Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies

Running, not enrolling

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04541030

Run by

National Cancer Institute (NCI)

People needed

241

Starts

2020-09-02

Expected to finish

2027-07-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• 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
• Men with NCCN high risk or very high-risk prostate cancer
• Biopsy Gleason 8
• No biopsy tissue available
• Missing surgical pathology whole mount, or unwilling to send surgical pathology whole mount to NCI for review
• Missing diagnostic PSA
• Missing clinical T stage
• Known lymph node positive or metastatic disease at time of diagnosis
• Missing MRI 6 months before diagnostic biopsy

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• National Cancer Institute (NCI) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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