take this anymore!” (Network the Movie, Circa 1976) (https://www.youtube.com/watch?v=rGIY5Vyj4YM) Also…I will tell you things you never see or hear in the next issue of PAACT. For example, you never hear someone say “my golf game is amazing” because people spend all day telling you why they aren’t that good at golf for some twisted reason, or you never hear someone say “when I go to Vegas I spend a lot of money on gambling” so who is really spending all that money in Vegas if no one really gambles when they are there, and finally you never hear anyone say “Bowling should be an Olympic sport”, so then why is Curling an Olympic Sport if we all agree bowling has no chance ever to be an Olympic sport?? Curling is just bowling on ice…right?! Ahh, in time we will answer these and other life changing questions.


NEWLY DIAGNOSED PROSTATE CANCER – PAACT’S STEP BY STEP

ONLINE TOOLJan Manarite • VP of Advocacy & Education

A diagnosis of prostate cancer is overwhelming - period. In addition, many messages are confusing. Patients hear that prostate cancer is slow-growing. They hear that men will die WITH prostate cancer, NOT OF prostate cancer. But they also hear that almost 30,000 men will die of prostate cancer this year in the United States alone?

This makes no sense – how can you have it both ways?

The answer is that every prostate cancer is different. The next question is – What type of prostate cancer do you have? How do you get a basic understanding without all the medical jargon?

PAACT’s Step By Step online tool is designed to help. It encourages men or caregivers to take their time, and is broken up into sections to simplify and clarify the process. This tool has a checklist of medical records to ask for, but more importantly it takes men to a basic understanding of their medical records, which is the most accurate way to develop a layman’s understanding of the type of prostate cancer they have. Remember – the patient is part of the treatment decision, not the doctor alone. This is the essence of Shared Decision-Making.

Support Group Leaders – If you would like to use this tool for the newly diagnosed men in your support group, PAACT can send you some small (4 x 6) Step By Step cards for free.

Call or email Molly at (616) 453-1477 or [email protected]

Find this tool at www.paact.help/newly-diagnosed-active-surveillance

If you have questions while you are using the tool, you can call PAACT’s Helpline at (844) PAACT 4U.


WWW.PAACT.HELPSOMETHING FOR EVERYONE

Jan Manarite • VP of Advocacy & Education

The new PAACT website is designed to make it easy to find information that applies to you – personally. Since every prostate cancer is different, the

EDUCATIONAL TOOLS TABS ON THE HOMEPAGE are designed to speak to you – the patient – in a way that you can see which section has information helpful to you, wherever you are in your prostate cancer journey.

PAACT’s ultimate goal is to help you and empower you.

Visit us today at www.PAACT.HELP or call our free Helpline at (844) PAACT4U.


ACKNOWLEDGEMENTS OF CONTRIBUTIONSOctober 1, 2015 through December 31, 2015

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MEMORIAL CONTRIBUTIONSIn Loving Memory of Lloyd J Ney, Sr.,

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