the 4kscore® blood test for risk of aggressive prostate cancer
TRANSCRIPT
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The 4Kscore® blood test for risk of aggressive prostate cancer
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Early detection of aggressive prostate cancerChallenges
• Serum PSA has a high false positive rate
• Over 1 million prostate biopsies performed annually in US• 75% biopsies will have low-grade, indolent (Gleason 6) or no prostate cancer• Serious complications of biopsies include infection and hospitalization
• Overtreatment- 67% of Gleason 6 indolent cancers at prostate biopsy are confirmed at radical prostatectomy
• Recommendation by USPSTF to stop PSA screening misses an opportunity to detect and treat men with high grade (Gleason ≥7), the aggressive form of prostate cancer
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The 4Kscore Test• The only blood test that accurately identifies risk for aggressive prostate
cancer
• Aggressive prostate cancer is defined by both high-grade disease and long term clinical outcomes (rate of prostate cancer metastases)
• Based on 10 years of work by scientists at Memorial Sloan-Kettering Cancer Center and evaluated in over 22,000 men in 12 clinical studies and validated in a prospective, blinded prebiopsy study of 1,012 men in US
• Included in the 2015 NCCN Guidelines for Prostate Cancer Early Detection
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2015 NCCN Prostate Cancer Early Detection Guidelines
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What is the 4Kscore Test?
Components Results
Total PSA
Free PSAIntact PSA hK2
+ Age, DRE, and prior biopsy status
Proprietary to OPKO {
% risk of havingaggressive prostate
cancer for an individual patient
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4Kscore Test: 10 years of clinical research conducted by Memorial Sloan Kettering Cancer Center and leading international cancer centers
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Prospective, blinded, multicenter US study validates 4Kscore Test
• 1,012 patients enrolled in 26 academic and community practices
• Referred for biopsy regardless of age, PSA, clinical findings or prior biopsy status
• Minimum of 10 core TRUS-guided biopsies performed
• The 4Kscore Test was performed at OPKO Lab, Nashville, TN
• Pathology conducted according to the established practice at each center
• Presented in the 2014 AUA Plenary Session and published in European Urology (http://dx.doi.org/10.1016/j.eururo.2014.10.021) Epub Ahead of Print
26 Clinical study sites
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Gleason score distribution in Prospective US Study
Negative or Gleason 6 prostate cancer
Aggressive (Gleason ≥ 7)
prostate cancer
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The 4Kscore Test has the greatest accuracy for predicting aggressive prostate cancer
Sensitivity
1 - Specificity
AUC = 0.5
4Kscore AUC = 0.82 1
AUC = area under the curve
Larger AUC = better accuracy for predicting
aggressive prostate cancer
PSA AUC = 0.69 1
AUC of other tests when applied to aggressive disease
PHI = 0.72, 0.67 2,3
PCA3 = 0.68 4
1. Parekh, D et al. http://dx.doi.org/10.1016/j.eururo.2014.10.021(Epub Ahead of Print)2. Catalona et al. J Urol. 185:1650 2011
3. Wang, W et al. Scientific Reports 4:1-8 20144. Chevli, K et al. J Urol 191:1743 2014
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The risk of aggressive prostate cancer predicted by the 4Kscore Test is confirmed by prostate biopsy
239 aggressive prostate cancers detected in 1,012
subjects
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4Kscore Test is more accurate than total PSA alone in predicting aggressive prostate cancer in subset of men with PSA 16-20ng/mL
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Improving the Specificity of Screening for Lethal Prostate Cancer Using Prostate-specific Antigen and a Panel of Kallikrein Markers: A Nested Case–Control Study Stattin, P et al. http://dx.doi.org/10.1016/j.eururo.2015.01.009(Epub Ahead of Print)
4Kscore Test Biomarkers> 7.5% (N =1510, 62%)
4Kscore Test Biomarkers≤ 7.5% (N = 922, 38%)
5 year10
year15
year20
year
= 2.4%= 5.6%= 9.9%= 16.4%
5 year10 year15 year20 year
= 0%= 0.2%= 1.0%= 1.8%
4Kscore> 7.5%
all men PSA ≥ 3
4Kscore≤ 7.5%
all men PSA ≥ 3
The 4Kscore Test predicts the probability of distant metastases within 20 years
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Clear result reporting for informed decision making
4Kscore =Personal Positive Predictive Value
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The 4Kscore Test Summary
• Included in the 2015 NCCN Guidelines for Prostate Cancer Early Detection
• Clinical utility was validated based on a decade of research in over 22,000 men in Europe and the United States
• Identifies the risk of aggressive prostate cancer for the individual patient• High grade prostate cancer pathology • Poor prostate cancer clinical outcomes within 20 years
• Has high sensitivity and high negative predictive value for aggressive prostate cancer
The only blood test that accurately identifies risk for aggressive prostate cancer