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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Diagnostic Value of 3-T MRI in Suspected Prostate Cancer

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Device: magnetic resonance imaging, Siemens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI done<br>Subjects with MRI prior prostate biopsies | Device: magnetic resonance imaging, Siemens<br>* Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device<br>|
| No Intervention: no MRI<br>No MRI before prostate biopsies | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at the end of the study (up to 1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at the end of the study (up to 1 year) | 
| 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. | at the end of the study (up to 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer diagnosis, magnetic resonance imaging, prostate biopsy