The 4Kscore blood test for risk of aggressive prostate cancer
Early detection of aggressive prostate cancer Challenges 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
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
2015 NCCN Prostate Cancer Early Detection Guidelines
What is the 4Kscore Test? Components Results Proprietary { to OPKO Total PSA Free PSA Intact PSA hk2 OPKO ALGORITHM % risk of having aggressive prostate cancer for an individual patient + Age, DRE, and prior biopsy status
4Kscore Test: 10 years of clinical research conducted by Memorial Sloan Kettering Cancer Center and leading international cancer centers
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.2014.10.0 21) Epub Ahead of Print 26 Clinical study sites
Gleason score distribution in Prospective US Study Negative or Gleason 6 prostate cancer Aggressive (Gleason 7) prostate cancer
The 4Kscore Test has the greatest accuracy for predicting aggressive prostate cancer Sensitivity AUC = area under the curve Larger AUC = better accuracy for predicting aggressive prostate cancer 4Kscore AUC = 0.82 1 PSA AUC = 0.69 1 AUC of other tests when applied to aggressive disease AUC = 0.5 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 1 - Specificity 3. Wang, W et al. Scientific Reports 4:1-8 2014 4. Chevli, K et al. J Urol 191:1743 2014
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
4Kscore Test is more accurate than total PSA alone in predicting aggressive prostate cancer in subset of men with PSA 16-20ng/mL
The 4Kscore Test predicts the probability of distant metastases within 20 years 4Kscore > 7.5% all men PSA 3 4Kscore Test Biomarkers > 7.5% (N =1510, 62%) 5 year 10 year 15 year 20 year = 2.4% = 5.6% = 9.9% = 16.4% all men PSA 3 4Kscore 7.5% 4Kscore Test Biomarkers 7.5% (N = 922, 38%) 5 year 10 year 15 year 20 year = 0% = 0.2% = 1.0% = 1.8% 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)
Clear result reporting for informed decision making 4Kscore = Personal Positive Predictive Value
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