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NOT YET RECRUITING
NCT05820724
PHASE2

PSMA PET Scan and mpMRI for Prostate Cancer Detection

Sponsor: VA Greater Los Angeles Healthcare System

View on ClinicalTrials.gov

Summary

Prospective, randomized, phase 2 clinical trial to determine if PSMA PET imaging plus mpMRI improves detection of clinically significant prostate cancer as compared to mpMRI alone.

Official title: Prostate Specific Membrane Antigen (PSMA) Scan and Multiparametric MRI for Prostate Biopsy Detection of Clinically Significant Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-05-01

Completion Date

2026-05-01

Last Updated

2023-04-24

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

PSMA PET scan

Subjects will undergo DCFPyL PET/CT imaging and mpMRI imaging prior to the prostate biopsy. The decision for biopsy targets will be made based on the combination of the findings of mpMRI and PSMA scans. The intervention includes a mpMRI, a PSMA PET scan, and a prostate biopsy.

OTHER

No PSMA PET

Subjects will undergo mpMRI imaging prior to the prostate biopsy. These subjects do not undergo a PSMA PET scan prior to the prostate biopsy. The decision for biopsy targets will be made based on the findings of mpMRI. The intervention includes a mpMRI and a prostate biopsy.

DRUG

18F- DCFPyl Injection

DCFPyL is a PSMA imaging ligand that was developed to enhance the detection of small lesions in the prostate or other pelvic areas. 18F- DCFPyl Injection will be administered prior to the PSMA PET/CT via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access under the direct supervision of study personnel.

Locations (1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States