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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02564549

Enrollment

Registered

2015-09-30

Start date

2015-10-05

Completion date

2017-10-13

Last updated

2017-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

low risk prostate cancer

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.

Interventions

PROCEDURETRUS-guided biopsy

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

PROCEDUREmpMRI 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame	Description
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.	3 years	To compare adherence with active surveillance requirements in Group 1 versus Group 2.
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026