Back to resultsEvaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
magnetic resonance imaging, Siemens
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostatic Neoplasms focused on measuring prostate cancer diagnosis, magnetic resonance imaging, prostate biopsy
Eligibility Criteria
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
Sites / Locations
- Oulu University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MRI done
no MRI
Arm Description
Subjects with MRI prior prostate biopsies
No MRI before prostate biopsies
Outcomes
Primary Outcome Measures
Number of Prostate Cancer Diagnoses in MRI and no MRI Groups
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
Number of Positive Biopsies in MRI and no MRI Groups
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
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.
Full Information
NCT ID
NCT01357512
First Posted
April 14, 2011
Last Updated
October 25, 2017
Sponsor
University of Oulu
Collaborators
Oulu University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01357512
Brief Title
Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer
Official Title
Evaluation of Diagnostic Value of 3-T MRI in Suspected Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
Collaborators
Oulu University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
prostate cancer diagnosis, magnetic resonance imaging, prostate biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI done
Arm Type
Experimental
Arm Description
Subjects with MRI prior prostate biopsies
Arm Title
no MRI
Arm Type
No Intervention
Arm Description
No MRI before prostate biopsies
Intervention Type
Device
Intervention Name(s)
magnetic resonance imaging, Siemens
Intervention Description
Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device
Primary Outcome Measure Information:
Title
Number of Prostate Cancer Diagnoses in MRI and no MRI Groups
Description
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.
Time Frame
at the end of the study (up to 1 year)
Secondary Outcome Measure Information:
Title
Number of Positive Biopsies in MRI and no MRI Groups
Description
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.
Time Frame
at the end of the study (up to 1 year)
Title
Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups
Description
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.
Time Frame
at the end of the study (up to 1 year)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markku Vaarala, MD PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
26033153
Citation
Tonttila PP, Lantto J, Paakko E, Piippo U, Kauppila S, Lammentausta E, Ohtonen P, Vaarala MH. Prebiopsy Multiparametric Magnetic Resonance Imaging for Prostate Cancer Diagnosis in Biopsy-naive Men with Suspected Prostate Cancer Based on Elevated Prostate-specific Antigen Values: Results from a Randomized Prospective Blinded Controlled Trial. Eur Urol. 2016 Mar;69(3):419-25. doi: 10.1016/j.eururo.2015.05.024. Epub 2015 May 29.
Results Reference
derived
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Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer
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