Advanced Magnetic Resonance Imaging (MRI) in Men With Suspected Prostate Cancer (MULTIPROS)
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|ClinicalTrials.gov Identifier: NCT02745496|
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : May 1, 2019
The clinical trial aims to address the critical challenge of differentiating aggressive from indolent prostate cancers by correlating prospectively collected MultiParametric (MP) Magnetic Resonance Imaging (MRI) data (index test) with the histopathology of radical prostatectomy specimens (reference standard).
The study design incorporates pre-biopsy MRI, routine standard of care Transrectal Ultrasound guided (TRUS) biopsies and MRI/Ultrasound (US) image fusion techniques to guide biopsies to the suspicious areas identified by MRI.
The hypothesis is that MP-MRI will allow pre-treatment determination of prostate cancer aggressiveness and MRI/US image fusion is expected to accurately co-locate cancer foci within the prostate gland for guiding biopsies.
Pre-treatment prediction of Gleason grade as a marker of cancer aggressiveness will better inform clinicians and patients to improve risk stratification and facilitate decision making on subsequent treatment.
Image fusion will allow accurate targeting of the most suspicious areas on MP-MRI for biopsy, which could obviate the need for multiple biopsies.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: TRUS Biopsy Procedure: TRUS/FUSION Biopsy||Not Applicable|
There is preliminary evidence suggesting that MultiParametric Magnetic Resonance Imaging (MP-MRI) can be a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Gleason grade (GG) is a critical predictor of the aggressiveness of PCa, but in up to one in three men, the histology of radical prostatectomy specimens is different from the histology of Transrectal Ultrasound (TRUS)-guided biopsies. This discrepancy contributes to- and is a sign of- poor risk stratification of men with localised PCa.
The research aims to answer the following questions:
- Can image-fusion techniques allow investigators to reliably target abnormal areas seen on MP-MRI?
- How reliable is pre-biopsy MP-MRI in correctly predicting aggressive disease?
The investigators envisage that MP-MRI information will reduce unnecessary biopsies and over-detection of indolent PCa, while improving the detection of aggressive disease.
• To determine whether using MP-MRI can improve cancer detection and characterization of prostate cancer
• To determine whether US/MRI FUSION guided biopsy can reduce the number of false negative biopsies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multiparametric Magnetic Resonance Imaging Characterization and Guided Biopsy of the Prostate in Men Suspected of Having Prostate Cancer|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Standard of Care Treatment
Procedure: TRUS Biopsy
Standard of Care Treatment
Procedure: TRUS/FUSION Biopsy
- Number of prostate cancers detected by MP-MRI when compared to gold standard prostatectomy specimen [ Time Frame: 4 years from first recruitment ]Number of prostate cancers detected by MP-MRI when compared to gold standard
- Number of clinically significant cancers detected by MP-MRI when compared to gold standard prostatectomy specimen [ Time Frame: 4 years from first recruitment ]
The definition of clinically significant disease will be based on the pathologic assessment of radical prostatectomy (RP) specimen and will include the presence of any the following three prognostic factors:
o Gleason grade >= 7 with pattern 4 or/and 5 Maximum cancer focus size more than 6mm measured in the axial plane Presence of extracapsular extension (ECE)
- Number of cancer detected in each randomised group, namely intervention group (TRUS/FUSION biopsy) versus standard of care (TRUS biopsy) [ Time Frame: 4 years from first recruitment ]Number of cancer detected in each randomised group
- Number of significant cancer detected in each randomised group, namely intervention group (TRUS/FUSION biopsy) versus standard of care (TRUS biopsy) [ Time Frame: 4 years from first recruitment ]Number of significant cancer detected in each randomised group
- Safety outcomes(death, post biopsy pain, bleeding, sepsis and hospitalization) of intervention (biopsy) in each of the two randomised groups. [ Time Frame: 4 years from first recruitment ]Number of participants with deaths, side effects (post biopsy pain, bleeding, sepsis and hospitalization) in each of the two randomised groups.
- Comparison of MRI negative standard of care TRUS guided biopsies with MRI positive TRUS histopathology to facilitate analysis of diagnostic accuracy of MRI in men suspected with target condition. [ Time Frame: 4 years from first recruitment ]Comparison of MRI negative standard of care TRUS guided biopsies with MRI positive TRUS histopathology
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745496
|Contact: Katherine Coll||01382 383116 ext email@example.com|
|Contact: Ghulam Nabi||01382 383192 ext firstname.lastname@example.org|
|Ninewells Hospital and Medical School||Recruiting|
|Dundee, Tayside, United Kingdom, DD5 4NT|
|Contact: Katherine Coll 01382 383116 ext 83116 email@example.com|
|Contact: Magdalena Szewczyk-Bieda firstname.lastname@example.org|
|Principal Investigator: Magdalena Szewczyk-Bieda|
|Study Director:||Ghulam Nabi||University of Dundee|