A Phase 4 interventional study of Triptorelin and Orchiectomy in Prostate Cancer, Metabolic Syndrome and Hypogonadism, sponsored by Herlev Hospital. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-10-28.
Sponsored by Herlev Hospital · Phase 4, Interventional, and Treatment
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 31 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Herlev Hospital is the lead sponsor of 195 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Triptorelin 22,5mg/24th week intramuscularly
Drug: Triptorelin
Androgen deprivation therapy by bilateral subcapsular orchiectomy
Procedure: Orchiectomy
Androgen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly.
Also known as: Pamorelin
Androgen deprivation therapy by bilateral subcapsular orchiectomy
Also known as: Subcapsular orchiectomy
Change in hepatic fat content
Change in hepatic fat content measured by Magnetic Resonance Spectroscopy
Time frame: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
Change in visceral/subcutaneous fat mass
Changes in visceral and subcutaneous fat mass measured by Magnetic Resonance Imaging.
Time frame: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
Correlation between Hepatic fat content and baseline androgen status
To investigate possible correlation between androgen status before commencing androgen deprivation therapy and hepatic fat content at baseline.
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)
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Herlev Hospital