MRI in Diagnosing Prostate Cancer

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. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

February 8, 2011
February 9, 2011
August 7, 2013
April 2011
April 2013   (Final data collection date for primary 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
Same as current
Complete list of historical versions of study NCT01292291 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
MRI in Diagnosing Prostate Cancer
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.


  • 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.

Not Applicable
Primary Purpose: Diagnostic
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 Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
April 2013   (Final data collection date for primary outcome measure)


  • 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


  • 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


  • 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
Sexes Eligible for Study: Male
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
Not Provided
CDR0000694647 ( Registry Identifier: PDQ (Physician Data Query) )
ISRCTN16082556 ( Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register) )
Not Provided
Not Provided
Not Provided
Not Provided
University College London Hospitals
Not Provided
Principal Investigator: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
National Cancer Institute (NCI)
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP