Spots Global Cancer Trial Database for Ga-68-PSMA-11 in Men With Prostate Cancer

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Trial Identification

Brief Title: Ga-68-PSMA-11 in Men With Prostate Cancer

Official Title: Utility of Ga-68-PSMA-11 in Management of Prostate Cancer

Study ID: NCT05744115

Conditions

Prostate Cancer

Prostate Adenocarcinoma

Interventions

Ga-68-PSMA-11

Study Description

Brief Summary: The purpose of this study is to provide access to Ga-68-PSMA-11 PET for evaluation of male veterans with newly diagnosed or biochemically recurrent prostate cancer. All patients will receive conventional imaging (MRI, CT, and/or a molecular imaging bone scan) as well as Ga-68-PSMA-11 PET in order to evaluate the utility of diagnostic testing in patients with positive PSA status, a comparison of results from conventional imaging and PSMA PET imagining will be performed.

Detailed Description: Participants (male veterans) with initial diagnosis of prostate cancer or biochemically recurrent disease that consent to participate in the study will receive both conventional imaging (MRI, CT, and/or molecular imaging bone scan) as well as Ga-68-PSMA-11 PET/CT. Following baseline assessment (Visit #1), Ga-68-PSMA-11 (3-7 mCi) will be administered as a single intravenous administration with PET/CT performed approximately 60 minutes after injection (Visit #2A). At approximately 120 minutes after injection of Ga-68-PSMA-11, the final evaluation for safety and tolerability will occur (Visit #2B)