MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102646
• Other study ID #: kk2013 MRI
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2014
• Last updated: October 27, 2015
• Start date: April 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Hypogonadism
• Metabolic Syndrome
• Metabolic Syndrome X
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Triptorelin
Androgen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly.

Procedure:
• Orchiectomy
Androgen deprivation therapy by bilateral subcapsular orchiectomy

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hepatic fat content	Change in hepatic fat content measured by Magnetic Resonance Spectroscopy	At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks	No
Secondary	Change in visceral/subcutaneous fat mass	Changes in visceral and subcutaneous fat mass measured by Magnetic Resonance Imaging.	At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks	No
Secondary	Correlation between Hepatic fat content and baseline androgen status	To investigate possible correlation between androgen status before commencing androgen deprivation therapy and hepatic fat content at baseline.	Androgen status measured before commencement of androgen deprivation therapy (ADT), hepatic fat content measured at baseline (within 1 month of commencing androgen deprivation therapy)	No