Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of Diagnostic Value of 3-T MRI in Suspected Prostate Cancer|
- Proportion of Prostate Cancer Diagnoses in MRI and no MRI Groups [ Time Frame: at the end of the study (up to 1 year) ] [ Designated as safety issue: No ]The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.
- Proportion of Positive Biopsies in MRI and no MRI Groups [ Time Frame: at the end of the study (up to 1 year) ] [ Designated as safety issue: No ]The number of biopsies with histology confirming prostate cancer are compared between MRI and no MRI groups. This measure will clarify if prostate cancer can be diagnosed more accurately, i.e. more biopsies with confirmed prostate cancer, after MRI.
- 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) ] [ Designated as safety issue: No ]Number of clinically significant prostate cancers detected with and without MRI. Clinically significant prostate cancer is determined by the Gleason grading and be the number of cancer-positive biopsy cores.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: MRI done
Subjects with MRI prior prostate biopsies
Device: magnetic resonance imaging, Siemens
Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device
No Intervention: no MRI
No MRI before prostate biopsies
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357512
|Oulu University Hospital|
|Oulu, Finland, 90029|
|Principal Investigator:||Markku Vaarala, MD PhD||Oulu University Hospital|