Study on PSMA PET Scan and mpMRI for Better Prostate Cancer Detection

Sponsor: VA Greater Los Angeles Healthcare System

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05820724

Provider View

This clinical trial is testing whether adding a PSMA PET scan to the standard mpMRI scan can improve the detection of significant prostate cancer compared to using the mpMRI scan alone.

Patient Parameters

Program Overview

The study aims to find out if combining a PSMA PET scan with an mpMRI scan can help doctors better detect important prostate cancer. Patients who have already had an mpMRI scan showing certain types of lesions and are planning to have a prostate biopsy can participate. Participants will be randomly assigned to either have an additional PSMA PET scan before their biopsy or proceed with the biopsy based on the mpMRI scan alone.

Description

This study involves patients who have had an mpMRI scan of the prostate as part of their regular medical care and have specific types of lesions (PI-RADS 4 or 5) that suggest a higher risk of significant prostate cancer. These patients are scheduled for a prostate biopsy, a procedure where small samples of prostate tissue are taken to check for cancer.

Participants who agree to join the study will be randomly divided into two groups. One group will have an additional PSMA PET scan before their biopsy, while the other group will not. For those who have the PSMA scan, the decision on where to take biopsy samples will be based on both the mpMRI and PSMA scan results. For those who do not have the PSMA scan, the biopsy will be guided by the mpMRI results alone.

All participants will have a standard biopsy procedure, which involves taking 12 tissue samples from the prostate. Additional samples will be taken from areas identified by the mpMRI and PSMA scans if applicable.

Eligibility Criteria

Inclusion Criteria

  • Have specific types of lesions (PI-RADS 4 or 5) on an mpMRI scan and have chosen to have a prostate biopsy.
  • Completed a prostate mpMRI scan within the last 9 months.
  • Able to provide written consent to participate in the study.
  • Willing to be randomly assigned to either have only the mpMRI scan or both the mpMRI and PSMA PET/CT scans.

Exclusion Criteria

  • Under 18 years old at the time of the scan.
  • Have a medical condition or serious illness that might interfere with the study or make it unsafe to participate.
  • Have a creatinine clearance level that does not meet the requirements for a prostate mpMRI scan.

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