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

NCT05744115 | Terminated Phase 3 FDA Drug

• 1 other identifier: 2031231
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

PSMA; Biochemically Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Ga-68-PSMA-11 PET/CT

EXPERIMENTAL

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

Drug: Ga-68-PSMA-11

Interventions

Ga-68-PSMA-11 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

Ga-68-PSMA-11 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male Veterans over the age of 18 years with previously diagnosed prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Truman VA Hospital

Columbia, Missouri, 65201, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Timothy J Hoffman, PhD

  Truman VA Hospital; Columbia, MO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Career Scientist

Model Details: 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).

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 24, 2023
• Study Start: July 27, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)