Prostate Specific Membrane Antigen (PSMA) Scan and Multiparametric MRI for Prostate Biopsy Detection of Clinically Significant Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- PSMA PET scan
- Conditions
- Prostate Cancer Diagnosis
- Sponsor
- VA Greater Los Angeles Healthcare System
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Detection of Clinically Significant Prostate Cancer
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
PSMA PET+mpMRI
PSMA PET+mpMRI guided prostate biopsy
Intervention: PSMA PET scan
PSMA PET+mpMRI
PSMA PET+mpMRI guided prostate biopsy
Intervention: 18F- DCFPyl Injection
mpMRI only
mpMRI only guided prostate biopsy
Intervention: No PSMA PET
Outcomes
Primary Outcomes
Detection of Clinically Significant Prostate Cancer
Time Frame: 12 weeks
Percentage of mpMRI and PSMA PET lesions positive for clinically significant prostate cancer
Secondary Outcomes
- Detection of Clinically Insignificant Prostate Cancer(12 weeks)
- Difference in PSMA PET and mpMRI Clinically Significant Cancer Detection(12 weeks)
- Correlation of AI Measures with Aggressiveness of Prostate Cancer(12 weeks)
- Correlation of PSMA PET intensity with Clinically Significant Prostate Cancer(12 weeks)
- Adverse Events Associated with 18F- DCFPyl(12 weeks)