4Kscore Using Serum Stored Uncentrifuged

CompletedOBSERVATIONAL
Enrollment

64

Participants

Timeline

Start Date

October 4, 2017

Primary Completion Date

March 27, 2018

Study Completion Date

October 31, 2018

Conditions
Prostate Cancer
Interventions
DIAGNOSTIC_TEST

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.

Trial Locations (1)

19107

Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia

All Listed Sponsors
lead

OPKO Health, Inc.

INDUSTRY

NCT04130776 - 4Kscore Using Serum Stored Uncentrifuged | Biotech Hunter | Biotech Hunter