Status:
COMPLETED
Prostate Cancer Upgrading Reference Set
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
Emory University
Stanford University
Conditions:
Prostate Cancer
Eligibility:
MALE
35-99 years
Brief Summary
Research repository designed to establish prostate cancer upgrading reference set and development of a risk prediction tool. Repository will include clinical information and biologics on a cohort of 2...
Detailed Description
The primary endpoint of this study is the presence of tumor upgrading at the time of radical prostatectomy. Upgrading is defined as: Gleason 3+4 or higher grade A secondary study endpoint is presence ...
Eligibility Criteria
Inclusion
- Prostate cancer, confirmed on prostate biopsy, within two years of scheduled radical prostatectomy.
- Prostate cancer must be graded as Gleason 3+3 on the biopsy immediately prior to radical prostatectomy. (Secondary eligibility will be established on central review of pathology slides, and blocks if available, at Cornell Central Pathology Laboratory to confirm eligibility.)
- Prostate cancer may have been detected on prior biopsy as well but must not be greater than Gleason 3+3. (Also requires Central Pathology Laboratory review.)
- Slides must be available for Central Pathology Laboratory review on any biopsy showing prostate cancer. FFPE Blocks may also be requested if available.
- Patient must have selected radical prostatectomy as treatment for prostate cancer.
- Signed informed consent.
- Blocks and/or slides from prostate biopsy and from radical prostatectomy must be available for analysis by Central Pathology laboratory.
- Willingness to provide long-term follow-up information regarding additional treatments and cancer status.
- Willingness to provide blood and urine specimens prior to radical prostatectomy for placement in the EDRN Upgrading Reference Set repository.
- Willingness to provide demographic and clinical information related to prostate cancer and prostate cancer risk (e.g., race/ethnicity, family history of prostate cancer).
Exclusion
- Gleason score greater than 3+3 on any prior prostate biopsy.
- Any treatment other than radical prostatectomy planned for prostate cancer.
- Prior treatment of the prostate with androgen deprivation, radiation, or other cytotoxic chemotherapy.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 16 2025
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT02189486
Start Date
August 1 2014
End Date
June 16 2025
Last Update
January 7 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229