MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

Study Overview
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Brief Summary
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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
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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.

Official Title
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MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin

Conditions
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Prostate Cancer, Metabolic Syndrome, Hypogonadism, Fatty Liver

Intervention / Treatment
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* Drug: Triptorelin
* Procedure: Orchiectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triptorelin<br>Triptorelin 22,5mg/24th week intramuscularly | Drug: Triptorelin<br>* Androgen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly.<br>* Other names: Pamorelin;|
| Active Comparator: orchiectomy<br>Androgen deprivation therapy by bilateral subcapsular orchiectomy | Procedure: Orchiectomy<br>* Androgen deprivation therapy by bilateral subcapsular orchiectomy<br>* Other names: Subcapsular orchiectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hepatic fat content | Change in hepatic fat content measured by Magnetic Resonance Spectroscopy | At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visceral/subcutaneous fat mass | Changes in visceral and subcutaneous fat mass measured by Magnetic Resonance Imaging. | At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks | 
| 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. | Androgen status measured before commencement of androgen deprivation therapy (ADT), hepatic fat content measured at baseline (within 1 month of commencing androgen deprivation therapy) |