Study on the Use of rhPSMA-7.3 (18F) PET/CT for Men with Prostate Cancer Under Active Surveillance

Program Overview

This study is testing a new imaging method called rhPSMA-7.3 (18F) PET/CT to see if it can improve the detection of significant prostate cancer in men who are on active surveillance. Active surveillance is a way of monitoring prostate cancer that is considered low-risk or favorable intermediate-risk, to avoid unnecessary treatment. The study will compare the effectiveness of this new imaging test with the standard MRI scans to see if it can find cancer that might need treatment sooner. About 120 men will participate in this study at Mount Sinai Hospital over a year. Participants will have one imaging visit, a confirmatory biopsy, and follow-up reviews of their clinical results. The study is funded by the Icahn School of Medicine at Mount Sinai and Blue Earth Diagnostics.

Description

This study is looking at whether a new imaging test, rhPSMA-7.3 (18F) PET/CT, can help find significant prostate cancer in men who are being monitored instead of treated right away. This approach, called active surveillance, is used for men with low-risk prostate cancer to avoid unnecessary treatment. The standard way to monitor these men includes regular PSA tests, physical exams, MRI scans, and biopsies. However, MRI scans can sometimes miss important cancer areas. The new PET/CT scan uses a special tracer that targets prostate cancer cells, potentially providing clearer images. The study will see if this new scan can find cancer that MRI might miss, helping doctors make better treatment decisions. Participants will have both the new PET/CT scan and the standard MRI before a biopsy. The study will compare the results of these scans with the biopsy findings to see which method is better at detecting significant cancer. The study involves minimal risk beyond standard procedures, and the findings could improve how prostate cancer is monitored in the future.

Eligibility Criteria

Locations