MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Ca

Multiparametric MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Cancer (MAVERICK)

Phase II non-inferiority randomized trial of annual systematic biopsies versus mpMRI and targeted biopsies for men with low risk prostate cancer on active surveillance with any volume Gleason's Score 6, but no prior MRI imaging of the prostate.

This is an unblinded, randomized trial of TRUS biopsy-based active surveillance versus mpMRI-based active surveillance. Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance. Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.

Inclusion Criteria:

• Prostate adenocarcinoma diagnosed by biopsy within 12 months prior to study registration.
• Gleason score ≤ 6
• PSA < 10 ng/mL
• Completed and documented history and physical addressing all inclusion/exclusion criteria.

Exclusion Criteria:

• A diagnosis of prostate adenocarcinoma on more than one set of prostate biopsies, on separate calendar dates.
• Previous MRI imaging of the prostate.
• Prior history of pelvic radiotherapy.
• Prior history of prostatectomy.
• Contraindication to prostate mpMRI (renal failure, hip prosthesis, pacemaker, etc).
• Contraindication to prostate biopsy via transrectal or transperineal approaches (including coagulopathy).
• Patients on testosterone replacement therapy who are unwilling to discontinue.
• Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements.
• Unable to understand, or unwilling to complete the informed consent process.