MedTrace Logo

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

NCT02564549 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-10-19

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Massey Cancer Center

    collaborator OTHER

  • Hunter Holmes Mcguire Veteran Affairs Medical Center

    collaborator FED

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Drew Moghanaki, MD, MPH · Massey Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-05
Primary Completion
2016-06-28
Completion
2017-10-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02564549 on ClinicalTrials.gov