MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Peter Busch Østergren, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT02102646
First received: March 27, 2014
Last updated: April 4, 2014
Last verified: April 2014
  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: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    To investigate possible correlation between androgen status before commencing androgen deprivation therapy and hepatic fat content at baseline.


Estimated Enrollment: 20
Study Start Date: April 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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 Names:
  • Triptorelin
  • 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

Ages Eligible for Study:   18 Years to 90 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102646

Contacts
Contact: Peter B Østergren, MD (+45) 38 68 15 05 peter.busch.oestergren@regionh.dk

Locations
Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Principal Investigator: Peter B Østergren, MD         
Sub-Investigator: Elizaveta Chabanova, Physicist         
Sub-Investigator: Caroline M Kistorp, MD, PhD         
Sub-Investigator: Mikkel Fode, MD, PhD         
Sub-Investigator: Jens Sønksen, Prof., DMSc.         
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Peter B Østergren, MD Department of Urology, Herlev Hospital, Denmark
  More Information

No publications provided

Responsible Party: Peter Busch Østergren, MD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02102646     History of Changes
Other Study ID Numbers: kk2013 MRI
Study First Received: March 27, 2014
Last Updated: April 4, 2014
Health Authority: Denmark: Ethics Committee

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
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 16, 2014