Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01357512|
Recruitment Status : Completed
First Posted : May 20, 2011
Results First Posted : June 17, 2015
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Device: magnetic resonance imaging, Siemens||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Diagnostic Value of 3-T MRI in Suspected Prostate Cancer|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||September 2017|
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
- Number of Prostate Cancer Diagnoses in MRI and no MRI Groups [ Time Frame: at the end of the study (up to 1 year) ]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.
- Number of Positive Biopsies in MRI and no MRI Groups [ Time Frame: at the end of the study (up to 1 year) ]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. Ten or 12 biopsies will be taken from prostates below 30 grams, or equal or above 30 grams, respectively.
- 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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357512
|Oulu University Hospital|
|Oulu, Finland, 90029|
|Principal Investigator:||Markku Vaarala, MD PhD||Oulu University Hospital|