Overview

This trial is active, not recruiting.

Condition prostatic neoplasms
Treatment magnetic resonance imaging, siemens
Sponsor University of Oulu
Collaborator Oulu University Hospital
Start date April 2011
End date December 2014
Trial size 130 participants
Trial identifier NCT01357512, PRODIAMRI

Summary

The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Subjects with MRI prior prostate biopsies
magnetic resonance imaging, siemens
Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device
(No Intervention)
No MRI before prostate biopsies

Primary Outcomes

Measure
Proportion of prostate cancer diagnoses in MRI and no MRI groups
time frame: at the end of the study (up to 1 year)

Secondary Outcomes

Measure
Proportion of positive biopsies in MRI and no MRI groups
time frame: at the end of the study (up to 1 year)
Proportion of clinically significant prostate cancers detected in MRI and no MRI groups
time frame: at the end of the study (up to 1 year)

Eligibility Criteria

Male participants from 40 years up to 72 years old.

Inclusion Criteria: - Informed consent - Suspected prostate cancer based on PSA value (total PSA 2,5-10 ng/ml and PSA free to total ratio <=0.15, or total PSA 10-20 ng/ml) - PSA and serum creatinine measurement less than 60 days before transrectal ultrasound-guided prostate biopsies - No evidence of PSA increase by non-cancerous factors (catheterization, bladder stones, urinary tract infection including bacterial prostatitis) Exclusion Criteria: - Previous prostate biopsies - Previous prostate surgery - Contraindication for MRI (such as pacemaker or inner ear implant) - Claustrophobia - Estimated glomerular filtration rate (eGFR) <40 ml/min - Suspected clinical T3-T4 prostate cancer based on digital rectal examination - Contraindication for transrectal ultrasound-guided prostate biopsies - body mass index >30

Additional Information

Official title Evaluation of Diagnostic Value of 3-T MRI in Suspected Prostate Cancer
Principal investigator Markku Vaarala, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by University of Oulu.