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

NCT01138527 | Completed

• 1 other identifier: RU PCa-MAP
• Study Type: observational
• Target: 148
• Locations: 8 countries
• Sites: 9

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.

Conditions

Prostate Cancer

Keywords

multi-parametric MRI approach

Outcome Measures

Primary Outcomes (1)

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

  December 2015

Secondary Outcomes (1)

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

  december 2015

Study Arms (1)

Biopsy-proven prostate cancer

Patients with biopsy-proven prostate cancer, planned for radical prostatectomy

Other: MRI examination

Interventions

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

Biopsy-proven prostate cancer

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients under hormone deprivation therapy.

Sponsors & Collaborators

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

Study Sites (9)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

Medical University Vienna

Vienna, Austria

Location

Ghent University Hospita

Ghent, Belgium

Location

University Health Network, Princess Margaret Hospital

Toronto, Canada

Location

University Medical Center Mannheim, Heidelberg University

Mannheim, Germany

Location

Radboud University Nijmegen Medical Centre

Nijmegen, 6525GA, Netherlands

Location

Norwegian University of Science and Technology

Trondheim, Norway

Location

Mount Vernon Hospital, Paul Strickland Scanner Centre

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tom W Scheenen, PhD

  Radiology, Radboud University Nijmegen Medical Centre

  PRINCIPAL INVESTIGATOR

• Jurgen J Fütterer, MD PhD

  Radiology, Radboud University Nijmegen Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 7, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: July 1, 2019
• Last Updated: May 13, 2021

Record last verified: 2018-09

Locations

DE (1); NO (1); US (2); BE (1); NL (1); CA (1); GB (1); AU (1)