Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers (IMPROD2_0)
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|ClinicalTrials.gov Identifier: NCT02844829|
Recruitment Status : Unknown
Verified July 2016 by Hannu Aronen, Turku University Hospital.
Recruitment status was: Recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
This study will enroll 200 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml or abnormal digital rectal examination.
Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) 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||Other: Prostate MRI||Not Applicable|
Specific aims of the current study are as follows:
i) To determine the sensitivity, specificity and accuracy of a novel rapid anatomical MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy
ii) To determine the sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer
iii) To develop statistical model for diagnosis of prostate cancer incorporating findings of a novel rapid MRI/DWI and selected biomarkers
iv) To assess the applicability of TRUS guided prostate biopsy based on MRI finding in patient with no previous prostate biopsy
v) To develop and validate an imaging protocol which will become the standard protocol for prostate imaging at Medical Imaging Centre of Southwest Finland (VSKK) / TYKS, Turku, Finland.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
MRI and biomarkers
Prostate MRI. Blood and urine biomarkers. Both prior to biopsy. Tissue samples during prostatectomy.
Other: Prostate MRI
MRI of the prostate prior to prostate biobsy
- Sensitivity, specificity and accuracy of MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy [ Time Frame: Baseline (MRI prior to prostate biopsy) ]
- Sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer [ Time Frame: Baseline and during procedure ]Serum and urine samples before prostate biopsy and tissue samples during prostatectomy
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): NCT02844829
|Contact: Hannu J Aronen, M.D. Ph.D.||+358 2 firstname.lastname@example.org|
|Department of Urology, Turku University Hospital||Recruiting|
|Turku, Western Finland Province, Finland, FI-20520|
|Contact: Peter J Boström, M.D., Ph.D +358 2 3130243 peter.boström@tyks.fi|
|Principal Investigator:||Hannu J Aronen, M.D. Ph.D.||Diagnostic radiology University of Turku|