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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of a Novel, Non-Invasive Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and Patients at Risk of Harboring Low-Risk Prostate Cancer: A Prospective Non-Randomized Clinical Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: virtual biopsy (VB) monitoring protocol


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual prostate biopsy (VB) monitoring<br>Prostate-specific antigen (PSA) and digital rectal exam (DRE) are standard of care for monitoring patients on active surveillance or at risk of having low-risk prostate cancer. A novel virtual biopsy (VB) monitoring protocol will be implemented: PSA bi-annually or more often according to the discretion of the urologist. Annual DRE. Visit with the urologist bi-annually. Multi-parametric MRI (mpMRI) every year for 3 years. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year. | Diagnostic Test: virtual biopsy (VB) monitoring protocol<br>* PSA bi-annually or more often according to the discretion of the urologist. Annual DRE. Visit with the urologist bi-annually. Multi-parametric MRI (mpMRI) every year for 3 years. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 3 years from start of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance Imaging (MRI)