MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

NCT02102646 | Completed Phase 4

• 1 other identifier: kk2013 MRI
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Metabolic Syndrome; Hypogonadism; Fatty Liver

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in visceral/subcutaneous fat mass

  At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks

• Correlation between Hepatic fat content and baseline androgen status

  Androgen status measured before commencement of androgen deprivation therapy (ADT), hepatic fat content measured at baseline (within 1 month of commencing androgen deprivation therapy)

Study Arms (2)

Triptorelin

ACTIVE COMPARATOR

Triptorelin 22,5mg/24th week intramuscularly

Drug: Triptorelin

orchiectomy

ACTIVE COMPARATOR

Androgen deprivation therapy by bilateral subcapsular orchiectomy

Procedure: Orchiectomy

Interventions

Triptorelin DRUG

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

Also known as: Pamorelin

Triptorelin

Orchiectomy PROCEDURE

Androgen deprivation therapy by bilateral subcapsular orchiectomy

Also known as: Subcapsular orchiectomy

orchiectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Implanted devices or foreign metallic bodies incompatible with Magnetic Resonance Imaging.
• claustrophobia
• Severe Psychiatric disease

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Metabolic Syndrome; Hypogonadism; Fatty Liver

Interventions

Triptorelin Pamoate; Orchiectomy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gonadal Disorders; Endocrine System Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Urologic Surgical Procedures, Male; Urologic Surgical Procedures

Study Officials

• Peter B Østergren, MD

  Department of Urology, Herlev Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 3, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

DK (1)