4Kscore Using Serum Stored Uncentrifuged

OPKO Health

Status: Completed

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifuged

Study type: Observational

Funder types: Industry

Identifiers

NCT04130776

20622

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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)