PSMA PET Scan and mpMRI for Prostate Cancer Detection

Phase 2

Not yet recruiting

• Conditions: Prostate Cancer Diagnosis
• Interventions: Other: No PSMA PET; Diagnostic Test: PSMA PET scan; Drug: 18F- DCFPyl Injection

• Registration Number: NCT05820724
• Lead Sponsor: VA Greater Los Angeles Healthcare System

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-20
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24
• Study Start: 2023-05-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mpMRI only	No PSMA PET	mpMRI only guided prostate biopsy
PSMA PET+mpMRI	PSMA PET scan	PSMA PET+mpMRI guided prostate biopsy
PSMA PET+mpMRI	18F- DCFPyl Injection	PSMA PET+mpMRI guided prostate biopsy

Primary Outcome Measures

Name	Time	Method
Detection of Clinically Significant Prostate Cancer	12 weeks	Percentage of mpMRI and PSMA PET lesions positive for clinically significant prostate cancer

Secondary Outcome Measures

Name	Time	Method
Detection of Clinically Insignificant Prostate Cancer	12 weeks	Percentage of mpMRI and PSMA PET lesions positive for clinically insignificant prostate cancer.
Difference in PSMA PET and mpMRI Clinically Significant Cancer Detection	12 weeks	Percentage of PSMA PET only (mpMRI negative) and PSMA PET overlapping with mpMRI lesions positive for clinically significant prostate cancer.
Correlation of AI Measures with Aggressiveness of Prostate Cancer	12 weeks	Correlate artificial intelligence measurement(s) (miPSMA index) of PSMA lesion(s) with aggressiveness of prostate cancer
Correlation of PSMA PET intensity with Clinically Significant Prostate Cancer	12 weeks	Correlate intensity of PSMA PET lesions with clinically significant prostate cancer.
Adverse Events Associated with 18F- DCFPyl	12 weeks	Safety - Patients will be monitored for adverse events during injection and for two hours after radiotracer administration.

Trial Locations

Locations (1)

VA Greater Los Angeles Healthcare System; 🇺🇸 Los Angeles, California, United States