Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies (NCT04541030)
UAB-NCI Collaborative Study on Integrating Genomic Prostate Score With MRI Targeted Prostate Biopsies
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- National Cancer Institute (NCI) — Bethesda, Maryland
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.