Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging and Biomarkers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-11-30

Brief Summary

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Prostate cancer has been the most common cancer in men in Finland over the last ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection. Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS) guided biopsy. Due to the low accuracy of TRUS, a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a risk of increase in complications, there is an increasing interest in developing more accurate non-invasive imaging modalities.

This study will enroll 150 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination. Multiparametric magnetic resonance imaging (mpMRI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI

Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies

Group Type EXPERIMENTAL

3T MRI (Magnetom Verio 3T, Erlangen, Germany)

Intervention Type DEVICE

Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)

Intervention Type DEVICE

Interventions

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3T MRI (Magnetom Verio 3T, Erlangen, Germany)

Intervention Type DEVICE

Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age: 40 to 85 years
* Clinical suspicion of prostate cancer based on: serum level of PSA from 2,5 ng/ml to 25 ng/ml in two following measurements and/or abnormal digital rectal examination
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria

* previous prostate biopsy in the last 6 months
* previous diagnosis of prostate carcinoma
* previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
* symptomatic of acute prostatitis
* contraindications for MRI (cardiac pacemaker, intracranial clips etc)
* uncontrolled serious infection
* claustrophobia
* any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No