Clinical trial · Observational
Evaluation and Predictive Value of Genetic Polymorphisms in the Management of Hormonal Treatment of 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)
Androgen deprivation therapy (ADT) by surgical castration or administration of LHRH agonists or antagonists is the gold-standard systemic treatment of Prostate Cancer. The efficacy, severity and frequency of side effects of ADT vary from a patient to another. The exact cause of this variability is not known, however certain genetic polymorphisms affecting enzymes implicated in the synthesis and metabolism of sex-steroids seem to be involved in these processes. To perform a longitudinal study to evaluate the prevalence of various genetic polymorphisms affecting genes in the sex-steroid synthesis and metabolism pathway (CYP1A1, CYP1B1, CYP19A1, 17HSD, HSD3B1, AR, ESR1, ESRRG, IL6, TNF-alpha) in men with Prostate Cancer receiving ADT and the possible association between polymorphisms and frequency and severity of side-effects of ADT.
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 |
|---|---|---|---|
| Saliva sample collection for genetic analyses | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Gonadoliberin antagonist treatment
- description
- Single arm study, all patients are treated the same way. Saliva sample collection for genetic analyses.
- interventionNames
- Genetic: Saliva sample collection for genetic analyses
Primary outcomes (3)
- measure
- Aging Males Symptoms questionnaire
- timeFrame
- 0 months
- measure
- Aging Males Symptoms questionnaire
- timeFrame
- 3 months
- measure
- Aging Males Symptoms questionnaire
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate cancer patients for which reimbursed ADT with a gonadoliberin antagonist is indicated, for a period of at least 6 months. Exclusion Criteria: * Prostate cancer patients who are already receiving ADT with a gonadoliberin antagonist.
References
Publications (25)
- BACKGROUNDMottet N, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Schmid HP, Van der Kwast T, Wiegel T, Zattoni F, Heidenreich A. EAU guidelines on prostate cancer. Part II: Treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur Urol. 2011 Apr;59(4):572-83. doi: 10.1016/j.eururo.2011.01.025. Epub 2011 Jan 25. PMID 21315502
- BACKGROUNDMohile SG, Mustian K, Bylow K, Hall W, Dale W. Management of complications of androgen deprivation therapy in the older man. Crit Rev Oncol Hematol. 2009 Jun;70(3):235-55. doi: 10.1016/j.critrevonc.2008.09.004. Epub 2008 Oct 25. PMID 18952456
- BACKGROUNDAllain TJ. Prostate cancer, osteoporosis and fracture risk. Gerontology. 2006;52(2):107-10. doi: 10.1159/000090956. PMID 16508318
- BACKGROUNDBenton MJ, White A. Osteoporosis: recommendations for resistance exercise and supplementation with calcium and vitamin D to promote bone health. J Community Health Nurs. 2006 Winter;23(4):201-11. doi: 10.1207/s15327655jchn2304_1. PMID 17064230
- BACKGROUNDDiamond TH, Higano CS, Smith MR, Guise TA, Singer FR. Osteoporosis in men with prostate carcinoma receiving androgen-deprivation therapy: recommendations for diagnosis and therapies. Cancer. 2004 Mar 1;100(5):892-9. doi: 10.1002/cncr.20056. PMID 14983482
- BACKGROUNDMcGrath SA, Diamond T. Osteoporosis as a complication of orchiectomy in 2 elderly men with prostatic cancer. J Urol. 1995 Aug;154(2 Pt 1):535-6. doi: 10.1097/00005392-199508000-00057. No abstract available. PMID 7609129
- BACKGROUNDOefelein MG, Ricchuiti V, Conrad W, Seftel A, Bodner D, Goldman H, Resnick M. Skeletal fracture associated with androgen suppression induced osteoporosis: the clinical incidence and risk factors for patients with prostate cancer. J Urol. 2001 Nov;166(5):1724-8. doi: 10.1016/s0022-5347(05)65661-3.