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

Prostate Cancer Clinical Trial

— PCa-MAP  

Official title:

Prostate Cancer Localization With a Multiparametric MR Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138527
• Other study ID #: RU PCa-MAP
• Status: Completed
• Start date: June 2010
• Est. completion date: July 2019

Study information

• Verified date: September 2018
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: July 2019
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna
Belgium	Ghent University Hospita	Ghent
Canada	University Health Network, Princess Margaret Hospital	Toronto
Germany	University Medical Center Mannheim, Heidelberg University	Mannheim
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen
Norway	Norwegian University of Science and Technology	Trondheim
United Kingdom	Mount Vernon Hospital, Paul Strickland Scanner Centre	London
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland
United States	David Geffen School of Medicine at UCLA	Los Angeles	California

Sponsors (11)

Lead Sponsor	Collaborator
Radboud University	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

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Germany,  Netherlands,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate		December 2015
Secondary	Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer		december 2015