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Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies

NCT04541030 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 241

Last updated 2026-05-22

No results posted yet for this study

Summary

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....

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Peter A Pinto, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04541030 on ClinicalTrials.gov