Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging and Biomarkers (IMPROD)
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.
Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany)
Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging|
- Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis [ Time Frame: 3 months ] [ Designated as safety issue: No ]Multiparametric MRI is performed in patients with clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE). The accuracy will be determined using the results from transrectal ultrasound guided biopsies.
- Predictive value of molecular markers to estimate prostate cancer diagnosis. [ Time Frame: 3 months ] [ Designated as safety issue: No ]molecular markers include PCR-analyses of multiple markers from biopsy material. The association of molecular marker status is used to estimate the risk of prostate cancer on biopsies.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies
|Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany) Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01864135
|Contact: Hannu J Aronen, MD, PhDfirstname.lastname@example.org|
|Contact: Peter Boström, MD, PhDemail@example.com|
|Turku University Hospital||Recruiting|
|Turku, Finland, 20521|
|Contact: Hannu J Aronen, MD, PhD +358-2-3133896 firstname.lastname@example.org|
|Contact: Peter Boström, MD, PhD +358-2-3135925 email@example.com|
|Principal Investigator:||Hannu J Aronen, MD, PhD||Department of Diagnostic Radiology, University of Turku|