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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified June 2025 by Mayo Clinic
Sponsor
Mayo Clinic
Information Provided by (Responsible Party)
Geoffrey Johnson
Clinicaltrials.gov Identifier
NCT05547386
Other Study ID Numbers:
22-003732
First Submitted
September 13, 2022
First Posted
September 20, 2022
Results First Posted
June 19, 2025
Last Update Posted
July 17, 2025
Last Verified
June 2025

ClinicalTrials.gov processed this data on July 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

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.

Condition or DiseaseIntervention/Treatment
Castration-Resistant Prostate CarcinomaMetastatic Prostate CarcinomaStage IVB Prostate Cancer AJCC v8
Procedure: Computed Tomography

Study Design

Study TypeInterventional
Actual Enrollment163 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official Title68Ga-PSMA-11 PET/CT for Screening Prior to 177Lu-PSMA-617 Therapy
Study Start DateMay 8, 2022
Actual Primary Completion DateDecember 30, 2023
Actual Study Completion DateDecember 30, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
Observational (68Ga-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial.
Procedure: Computed Tomography
Undergo PET/CT scan

Outcome Measures

Primary Outcome Measures
  1. Patients Reporting Adverse Reactions
    Safety of gallium Ga 68 gozetotide \[68Ga-prostate-specific membrane antigen (PSMA)-11\] assessed by the number of patients reporting unexpected adverse reactions from the time of injection until the time they leave the care of the division of nuclear medicine. If any adverse reactions are reported, the patient will be evaluated by a nurse and/or physician and will receive appropriate care. The principal investigator (PI) or those designated by the PI will ascertain the severity of the adverse event and how likely the adverse reaction was associated with the injected 68Ga-PSMA-11.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyMale
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsMayo Clinic
Locations
Mayo Clinic in Rochester | Rochester Minnesota, United States, 55905
Investigators
Principal Investigator: Geoffrey B. Johnson, M.D., Ph.D., Mayo Clinic in Rochester
Study Documents (Full Text)
Documents provided by Mayo Clinic: Study Protocol  September 21, 2022Documents provided by Mayo Clinic: Informed Consent Form  May 2, 2023