Clinical trial · Observational
Prospective Observation Study of Insulin Sensitivity During and After Gonadotropin Releasing Hormone Agonist Therapy for Prostate Cancer
Prospective Observation Study of Insulin Sensitivity During and After Gonadotropin Releasing Hormone (GnRH) Agonist Therapy for Prostate Cancer
- 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 research study is to find out if a certain type of hormone therapy, gonadotropin-releasing hormone agonist (GnRH agonist), affects the way the body produces and responds to insulin. The investigators will evaluate the changes in insulin sensitivity during and after GnRH agonist treatment for prostate cancer. The investigators are assessing the possibility that treatment-related insulin resistance may contribute to the risk of diabetes and/or cardiovascular disease in men with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gonadotropin Releasing Hormone Agonist Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- GnRH agonist for 24 months
- interventionNames
- Drug: Gonadotropin Releasing Hormone Agonist Therapy
- label
- Group 2
- description
- GnRH agonist for 6 months
- interventionNames
- Drug: Gonadotropin Releasing Hormone Agonist Therapy
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adenocarcinoma of the prostate, clinical stage M0 * Scheduled to initiate GnRH agonist therapy with intended treatment duration of greater than 24 months (Group A) * Scheduled for radiation therapy and neoadjuvant GnRH agonist therapy with intended 6 month duration of treatment (Group B) * Karnofsky Performance Status 90 or 100 * Local or local-regional disease (Group B) Exclusion Criteria: * Prior hormone therapy (GnRH agonist or antiandrogen) * History of bilateral orchiectomy * Known diabetes mellitus or glucose intolerance * Current treatment with anabolic agents or metabolic agents known to affect insulin or glucose levels
References
Publications (1)
- RESULTSaylor PJ, Karoly ED, Smith MR. Prospective study of changes in the metabolomic profiles of men during their first three months of androgen deprivation therapy for prostate cancer. Clin Cancer Res. 2012 Jul 1;18(13):3677-85. doi: 10.1158/1078-0432.CCR-11-3209. Epub 2012 May 15. PMID 22589396