Ga-68-PSMA-11 in Men With Prostate Cancer (Ga68-PSMA-11)

Timothy Hoffman

Status and phase: Terminated; Phase 3

Conditions: Prostate Adenocarcinoma; Prostate Cancer

Treatments: Drug: Ga-68-PSMA-11

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05744115

2031231

Details and patient eligibility

About

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.

Full 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)

Enrollment: 38 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Ga-68-PSMA-11 PET/CT

Experimental group

Description:

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

Treatment:

Drug: Ga-68-PSMA-11