MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

Herlev Hospital

Status and phase: Completed; Phase 4

Conditions: Fatty Liver; Hypogonadism; Prostate Cancer; Metabolic Syndrome

Treatments: Procedure: Orchiectomy; Drug: Triptorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT02102646

kk2013 MRI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Triptorelin

Active Comparator group

Description:

Triptorelin 22,5mg/24th week intramuscularly

Treatment:

Drug: Triptorelin

orchiectomy

Active Comparator group

Description:

Androgen deprivation therapy by bilateral subcapsular orchiectomy

Treatment:

Procedure: Orchiectomy