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

April 30, 2018 updated by: Veeru Kasivisvanathan, University College, London

A Randomized Control Trial of Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Trans-rectal Ultrasound Guided Biopsy for the Diagnosis of Prostate Cancer in Men Without Prior Biopsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The classical pathway for the diagnosis of prostate cancer is trans-rectal ultrasound guided (TRUS) biopsy of the prostate following a raised PSA. This is currently the mainstay for prostate cancer diagnosis in the majority of centres. It has many advantages and can be performed routinely under local anaesthetic in an outpatient setting. However it does have some limitations, including the over-diagnosis of insignificant cancer and the under-diagnosis of significant cancer.

An alternative pathway for the diagnosis of prostate cancer in men with raised prostate specific antigen (PSA) is to perform a multi-parametric MRI to localize cancer and to use this information to influence conduct of a subsequent biopsy, known as an MRI-targeted biopsy. MRI-targeted biopsy has been shown in preliminary studies to detect a similar amount of clinically significant cancer to TRUS-biopsy but may have several advantages, for example in reducing the number of men who require biopsy.

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.

A 'clinically insignificant cancer' is cancer which is unlikely to progress or affect a man's life expectancy and therefore does not warrant treatment. However when diagnosed with insignificant cancer a large proportion of patients request treatment in case a more significant cancer is present. A prostate cancer detection pathway that finds significant cancers while avoiding the diagnosis of insignificant cancer is a major unmet need.

The potential implications of this trial include:

  • A redefining of the prostate cancer diagnostic pathway
  • A reduction in the number of patients undergoing prostate biopsy
  • A reduction in the number of biopsy cores taken per patient
  • A reduction in biopsy-related sepsis, pain and other side effects
  • A reduction in the over-diagnosis of clinically insignificant prostate cancer
  • A reduction of the economic burden of diagnosing and treating prostate cancer

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
  2. Serum PSA ≤ 20ng/ml within the previous 3 months
  3. Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months
  4. Fit to undergo all procedures listed in protocol
  5. Able to provide written informed consent

Exclusion Criteria:

  1. Prior prostate biopsy
  2. Prior treatment for prostate cancer
  3. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min)
  4. Contraindication to prostate biopsy
  5. Men in whom artifact would reduce the quality of the MRI
  6. Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
  7. Unfit to undergo any procedures listed in protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI-arm
Men in this arm will undergo multi-parametric MRI. In the presence of a suspicious area, a man will undergo MRI-targeted biopsy with cores targeted to the suspicious lesion. In the absence of a suspicious area, no biopsy will be taken.
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
Active Comparator: TRUS-biopsy arm
Men in this arm undergo standard 12-core trans-rectal ultrasound guided prostate biopsy
Procedure: TRUS-biopsy
This will be a standard 12 core trans-rectal prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of men with clinically significant detected
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
When histology results available, at an expected average of 30 days post-biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of men in MRI arm who avoid biopsy
Time Frame: When MRI results available, at an expected average of 30 days post-MRI
When MRI results available, at an expected average of 30 days post-MRI
Proportion of men with MRI score 3, 4 or 5 who have no clinically significant cancer detected
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
When histology results available, at an expected average of 30 days post-biopsy
Proportion of men who go on to definitive treatment for prostate cancer
Time Frame: After treatment decision, at an expected average of 30 days post-biopsy
Definitive treatment can be localised (e.g. radical prostatectomy, radiotherapy, brachytherapy) or systemic (hormone therapy, chemotherapy)
After treatment decision, at an expected average of 30 days post-biopsy
Cancer core length of the most involved biopsy core (maximum cancer core length)
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
Cancer core length in mm
When histology results available, at an expected average of 30 days post-biopsy
Proportion of men with post-biopsy adverse events
Time Frame: 30 days post biopsy
30 days post biopsy
EQ-5D-5L Quality of Life scores
Time Frame: Baseline, 24 hours post intervention and 30 days post intervention
EQ-5D gives a measure of health-related quality of life. The descriptive system gives a weighted index score from 0-1 where 1 is perfect health and 0 is the worst health possible. The visual analogue score is a measure of overall self-rated health status where 100 is the best imaginable health state and 0 is the worst imaginable health state.
Baseline, 24 hours post intervention and 30 days post intervention
Proportion of men undergoing Radical prostatectomy who have Gleason grade upgrading
Time Frame: An expected average of 90 days post-biopsy
An expected average of 90 days post-biopsy
Cost per diagnosis of cancer
Time Frame: 30 days post-biopy
30 days post-biopy
Proportion of men with clinically insignificant detected
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
When histology results available, at an expected average of 30 days post-biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

M.D. Anderson Cancer Center
Mayo Clinic
Radboud University Medical Center
Sunnybrook Health Sciences Centre
University College London Hospitals
Göteborg University
Helsinki University Central Hospital
University of Chicago
University of Roma La Sapienza
Weill Medical College of Cornell University
Erasmus Medical Center
University Hospital, Bordeaux
Royal Free Hospital NHS Foundation Trust
University Hospital Heidelberg
University Hospital, Lille
Jewish General Hospital
University Hospital Southampton NHS Foundation Trust
University Ghent
National Institute for Health Research, United Kingdom
University of Oulu
University Hospital of Cologne
London North West Healthcare NHS Trust
Princess Alexandra Hospital NHS Trust
University Hospital, Aachen
San Raffaele University Hospital, Italy
Hunter Holmes Mcguire Veteran Affairs Medical Center
Hampshire Hospitals NHS Foundation Trust
The Whittington Hospital NHS Trust
Centro de Urologia Argentina

Investigators

  • Study Chair: Caroline Moore, MD FRCS, University College Hospital London and University College London
  • Study Chair: Mark Emberton, MD FRCS, University College Hospital London and University College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRF-2014-07-146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Neoplasm

Clinical Trials on MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe