Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging and Biomarkers (IMPROD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01864135|
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : January 21, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany) Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||November 2015|
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)|
- Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis [ Time Frame: 3 months ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864135
|Turku University Hospital|
|Turku, Finland, 20521|
|Principal Investigator:||Hannu J Aronen, MD, PhD||Department of Diagnostic Radiology, University of Turku|