MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism
Conditions
Prostate Cancer - Metabolic Syndrome - Hypogonadism - Fatty Liver
Conditions: official terms
Fatty Liver - Hypogonadism - Metabolic Syndrome X - Prostatic Neoplasms
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Triptorelin Type: Drug
Name: Orchiectomy Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Male
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
Location
Herlev Hospital
Herlev, Denmark
Status: Recruiting
Start Date
April 2014
Completion Date
June 2015
Sponsors
Herlev Hospital
Source
Herlev Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page