PSMA PET Scan and mpMRI for Prostate Cancer Detection

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer Diagnosis

Intervention / Treatment
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* Diagnostic Test: PSMA PET scan
* Other: No PSMA PET
* Drug: 18F- DCFPyl Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSMA PET+mpMRI<br>PSMA PET+mpMRI guided prostate biopsy | Diagnostic Test: PSMA PET scan<br>* 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.<br>* Other names: DCFPyL PET/CT imaging;Drug: 18F- DCFPyl Injection<br>* 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.<br>* Other names: DCFPyl;|
| Active Comparator: mpMRI only<br>mpMRI only guided prostate biopsy | Other: No PSMA PET<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Clinically Significant Prostate Cancer | Percentage of mpMRI and PSMA PET lesions positive for clinically significant prostate cancer | 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psma PETCT, prostate mpMRI, prostate needle biopsy, DCFPyL PET/CT