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

University of Oulu

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Device: magnetic resonance imaging, Siemens

Study type: Interventional

Funder types: Other

Identifiers

NCT01357512

PRODIAMRI

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: Male

Ages: 40 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

MRI done

Experimental group

Description:

Subjects with MRI prior prostate biopsies

Treatment:

Device: magnetic resonance imaging, Siemens

no MRI

No Intervention group

Description:

No MRI before prostate biopsies