CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 163 enrolled
Drug / intervention
Gallium Ga 68 Gozetotide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05547386
NCT05547386Phase 3Completed

68Ga-PSMA-11 PET/CT for Screening Prior to 177Lu-PSMA-617 Therapy

Mayo Clinic·interventional·Posted Sep 21, 2022·Updated Jul 18, 2025

In Brief

A Phase 3 clinical trial evaluating Computed Tomography, Gallium Ga 68 Gozetotide, and 1 other intervention for Castration-Resistant Prostate Carcinoma and 2 related conditions. Completed, enrolled 163 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedSep 21, 2022
Enrollment StartMay 9, 2022
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.8 years ago

Interventions

Computed Tomographyprocedure

Undergo PET/CT scan

Gallium Ga 68 Gozetotidedrug

Given IV

Positron Emission Tomographyprocedure

Undergo PET/CT scan