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

Prostate Cancer Clinical Trial

— Ga68-PSMA-11  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05744115
• Other study ID #: 2031231
• Status: Terminated
• Phase: Phase 3
• Start date: July 27, 2021
• Est. completion date: April 14, 2022

Study information

• Verified date: February 2023
• Source: Harry S. Truman Memorial Veterans' Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: April 14, 2022
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Truman VA Hospital	Columbia	Missouri

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concurrence with Conventional Imaging	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	Up to 28 days