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

NCT ID: NCT05547386

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2023-12-31

Brief 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.

Detailed 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.

Conditions

Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Observational (68Ga-PSMA-11 PET/CT)

Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial.

Group Type: EXPERIMENTAL

Computed Tomography

Intervention Type: PROCEDURE

Undergo PET/CT scan

Gallium Ga 68 Gozetotide

Intervention Type: DRUG

Given IV

Positron Emission Tomography

Intervention Type: PROCEDURE

Undergo PET/CT scan

Interventions

Computed Tomography

Undergo PET/CT scan

Intervention Type: PROCEDURE

Gallium Ga 68 Gozetotide

Given IV

Intervention Type: DRUG

Positron Emission Tomography

Undergo PET/CT scan

Intervention Type: PROCEDURE

Other Intervention Names

CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT; CT Scan; tomography; (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC; (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC; (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; (68Ga)Glu-urea-Lys(Ahx)-HBED-CC; 68Ga-DKFZ-PSMA-11; 68Ga-HBED-CC-PSMA; 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC; 68Ga-PSMA; 68Ga-PSMA-11; 68Ga-PSMA-HBED-CC; [68Ga] Prostate-specific Membrane Antigen 11; [68Ga]GaPSMA-11; Ga PSMA; Ga-68 labeled DKFZ-PSMA-11; Ga-68 labeled PSMA-11; GA-68 PSMA-11; Gallium Ga 68 PSMA-11; Gallium Ga 68-labeled PSMA-11; GALLIUM GA-68 GOZETOTIDE; Gallium-68 PSMA; Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; GaPSMA; PSMA-HBED-CC GA-68; Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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) for PSMA-targeted radionuclide therapy by a nuclear medicine physician or Radiologist in the 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 radionuclide therapy in all regards except for having completed a PSMA-targeted PET scan showing PSMA-positive prostate cancer
• It is acceptable for a patient to be potentially eligible for therapy, but have a relative contraindication, such as a minor laboratory abnormality, and be on the 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/magnetic resonance (MR), or for whom a repeat 68Ga-PSMA-11 PET/CT exam is needed per the clinical 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 Criteria

• A patient who is unable to consent per Mayo guidelines
• A patient who is unable to lay still, or otherwise successfully complete the imaging exam

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Geoffrey Johnson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geoffrey B. Johnson, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2022-04135

Identifier Type: REGISTRY

Identifier Source: secondary_id

22-003732

Identifier Type: -

Identifier Source: org_study_id