Clinical trial NCT01357512: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: prostate cancer diagnosis
magnetic resonance imaging
prostate biopsy
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2011-05-20
Enrollment: 130
Sex: MALE
Minimum age (years): 40
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Number of Prostate Cancer Diagnoses in MRI and no MRI Groups
timeFrame: at the end of the study (up to 1 year)
Secondary outcomes:
measure: Number of Positive Biopsies in MRI and no MRI Groups
timeFrame: at the end of the study (up to 1 year)
measure: Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups
timeFrame: at the end of the study (up to 1 year)
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Markku Vaarala, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.