4Kscore Using Serum Stored Uncentrifuged

N/ACompletedNCT04130776

OPKO Health, Inc.64 enrolled

Overview

The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure

Study Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer

Interventions

Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifugedDIAGNOSTIC_TEST

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.

Eligibility

Sex: MALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men capable of donating five 5 mL tubes of whole blood * 40 to 80 years old * No prior diagnosis of prostate cancer; prior negative prostate biopsy included * Total PSA (tPSA) value measured within last year to be: at 1.5 ng/mL to 4 ng/mL, 4.1 ng/mL to 10 ng/mL and 10 ng/mL and above Exclusion Criteria: * In the previous 96 hours (4 days), underwent a digital rectal exam * Any invasive urologic procedure in the 6 months prior to study participation * Underwent any procedure to treat symptomatic benign prostatic hyperplasia in the last 6 months * Radical prostatectomy since tPSA measurement * Received within the previous 6 months 5-alpha reductase inhibitor (5-ARI) therapy such as Avodart (dutasteride) or Proscar (finasteride)

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

tPSA changes in 3 days

Measure tPSA in serum samples at day 0, 1, 2 and 3

Time frame: Day 0, 1, 2 and 3

fPSA changes in 3 days

Measure fPSA in serum samples at day 0, 1, 2 and 3

Time frame: Day 0, 1, 2 and 3

iPSA changes in 3 days

Measure iPSA in serum samples at day 0, 1, 2 and 3

Time frame: Day 0, 1, 2 and 3

hK2 changes in 3 days

Measure hK2 in serum samples at day 0, 1, 2 and 3

Time frame: Day 0, 1, 2 and 3

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.