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

Prostate Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160597
• Other study ID #: 21-001122
• Secondary ID: NCI-2021-12975
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 13, 2022
• Est. completion date: January 7, 2026

Study information

• Verified date: February 2024
• Source: Jonsson Comprehensive Cancer Center
• Contact: Wesley Armstrong
• Phone: 310-206-1146
• Email: warmstrong[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 7, 2026
• Est. primary completion date: January 7, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Men with suspicion of clinically significant prostate cancer with prior inconclusive, discordant or negative magnetic resonance imaging/ultrasound (MRI/US) fusion prostate biopsy

• Scheduled for a repeat transrectal ultrasound (TRUS) prostate biopsy by standard of care

• Focal 68Ga-PSMA-11 uptake within the prostate

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)

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

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

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of clinically significant prostate cancer	Defined as the percentage of clinically significant prostate cancer (Gleason score 7 or more) in patients with focal 68Ga-PSMA-11 uptake within the prostate	Up to 3 years