MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Prostate Cancer Metabolic Syndrome Hypogonadism Fatty Liver

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Triptorelin

Triptorelin 22,5mg/24th week intramuscularly

Group Type ACTIVE_COMPARATOR

Triptorelin

Intervention Type DRUG

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

orchiectomy

Androgen deprivation therapy by bilateral subcapsular orchiectomy

Group Type ACTIVE_COMPARATOR

Orchiectomy

Intervention Type PROCEDURE

Androgen deprivation therapy by bilateral subcapsular orchiectomy

Interventions

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Triptorelin

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

Intervention Type DRUG

Orchiectomy

Androgen deprivation therapy by bilateral subcapsular orchiectomy

Intervention Type PROCEDURE

Other Intervention Names

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Pamorelin Subcapsular orchiectomy

Eligibility Criteria

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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)