MRI in Diagnosing Prostate Cancer
Conditions
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
Study Design
Primary Purpose: Diagnostic
Intervention
Name: biologic sample preservation procedure Type: Other
Name: laboratory biomarker analysis Type: Other
Name: study of socioeconomic and demographic variables Type: Other
Name: diffusion-weighted magnetic resonance imaging Type: Procedure
Name: dynamic contrast-enhanced magnetic resonance imaging Type: Procedure
Name: multiparametric magnetic resonance imaging Type: Procedure
Name: quality-of-life assessment Type: Procedure
Name: transperineal prostate biopsy Type: Procedure
Name: transrectal prostate biopsy Type: Procedure
Name: ultrasound-guided prostate biopsy Type: Procedure
Overall Status
Not yet recruiting
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Male
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
Location
Start Date
April 2011
Sponsors
University College London Hospitals
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page