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Completed

NCT Number: NCT02102646

MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

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.

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Key information

Conditions

Prostate Cancer Digestive System Diseases Endocrine System Diseases Fatty Liver Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Hypogonadism Insulin Resistance Liver Diseases Male Urogenital Diseases Metabolic Diseases Metabolic Syndrome Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Herlev Hospital

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triptorelin

Drug

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

Other names: Pamorelin

Orchiectomy

Procedure

Androgen deprivation therapy by bilateral subcapsular orchiectomy

Other names: Subcapsular orchiectomy

Primary outcomes

  1. Change in hepatic fat content

    Time frame: 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 outcomes

  1. Change in visceral/subcutaneous fat mass

    Time frame: 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.

  2. Correlation between Hepatic fat content and baseline androgen status

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2014
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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