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

NCT01357512 | Completed Results

• 1 other identifier: PRODIAMRI
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

prostate cancer diagnosis; magnetic resonance imaging; prostate biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Positive Biopsies in MRI and no MRI Groups

  at the end of the study (up to 1 year)

• Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups

  at the end of the study (up to 1 year)

Study Arms (2)

MRI done

EXPERIMENTAL

Subjects with MRI prior prostate biopsies

Device: magnetic resonance imaging, Siemens

no MRI

NO INTERVENTION

No MRI before prostate biopsies

Interventions

magnetic resonance imaging, Siemens DEVICE

Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device

MRI done

Eligibility Criteria

• Age: 40 Years - 72 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead
• Oulu University Hospital: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, 90029, Finland

Location

Related Publications (1)

• 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.

  PMID: 26033153 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Chief urologist Markku Vaarala
• Organization: Oulu University Hospital and Univeristy of Oulu

markku.vaarala@oulu.fi

+3588315

Study Officials

• Markku Vaarala, MD PhD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: May 20, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: September 1, 2017
• Last Updated: December 2, 2017
• Results First Posted: June 17, 2015

Record last verified: 2017-10

Locations

FI (1)