Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Oulu University Hospital
Information provided by (Responsible Party):
Markku Vaarala, MD, PhD, University of Oulu Identifier:
First received: April 14, 2011
Last updated: January 10, 2015
Last verified: January 2015

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 Intervention
Prostatic Neoplasms
Device: magnetic resonance imaging, Siemens

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 130
Study Start Date: April 2011
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   40 Years to 72 Years
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01357512

Oulu University Hospital
Oulu, Finland, 90029
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Principal Investigator: Markku Vaarala, MD PhD Oulu University Hospital
  More Information

No publications provided

Responsible Party: Markku Vaarala, MD, PhD, MD, PhD, University of Oulu Identifier: NCT01357512     History of Changes
Other Study ID Numbers: PRODIAMRI
Study First Received: April 14, 2011
Last Updated: January 10, 2015
Health Authority: Finland: National Supervisory Authority for Welfare and Health

Keywords provided by University of Oulu:
prostate cancer diagnosis
magnetic resonance imaging
prostate biopsy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on March 03, 2015