MRI in Diagnosing Prostate Cancer
This study is not yet open for participant recruitment.
Verified September 2011 by National Cancer Institute (NCI)
Sponsor:
University College London Hospitals
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
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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) |
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 More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01292291 History of Changes |
| Other Study ID Numbers: | CDR0000694647, MRC-PR11, EU-21104, UCL-11/009 |
| Study First Received: | February 8, 2011 |
| Last Updated: | September 10, 2011 |
| 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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013