68Ga-PSMA-11 PET in Patients With Prostate Cancer

Last updated: October 27, 2023
Sponsor: University of Colorado, Denver
Overall Status: Completed

Phase

3

Condition

Adenocarcinoma

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

Ga-PSMA-11

Clinical Study ID

NCT05197257
21-4070.cc
  • Ages 18-100
  • Male

Study Summary

Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histopathologically proven prostate adenocarcinoma
  • Age ≥ 18 years
  • Patients already diagnosed with prostate cancer: Primary Staging: intermediate andhigh-risk patients per NCCN guidelines
  • Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy orradiation therapy (external beam or brachytherapy): a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equalto 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a seconddetermination of a PSA level of >0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenixconsensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA
  • Ability to understand a written informed consent document, and the willingness to signit.

Exclusion

Exclusion Criteria:

  • Unable to lie flat, still or tolerate a PET/CT scan, or any other condition that wouldpreclude PET/CT imaging.
  • Patients with any medical condition or circumstance that the investigator believes maycompromise the data collection or lead to a failure to fulfil the study requirements.
  • Patients with known hypersensitivity to the active substance or to any of theexcipients of the investigational product.

Study Design

Total Participants: 39
Treatment Group(s): 1
Primary Treatment: Ga-PSMA-11
Phase: 3
Study Start date:
September 29, 2021
Estimated Completion Date:
April 14, 2022

Study Description

This is a prospective, Phase III, single-center, open-label to provide extended access in patients with biochemically recurrent prostate cancer. Approximately 100 patients are planned for enrollment in this study. Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

The intervention is a PET scan with the radiolabelled Prostate-specific membrane antifen (PSMA) ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.

AEs will be collected during injection and uptake phase (45-120 min posts infusion) of Ga-68 PSMA-11 PET/CT scan. All safety events will be recorded up to 120 min post injection.

Men with pathologically proven prostate adenocarcinoma, high risk cancer at diagnosis, evidence of biochemical recurrence, or known metastatic disease planned to start and change systemic therapy regimen.

One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with 100 MBq (3mCi)-300 MBq( 7mCi) of 68Ga-PSMA-11 via this catheter.

Connect with a study center

  • Colorado Research Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • UCHealth-Metro Denver

    Denver, Colorado 80217-3364
    United States

    Site Not Available

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