NCT02564549

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)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2015-10-05
• Primary completion: 2016-06-28
• Completion: 2017-10-13
• First posted: 2015-09-30
• Last updated: 2017-10-19

Locations

1 site across 1 country: United States