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

Phase

Condition

Prostate Cancer

Urologic Cancer

Carcinoma

Treatment

Transrectal Ultrasonography Guided Biopsy

Biopsy of Prostate

Gallium Ga 68 Gozetotide

Clinical Study ID

NCT05160597

21-001122

NCI-2021-12975

Ages 18-90
Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Men with suspicion of clinically significant prostate cancer with priorinconclusive, discordant or negative magnetic resonance imaging/ultrasound (MRI/US)fusion prostate biopsy
Scheduled for a repeat transrectal ultrasound (TRUS) prostate biopsy by standard ofcare
Focal 68Ga-PSMA-11 uptake within the prostate

Exclusion

Exclusion Criteria:

Negative 68Ga-PSMA-11 uptake within the prostate (screening failure)
Age < 18 and > 90 years
Recurrent prostate cancer
Inability to provide written informed consent
Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)

Study Design

Transrectal Ultrasonography Guided Biopsy

January 13, 2022

January 07, 2027

Study Description

PRIMARY OBJECTIVE:

I. To assess the detection rate of clinically significant prostate cancer (Gleason score 7 or more) in patients with focal gallium Ga 68 gozetotide (68Ga-PSMA-11) uptake within the prostate.

OUTLINE:

SCREENING PROCEDURE: Patients receive 68Ga-PSMA-11 intravenously (IV) and 50-100 minutes later, undergo a PET/CT scan. Only patients with 68Ga-PSMA-11 uptake within the prostate proceed to image-guided biopsy.

IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care transrectal ultrasonography guided biopsy (TRUS).

Connect with a study center

UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California 90095
United States
Site Not Available
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90095
United States
Site Not Available

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