Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
714 participants
INTERVENTIONAL
2011-04-30
Brief Summary
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PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in diagnosing prostate cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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DIAGNOSTIC
Interventions
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biologic sample preservation procedure
laboratory biomarker analysis
study of socioeconomic and demographic variables
diffusion-weighted magnetic resonance imaging
dynamic contrast-enhanced magnetic resonance imaging
multiparametric magnetic resonance imaging
quality-of-life assessment
transperineal prostate biopsy
transrectal prostate biopsy
ultrasound-guided prostate biopsy
Eligibility Criteria
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Inclusion Criteria
* 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
MALE
No
Sponsors
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University College London Hospitals
OTHER
Principal Investigators
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Mark Emberton, MD, FRCS, MBBS
Role: PRINCIPAL_INVESTIGATOR
University College London Hospitals
References
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Stavrinides V, Norris JM, Karapanagiotis S, Giganti F, Grey A, Trahearn N, Freeman A, Haider A, Carmona Echeverria LM, Bott SRJ, Brown LC, Burns-Cox N, Dudderidge TJ, El-Shater Bosaily A, Ghei M, Henderson A, Hindley RG, Kaplan RS, Oldroyd R, Parker C, Persad R, Rosario DJ, Shergill IS, Winkler M, Kirkham A, Punwani S, Whitaker HC, Ahmed HU, Emberton M; PROMIS Group. Regional Histopathology and Prostate MRI Positivity: A Secondary Analysis of the PROMIS Trial. Radiology. 2023 Apr;307(1):e220762. doi: 10.1148/radiol.220762. Epub 2022 Dec 13.
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.
Other Identifiers
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CDR0000694647
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-21104
Identifier Type: -
Identifier Source: secondary_id
UCL-11/009
Identifier Type: -
Identifier Source: secondary_id
ISRCTN16082556
Identifier Type: REGISTRY
Identifier Source: secondary_id
MRC-PR11
Identifier Type: -
Identifier Source: org_study_id