Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach (PCa-MAP)

May 12, 2021 updated by: Radboud University Medical Center

Prostate Cancer Localization With a Multiparametric MR Approach

The primary objective of this prospective multi-centre study is to prove the diagnostic accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other prostate tissue. The gold standard for distinguishing the tissue types is the analysis of whole-mount sections of the resected prostate by a genitourinary histopathologist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Goal Proving that multi-parametric MR imaging in a multi-centre setting allows for localizing clinically significant (volume > 0.5cc; Gleason > 6) prostate carcinoma in the prostate.

Objective 1

To determine the diagnostic accuracy (area under the receiver-operating characteristic curve) of 3-Tesla multi-modality non-endorectal coil (ERC) MR imaging in localizing prostate cancer, by correlating:

  1. focal areas of low signal intensity on T2-weighted images;
  2. the extent and degree of deviating metabolite ratios derived from MRSI. This can be the choline+creatine/citrate ratio or if possible, the choline / citrate ratio;
  3. the extent and degree of apparent diffusion coefficient reduction on DWI;
  4. the extent and degree of perfusion abnormality on DCE-MRI; with the presence or absence of cancer at (reconstructed) whole mount section histopathology.

Objective 2 Proving that multi-modality MR data allows for predicting tumor grade. The parameters from the different MR methods for a tumor focus can be correlated to the local Gleason grade of the corresponding lesion in the histopathological specimens.

Study Type

Observational

Enrollment (Actual)

148

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

  • Austria
      • Vienna, Austria
        • Medical University Vienna
  • Belgium
      • Ghent, Belgium
        • Ghent University Hospita
  • Canada
      • Toronto, Canada
        • University Health Network, Princess Margaret Hospital
  • Germany
      • Mannheim, Germany
        • University Medical Center Mannheim, Heidelberg University
  • Netherlands
      • Nijmegen, Netherlands, 6525GA
        • Radboud University Nijmegen Medical Centre
  • Norway
      • Trondheim, Norway
        • Norwegian University of Science and Technology
  • United Kingdom
      • London, United Kingdom
        • Mount Vernon Hospital, Paul Strickland Scanner Centre
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine at UCLA
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medical Institutions

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

Sampling Method

Probability Sample

Study Population

Biopsy-proven patients with prostate cancer, planned for radical prostatectomy.

Description

Inclusion Criteria:

  • Biopsy-proven diagnosis of adenocarcinoma of the prostate
  • Subject will sign a consent form prior to study entry
  • Radical prostatectomy and histopathological exam planned
  • The time interval between last biopsy and the MR exam must be at least 4 weeks
  • The time interval between MR exam and radical prostatectomy should not exceed 12 weeks

Exclusion Criteria:

  • Subjects who are unable to give valid informed consent
  • Subjects who are unwilling or unable to undergo an MR exam, including subjects with contra-indications to MR exams
  • Therapy or surgical procedure applied to the prostate or to other organs in vicinity to the prostate: among the therapies preventing inclusion are any form of radiation therapy, cryo-therapy, thermal-therapy, therapy based on any other medication (including hormonal therapy).
  • Patients under hormone deprivation therapy.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Biopsy-proven prostate cancer
Patients with biopsy-proven prostate cancer, planned for radical prostatectomy
Other: MRI examination
45-minute MRI examination of the prostate and surrounding tissues with T2-weighted MRI, diffusion-weighted MRI, Spectroscopic Imaging and dynamic contrast enhanced imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate
Time Frame: December 2015
December 2015

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer
Time Frame: december 2015
december 2015

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Collaborators

Johns Hopkins University
University Health Network, Toronto
Medical University of Vienna
University of California, Los Angeles
Norwegian University of Science and Technology
Heidelberg University
University Hospital, Ghent
Siemens AG
Mount Vernon Hospital
Multi-Imagem and CDPI, Rio de Janeiro, Brasil

Investigators

  • Principal Investigator: Tom W Scheenen, PhD, Radiology, Radboud University Nijmegen Medical Centre
  • Principal Investigator: Jurgen J Fütterer, MD PhD, Radiology, Radboud University Nijmegen Medical Centre

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

June 1, 2010

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

June 4, 2010

First Submitted That Met QC Criteria

June 4, 2010

First Posted (Estimate)

June 7, 2010

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RU PCa-MAP

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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