NCT02189486Completed
Prostate Cancer Upgrading Reference Set
Biomarkers and Clinical Parameters Associated With Gleason Score Upgrading
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
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 240 men, to predict presence of high grade cancer at time of prostatectomy (removal of prostate) among patients with a low grade cancer diagnosis at time of biopsy.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 382 (actual)
- First submitted
- 8 Jul 2014
- Start date
- 1 Aug 2014
- Primary completion date
- 16 Jun 2025
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Diseases
- Prostate cancer
- NCT number
- NCT02189486
What you commit to
- Study type: Observational
- Participants enrolled: 382
- From 1 Aug 2014 to the primary completion date, 16 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Gleason score greater than 3+3 on any prior prostate biopsy.
- Prior treatment of the prostate with androgen deprivation, radiation, or other cytotoxic chemotherapy.
Other illness
- Any treatment other than radical prostatectomy planned for prostate cancer.
Who the study is looking for
- 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).
Age in the registry: 35 years to 99 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.