MRI and Biomarkers in Prostate Cancer (Multi-IMPROD)
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|ClinicalTrials.gov Identifier: NCT02241122|
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : April 18, 2018
Prostate cancer has been the most common neoplastic disease 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. Because of the low accuracy of TRUS a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a significant risk of complications, there is an increasing interest in developing more accurate non-invasive imaging modalities.
This prospective multi-institutional study will enroll 400 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. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 1.5/3 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||Procedure: prostate biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging Targeted Biopsies and Biomarkers (Multi-institutional Study)|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||April 1, 2018|
Experimental: MRI guided prostate biopsy
prostate biopsy after MR-imaging
Procedure: prostate biopsy
- Diagnostic accuracy of biparametric MRI (T2wi+DWI) in prostate cancer diagnosis [ Time Frame: 18 months ]Biparametric MRI (T2wi+DWI) is performed in patients with a clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE). The accuracy will be determined using the results from transrectal ultrasound guided biopsies.
- Diagnostic accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis [ Time Frame: 18 months ]
Accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis will be evaluated.
Gene expression profile of selected genes will be compared between cancer and non-cancer cases to investage optimal gene expression panels for prostate cancer risk prediction. Similarly serum and urine marker profiles are compared between cancer and non-cancer cases
- Evaluation of bacterial strains [ Time Frame: 18 months ]The bacterial resistance towards antibiotics is evaluated.
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): NCT02241122
|Department of Urology, Helsinki University Hospital|
|Department of Urology, Kuopio University Hospital|
|Department of Urology, Pori Central Hospital|
|Department of Urology, Tampere University Hospital|
|Turku University Hospital|
|Turku, Finland, 2050|
|Principal Investigator:||Peter Boström, MD, PhD||Department of Urology, University of Turku and Turku University Hospital|