Date: 2016-02-09
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in Reviews in 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
Country:
Trial details:
Latest
news: * On February 9, 2016, OPKO Health announced the results of a study for the 4Kscore® Test's clinical utility in reducing the number of prostate biopsies performed, while increasing the probability of detecting aggressive prostate cancer in men with abnormal prostate-specific antigen (PSA) levels and or digital rectal examination (DRE) results. The peer-reviewed study, "The 4Kscore® Test Reduces Prostate Biopsy Rates in Community and Academic Urology Practices", written by Badrinath Konety , MD, et al. and published in the January 2016 edition of Reviews in Urology, a MedReviews, LLC . Publication, which included 611 patients seen by 35 academic and community urologists across the United States , indicated that consideration of results from the 4Kscore tests led to 64.6% fewer prostate biopsies being performed among participating patients.
Dr. Konety and colleagues evaluated the influence of the 4Kscore test on urologist-patient decisions about whether to perform a biopsy in men who had an abnormal PSA and or DRE result. Test results for patients were stratified into low risk ( < 7.5%), intermediate risk (7.5%-19.9%) and high risk (?20%) for developing aggressive prostate cancer. Nearly half (49.3%) of the men were categorized as low risk; 25.7% and 25.0% fell into the intermediate-risk and high-risk categories, respectively. Notably, the 4Kscore test results influenced biopsy decisions in 88.7% of the men. In the three risk groups, a biopsy was avoided in 94.0%, 52.9%, and 19.0% of men in the low, intermediate, and high-risk categories, respectively.
A higher 4Kscore test result was significantly associated with a greater likelihood of having a prostate biopsy (P < 0.001). Among the 171 men who had a biopsy, 45 of the 104 cases (43.3%) with a high-risk 4Kscore test result (?20% risk) were found to have aggressive prostate cancer upon prostate biopsy.
