Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes
18 Years and older, Male
This phase II trial studies how well a positron emission tomography (PET) / computed tomography (CT) scan using fluciclovine F18 compared with a PET / CT scan with gallium Ga 68-labeled PSMA-11 works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma. Fluciclovine F18 and gallium Ga 68-labeled PSMA-11 are types of tracers, called radiotracers, that are injected and can accumulate in tumor cells to develop images of them during a PET / CT scan. It is not yet known whether giving fluciclovine F18 or gallium Ga 68-labeled PSMA-11 may work better in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.
I. Improve the outcomes of post-prostatectomy radiotherapy prostate cancer patients via selection and treatment optimization with advanced molecular imaging with dose escalation.
II. Establish the role of advanced molecular imaging with fluciclovine F18 (fluciclovine [18F]) and gallium Ga 68-labeled prostate specific membrane antigen PSMA-11 (68Ga PSMA) PET/CT in influencing post-prostatectomy radiotherapy decision-making.
III. Establish the role of advanced molecular imaging with fluciclovine (18F) or 68Ga PSMA in altering radiotherapy treatment volumes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive fluciclovine F18 intravenously (IV) and undergo a PET/CT over approximately 30 minutes.
ARM II: Patients receive Gallium Ga 68-labeled PSMA-11 IV, wait 60 minutes, then undergo a PET/CT over approximately 30 minutes.
After completion of study treatment, patients are followed up every 6 months for up to 5 years.