64
Participants
Start Date
October 4, 2017
Primary Completion Date
March 27, 2018
Study Completion Date
October 31, 2018
Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifuged
The 4Kscore Test helps clarify the biopsy decision-making process by determining a patient specific probability for finding aggressive, Gleason score 7 or higher prostate cancer upon biopsy. These are the aggressive prostate cancers that always require medical treatment or intervention. The 4Kscore Test relies on the measurement of four prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The blood test results are combined in an algorithm with patient age, digital rectal exam (nodules, no nodules), and prior negative biopsy (yes, no) to give physicians a personal score for each patient. The 4Kscore Test predicts the risk percent score from \<1% to \>95% of a man having aggressive cancer in a prospective biopsy.
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia
OPKO Health, Inc.
INDUSTRY