RecruitingEarly Phase 1NCT05852041

rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance

A Pilot Study of rhPSMA-PET MRI Imaging for the Detection of Clinically Actionable Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance

Sponsor

Northwestern University

Enrollment

40 participants

Start Date

Jun 7, 2023

Study Type

INTERVENTIONAL

Conditions

Prostate Adenocarcinoma Stage I Prostate Cancer AJCC v8 Stage IIB Prostate Cancer AJCC v8 Stage IIA Prostate Cancer AJCC v8

Summary

This clinical trial evaluates whether positron emission tomography-magnetic resonance imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane antigen (rhPSMA)-7.3 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance. A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. The radioactive drug used in this study, rhPSMA-7.3, attaches to the abnormal cells in the body at a different rate than normal cells which allows the scanner to create a detailed picture of how the body is working. An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body. A multiparametric (mp)MRI is a type of MRI scan that creates a more detailed picture of the prostate gland. Using rhPSMA-73 with PET-MRI and mpMRI may be more effective in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of imaging scan — combining a PET scan with an MRI — using a tracer called rhPSMA-73, to better detect where prostate cancer is located in men who have low-risk or early-stage disease. The goal is to help doctors decide whether active surveillance (watchful waiting) is the safest approach rather than immediate treatment. **You may be eligible if...** - You are a man aged 18 or older with a life expectancy of at least 10 years - You have been diagnosed with low-grade prostate cancer (Gleason Grade 1 or 2) confirmed by biopsy in the past 3–15 months - Your cancer is considered low risk or favorable intermediate risk by standard guidelines - Your prostate cancer biopsy genetic score (Decipher) is 0.45 or higher - You are willing to have a repeat biopsy after the scan **You may NOT be eligible if...** - You have previously been treated for prostate cancer (surgery, radiation, hormones, or chemotherapy) - Your cancer is classified as very low risk by current guidelines - Your Decipher score is below 0.45 - You have had certain prostate procedures (like TURP or UroLift) in the past - You have a pacemaker or hip replacement that makes MRI unsafe - You have taken hormone-blocking medications in the past month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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