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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2022-04-14

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Prostate Cancer Prostate Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All eligible and consenting participants (male veterans) will receive a single administration of 3-7mCi Ga-68-PSMA-11 per enrollment in addition to conventional imaging (MRI, CT, and/or molecular imaging bone scan).

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ga-68-PSMA-11 PET/CT

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

Group Type EXPERIMENTAL

Ga-68-PSMA-11

Intervention Type DRUG

Ga-68-PSMA-11 is produced via a lyophilized Sterile Cold kit. Ga-68 is eluted from a Ge-68/Ga-68 generator into a vial containing the premixed peptide and buffer. PSMA-11 radiolabeled with Ga-68 is administered to patients following verification of standard quality controls including activity measurement, pH, radiochemical purity, and visual inspection

Interventions

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Ga-68-PSMA-11

Ga-68-PSMA-11 is produced via a lyophilized Sterile Cold kit. Ga-68 is eluted from a Ge-68/Ga-68 generator into a vial containing the premixed peptide and buffer. PSMA-11 radiolabeled with Ga-68 is administered to patients following verification of standard quality controls including activity measurement, pH, radiochemical purity, and visual inspection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No