MRI in Diagnosing Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01292291

Recruitment Status : Unknown

Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was: Not yet recruiting

First Posted : February 9, 2011

Last Update Posted : August 7, 2013

Sponsor:

Information provided by:

National Cancer Institute (NCI)

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Other: biologic sample preservation procedure Other: laboratory biomarker analysis Other: study of socioeconomic and demographic variables Procedure: diffusion-weighted magnetic resonance imaging Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: multiparametric magnetic resonance imaging Procedure: quality-of-life assessment Procedure: transperineal prostate biopsy Procedure: transrectal prostate biopsy Procedure: ultrasound-guided prostate biopsy	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	714 participants
Primary Purpose:	Diagnostic
Official Title:	PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer
Study Start Date :	April 2011
Estimated Primary Completion Date :	April 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Prostate cancer

MedlinePlus related topics: MRI Scans Prostate Cancer

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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 :

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
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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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): NCT01292291

Sponsors and Collaborators

University College London Hospitals

Investigators

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Principal Investigator:	Mark Emberton, MD, FRCS, MBBS	University College London Hospitals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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ClinicalTrials.gov Identifier:	NCT01292291
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) )
First Posted:	February 9, 2011 Key Record Dates
Last Update Posted:	August 7, 2013
Last Verified:	September 2011

Keywords provided by National Cancer Institute (NCI):


stage I prostate cancer stage IIA prostate cancer stage IIB prostate cancer

Additional relevant MeSH terms:

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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms	Neoplasms by Site Neoplasms Prostatic Diseases

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