PRostate Evaluation for Clinically Important Disease: Sampling Using Image-guidance Or Not?

Summary

This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each participant will be randomly allocated to one of the biopsy tests.

We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS biopsy.

Conditions

• Prostate Neoplasm

Interventions

DEVICE

MRI

This will be a multi-parametric MRI of the prostate

PROCEDURE

MRI-targeted biopsy

This will be a biopsy targeted to suspicious areas on the MRI

PROCEDURE

TRUS-biopsy

This will be a standard 12 core trans-rectal prostate biopsy

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• University Hospital, Lille

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• London North West Healthcare NHS Trust

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• University College London Hospitals

  collaborator OTHER

• University Ghent

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Jewish General Hospital

  collaborator OTHER

• University of Roma La Sapienza

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Hunter Holmes Mcguire Veteran Affairs Medical Center

  collaborator FED

• University Hospital Heidelberg

  collaborator OTHER

• University Hospital, Aachen

  collaborator OTHER

• Hampshire Hospitals NHS Foundation Trust

  collaborator OTHER

• Princess Alexandra Hospital NHS Trust

  collaborator OTHER

• San Raffaele University Hospital, Italy

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• University Hospital Southampton NHS Foundation Trust

  collaborator OTHER

• University of Oulu

  collaborator OTHER

• The Whittington Hospital NHS Trust

  collaborator OTHER_GOV

• University Hospital of Cologne

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Centro de Urologia Argentina

  collaborator UNKNOWN

• Weill Medical College of Cornell University

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• University College, London

  lead OTHER

Principal Investigators

• Caroline Moore, MD FRCS · University College Hospital London and University College London

• Mark Emberton, MD FRCS · University College Hospital London and University College London

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• United Kingdom

Study Locations