Status:
COMPLETED
4Kscore Using Serum Stored Uncentrifuged
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
40-80 years
Brief Summary
The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 4 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2018
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04130776
Start Date
October 4 2017
End Date
October 31 2018
Last Update
October 17 2019
Active Locations (1)
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1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107