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MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02102646
First Posted: April 3, 2014
Last Update Posted: October 28, 2015
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.
Information provided by (Responsible Party):
Peter Busch Østergren, Herlev Hospital
March 27, 2014
April 3, 2014
October 28, 2015
April 2014
October 2015   (Final data collection date for primary outcome measure)
Change in hepatic fat content [ Time Frame: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks ]
Change in hepatic fat content measured by Magnetic Resonance Spectroscopy
Same as current
Complete list of historical versions of study NCT02102646 on ClinicalTrials.gov Archive Site
  • Change in visceral/subcutaneous fat mass [ Time Frame: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks ]
    Changes in visceral and subcutaneous fat mass measured by Magnetic Resonance Imaging.
  • Correlation between Hepatic fat content and baseline androgen status [ Time Frame: Androgen status measured before commencement of androgen deprivation therapy (ADT), hepatic fat content measured at baseline (within 1 month of commencing androgen deprivation therapy) ]
    To investigate possible correlation between androgen status before commencing androgen deprivation therapy and hepatic fat content at baseline.
Same as current
Not Provided
Not Provided
 
MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism
MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin
The purpose of this study is to investigate if androgen deprivation therapy in men with prostate cancer increases hepatic fat content and changes visceral/subcutaneous fat distribution.
This is a substudy of the ongoing randomized trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin (EudraCT number: 2013-002553-29). 20 consecutive patients are anticipated to participate regardless of assignment to either orchiectomy or triptorelin.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Prostate Cancer
  • Metabolic Syndrome
  • Hypogonadism
  • Fatty Liver
  • Drug: Triptorelin
    Androgen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly.
    Other Name: Pamorelin
  • Procedure: Orchiectomy
    Androgen deprivation therapy by bilateral subcapsular orchiectomy
    Other Name: Subcapsular orchiectomy
  • Active Comparator: Triptorelin
    Triptorelin 22,5mg/24th week intramuscularly
    Intervention: Drug: Triptorelin
  • Active Comparator: orchiectomy
    Androgen deprivation therapy by bilateral subcapsular orchiectomy
    Intervention: Procedure: Orchiectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
October 2015
October 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eligible for inclusion are patients who are included in the already ongoing Randomised trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin (EudraCT number: 2013-002553-29)

Exclusion Criteria:

  • Implanted devices or foreign metallic bodies incompatible with Magnetic Resonance Imaging.
  • claustrophobia
  • Severe Psychiatric disease
Sexes Eligible for Study: Male
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT02102646
kk2013 MRI
No
Not Provided
Not Provided
Peter Busch Østergren, Herlev Hospital
Herlev Hospital
Not Provided
Principal Investigator: Peter B Østergren, MD Department of Urology, Herlev Hospital, Denmark
Herlev Hospital
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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