Back to resultsMRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism
Primary Purpose
Prostate Cancer, Metabolic Syndrome, Hypogonadism
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Triptorelin
Orchiectomy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Herlev Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Triptorelin
orchiectomy
Arm Description
Triptorelin 22,5mg/24th week intramuscularly
Androgen deprivation therapy by bilateral subcapsular orchiectomy
Outcomes
Primary Outcome Measures
Change in hepatic fat content
Change in hepatic fat content measured by Magnetic Resonance Spectroscopy
Secondary Outcome Measures
Change in visceral/subcutaneous fat mass
Changes in visceral and subcutaneous fat mass measured by Magnetic Resonance Imaging.
Correlation between Hepatic fat content and baseline androgen status
To investigate possible correlation between androgen status before commencing androgen deprivation therapy and hepatic fat content at baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02102646
Brief Title
MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism
Official Title
MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Metabolic Syndrome, Hypogonadism, Fatty Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triptorelin
Arm Type
Active Comparator
Arm Description
Triptorelin 22,5mg/24th week intramuscularly
Arm Title
orchiectomy
Arm Type
Active Comparator
Arm Description
Androgen deprivation therapy by bilateral subcapsular orchiectomy
Intervention Type
Drug
Intervention Name(s)
Triptorelin
Other Intervention Name(s)
Pamorelin
Intervention Description
Androgen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly.
Intervention Type
Procedure
Intervention Name(s)
Orchiectomy
Other Intervention Name(s)
Subcapsular orchiectomy
Intervention Description
Androgen deprivation therapy by bilateral subcapsular orchiectomy
Primary Outcome Measure Information:
Title
Change in hepatic fat content
Description
Change in hepatic fat content measured by Magnetic Resonance Spectroscopy
Time Frame
At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
Secondary Outcome Measure Information:
Title
Change in visceral/subcutaneous fat mass
Description
Changes in visceral and subcutaneous fat mass measured by Magnetic Resonance Imaging.
Time Frame
At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
Title
Correlation between Hepatic fat content and baseline androgen status
Description
To investigate possible correlation between androgen status before commencing androgen deprivation therapy and hepatic fat content at baseline.
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)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter B Østergren, MD
Organizational Affiliation
Department of Urology, Herlev Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism
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