PSMA PET Scan and mpMRI for Prostate Cancer Detection

Prostate Cancer Diagnosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05820724
• Other study ID #: 1685514-1
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2023
• Source: VA Greater Los Angeles Healthcare System
• Contact: William Aronson, MD
• Phone: 310-268-3446
• Email: william.aronson[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer Diagnosis
• Prostatic Neoplasms

Intervention

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

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System	Lantheus Medical Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Clinically Significant Prostate Cancer	Percentage of mpMRI and PSMA PET lesions positive for clinically significant prostate cancer	12 weeks
Secondary	Detection of Clinically Insignificant Prostate Cancer	Percentage of mpMRI and PSMA PET lesions positive for clinically insignificant prostate cancer.	12 weeks
Secondary	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
Secondary	Correlation of PSMA PET intensity with Clinically Significant Prostate Cancer	Correlate intensity of PSMA PET lesions with clinically significant prostate cancer.	12 weeks
Secondary	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
Secondary	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