Working… Menu

Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01357512
Recruitment Status : Completed
First Posted : May 20, 2011
Results First Posted : June 17, 2015
Last Update Posted : December 2, 2017
Oulu University Hospital
Information provided by (Responsible Party):
Markku Vaarala, MD, PhD, University of Oulu

Brief 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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Device: magnetic resonance imaging, Siemens Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01357512

Layout table for location information
Oulu University Hospital
Oulu, Finland, 90029
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Layout table for investigator information
Principal Investigator: Markku Vaarala, MD PhD Oulu University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Markku Vaarala, MD, PhD, MD, PhD, University of Oulu Identifier: NCT01357512     History of Changes
Other Study ID Numbers: PRODIAMRI
First Posted: May 20, 2011    Key Record Dates
Results First Posted: June 17, 2015
Last Update Posted: December 2, 2017
Last Verified: October 2017
Keywords provided by Markku Vaarala, MD, PhD, University of Oulu:
prostate cancer diagnosis
magnetic resonance imaging
prostate biopsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases