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

NCT ID: NCT02564549

Last Updated: 2017-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-05
• Study Completion Date: 2017-10-13

Brief Summary

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.

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Multiparametric MRI; Gleason's Score 6

Keywords

low risk prostate cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

TRUS-guided biopsy

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

mpMRI with targeted biopsy

Intervention Type: PROCEDURE

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

Interventions

TRUS-guided biopsy

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Prostate adenocarcinoma diagnosed by biopsy within 12 months prior to study registration.
• Gleason score ≤ 6
• PSA < 10 ng/mL

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Massey Cancer Center

OTHER

Sponsor Role: collaborator

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Drew Moghanaki, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Locations

Hunter Holmes Mcguire Veteran Affairs Medical Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

NCI-2015-01739

Identifier Type: REGISTRY

Identifier Source: secondary_id

02147

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-14-10633

Identifier Type: -

Identifier Source: org_study_id