Clinical trial · Interventional
MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism
MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin
NCT02102646CI-TRIAL-00019622completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatty Liver | — | UNRESOLVED | — |
| Hypogonadism | — | UNRESOLVED | — |
| Metabolic Syndrome | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orchiectomy | Procedure | — | UNRESOLVED |
| Triptorelin | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Triptorelin
- description
- Triptorelin 22,5mg/24th week intramuscularly
- interventionNames
- Drug: Triptorelin
- type
- ACTIVE_COMPARATOR
- label
- orchiectomy
- description
- Androgen deprivation therapy by bilateral subcapsular orchiectomy
- interventionNames
- Procedure: Orchiectomy
Primary outcomes (1)
- measure
- Change in hepatic fat content
- timeFrame
- At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.