Spots Global Cancer Trial Database for Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer

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Trial Identification

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

Official Title: 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

Study ID: NCT03823001

Conditions

Prostate Cancer

Interventions

virtual biopsy (VB) monitoring protocol

Study Description

Brief Summary: 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: 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.