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ACTIVE NOT RECRUITING
NCT05160597
EARLY_PHASE1

Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy

Sponsor: Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

This early phase I trial studies how well an image-guided prostate biopsy using the imaging agent 68Ga-prostate-specific membrane antigen (PSMA)-11 with a positron emission tomography/computed tomography (PET/CT) scan works in diagnosing prostate cancer in men with a prior negative or inconclusive prostate biopsy. PSMA is a protein that is found on the surface of prostate cancer cells. 68Ga-PSMA-11 is made up of a substance that binds to PSMA on tumor cells, linked with a radioactive substance that can then be seen on imaging scans such as PET/CT. 68Ga-PSMA-11 PET/CT-guided biopsy may help improve the detection rate of prostate cancer. This may help reduce over-diagnosis and over-treatment in men with low-risk prostate cancer and under-treatment in men with high-risk prostate cancer.

Official title: Evaluation of 68Ga-PSMA-11 PET Guided Prostate Biopsy in Men With Suspicion of Clinically Significant Prostate Cancer and Prior Negative/Inconclusive Biopsy: A Prospective Exploratory Study

Key Details

Gender

MALE

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-01-13

Completion Date

2027-01-07

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

PROCEDURE

Biopsy of Prostate

Undergo image-guided prostate biopsy

OTHER

Gallium Ga 68 Gozetotide

Given IV

PROCEDURE

Transrectal Ultrasonography Guided Biopsy

Undergo standard of care TRUS

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States