68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer

Last updated: July 8, 2025
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

3

Condition

Carcinoma

Urologic Cancer

Prostate Disorders

Treatment

Computed Tomography

Positron Emission Tomography

Gallium Ga 68 Gozetotide

Clinical Study ID

NCT05547386
22-003732
NCI-2022-04135
  • Ages > 18
  • Male

Study Summary

This phase III study provides access to 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) imaging for patients with castrate-resistant prostate cancer that has spread to other places in the body (metastatic) being considered for177Lu-PSMA-617 therapy. T PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of this tracer. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Combining a PET scan with a CT scan can help make the images easier to interpret. The 68Ga-PSMA-11 PET/CT scan is done with a very small amount of radioactive tracer call 68- gallium PSMA-11. In patients that have been diagnosed with prostate cancer, a protein called prostate-specific membrane antigen (PSMA) appears in large amounts on the surface of the cancerous cells. The radioactive imaging agent (68Ga-PSMA-11) has been designed to circulate through the body and attach itself to the PSMA protein on prostate cancer cells. A PET/CT scan is then used to detect the location of prostate cancer lesions. By gaining access to 68Ga-PSMA-11 PET/CT scans, patients may be safely screened for 177Lu-PSMA-617 therapy in the treatment of metastatic castrate resistant prostate cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • An adult male patient who is actively under the care of a medical oncology,radiation oncology or urology physician at Mayo Clinic

  • An adult male patient who is deemed eligible (or potentially/likely eligible) forPSMA-targeted radionuclide therapy by a nuclear medicine physician or Radiologist inthe nuclear medicine therapy practice, or by the Prostate Theranostic Tumor Board (PTuB)

  • Eligibility will be documented in the medical record by the clinical practice

  • It is acceptable for the patient to be eligible for PSMA-targeted radionuclidetherapy in all regards except for having completed a PSMA-targeted PET scanshowing PSMA-positive prostate cancer

  • It is acceptable for a patient to be potentially eligible for therapy, but havea relative contraindication, such as a minor laboratory abnormality, and be onthe list for discussion at the PTuB in the future

  • An adult male patient who has not received a 68Ga-PSMA-11 PET/CT or PET/magneticresonance (MR), or for whom a repeat 68Ga-PSMA-11 PET/CT exam is needed per theclinical practice to ensure eligibility

  • An adult male patient who does not otherwise have access to a reimbursable clinical 68Ga-PSMA-11 PET scan

  • An adult above the ages of 18

Exclusion

Exclusion Criteria:

  • A patient who is unable to consent per Mayo guidelines

  • A patient who is unable to lay still, or otherwise successfully complete the imagingexam

Study Design

Total Participants: 163
Treatment Group(s): 3
Primary Treatment: Computed Tomography
Phase: 3
Study Start date:
May 09, 2022
Estimated Completion Date:
December 31, 2023

Study Description

PRIMARY OBJECTIVE:

I. To overcome a clinical access issue that would otherwise block patients from reimbursement of a new cancer therapy, and therefore block or significantly delay their care.

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV) and then undergo a positron emission tomography (PET)/computed tomography (CT) scan throughout the trial.

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

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