Date: 2015-05-15
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in European Urology
Company: Opko Health (USA - Fl)
Product: 4Kscore® Test
Action
mechanism: The 4Kscore is a blood test that accurately identifies risk for aggressive prostate cancer. The 4Kscore measures the blood plasma levels of four different prostate-derived kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human Kallikrein 2 (hK2). These biomarkers are combined with a patient\'s age, Digital Rectal Exam (DRE) status (nodule / no nodule), and prior negative biopsy status (yes / no) using a proprietary algorithm to calculate the risk (probability) of finding a Gleason Score 7 or higher prostate cancer. The four kallikrein panel of biomarkers utilized in the 4Kscore Test is based on over a decade of research conducted by scientists at Memorial Sloan-Kettering Cancer Center and leading European institutions. The 4Kscore Test provides individualized risk for the presence of aggressive prostate cancer and adds new information to the shared decision making discussion between a Urologist and patient. The 4Kscore Test was developed and validated by OPKO Lab in a 1,012 patient blinded, prospective study in the U.S. in 2014.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology - Diagnostic
Country:
Trial details:
Latest
news: * On May 15, 2015, Opko Health announced the online publication of a study entitled \"A Four-kallikrein Panel Predicts High -grade Cancer on Biopsy: Independent Validation in a Community Cohort\" in the journal European Urology. The study shows that the four kallikrein panel of biomarkers utilized in the OPKO 4Kscore® Test (Total PSA, Free PSA, Intact PSA and hK2) accurately identifies risk for aggressive prostate cancer prior to prostate biopsy in a population of men referred for prostate biopsy based on Total PSA level and a Free PSA to Total PSA ratio. The study evaluated the accuracy of the four kallikrein biomarkers in the 4Kscore along with age, DRE and an algorithm (4K algorithm) to predict risk of aggressive prostate cancer in a large community-based setting at Skåne University Hospital , Malmö, Sweden . Like the 4Kscore US Validation study, the Malmö study was conducted on men being referred for prostate biopsy, but in this study, the criteria for referral explicitly included high-risk men with an elevated PSA (greater than or equal to 3 ng/mL) and a low percentage of Free PSA to Total PSA (less than or equal to 20%). These inclusion criteria selected for men with a higher risk for having aggressive prostate cancer than the cohort studied in the 4Kscore US Validation Study. Of the 749 men recruited for the trial, a total of 156 men (21%) were found to have aggressive prostate cancer defined as Gleason score greater than or equal to 7. The results demonstrated that the 4K algorithm discriminated men with aggressive prostate cancer from men who did not have aggressive disease with an area under the curve (AUC) of 0.78. The study also reported that even in this high risk patient population, a substantial number of biopsies (25%) could have been avoided. A decision curve analysis also demonstrated a significant net benefit for the use of the 4K algorithm in this cohort compared to performing biopsy on all men, the current standard of care.
