Evaluating Fluciclovine 18F PETCT Scans to Detect Recurrent Prostate Cancer in Men with Negative or Unclear Previous PSMA PETCT Results

What this Trial Is About

Researchers are evaluating the use of fluciclovine 18F PETCT scans to detect recurrent prostate cancer in male patients whose earlier PSMA PETCT scans were negative or inconclusive. This observational study takes place at two specialized nuclear medicine centers in Germany and focuses on patients with biochemical recurrence after previous definitive treatment for prostate cancer. The study aims to assess the technical performance of this imaging method in a real-world clinical setting over a 12-month observation period. Each participant undergoes a fluciclovine PETCT scan as part of their routine care. The scans are pseudonymized and centrally reviewed by three independent nuclear medicine physicians who do not know the local sites evaluation. Follow-up assessments occur at one month, including a questionnaire to the referring physician about changes in treatment plans, and at 12 months to gather additional imaging results, PSA levels, treatment outcomes, and histopathological data when available. These follow-ups help confirm true positive and false positive findings. During the study, researchers collect comprehensive data such as additional imaging studies, PSA measurements, and treatment responses to understand the detection accuracy of fluciclovine PETCT. They measure patient-level detection rates and region-level detection rates, analyze detection based on PSA levels, observe changes in intended management, and assess agreement among readers. Participant involvement includes the initial scan and follow-up evaluations over one year, supporting detailed monitoring of disease recurrence and imaging performance.

A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET