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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 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
Medical University of Vienna
University Health Network, Toronto
Heidelberg University
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01138527
First received: June 4, 2010
Last updated: November 5, 2014
Last verified: November 2014
  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:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate [ Time Frame: December 2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer [ Time Frame: december 2015 ] [ Designated as safety issue: No ]

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
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 90095
Contact: Daniel J Margolis, MD       DMargolis@mednet.ucla.edu   
United States, Maryland
Johns Hopkins Medical Institutions Completed
Baltimore, Maryland, United States, 21287
Austria
Medical University Vienna Recruiting
Vienna, Austria
Contact: Stephan Gruber, MD       stephan@nmr.at   
Contact: Thomas Helbich, MD, PhD       Thomas.Helbich@akhwien.at   
Belgium
Ghent University Hospita Recruiting
Ghent, Belgium
Contact: Geert M Villeirs, MD, PhD       Geert.Villeirs@ugent.be   
Brazil
Multi-Imagem and CDPI - Clínica de Diagnóstico por Imagem Withdrawn
Rio de Janeiro, Brazil
Canada
University Health Network, Princess Margaret Hospital Completed
Toronto, Canada
Germany
German Cancer Research Centre, DKFZ Withdrawn
Heidelberg, Germany
University Medical Center Mannheim, Heidelberg University 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 Completed
Trondheim, Norway
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
Medical University of Vienna
University Health Network, Toronto
Heidelberg University
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: Radboud University
ClinicalTrials.gov Identifier: NCT01138527     History of Changes
Other Study ID Numbers: RU PCa-MAP
Study First Received: June 4, 2010
Last Updated: November 5, 2014
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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014