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

• Conditions: Prostate Cancer
• Interventions: Genetic: Saliva sample collection for genetic analyses

• Registration Number: NCT02440802
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Prostate cancer patients for which reimbursed ADT with a gonadoliberin antagonist is indicated, for a period of at least 6 months will lbe enrolled. At 0, 3 months and 6 months of ADT, Aging Males' Symptoms (AMS), EQ-5D (EuroQoL), and hot flashes intensity and frequency (Moyad scale) will be collected, as well as routine assessments: vital signs (blood pressure, heart rate), weight, waist perimeter, fat percentage, Body Mass Index (BMI) and routine laboratory assessments. Determine genotypes of polymorphisms of interest by pyrosequencing. Determine the prevalence of the polymorphisms of interest in the studied population. Perform initial assessment of the association between genetic polymorphisms and questionnaire results.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gonadoliberin antagonist treatment	Saliva sample collection for genetic analyses	Single arm study, all patients are treated the same way. Saliva sample collection for genetic analyses.

Primary Outcome Measures

Name	Time	Method
Aging Males Symptoms questionnaire	6 months

Trial Locations

Locations (20)

ASZ Aalst; 🇧🇪 Aalst, Belgium

JESSA Ziekenhuis; 🇧🇪 Hasselt, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium

AZ St Jozef; 🇧🇪 Turnhout, Belgium

Jan Ypermanziekenhuis; 🇧🇪 Ieper, Belgium

CHR Citadelle; 🇧🇪 Liege, Belgium

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

CHu Saint Pierre; 🇧🇪 Brussels, Belgium

AZ Sint Blasius; 🇧🇪 Dendermonde, Belgium

CHU Tivoli; 🇧🇪 La Louviere, Belgium

AZ Sint Jozef; 🇧🇪 Malle, Belgium

Clinique Saint Luc Bouge; 🇧🇪 Namur, Belgium

OLV Aalst; 🇧🇪 Aalst, Belgium

Hopital Erasme; 🇧🇪 Brussels, Belgium

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

ZNA Jan Palfijn; 🇧🇪 Merksem, Belgium

AZ Damiaan; 🇧🇪 Oostende, Belgium

CH Mouscron; 🇧🇪 Mouscron, Belgium

AZ Jan Portaels; 🇧🇪 Vilvoorde, Belgium

CHU Mont-Godinne; 🇧🇪 Yvoir, Belgium