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Trial Title:
MRI in Diagnosing Prostate Cancer
NCT ID:
NCT01292291
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
stage I prostate cancer
stage IIA prostate cancer
stage IIB prostate cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Primary purpose:
Diagnostic
Intervention:
Intervention type:
Other
Intervention name:
biologic sample preservation procedure
Intervention type:
Other
Intervention name:
laboratory biomarker analysis
Intervention type:
Other
Intervention name:
study of socioeconomic and demographic variables
Intervention type:
Procedure
Intervention name:
diffusion-weighted magnetic resonance imaging
Intervention type:
Procedure
Intervention name:
dynamic contrast-enhanced magnetic resonance imaging
Intervention type:
Procedure
Intervention name:
multiparametric magnetic resonance imaging
Intervention type:
Procedure
Intervention name:
quality-of-life assessment
Intervention type:
Procedure
Intervention name:
transperineal prostate biopsy
Intervention type:
Procedure
Intervention name:
transrectal prostate biopsy
Intervention type:
Procedure
Intervention name:
ultrasound-guided prostate biopsy
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.
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.
Criteria for eligibility:
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
Gender:
Male
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 2011
Lead sponsor:
Agency:
University College London Hospitals
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01292291
