MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02102646

Enrollment

Registered

2014-04-03

Start date

2014-04-30

Completion date

2015-10-31

Last updated

2015-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Metabolic Syndrome, Hypogonadism, Fatty Liver

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.

Interventions

DRUGTriptorelin

Androgen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly.

PROCEDUREOrchiectomy

Androgen deprivation therapy by bilateral subcapsular orchiectomy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026