MRI in Diagnosing Prostate Cancer

University College London Hospitals NHS Foundation Trust (UCLH)

Status: Unknown

Conditions: Prostate Cancer

Treatments: Procedure: quality-of-life assessment; Procedure: transperineal prostate biopsy; Other: study of socioeconomic and demographic variables; Other: biologic sample preservation procedure; Procedure: multiparametric magnetic resonance imaging; Procedure: ultrasound-guided prostate biopsy; Other: laboratory biomarker analysis; Procedure: transrectal prostate biopsy; Procedure: diffusion-weighted magnetic resonance imaging; Procedure: dynamic contrast-enhanced magnetic resonance imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01292291

UCL-11/009

MRC-PR11

EU-21104

CDR0000694647 (Registry Identifier)

ISRCTN16082556 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 714 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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