NCT04130776
Completed
Not Applicable
Demonstrating the Stability of the Analytes Measured for 4Kscore: Total PSA (tPSA), Free PSA (fPSA), Intact PSA (iPSA), and Human Kallikrein 2 (hk2) in Clinical Serum Samples Stored Uncentrifuged Before Testing
ConditionsProstate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- OPKO Health, Inc.
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- fPSA changes in 3 days
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure
Investigators
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)
Outcomes
Primary Outcomes
fPSA changes in 3 days
Time Frame: Day 0, 1, 2 and 3
Measure fPSA in serum samples at day 0, 1, 2 and 3
hK2 changes in 3 days
Time Frame: Day 0, 1, 2 and 3
Measure hK2 in serum samples at day 0, 1, 2 and 3
tPSA changes in 3 days
Time Frame: Day 0, 1, 2 and 3
Measure tPSA in serum samples at day 0, 1, 2 and 3
iPSA changes in 3 days
Time Frame: Day 0, 1, 2 and 3
Measure iPSA in serum samples at day 0, 1, 2 and 3
Study Sites (1)
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