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Completed

NCT Number: NCT01138527

Prostate Cancer Localization With a Multiparametric Magnetic Resonance (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.

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Key information

Sex eligibility

Male

Study type

Observational

Primary location

Medical University Vienna, Vienna, Austria

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About this study

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:

  • focal areas of low signal intensity on T2-weighted images;
  • 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;
  • the extent and degree of apparent diffusion coefficient reduction on DWI;
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI examination

Other

45-minute MRI examination of the prostate and surrounding tissues with T2-weighted MRI, diffusion-weighted MRI, Spectroscopic Imaging and dynamic contrast enhanced imaging

Primary outcomes

  1. Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate

    Time frame: December 2015

Secondary outcomes

  1. Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer

    Time frame: december 2015

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

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

Registry information

Official study title

Prostate Cancer Localization With a Multiparametric MR Approach

Acronym: PCa-MAP

Important dates

Study start
2010
Primary completion
2015
Study completion
2019
First posted
Jun 7, 2010
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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