PSMA PET Scan and mpMRI for Prostate Cancer Detection

VA Greater Los Angeles Healthcare System

Status and phase: Not yet enrolling; Phase 2

Conditions: Prostate Cancer Diagnosis

Treatments: Drug: 18F- DCFPyl Injection; Other: No PSMA PET; Diagnostic Test: PSMA PET scan

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT05820724

1685514-1

Details and patient eligibility

About

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.

Full description

This a prospective, randomized, phase 2 clinical trial. We will enroll patients who underwent mpMRI of the prostate as part of their standard clinical care, have PI-RADS 4, or 5 lesion(s) on mpMRI, and are scheduled to undergo fusion guided prostate biopsy. Subjects that sign the consent form will be randomized to undergo DCFPyL PET/CT imaging or no PSMA PET imaging prior to the prostate biopsy. In the PSMA scan cohort, decision for biopsy targets will be made based on the combination of the findings of mpMRI and PSMA scans. In the no PSMA scan (control) group, the biopsy will be performed based on mpMRI findings. Each patient will undergo 12 core systematic biopsy as the standard of care. Two additional biopsies for each mpMRI and PSMA PET and overlap lesion will also performed.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with PI-RADS 4-5 lesion(s) on mpMRI and have elected to undergo a prostate biopsy
• Prostate mpMRI completed within 9 months prior to enrollment
• Patient capable of providing written informed consent
• Patient willing to be randomized to prostate mpMRI only vs prostate mpMRI + DCFPyL PET/CT

Exclusion criteria

• Less than 18 years-old at the time of radiotracer administration
• Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.
• Creatinine clearance exceeding institutional requirements for prostate mpMRI

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

PSMA PET+mpMRI

Experimental group

Description:

PSMA PET+mpMRI guided prostate biopsy

Treatment:

Diagnostic Test: PSMA PET scan

Drug: 18F- DCFPyl Injection

mpMRI only

Active Comparator group

Description:

mpMRI only guided prostate biopsy

Treatment:

Other: No PSMA PET