Study of Flotufolastat F 18 PETCT Scan to Detect Remaining or Returning Prostate Cancer After Focal Therapy

What this Trial Is About

Researchers are evaluating the accuracy of flotufolastat F 18 PETCT imaging to detect remaining or returning prostate cancer after focal therapy. This phase II trial focuses on men who have undergone focal treatments like laser or cryotherapy within the past 6 to 36 months. Flotufolastat F 18 binds to a protein on prostate cancer cells, allowing the imaging to highlight cancer areas by combining metabolic and anatomical information from PET and CT scans. Participants receive an intravenous injection of flotufolastat F 18, followed by a whole-body PETCT scan 50 to 100 minutes later lasting 20 to 50 minutes. Within three months after imaging, they undergo a PETCTultrasound fusion-guided prostate biopsy. After these procedures, follow-up visits occur one month post-biopsy and then annually for up to ten years to monitor outcomes. During the study, researchers assess how accurately the imaging detects prostate cancer compared to biopsy results and examine the optimal imaging uptake thresholds related to cancer severity. The study also explores how flotufolastat F 18 distributes in the prostate compared to another tracer. Safety and effectiveness are monitored through these imaging and biopsy procedures, with long-term observation extending up to ten years.

An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer.