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PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer


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Trial Information

PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Outcome Measure:

Safety of multiparametric magnetic resonance imaging (MP-MRI)

Safety Issue:

Yes

Principal Investigator

Mark Emberton, MD, FRCS, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University College London Hospitals

Authority:

Unspecified

Study ID:

CDR0000694647

NCT ID:

NCT01292291

Start Date:

April 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIA prostate cancer
  • stage IIB prostate cancer
  • Prostatic Neoplasms

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