Testing the Effectiveness of Neoadjuvant Androgen Deprivation Therapy Using 18F-Flotufolastat PSMA PETCT in Men with High-Risk Localized Prostate Cancer

What this Trial Is About

Researchers are evaluating the effectiveness of neoadjuvant androgen deprivation therapy ADT in patients with localized high-risk prostate cancer. This phase II, open-label study focuses on how ADT affects prostate-specific membrane antigen PSMA uptake measured by 18F-Flotufolastat PSMA PETCT scans. The study also aims to explore how changes in PSMA uptake predict biochemical recurrence-free survival after treatment. Participants will receive one of four ADT drugsleuprolide, degarelix, relugolix, or triptorelinadministered over six months in two treatment cycles. Leuprolide and triptorelin are given as muscle injections every three months, degarelix as a subcutaneous injection every 28 days, and relugolix as a daily oral pill. Those receiving leuprolide or triptorelin will also take bicalutamide daily for 30 days. After six months of ADT, participants undergo a PET scan with 18F-Flotufolastat followed by radical prostatectomy surgery. During the study, participants will have baseline and post-treatment PET scans to assess changes in PSMA uptake. They will be monitored for response rates using imaging criteria and biochemical markers like prostate-specific antigen PSA. Follow-up will continue for up to 48 months after prostate removal to track symptom changes and biochemical recurrence. Safety and efficacy will be assessed through imaging, blood tests, and clinical evaluations throughout the study period.

Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT