68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer
68Ga-PSMA-11 PET/CT for Screening Prior to 177Lu-PSMA-617 Therapy
2 other identifiers
interventional
163
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2022
CompletedFirst Submitted
Initial submission to the registry
September 14, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedResults Posted
Study results publicly available
July 9, 2025
CompletedJuly 18, 2025
July 1, 2025
1.6 years
September 14, 2022
June 20, 2025
July 8, 2025
Conditions
Outcome Measures
Primary Outcomes (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.
From the time of injection until the time after imaging scan is complete, up to 1 day
Study Arms (1)
Observational (68Ga-PSMA-11 PET/CT)
EXPERIMENTALPatients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial.
Interventions
Undergo PET/CT scan
Given IV
Undergo PET/CT scan
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Geoffrey Johnson, M.D., Ph.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey B. Johnson, M.D., Ph.D.
Mayo Clinic in Rochester
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 14, 2022
First Posted
September 21, 2022
Study Start
May 9, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
July 18, 2025
Results First Posted
July 9, 2025
Record last verified: 2025-07