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MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02102646
First Posted: April 3, 2014
Last Update Posted: October 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter Busch Østergren, Herlev Hospital
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Metabolic Syndrome Hypogonadism Fatty Liver Drug: Triptorelin Procedure: Orchiectomy Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin

Resource links provided by NLM:


Further study details as provided by Peter Busch Østergren, Herlev Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 31
Study Start Date: April 2014
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Triptorelin
Triptorelin 22,5mg/24th week intramuscularly
Drug: Triptorelin
Androgen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly.
Other Name: Pamorelin
Active Comparator: orchiectomy
Androgen deprivation therapy by bilateral subcapsular orchiectomy
Procedure: Orchiectomy
Androgen deprivation therapy by bilateral subcapsular orchiectomy
Other Name: Subcapsular orchiectomy

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102646


Locations
Denmark
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Peter B Østergren, MD Department of Urology, Herlev Hospital, Denmark
  More Information

Responsible Party: Peter Busch Østergren, MD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02102646     History of Changes
Other Study ID Numbers: kk2013 MRI
First Submitted: March 27, 2014
First Posted: April 3, 2014
Last Update Posted: October 28, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Prostatic Neoplasms
Metabolic Syndrome X
Fatty Liver
Hypogonadism
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases
Gonadal Disorders
Endocrine System Diseases
Androgens
Triptorelin Pamoate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents