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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
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 170 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Study 1 is offered to 140 patients with newly diagnosed localized prostate cancer and is comparing mMRI to TRUS and DRE in the assessment of the clinical stage of prostate cancer.
  • Study 2 is offered to 55 patients with newly diagnosed localized prostate cancer who have undergone Brachytherapy and is comparing MRI to CT scan performed 4 weeks after surgery in the evaluation of postoperative dosimetry (treatment effect).
  • Study 3 is offered to 55 patients scheduled for re-biopsy due to continuing suspicion of prostate cancer after standard TRUS-guided biopsies with negative findings. Standardised TRUS-guided re-biopsies as well as TRUS biopsies of any MRI-suspicious lesion are performed in the same session and marked separately. The MRI-targeted biopsies are compared to the standard TRUS-guided re-biopsies to see if multiparametric MRI can detect prostate cancer invisible on transrectal ultrasound; in order to improve detection rate.
Criteria

Inclusion Criteria Study 1:

  • Patients with newly diagnosed localized (T1-2) or locally advanced (T3)prostate cancer

Exclusion Criteria Study 1:

  • Metastatic prostate cancer
  • Prostate cancer treatment
  • Known allergic reaction to Gadolinium-based MRI contrast agent
  • Prostate biopsy during the last 21 days
  • Impaired renal function with GFR < 30 ml / min
  • pacemaker
  • Magnetic metal residues in the body
  • Claustrophobia
  • Psychiatric disorders
  • Age under 18 years

Inclusion Criteria Study 2:

- Patients with localized prostate cancer who underwent brachytherapy 4 weeks prior to MRI.

Exclusion Criteria Study 2:

  • Metastatic prostate cancer
  • Prostate cancer treatment other than Brachytherapy
  • Known allergic reaction to Gadolinium-based MRI contrast agent
  • Prostate biopsy during the last 21 days
  • Impaired renal function with GFR < 30 ml / min
  • pacemaker
  • Magnetic metal residues in the body
  • Claustrophobia
  • Psychiatric disorders
  • Age under 18 years

Inclusion Criteria Study 3:

  • Patients scheduled for re-biopsy due to continuing suspicion of prostate cancer after standard TRUS-guided biopsies with negative findings.

Exclusion Criteria Study 3:

  • Histological positive prostate biopsies and known prostate cancer
  • Metastatic prostate cancer
  • Known allergic reaction to Gadolinium-based MRI contrast agent
  • Prostate biopsy during the last 21 days
  • Impaired renal function with GFR < 30 ml / min
  • pacemaker
  • Magnetic metal residues in the body
  • Claustrophobia
  • Psychiatric disorders
  • Age under 18 years

Information from the National Library of Medicine

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


Locations
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Denmark
Department of Urology, Herlev University Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
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Principal Investigator: Lars P. Boesen, M.D. Department of Urology and Radiology

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Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01640262     History of Changes
Other Study ID Numbers: H-1-2011-066
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: May 2014

Keywords provided by Copenhagen University Hospital at Herlev:
prostate biopsy
prostate cancer
Magnetic Resonance Imaging
Neoplasm Staging

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases