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

NCT ID: NCT01357512

Last Updated: 2017-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2017-09-30

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.

Detailed Description

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Conditions

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Prostatic Neoplasms

Keywords

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prostate cancer diagnosis magnetic resonance imaging prostate biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI done

Subjects with MRI prior prostate biopsies

Group Type EXPERIMENTAL

magnetic resonance imaging, Siemens

Intervention Type DEVICE

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

no MRI

No MRI before prostate biopsies

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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magnetic resonance imaging, Siemens

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

Intervention Type DEVICE

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

72 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Oulu University Hospital

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Markku Vaarala, MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markku Vaarala, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 26033153 (View on PubMed)

Other Identifiers

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PRODIAMRI

Identifier Type: -

Identifier Source: org_study_id