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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptorelin | Active Comparator | Triptorelin 22,5mg/24th week intramuscularly |
|
| orchiectomy | Active Comparator | Androgen deprivation therapy by bilateral subcapsular orchiectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin | Drug | Androgen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visceral/subcutaneous fat mass | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter B Østergren, MD | Department of Urology, Herlev Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D024821 | Metabolic Syndrome |
| D007006 | Hypogonadism |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| D009919 | Orchiectomy |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Orchiectomy | Procedure | Androgen deprivation therapy by bilateral subcapsular orchiectomy |
|
|
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) |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D002369 | Castration |
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013519 | Urogenital Surgical Procedures |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |