Ga68-PSMA-11: Ga-68-PSMA-11 in Men With Prostate Cancer

Sponsor

Timothy Hoffman (U.S. Fed)

Overall Status

Terminated

CT.gov ID

NCT05744115

Collaborator

Harry S. Truman Memorial Veterans' Hospital (U.S. Fed), University of Missouri-Columbia (Other), Telix Pharmaceuticals, Ltd (Other)

Enrollment

Location

Arm

8.6

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostate Adenocarcinoma	Drug: Ga-68-PSMA-11	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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).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).

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Utility of Ga-68-PSMA-11 in Management of Prostate Cancer

Actual Study Start Date :

Jul 27, 2021

Actual Primary Completion Date :

Apr 14, 2022

Actual Study Completion Date :

Apr 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ga-68-PSMA-11 PET/CT Administration of Ga-68-PSMA-11 and acquisition of PET/CT	Drug: 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

Arm

Intervention/Treatment

Experimental: Ga-68-PSMA-11 PET/CT

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

Drug: 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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Truman VA Hospital	Columbia	Missouri	United States	65201

Sponsors and Collaborators

Timothy Hoffman
Harry S. Truman Memorial Veterans' Hospital
University of Missouri-Columbia
Telix Pharmaceuticals, Ltd

Investigators

Principal Investigator: Timothy J Hoffman, PhD, Truman VA Hospital; Columbia, MO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Timothy Hoffman, Research Career Scientist, Harry S. Truman Memorial Veterans' Hospital

ClinicalTrials.gov Identifier:

NCT05744115

Other Study ID Numbers:

2031231

First Posted:

Feb 24, 2023

Last Update Posted:

Feb 24, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Timothy Hoffman, Research Career Scientist, Harry S. Truman Memorial Veterans' Hospital

PSMA

Biochemically Recurrent Prostate Cancer

Additional relevant MeSH terms:

Prostatic Neoplasms

Gallium 68 PSMA-11

Study Results

No Results Posted as of Feb 24, 2023