Clinical trial NCT01138527: Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach
Official title: Prostate Cancer Localization With a Multiparametric MR Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: multi-parametric MRI approach
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Siemens AG
name: Mount Vernon Hospital
name: Multi-Imagem and CDPI, Rio de Janeiro, Brasil
name: Norwegian University of Science and Technology
name: University of California, Los Angeles
name: University Hospital, Ghent
name: Johns Hopkins University
name: Medical University of Vienna
name: University Health Network, Toronto
name: Heidelberg University
First posted: 2010-06-07
Enrollment: 148
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Biopsy-proven patients with prostate cancer, planned for radical prostatectomy.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate
timeFrame: December 2015
Secondary outcomes:
measure: Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer
timeFrame: december 2015
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
city: Vienna
country: Austria
facility: Medical University Vienna
city: Ghent
country: Belgium
facility: Ghent University Hospita
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
city: Mannheim
country: Germany
facility: University Medical Center Mannheim, Heidelberg University
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
city: London
country: United Kingdom
facility: Mount Vernon Hospital, Paul Strickland Scanner Centre
Study officials:
affiliation: Radiology, Radboud University Nijmegen Medical Centre
name: Tom W Scheenen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiology, Radboud University Nijmegen Medical Centre
name: Jurgen J Fütterer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: