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Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes

Status
Active
Cancer Type
Prostate Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male
Study Type
Treatment
NCD ID
NCT03762759
Protocol IDs
RAD4516-18 (primary)
NCI-2018-02702
IRB00106863
Study Sponsor
Emory University Hospital / Winship Cancer Institute

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.
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