Ga-68-PSMA-11 in Men With Prostate Cancer

Phase 3

Terminated

• Conditions: Prostate Adenocarcinoma; Prostate Cancer
• Interventions: Drug: Ga-68-PSMA-11

• Registration Number: NCT05744115
• Lead Sponsor: Timothy Hoffman

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)

Study Timeline

• Study Start: 2021-07-27
• Primary Completion: 2022-04-14
• Study Completion: 2022-04-14
• Status Verified: 2023-02
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Study First Posted: 2023-02-24
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 38

Inclusion Criteria

• Able to tolerate PET/CT imaging and one or more of the following:
• Patients with newly diagnosed prostate cancer with primary staging classified at high/intermediate risk per NCCN guidelines OR
• Biochemical Recurrence: Patients with rising PSA after definitive therapy with prostatectomy or radiation therapy or other local therapies

Exclusion Criteria

• Claustrophobia or any other condition that would preclude PET/CT imaging.
• Any constellation of medical conditions that indicate expectancy of less than one year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ga-68-PSMA-11 PET/CT	Ga-68-PSMA-11	Administration of Ga-68-PSMA-11 and acquisition of PET/CT

Primary Outcome Measures

Name	Time	Method
Concurrence with Conventional Imaging	Up to 28 days	Localized vs extra-pelvic recurrence will be determined for each patient based on Ga-68-PSMA-11 PET/CT and standard-of-care radiological imaging

Trial Locations

Locations (1)

Truman VA Hospital; 🇺🇸 Columbia, Missouri, United States