Fluciclovine F18 or Gallium Ga 68-labeled PSMA-11 PET/CT in Enhancing Outcomes in Patients with Prostate Adenocarcinoma
Prostate Cancer
Unknown Primary
RAD4516-18 (primary)
NCI-2018-02702
IRB00106863
Summary
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.
Objectives
PRIMARY OBJECTIVES
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.
Eligibility
- Adenocarcinoma of the prostate, post radical-prostatectomy
- Detectable prostate-specific antigen (PSA)
- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
- No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan
- No definitive findings of systemic (extrapelvic) metastasis on CT and/or magnetic resonance (MR) scan of pelvis (and, if performed, abdomen)
- Willingness to undergo pelvic radiotherapy
Treatment Sites in Georgia
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