MRI in Diagnosing Prostate Cancer
August 6, 2013 updated by: University College London Hospitals
PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find prostate cancer and learn the extent of disease.
PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in diagnosing prostate cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
- Other: biologic sample preservation procedure
- Other: laboratory biomarker analysis
- Procedure: diffusion-weighted magnetic resonance imaging
- Procedure: dynamic contrast-enhanced magnetic resonance imaging
- Procedure: quality-of-life assessment
- Other: study of socioeconomic and demographic variables
- Procedure: multiparametric magnetic resonance imaging
- Procedure: transperineal prostate biopsy
- Procedure: transrectal prostate biopsy
- Procedure: ultrasound-guided prostate biopsy
Detailed Description
OBJECTIVES:
- To determine the ability of multiparametric magnetic resonance imaging (MP-MRI) to identify men who can safely avoid unnecessary biopsy.
- To assess the ability of the MP-MRI-based diagnostic pathway to improve the rate of detection of clinically significant cancer as compared to transrectal ultrasound (TRUS) biopsy.
- To estimate the cost-effectiveness of an MP-MRI based diagnostic pathway.
OUTLINE: This is a multicenter study.
Patients undergo multiparametric magnetic resonance imaging (MRI) (T2-weighted imaging, diffusion-weighted MRI, and dynamic contrast-enhanced MRI) followed by template prostate mapping and transrectal ultrasound biopsy.
Some patients may undergo blood, urine, and tissue sample collection periodically for biomarker studies. Samples are banked for future research analysis.
Patients complete a quality-of-life questionnaire (EQ-5D) at baseline, during, and after completion of study. An economic analysis will be performed for cost-effectiveness.
After completion of study intervention, patients are followed up periodically.
Study Type
Interventional
Enrollment (Anticipated)
714
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
DISEASE CHARACTERISTICS:
- Men at risk of prostate cancer who have been advised to have a prostate biopsy
- Suspected stage ≤ T2 on rectal examination (organ confined)
- Serum PSA ≤ 15 ng/mL within the past 3 months
PATIENT CHARACTERISTICS:
- Fit for general/spinal anesthesia
- Fit to undergo all protocol procedures including a transrectal ultrasound
- No evidence of a urinary tract infection or history of acute prostatitis within the past 3 months
- No contraindication to MRI (e.g., claustrophobia, pacemaker, or estimated GFR ≤ 50)
- No other medical condition precluding procedures described in the protocol
PRIOR CONCURRENT THERAPY:
- No prior prostate biopsy, prostate surgery, or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction are acceptable)
- No prior hip replacement surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Safety of multiparametric magnetic resonance imaging (MP-MRI)
|
|
Recruitment
|
|
Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values
|
|
Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Proportion of men who could safely avoid biopsy
|
|
Proportion of men testing positive on MP-MRI
|
|
Performance characteristics of TRUS versus template prostate mapping (TPM)
|
|
Evaluation of the optimal combination of MP-MRI functional parameters
|
|
Intra-observer variability in the reporting of MP-MRI
|
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Evaluation of socio-demographic, clinical, imaging and radiological variables in relation to the detection of clinically significant prostate cancer
|
|
Health-related quality of life using the EQ-5D questionnaire
|
|
Resource use and costs for further economic evaluation
|
|
Translational research
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mark Emberton, MD, FRCS, MBBS, University College London Hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Brown LC, Ahmed HU, Faria R, El-Shater Bosaily A, Gabe R, Kaplan RS, Parmar M, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham A, Oldroyd R, Parker C, Bott S, Burns-Cox N, Dudderidge T, Ghei M, Henderson A, Persad R, Rosario DJ, Shergill I, Winkler M, Soares M, Spackman E, Sculpher M, Emberton M. Multiparametric MRI to improve detection of prostate cancer compared with transrectal ultrasound-guided prostate biopsy alone: the PROMIS study. Health Technol Assess. 2018 Jul;22(39):1-176. doi: 10.3310/hta22390.
- Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Anticipated)
April 1, 2013
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
February 8, 2011
First Submitted That Met QC Criteria
February 8, 2011
First Posted (Estimate)
February 9, 2011
Study Record Updates
Last Update Posted (Estimate)
August 7, 2013
Last Update Submitted That Met QC Criteria
August 6, 2013
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRC-PR11
- CDR0000694647 (Registry Identifier: PDQ (Physician Data Query))
- EU-21104
- UCL-11/009
- ISRCTN16082556 (Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.