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

Virginia Commonwealth University28 enrolled

Overview

Phase II non-inferiority randomized trial of annual systematic biopsies versus mpMRI and targeted biopsies for men with low risk prostate cancer on active surveillance with any volume Gleason's Score 6, but no prior MRI imaging of the prostate.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Cancer Prostate Adenocarcinoma Multiparametric MRI Gleason's Score 6

Interventions

TRUS-guided biopsyPROCEDURE

Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance.

mpMRI with targeted biopsyPROCEDURE

Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hunter Holmes Mcguire Veteran Affairs Medical Center

Richmond, Virginia, United States

Outcomes

Primary Outcomes

To asses the detection rate of Gleason score ≥ 4+3 in patients with low-risk prostate cancer who undergo transrectal ultrasound (TRUS) biopsy-based active surveillance (Group 1) versus patients who undergo mpMRI-based active surveillance (Group 2).

Time frame: 3 years

Secondary Outcomes

Percentage of patients in Group 1 versus Group 2 who remain on active surveillance from the time of randomization until the end of study participation.

To compare adherence with active surveillance requirements in Group 1 versus Group 2.

Time frame: 3 years

To compare the rate of biopsy-related infections in Group 1 versus Group 2.

Time frame: 3 years

To compare the missed rate of occult Gleason score ≥ 4+3 by template biopsy at end of study in Group 1 versus Group 2.

Time frame: 3 years

Data from ClinicalTrials.gov

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