Fluciclovine F18 or Gallium Ga 68-labeled PSMA-11 PET/CT in Enhancing Outcomes in Patients with Prostate Adenocarcinoma

Active:	Yes
Cancer Type:	Prostate Cancer Unknown Primary	NCT ID:	NCT03762759
Trial Phases:	Phase II	Protocol IDs:	RAD4516-18 (primary) NCI-2018-02702 IRB00106863
Eligibility:	18 Years and older, Male	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT03762759

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.

Treatment Sites in Georgia

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Grady Memorial Hospital
80 Jesse Hill Jr. Drive, SE
Atlanta, GA 30303
www.gradyhealth.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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