Phase 2 Study of Relugolix to Improve PSMA PETCT Imaging in Men With High or Very High Risk Prostate Cancer

What this Trial Is About

Researchers are evaluating how a short course of androgen deprivation therapy ADT with relugolix affects the expression of prostate-specific membrane antigen PSMA and the quality of diagnostic imaging using PSMA PETCT in patients with high or very high risk prostate cancer. PSMA PETCT is commonly used to detect prostate cancer, but it has limitations in identifying cancer spread to lymph nodes. Relugolix works by reducing testosterone production, which may increase PSMA expression on tumor cells, potentially improving detection of smaller cancer areas. Participants are assigned to one of three groups receiving different durations of relugolix 5, 10, or 15 days. Each patient undergoes a PSMA PETCT scan with flotufolastat F 18 before starting relugolix and another scan after completing their assigned treatment duration. Following these scans, patients have robotic radical prostatectomy with pelvic lymph node dissection within 90 days. Blood samples are collected throughout the study to monitor effects and safety. During the trial, patients have multiple PETCT scans and blood tests to assess changes in PSMA expression and lymph node involvement. Researchers measure uptake values of the radioactive tracer in tumors before and after ADT to evaluate imaging improvements. They also monitor for any adverse events up to 90 days after the second scan. The studys total duration includes treatment, imaging, surgery, and follow-up assessments to understand the impact of relugolix on prostate cancer imaging.

Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial