MRI in Diagnosing Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01292291
First received: February 8, 2011
Last updated: August 6, 2013
Last verified: September 2011
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 714
Study Start Date: April 2011
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292291

Sponsors and Collaborators
University College London Hospitals
Investigators
Principal Investigator: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01292291     History of Changes
Other Study ID Numbers: MRC-PR11, CDR0000694647, EU-21104, UCL-11/009, ISRCTN16082556
Study First Received: February 8, 2011
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage IIA prostate cancer
stage IIB prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014