MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

October 27, 2015 updated by: Peter Busch Østergren, Herlev Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Triptorelin
Triptorelin 22,5mg/24th week intramuscularly
Drug: Triptorelin
Androgen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly.
Other Names:
  • Pamorelin
Active Comparator: orchiectomy
Androgen deprivation therapy by bilateral subcapsular orchiectomy
Procedure: Orchiectomy
Androgen deprivation therapy by bilateral subcapsular orchiectomy
Other Names:
  • Subcapsular orchiectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
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.
Androgen status measured before commencement of androgen deprivation therapy (ADT), hepatic fat content measured at baseline (within 1 month of commencing androgen deprivation therapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Peter B Østergren, MD, Department of Urology, Herlev Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

March 31, 2014

First Posted (Estimate)

April 3, 2014

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kk2013 MRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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