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

Turku University Hospital (TYKS)

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany); Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)

Study type: Interventional

Funder types: Other

Identifiers

NCT01864135

112/180/2012

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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175 participants in 1 patient group

MRI

Experimental group

Description:

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

Treatment:

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

Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)