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

Case Comprehensive Cancer Center

Overview

The purpose of this study is to examine the use of MRI surveillance for patients with no prostate cancer, potential prostate cancer, or diagnosed low-grade 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Prostate Cancer

Interventions

virtual biopsy (VB) monitoring protocolDIAGNOSTIC_TEST

1. PSA bi-annually or more often according to the discretion of the urologist. 2. Annual DRE. 3. Visit with the urologist bi-annually. 4. Multi-parametric MRI (mpMRI) every year for 3 years. 5. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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.

Locations (1)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria)

Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria). This metric will determine if the the VB protocol is statistically equal to (or greater than) the negative predictive value of the standard of care TRUS prostate biopsy.

Time frame: Up to 3 years from start of study

Data from ClinicalTrials.gov

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