4Kscore Using Serum Stored Uncentrifuged
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT04130776
- Lead Sponsor
- OPKO Health, Inc.
- Brief Summary
The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 64
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method fPSA changes in 3 days Day 0, 1, 2 and 3 Measure fPSA in serum samples at day 0, 1, 2 and 3
hK2 changes in 3 days Day 0, 1, 2 and 3 Measure hK2 in serum samples at day 0, 1, 2 and 3
tPSA changes in 3 days Day 0, 1, 2 and 3 Measure tPSA in serum samples at day 0, 1, 2 and 3
iPSA changes in 3 days Day 0, 1, 2 and 3 Measure iPSA in serum samples at day 0, 1, 2 and 3
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States