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MRI in Diagnosing Prostate Cancer

This study is not yet open for participant recruitment.
Verified September 2011 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01292291
First received: February 8, 2011
Last updated: September 10, 2011
Last verified: September 2011
History of Changes

February 8, 2011
September 10, 2011
April 2011
April 2013   (final data collection date for primary outcome measure)
  • Safety of multiparametric magnetic resonance imaging (MP-MRI) [ Designated as safety issue: Yes ]
  • Recruitment [ Designated as safety issue: No ]
  • Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values [ Designated as safety issue: Yes ]
  • Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01292291 on ClinicalTrials.gov Archive Site
  • Proportion of men who could safely avoid biopsy [ Designated as safety issue: Yes ]
  • Proportion of men testing positive on MP-MRI [ Designated as safety issue: No ]
  • Performance characteristics of TRUS versus template prostate mapping (TPM) [ Designated as safety issue: No ]
  • Evaluation of the optimal combination of MP-MRI functional parameters [ Designated as safety issue: No ]
  • Intra-observer variability in the reporting of MP-MRI [ Designated as safety issue: No ]
  • Evaluation of socio-demographic, clinical, imaging and radiological variables in relation to the detection of clinically significant prostate cancer [ Designated as safety issue: No ]
  • Health-related quality of life using the EQ-5D questionnaire [ Designated as safety issue: No ]
  • Resource use and costs for further economic evaluation [ Designated as safety issue: No ]
  • Translational research [ Designated as safety issue: No ]
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.

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.
Interventional
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
714
Not Provided
April 2013   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Not Provided
Not Provided
 
NCT01292291
CDR0000694647, MRC-PR11, EU-21104, UCL-11/009
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