NCT04541030Active, not recruiting
Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies
UAB-NCI Collaborative Study on Integrating Genomic Prostate Score With MRI Targeted Prostate Biopsies
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
Background: Prostate cancer is one of the most common cancers in men. For some men, their cancer is monitored. Others have surgery to remove the prostate. Focal therapy is another treatment option. It treats the areas of cancer selectively, which leaves the rest of the prostate intact. This can help lessen side effects. Men who get focal therapy must be chosen carefully. The Oncotype DX Genomic Prostate Score (GPS) assay tests biopsy samples for certain cancer-related genes. It then then gives a score from 1 to 100 to predict the likelihood of poor outcomes. The GPS is used to choose men for focal therapy. Researchers want to test the GPS further. Objective: To assess how GPS may be useful when used with MRI to improve how men are chosen for focal therapy of prostate cancer. Eligibility: Men age 18 and older who had NCCN low or intermediate risk prostate cancer and had MRI and radical prostatectomy at the Urologic Oncology Branch, National Cancer Institute and collaborating centers. Design: This is a multisite study. It will review data and samples that were collected in the past. Samples and images from up to 277 participants will be used. Tumor tissue will be tested with the GPS. Data such as age at diagnosis, race, biopsy results, and pathology results will be merged with the GPS results. Data will be entered into an in-house electronic system. It will be password protected. All data will be kept in secure sites that comply with NIH security standards.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 241 (actual)
- First submitted
- 5 Sept 2020
- Start date
- 2 Sept 2020
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Prostate cancer
- NCT number
- NCT04541030
What you commit to
- Study type: Observational
- Participants enrolled: 241
- From 2 Sept 2020 to the primary completion date, 1 Jul 2027
- 2 sites 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
- Any active therapy received for prostate cancer (e.g., hormonal treatment, radiation, chemotherapy, biologic agents, surgery) prior to radical prostatectomy. 5 alpha reductase inhibitor treatment will not be considered to be hormonal treatment for this definition
- Missing surgical pathology whole mount, or unwilling to send surgical pathology whole mount to NCI for review
- Missing MRI 6 months before diagnostic biopsy
Other illness
- Men with NCCN high risk or very high-risk prostate cancer
- Known lymph node positive or metastatic disease at time of diagnosis
Other
- Biopsy Gleason 8
- No biopsy tissue available
- Missing diagnostic PSA
- Missing clinical T stage
Criteria the registry did not label
- INCLUSION CRITERIA:
- Samples and images from men \> =18 with NCCN very low, low, or intermediate risk prostate cancer with tumor tissue that meet the pathologic tissue requirements of the Oncotype DX Genomic Prostate Score assay
- Biopsy Gleason Score 7 or lower within 6 months preceding radical prostatectomy
- 3Tesla MRI with/without coil performed within 6 months preceding diagnostic biopsy
- Availability of diagnostic biopsy
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Institute (NCI) Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.