Advanced Magnetic Resonance Imaging (MRI) in Men With Suspected Prostate Cancer (MULTIPROS)

June 24, 2021 updated by: Ghulam Nabi, University of Dundee

Multiparametric Magnetic Resonance Imaging Characterization and Guided Biopsy of the Prostate in Men Suspected of Having Prostate Cancer

The clinical trial aims to address the critical challenge of differentiating aggressive from indolent prostate cancers by correlating prospectively collected MultiParametric (MP) Magnetic Resonance Imaging (MRI) data (index test) with the histopathology of radical prostatectomy specimens (reference standard).

The study design incorporates pre-biopsy MRI, routine standard of care Transrectal Ultrasound guided (TRUS) biopsies and MRI/Ultrasound (US) image fusion techniques to guide biopsies to the suspicious areas identified by MRI.

The hypothesis is that MP-MRI will allow pre-treatment determination of prostate cancer aggressiveness and MRI/US image fusion is expected to accurately co-locate cancer foci within the prostate gland for guiding biopsies.

Pre-treatment prediction of Gleason grade as a marker of cancer aggressiveness will better inform clinicians and patients to improve risk stratification and facilitate decision making on subsequent treatment.

Image fusion will allow accurate targeting of the most suspicious areas on MP-MRI for biopsy, which could obviate the need for multiple biopsies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is preliminary evidence suggesting that MultiParametric Magnetic Resonance Imaging (MP-MRI) can be a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Gleason grade (GG) is a critical predictor of the aggressiveness of PCa, but in up to one in three men, the histology of radical prostatectomy specimens is different from the histology of Transrectal Ultrasound (TRUS)-guided biopsies. This discrepancy contributes to- and is a sign of- poor risk stratification of men with localised PCa.

The research aims to answer the following questions:

  1. Can image-fusion techniques allow investigators to reliably target abnormal areas seen on MP-MRI?
  2. How reliable is pre-biopsy MP-MRI in correctly predicting aggressive disease?

The investigators envisage that MP-MRI information will reduce unnecessary biopsies and over-detection of indolent PCa, while improving the detection of aggressive disease.

Primary Objectives

• To determine whether using MP-MRI can improve cancer detection and characterization of prostate cancer

Secondary Objectives

• To determine whether US/MRI FUSION guided biopsy can reduce the number of false negative biopsies.

Study Type

Interventional

Enrollment (Actual)

603

Phase

  • Not Applicable

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

  • United Kingdom
    • Tayside
      • Dundee, Tayside, United Kingdom, DD5 4NT
        • Ninewells Hospital and Medical School

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

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males between the age of 40-75 at referral
  • With at least 10 years life expectancy
  • With clinically localised PCa: Prostate Specific Antigen (PSA) ≤20 ng/ml
  • And/or abnormal Digital Rectal Examination (DRE) but < T3 disease
  • Ability to informed consent

Exclusion Criteria:

  • Unable to give informed consent
  • Prior prostatic biopsy within 12 months
  • Contraindications to biopsy
  • Poor general health and life expectancy < 10 years
  • Previous diagnosis of acute prostatitis within 12 months
  • History of prostate cancer
  • Prior transurethral prostatectomy
  • Contraindications to MRI (cardiac pacemakers, allergic reaction to gadolinium based contrast, renal function with baseline eGRF 30 ml/min, intracranial clips, claustrophobia)
  • Previous hip replacement

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: TRUS Biopsy
Standard of Care Treatment
Procedure: TRUS Biopsy
Standard of Care Treatment
OTHER: TRUS/FUSION Biopsy
Interventional Treatment
Procedure: TRUS/FUSION Biopsy
Interventional Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of prostate cancers detected by MP-MRI when compared to gold standard prostatectomy specimen
Time Frame: 5 years from first recruitment
Number of prostate cancers detected by MP-MRI when compared to gold standard
5 years from first recruitment
Number of clinically significant cancers detected by MP-MRI when compared to gold standard prostatectomy specimen
Time Frame: 5 years from first recruitment

The definition of clinically significant disease will be based on the pathologic assessment of radical prostatectomy (RP) specimen and will include the presence of any the following three prognostic factors:

o Gleason grade >= 7 with pattern 4 or/and 5 Maximum cancer focus size more than 6mm measured in the axial plane Presence of extracapsular extension (ECE)
5 years from first recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cancer detected in each randomised group, namely intervention group (TRUS/FUSION biopsy) versus standard of care (TRUS biopsy)
Time Frame: 5 years from first recruitment
Number of cancer detected in each randomised group
5 years from first recruitment
Number of significant cancer detected in each randomised group, namely intervention group (TRUS/FUSION biopsy) versus standard of care (TRUS biopsy)
Time Frame: 5 years from first recruitment
Number of significant cancer detected in each randomised group
5 years from first recruitment
Safety outcomes(death, post biopsy pain, bleeding, sepsis and hospitalization) of intervention (biopsy) in each of the two randomised groups.
Time Frame: 4 years from first recruitment
Number of participants with deaths, side effects (post biopsy pain, bleeding, sepsis and hospitalization) in each of the two randomised groups.
4 years from first recruitment
Comparison of MRI negative standard of care TRUS guided biopsies with MRI positive TRUS histopathology to facilitate analysis of diagnostic accuracy of MRI in men suspected with target condition.
Time Frame: 5 years from first recruitment
Comparison of MRI negative standard of care TRUS guided biopsies with MRI positive TRUS histopathology
5 years from first recruitment

Collaborators and Investigators

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

Sponsor

University of Dundee

Collaborators

NHS Tayside
Chief Scientist Office of the Scottish Government
Prostate Cancer UK
Tayside Clinical Trials Unit
Health Informatics Centre

Investigators

  • Study Director: Ghulam Nabi, University of Dundee

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 (ACTUAL)

December 1, 2014

Primary Completion (ACTUAL)

August 1, 2020

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (ESTIMATE)

April 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 24, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MULTIPROS Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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