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

Multiparametric MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Cancer (MAVERICK)

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer; Prostate Adenocarcinoma; Multiparametric MRI; Gleason's Score 6
• Intervention / Treatment: Procedure: TRUS-guided biopsy; Procedure: mpMRI with targeted biopsy

Detailed Description

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
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes Mcguire Veteran Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 (TRUS-guided biopsy); Baseline and annual systematic TRUS-guided biopsy performed as per standard of care by urologists for a total of one baseline diagnostic biopsy and two active surveillance systematic biopsies.; mpMRI at the end of the 2nd year with targeted biopsy of any Prostate Imaging Reporting and Data System (PI-RADS) 4 or 5 lesion. Patients needing image- guided targeted biopsies will undergo this procedure by interventional radiology, which is a common standard of care at HHM VAMC.; Optional transperineal template biopsy of the prostate performed at end of 2nd year (month 25-30).; Patients will be followed, as per standard of care, for any potential infections from biopsies.; Annual PSA tests performed as per routine standard of care.	Procedure: TRUS-guided biopsy; Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance.
Experimental: Group 2 (mpMRI with targeted biopsy); Baseline systematic transrectal ultrasound-guided biopsy performed as per standard of care by urologists.; Baseline and annual mpMRI with targeted biopsy of any Prostate Imaging Reporting and Data System (PI-RADS) 4 or 5 lesion. Patients needing image- guided targeted biopsies will undergo this procedure by interventional radiology, which is a common standard of care at HHM VAMC.; Optional transperineal template biopsy of the prostate performed at end of 2nd year (month 25-30).; Patients will be followed, as per standard of care, for any potential infections from biopsies.; Annual PSA tests performed as per routine standard of care.	Procedure: mpMRI with targeted biopsy; Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years
To compare the rate of biopsy-related infections in Group 1 versus Group 2.		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.		3 years

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Massey Cancer Center; Hunter Holmes Mcguire Veteran Affairs Medical Center
• Investigators: Principal Investigator: Drew Moghanaki, MD, MPH, Massey Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2015
• Primary Completion (Actual): June 28, 2016
• Study Completion (Actual): October 13, 2017

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): September 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: low risk prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: MCC-14-10633; NCI-2015-01739 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 02147 (Other Identifier: Hunter Holmes McGuire VAMC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No