MRI in Diagnosing Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01292291
• Other study ID #: MRC-PR11
• Secondary ID: CDR0000694647EU-
• Status: Not yet recruiting
• Phase: N/A
• First received: February 8, 2011
• Last updated: August 6, 2013
• Start date: April 2011

Study information

• Verified date: September 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 714
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• biologic sample preservation procedure

• laboratory biomarker analysis

• study of socioeconomic and demographic variables

Procedure:
• diffusion-weighted magnetic resonance imaging

• dynamic contrast-enhanced magnetic resonance imaging

• multiparametric magnetic resonance imaging

• quality-of-life assessment

• transperineal prostate biopsy

• transrectal prostate biopsy

• ultrasound-guided prostate biopsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of multiparametric magnetic resonance imaging (MP-MRI)			Yes
Primary	Recruitment			No
Primary	Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values			Yes
Primary	Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values			No
Secondary	Proportion of men who could safely avoid biopsy			Yes
Secondary	Proportion of men testing positive on MP-MRI			No
Secondary	Performance characteristics of TRUS versus template prostate mapping (TPM)			No
Secondary	Evaluation of the optimal combination of MP-MRI functional parameters			No
Secondary	Intra-observer variability in the reporting of MP-MRI			No
Secondary	Evaluation of socio-demographic, clinical, imaging and radiological variables in relation to the detection of clinically significant prostate cancer			No
Secondary	Health-related quality of life using the EQ-5D questionnaire			No
Secondary	Resource use and costs for further economic evaluation			No
Secondary	Translational research			No