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

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.