Spots Global Cancer Trial Database for Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer

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Trial Identification

Brief Title: Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer

Official Title: 68Ga-NeoBOMB1 and 68Ga-PSMA R2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer

Study ID: NCT03698370

Conditions

Prostate Adenocarcinoma

PSA Progression

Recurrent Prostate Carcinoma

Interventions

Gallium Ga 68 DOTA-NeoBOMB1

Gallium Ga 68 PSMA-R2

Study Description

Brief Summary: This phase II trial studies how well gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 positron emission tomography (PET)/magnetic resonance imaging (MRI) work in diagnosing participants with prostate cancer that has come back. Diagnostic procedures, such as gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 PET/MRI, may help find and diagnose prostate cancer and find out how far the disease has spread.

Detailed Description: PRIMARY OBJECTIVES: I. To evaluate gallium Ga 68 DOTA-NeoBOMB1 (68Ga-NeoBOMB1) and gallium Ga 68 PSMA-R2 (68Ga-PSMA R2) PET/MRI for detection of recurrent prostate cancer after initial therapy in patients meeting the criterion of biochemical recurrence. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive gallium Ga 68 DOTA-NeoBOMB1 intravenously (IV) and 45 minutes later, undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 PSMA-R2 IV then undergo PET/MRI 45-60 minutes later. ARM II: Participants receive gallium Ga 68 PSMA-R2 IV and 45-60 minutes later undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 DOTA-NeoBOMB1 IV then undergo PET/MRI 45 minutes later. After completion of study, participants are followed up at 12 months.