MRI in Diagnosing Prostate Cancer

August 6, 2013 updated by: University College London Hospitals

PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find prostate cancer and learn the extent of disease.

PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in diagnosing prostate cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To determine the ability of multiparametric magnetic resonance imaging (MP-MRI) to identify men who can safely avoid unnecessary biopsy.
  • To assess the ability of the MP-MRI-based diagnostic pathway to improve the rate of detection of clinically significant cancer as compared to transrectal ultrasound (TRUS) biopsy.
  • To estimate the cost-effectiveness of an MP-MRI based diagnostic pathway.

OUTLINE: This is a multicenter study.

Patients undergo multiparametric magnetic resonance imaging (MRI) (T2-weighted imaging, diffusion-weighted MRI, and dynamic contrast-enhanced MRI) followed by template prostate mapping and transrectal ultrasound biopsy.

Some patients may undergo blood, urine, and tissue sample collection periodically for biomarker studies. Samples are banked for future research analysis.

Patients complete a quality-of-life questionnaire (EQ-5D) at baseline, during, and after completion of study. An economic analysis will be performed for cost-effectiveness.

After completion of study intervention, patients are followed up periodically.

Study Type

Interventional

Enrollment (Anticipated)

714

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Men at risk of prostate cancer who have been advised to have a prostate biopsy
  • Suspected stage ≤ T2 on rectal examination (organ confined)
  • Serum PSA ≤ 15 ng/mL within the past 3 months

PATIENT CHARACTERISTICS:

  • Fit for general/spinal anesthesia
  • Fit to undergo all protocol procedures including a transrectal ultrasound
  • No evidence of a urinary tract infection or history of acute prostatitis within the past 3 months
  • No contraindication to MRI (e.g., claustrophobia, pacemaker, or estimated GFR ≤ 50)
  • No other medical condition precluding procedures described in the protocol

PRIOR CONCURRENT THERAPY:

  • No prior prostate biopsy, prostate surgery, or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction are acceptable)
  • No prior hip replacement surgery

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety of multiparametric magnetic resonance imaging (MP-MRI)
Recruitment
Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values
Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values

Secondary Outcome Measures

Outcome Measure
Proportion of men who could safely avoid biopsy
Proportion of men testing positive on MP-MRI
Performance characteristics of TRUS versus template prostate mapping (TPM)
Evaluation of the optimal combination of MP-MRI functional parameters
Intra-observer variability in the reporting of MP-MRI
Evaluation of socio-demographic, clinical, imaging and radiological variables in relation to the detection of clinically significant prostate cancer
Health-related quality of life using the EQ-5D questionnaire
Resource use and costs for further economic evaluation
Translational research

Collaborators and Investigators

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

Sponsor

University College London Hospitals

Investigators

  • Principal Investigator: Mark Emberton, MD, FRCS, MBBS, University College London Hospitals

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

April 1, 2011

Primary Completion (Anticipated)

April 1, 2013

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

February 8, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-PR11
  • CDR0000694647 (Registry Identifier: PDQ (Physician Data Query))
  • EU-21104
  • UCL-11/009
  • ISRCTN16082556 (Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Prostate Cancer

Clinical Trials on biologic sample preservation procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe