Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Advanced Magnetic Resonance Imaging (MRI) in Men With Suspected Prostate Cancer (MULTIPROS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02745496
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
NHS Tayside
Prostate Cancer UK
Tayside Clinical Trials Unit
Health Informatics Centre
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Dundee

Brief Summary:

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

Detailed Description:

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:

  1. Can image-fusion techniques allow investigators to reliably target abnormal areas seen on MP-MRI?
  2. 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.

Primary Objectives

• To determine whether using MP-MRI can improve cancer detection and characterization of prostate cancer

Secondary Objectives

• To determine whether US/MRI FUSION guided biopsy can reduce the number of false negative biopsies.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
TRUS Biopsy
Standard of Care Treatment
Procedure: TRUS Biopsy
Standard of Care Treatment

TRUS/FUSION Biopsy
Interventional Treatment
Procedure: TRUS/FUSION Biopsy
Interventional Treatment




Primary Outcome Measures :
  1. 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

  2. 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)



Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males between the age of 40-75 at referral
  • With at least 10 years life expectancy
  • With clinically localised PCa: Prostate Specific Antigen (PSA) ≤20 ng/ml
  • And/or abnormal Digital Rectal Examination (DRE) but < T3 disease
  • Ability to informed consent

Exclusion Criteria:

  • Unable to give informed consent
  • Prior prostatic biopsy within 12 months
  • Contraindications to biopsy
  • Poor general health and life expectancy < 10 years
  • Previous diagnosis of acute prostatitis within 12 months
  • History of prostate cancer
  • Prior transurethral prostatectomy
  • Contraindications to MRI (cardiac pacemakers, allergic reaction to gadolinium based contrast, renal function with baseline eGRF 30 ml/min, intracranial clips, claustrophobia)
  • Previous hip replacement

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Katherine Coll 01382 383116 ext 83116 k.z.coll@dundee.ac.uk
Contact: Ghulam Nabi 01382 383192 ext 83192 g.nabi@dundee.ac.uk

Locations
Layout table for location information
United Kingdom
Ninewells Hospital and Medical School Recruiting
Dundee, Tayside, United Kingdom, DD5 4NT
Contact: Katherine Coll    01382 383116 ext 83116    k.z.coll@dundee.ac.uk   
Contact: Magdalena Szewczyk-Bieda       m.szewczyk-bieda@nhs.net   
Principal Investigator: Magdalena Szewczyk-Bieda         
Sponsors and Collaborators
University of Dundee
NHS Tayside
Prostate Cancer UK
Tayside Clinical Trials Unit
Health Informatics Centre
Chief Scientist Office of the Scottish Government
Investigators
Layout table for investigator information
Study Director: Ghulam Nabi University of Dundee

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Dundee
ClinicalTrials.gov Identifier: NCT02745496    
Other Study ID Numbers: MULTIPROS Study
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Dundee:
Image-guided biopsy
Tumour detection
Diagnostic
Biomarkers
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases