4Kscore Using Serum Stored Uncentrifuged

NCT ID: NCT04130776

Last Updated: 2019-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-04
• Study Completion Date: 2018-10-31

Brief Summary

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

Conditions

Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

OPKO Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Ryan Mark

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

20622

Identifier Type: -

Identifier Source: org_study_id