Evaluation and Predictive Value of Genetic Polymorphisms in the Management of Hormonal Treatment of Prostate Cancer

NCT02440802 | Unknown

• 1 other identifier: B403201317385
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 20

Brief Summary

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

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Aging Males Symptoms questionnaire

  0 months

• Aging Males Symptoms questionnaire

  3 months

• Aging Males Symptoms questionnaire

  6 months

Study Arms (1)

Gonadoliberin antagonist treatment

Single arm study, all patients are treated the same way. Saliva sample collection for genetic analyses.

Genetic: Saliva sample collection for genetic analyses

Interventions

Saliva sample collection for genetic analyses GENETIC

Patients with Prostate cancer receiving androgen deprivation treatment with a GnRH antagonist will be followed-up for 6 months for quality of life. At Baseline, 3 months and 6 months of treatment QoL data will be collected, as well as body parameters. At Baseline, once, a saliva sample will be collected for genetic analyses.

Gonadoliberin antagonist treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate cancer patients for which reimbursed androgen deprivation therapy with a gonadoliberin antagonist is indicated, for aperiod of at least 6 months.

You may qualify if:

• Prostate cancer patients for which reimbursed ADT with a gonadoliberin antagonist is indicated, for a period of at least 6 months.

You may not qualify if:

• Prostate cancer patients who are already receiving ADT with a gonadoliberin antagonist.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (20)

ASZ Aalst

Aalst, 9300, Belgium

RECRUITING

OLV Aalst

Aalst, 9300, Belgium

RECRUITING

ZNA Middelheim

Antwerp, 2020, Belgium

RECRUITING

CHu Saint Pierre

Brussels, 1000, Belgium

RECRUITING

Hopital Erasme

Brussels, 1070, Belgium

RECRUITING

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

RECRUITING

AZ Sint Blasius

Dendermonde, 9200, Belgium

RECRUITING

JESSA Ziekenhuis

Hasselt, 3500, Belgium

RECRUITING

Jan Ypermanziekenhuis

Ieper, 8900, Belgium

WITHDRAWN

CHU Tivoli

La Louvière, 7100, Belgium

RECRUITING

CHR Citadelle

Liège, 4000, Belgium

RECRUITING

AZ Sint Jozef

Malle, 2390, Belgium

WITHDRAWN

ZNA Jan Palfijn

Merksem, 2170, Belgium

RECRUITING

CH Mouscron

Mouscron, 7700, Belgium

RECRUITING

Clinique Saint Luc Bouge

Namur, 5004, Belgium

RECRUITING

AZ Damiaan

Ostend, 8400, Belgium

RECRUITING

AZ Delta

Roeselare, 8800, Belgium

RECRUITING

AZ St Jozef

Turnhout, 2300, Belgium

RECRUITING

AZ Jan Portaels

Vilvoorde, 1800, Belgium

RECRUITING

CHU Mont-Godinne

Yvoir, 5530, Belgium

RECRUITING

Related Publications (25)

• Mottet 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 BACKGROUND

• Mohile 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 BACKGROUND

• Allain TJ. Prostate cancer, osteoporosis and fracture risk. Gerontology. 2006;52(2):107-10. doi: 10.1159/000090956.

  PMID: 16508318 BACKGROUND

• Benton 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 BACKGROUND

• Diamond 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 BACKGROUND

• McGrath 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 BACKGROUND

• Oefelein 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.

  PMID: 11586210 BACKGROUND

• Braga-Basaria M, Dobs AS, Muller DC, Carducci MA, John M, Egan J, Basaria S. Metabolic syndrome in men with prostate cancer undergoing long-term androgen-deprivation therapy. J Clin Oncol. 2006 Aug 20;24(24):3979-83. doi: 10.1200/JCO.2006.05.9741.

  PMID: 16921050 BACKGROUND

• Galvao DA, Spry NA, Taaffe DR, Newton RU, Stanley J, Shannon T, Rowling C, Prince R. Changes in muscle, fat and bone mass after 36 weeks of maximal androgen blockade for prostate cancer. BJU Int. 2008 Jul;102(1):44-7. doi: 10.1111/j.1464-410X.2008.07539.x. Epub 2008 Mar 11.

  PMID: 18336606 BACKGROUND

• Galvao DA, Taaffe DR, Spry N, Joseph D, Turner D, Newton RU. Reduced muscle strength and functional performance in men with prostate cancer undergoing androgen suppression: a comprehensive cross-sectional investigation. Prostate Cancer Prostatic Dis. 2009;12(2):198-203. doi: 10.1038/pcan.2008.51. Epub 2008 Oct 14.

  PMID: 18852703 BACKGROUND

• Smith MR, Lee H, McGovern F, Fallon MA, Goode M, Zietman AL, Finkelstein JS. Metabolic changes during gonadotropin-releasing hormone agonist therapy for prostate cancer: differences from the classic metabolic syndrome. Cancer. 2008 May 15;112(10):2188-94. doi: 10.1002/cncr.23440.

  PMID: 18348297 BACKGROUND

• Smith MR, O'Malley AJ, Keating NL. Gonadotrophin-releasing hormone agonists, diabetes and cardiovascular disease in men with prostate cancer: which metabolic syndrome? BJU Int. 2008 Jun;101(11):1335-6. doi: 10.1111/j.1464-410X.2008.07707.x. No abstract available.

  PMID: 18454791 BACKGROUND

• D'Amico AV, Denham JW, Bolla M, Collette L, Lamb DS, Tai KH, Steigler A, Chen MH. Short- vs long-term androgen suppression plus external beam radiation therapy and survival in men of advanced age with node-negative high-risk adenocarcinoma of the prostate. Cancer. 2007 May 15;109(10):2004-10. doi: 10.1002/cncr.22628.

  PMID: 17397033 BACKGROUND

• D'Amico AV, Denham JW, Crook J, Chen MH, Goldhaber SZ, Lamb DS, Joseph D, Tai KH, Malone S, Ludgate C, Steigler A, Kantoff PW. Influence of androgen suppression therapy for prostate cancer on the frequency and timing of fatal myocardial infarctions. J Clin Oncol. 2007 Jun 10;25(17):2420-5. doi: 10.1200/JCO.2006.09.3369.

  PMID: 17557956 BACKGROUND

• D'Amico AV, Loffredo M, Renshaw AA, Loffredo B, Chen MH. Six-month androgen suppression plus radiation therapy compared with radiation therapy alone for men with prostate cancer and a rapidly increasing pretreatment prostate-specific antigen level. J Clin Oncol. 2006 Sep 1;24(25):4190-5. doi: 10.1200/JCO.2006.06.8239.

  PMID: 16943536 BACKGROUND

• Efstathiou JA, Bae K, Shipley WU, Hanks GE, Pilepich MV, Sandler HM, Smith MR. Cardiovascular mortality after androgen deprivation therapy for locally advanced prostate cancer: RTOG 85-31. J Clin Oncol. 2009 Jan 1;27(1):92-9. doi: 10.1200/JCO.2007.12.3752. Epub 2008 Dec 1.

  PMID: 19047297 BACKGROUND

• Ross RW, Oh WK, Xie W, Pomerantz M, Nakabayashi M, Sartor O, Taplin ME, Regan MM, Kantoff PW, Freedman M. Inherited variation in the androgen pathway is associated with the efficacy of androgen-deprivation therapy in men with prostate cancer. J Clin Oncol. 2008 Feb 20;26(6):842-7. doi: 10.1200/JCO.2007.13.6804.

  PMID: 18281655 BACKGROUND

• Jim HS, Park JY, Permuth-Wey J, Rincon MA, Phillips KM, Small BJ, Jacobsen PB. Genetic predictors of fatigue in prostate cancer patients treated with androgen deprivation therapy: preliminary findings. Brain Behav Immun. 2012 Oct;26(7):1030-6. doi: 10.1016/j.bbi.2012.03.001. Epub 2012 Mar 28.

  PMID: 22475653 BACKGROUND

• Shearman AM, Cupples LA, Demissie S, Peter I, Schmid CH, Karas RH, Mendelsohn ME, Housman DE, Levy D. Association between estrogen receptor alpha gene variation and cardiovascular disease. JAMA. 2003 Nov 5;290(17):2263-70. doi: 10.1001/jama.290.17.2263.

  PMID: 14600184 BACKGROUND

• Alevizaki M, Cimponeriu AT, Garofallaki M, Sarika HL, Alevizaki CC, Papamichael C, Philippou G, Anastasiou EA, Lekakis JP, Mavrikakis M. The androgen receptor gene CAG polymorphism is associated with the severity of coronary artery disease in men. Clin Endocrinol (Oxf). 2003 Dec;59(6):749-55. doi: 10.1046/j.1365-2265.2003.01917.x.

  PMID: 14974917 BACKGROUND

• Fox CS, Yang Q, Cupples LA, Guo CY, Atwood LD, Murabito JM, Levy D, Mendelsohn ME, Housman DE, Shearman AM. Sex-specific association between estrogen receptor-alpha gene variation and measures of adiposity: the Framingham Heart Study. J Clin Endocrinol Metab. 2005 Nov;90(11):6257-62. doi: 10.1210/jc.2005-0670. Epub 2005 Sep 6.

  PMID: 16144952 BACKGROUND

• Elfassihi L, Giroux S, Bureau A, Laflamme N, Cole DE, Rousseau F. Association with replication between estrogen-related receptor gamma (ESRRgamma) polymorphisms and bone phenotypes in women of European ancestry. J Bone Miner Res. 2010 Apr;25(4):901-11. doi: 10.1359/jbmr.091014.

  PMID: 19821770 BACKGROUND

• Crandall CJ, Crawford SL, Gold EB. Vasomotor symptom prevalence is associated with polymorphisms in sex steroid-metabolizing enzymes and receptors. Am J Med. 2006 Sep;119(9 Suppl 1):S52-60. doi: 10.1016/j.amjmed.2006.07.007.

  PMID: 16949389 BACKGROUND

• Rodriguez-Gonzalez G, Ramirez-Moreno R, Perez P, Bilbao C, Lopez-Rios L, Diaz-Chico JC, Lara PC, Serra-Majem L, Chirino R, Diaz-Chico BN. The GGN and CAG repeat polymorphisms in the exon-1 of the androgen receptor gene are, respectively, associated with insulin resistance in men and with dyslipidemia in women. J Steroid Biochem Mol Biol. 2009 Feb;113(3-5):202-8. doi: 10.1016/j.jsbmb.2008.12.009. Epub 2008 Dec 30.

  PMID: 19159685 BACKGROUND

• Moyad MA. Promoting general health during androgen deprivation therapy (ADT): a rapid 10-step review for your patients. Urol Oncol. 2005 Jan-Feb;23(1):56-64. doi: 10.1016/j.urolonc.2005.03.018.

  PMID: 15885584 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

One saliva sample (2mL) will be collected once at baseline for single nucleotide polymorphism analyses.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bertrand TOMBAL, MD, PhD

  Cliniques Universitaires Saint Luc, Brussels

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertrand TOMBAL, MD, PhD

CONTACT

003227641409; bertrand.tombal@uclouvain.be

Valentina BUTOESCU, PharmD

CONTACT

003227643546; valentina.butoescu@uclouvain.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 12, 2015
• Study Start: April 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

BE (20)