4Kscore Using Serum Stored Uncentrifuged

Completed

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT04130776

Run by

OPKO Health, Inc.

People needed

64

Starts

2017-10-04

Expected to finish

2018-10-31

Last updated by the study team

2019-10-17

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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