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

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: Prostate Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 148

Contacts and Locations

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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	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	december 2015

Collaborators and Investigators

• 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

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: multi-parametric MRI approach
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: RU PCa-MAP