MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

Phase 4

Completed

• Conditions: Hypogonadism; Fatty Liver; Metabolic Syndrome; Prostate Cancer
• Interventions: Procedure: Orchiectomy; Drug: Triptorelin

• Registration Number: NCT02102646
• Lead Sponsor: Herlev Hospital

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.

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-31
• Study Start: 2014-04
• Study First Posted: 2014-04-03
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
orchiectomy	Orchiectomy	Androgen deprivation therapy by bilateral subcapsular orchiectomy
Triptorelin	Triptorelin	Triptorelin 22,5mg/24th week intramuscularly

Primary Outcome Measures

Name	Time	Method
Change in hepatic fat content	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

Secondary Outcome Measures

Name	Time	Method
Change in visceral/subcutaneous fat mass	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	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.

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark