Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer

This study will use MRI instead of prostate biopsy in combination with regularly scheduled
urologist visits, interval PSA checks, and annual DRE to help establish a non-invasive method
for 1) participants with a negative prostate MRI (PI-RADS 1 or 2) who have never had a
biopsy; 2) participants with a positive MRI (PI-RADS score of 3, 4, or 5) and negative
MRI-targeted biopsy pathology; and 3) monitoring participants with clinically diagnosed low
risk prostate cancer who are on active surveillance. However, if at any point, clinical
suspicion indicated either by the presence of suspicious lesions on the MRI, rising PSA,
and/or positive DRE arises, then an immediate biopsy will be performed.

Inclusion Criteria:

- Biopsy-naive patients with a negative prostate MRI (PI-RADS score 1 or 2); or

- Patients with a PI-RADS score of 3, 4, or 5 on MRI and a negative MR-targeted biopsy;
or

- Patients on active surveillance with a negative prostate MRI (PI-RADS 1 or 2).

Exclusion Criteria:

- Positive DRE;

- PSA > 10 ng/ml or unstable PSA (doubling time <3 years) during the last year prior to
enrolling in this study;

- PSAD > 0.15 (calculated using most recent PSA divided by MRI prostate volume);

- First degree relative diagnosed with prostate cancer

- First degree relative diagnosed with a BRCA2 or Lynch syndrome associated gene causing
any cancer.

- Patient carries a mutation on BRCA2 or a mismatch repair gene associated with Lynch
syndrome (MLHl, MSH2, MSH6, PMS2); known BRCA2 or known mismatch repair gene mutation
in the family (Lynch Syndrome) and patient has not had testing; or family history
consistent with BRCA2 or Lynch syndrome and there is no known BRCA2 or mismatch repair
gene in the family.