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

This study is currently recruiting participants.
Verified July 2011 by Radboud University
Sponsor:
Collaborators:
Siemens AG
Mount Vernon Hospital
Multi-Imagem and CDPI, Rio de Janeiro, Brasil
Norwegian University of Science and Technology
University of California, Los Angeles
University Hospital, Ghent
Johns Hopkins University
German Cancer Research Center
Medical University of Vienna
University Health Network, Toronto
University of Heidelberg
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01138527
First received: June 4, 2010
Last updated: August 10, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Prostate Cancer
 Other: MRI examination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prostate Cancer Localization With a Multiparametric MR Approach

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Biospecimen Retention:   Samples Without DNA

fixed histopathology slides of resected prostates at local institutions: Not different from clinical routine


Estimated Enrollment: 200
Study Start Date: June 2010
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138527

Contacts
Contact: Tom W Scheenen, PhD +31 24 3613157 t.scheenen@rad.umcn.nl
Contact: Jurgen J Fütterer, MD PhD +31 24 3655789 j.futterer@rad.umcn.nl

Locations
United States, California
David Geffen School of Medicine at UCLA Recruiting
Los Angeles, California, United States
Contact: Daniel J Margolis, MD         DMargolis@mednet.ucla.edu    
United States, Maryland
Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States
Contact: Kasia Macura, MD, PhD         kmacura@jhmi.edu    
Austria
Medical University Vienna Not yet recruiting
Vienna, Austria
Contact: Stephan Gruber, MD         stephan@nmr.at    
Contact: Thomas Helbich, MD, PhD         Thomas.Helbich@akhwien.at    
Belgium
Ghent University Hospita Not yet recruiting
Ghent, Belgium
Contact: Geert M Villeirs, MD, PhD         Geert.Villeirs@ugent.be    
Brazil
Multi-Imagem and CDPI - Clínica de Diagnóstico por Imagem Recruiting
Rio de Janeiro, Brazil
Contact: Leonardo Bittencourt         lkayat@terra.com.br    
Canada
University Health Network, Princess Margaret Hospital Not yet recruiting
Toronto, Canada
Contact: Massom Haider, MD, PhD         m.haider@utoronto.ca    
Germany
German Cancer Research Centre, DKFZ Not yet recruiting
Heidelberg, Germany
Contact: Patrick Zamecnik, MD         p.zamecnik@dkfz.de    
Contact: Heinz-Peter Schlemmer, MD, PhD         h.schlemmer@Dkfz-Heidelberg.de    
University Medical Center Mannheim, Heidelberg University Not yet recruiting
Mannheim, Germany
Contact: Dietmar Dinter, MD         Dietmar.Dinter@umm.de    
Contact: Henrik Michaely, MD         Henrik.Michaely@umm.de    
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6525GA
Contact: Tom W Scheenen, PhD         t.scheenen@rad.umcn.nl    
Contact: Jurgen J Fütterer, MD PhD         j.futterer@rad.umcn.nl    
Principal Investigator: Jurgen J Futterer, MD PhD            
Norway
Norwegian University of Science and Technology Recruiting
Trondheim, Norway
Contact: Ingrid Gribbestad         ingrid.s.gribbestad@ntnu.no    
United Kingdom
Mount Vernon Hospital, Paul Strickland Scanner Centre Active, not recruiting
London, United Kingdom
Sponsors and Collaborators
Radboud University
Siemens AG
Mount Vernon Hospital
Multi-Imagem and CDPI, Rio de Janeiro, Brasil
Norwegian University of Science and Technology
University of California, Los Angeles
University Hospital, Ghent
Johns Hopkins University
German Cancer Research Center
Medical University of Vienna
University Health Network, Toronto
University of Heidelberg
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
  More Information

No publications provided

Responsible Party: Tom WJ Scheenen, Jurgen J Fütterer, Radiology, Radboud University Nijmegen Medical Centre, the Netherlands
ClinicalTrials.gov Identifier: NCT01138527     History of Changes
Other Study ID Numbers: RU PCa-MAP
Study First Received: June 4, 2010
Last Updated: August 10, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
multi-parametric MRI approach

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013