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

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ClinicalTrials.gov Identifier: NCT01138527
Recruitment Status : Unknown
Verified November 2015 by Radboud University.
Recruitment status was:  Active, not recruiting
First Posted : June 7, 2010
Last Update Posted : November 10, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Prostate Cancer Other: MRI examination

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 Design

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prostate Cancer Localization With a Multiparametric MR Approach
Study Start Date : June 2010
Primary Completion Date : August 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate [ Time Frame: December 2015 ]

Secondary Outcome Measures :
  1. Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer [ Time Frame: december 2015 ]

Biospecimen Retention:   Samples Without DNA
fixed histopathology slides of resected prostates at local institutions: Not different from clinical routine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Biopsy-proven patients with prostate cancer, planned for radical prostatectomy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138527

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

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01138527     History of Changes
Other Study ID Numbers: RU PCa-MAP
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015

Keywords provided by Radboud University:
multi-parametric MRI approach

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