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

Completed

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01138527

Run by

Radboud University Medical Center

People needed

148

Starts

2010-06-01

Expected to finish

2019-07-01

Last updated by the study team

2021-05-13

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

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
• 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.

Where it is running

• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
• 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
• Norwegian University of Science and Technology — Trondheim, Norway
• Mount Vernon Hospital, Paul Strickland Scanner Centre — London, United Kingdom

Full record on ClinicalTrials.gov

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