Evaluation of Modern MRI in the Diagnosis of Prostate Cancer in a Danish Setup
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|ClinicalTrials.gov Identifier: NCT01640262|
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : February 3, 2016
Clinical staging of prostate cancer in Denmark is determined solely by digital rectal examination and sometimes by TRUS, even though the investigators know these examinations are inaccurate and have limitations. Since the majority of men diagnosed with prostate cancer will die with their disease and not of their disease, and the different treatment-options may imply greater side effects, it is important to improve the diagnostic localization and staging of the tumour for optimal clinical management and therapy selection.
The development of modern multiparametric-high-field-magnetic-imaging (mMRI) offers new possibilities and approaches in detection, localization and staging of prostate cancer due to its high resolution and soft-tissue contrast. mMRI can provide information about the morphological, metabolic and cellular changes and characterize tissue- and tumour- vascularity and correlate it with tumour aggressiveness. This helps to locate and stage a possible tumour and to guide targeted-biopsies towards disease-suspicious areas. Internationally published data support the rapidly growing use of multiparametric MRI, as being the most sensitive and specific imaging tool for prostate cancer patients.
While mMRI internationally is a well recognized and accepted method for detection, localization and staging of prostate cancer, the use of mMRI in the diagnosis of PCa in Denmark has never been applied. Therefore, this project is carried out in order to evaluate the use of modern mMRI in the diagnosis of prostate cancer in a Danish setup.
|Condition or disease||Intervention/treatment|
|Prostatic Neoplasms||Other: Multiparametric magnetic resonance imaging (mMRI)|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||170 participants|
|Official Title:||Evaluation of Modern MRI in the Diagnosis of Prostate Cancer in a Danish Setup|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
localized prostate cancer
Danish men with localized prostate cancer
Other: Multiparametric magnetic resonance imaging (mMRI)
A mMRI is performed before treatment of the patient and is compared to the standard diagnostic tools for evaluating the clinical stage and diagnose of prostate cancer
- Change in the diagnosis and treatment planning based on MRI examination [ Time Frame: The participants will be followed for the duration of the hospital diagnostic investagation, an expected average of 4 weeks ]
Study 1: Change in clinical T-stage (TNM-classification) at baseline compared to the patological T-stage after curative treatment approx. 4 weeks later.
Study 2: Change in prostatic volumen expressed in milliliter(ml) on CT and MRI 4 weeks after brachytherapy-operation compared to the prostatic volumen on TRUS at baseline.
Study 3: Change detectionrate of prostatecancer using MRI-targeted biopsies.
- To gain experience in the use of modern multiparametric MRI in Denmark to evaluate prostatic tumors. [ Time Frame: 2 years ]This study forms the basis for investigating whether modern MRI should be used as an adjunct diagnostic tool for selected patients in the diagnosis of prostate cancer
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): NCT01640262
|Department of Urology, Herlev University Hospital|
|Herlev, Denmark, 2730|
|Principal Investigator:||Lars P. Boesen, M.D.||Department of Urology and Radiology|