Clinical trial NCT02440802: Evaluation and Predictive Value of Genetic Polymorphisms in the Management of Hormonal Treatment of Prostate Cancer
Official title: Evaluation and Predictive Value of Genetic Polymorphisms in the Management of Hormonal Treatment of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2015-05-12
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aging Males Symptoms questionnaire
timeFrame: 0 months
measure: Aging Males Symptoms questionnaire
timeFrame: 3 months
measure: Aging Males Symptoms questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Aalst
country: Belgium
facility: OLV Aalst
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brussels
country: Belgium
facility: CHu Saint Pierre
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
city: Hasselt
country: Belgium
facility: JESSA Ziekenhuis
city: Ieper
country: Belgium
facility: Jan Ypermanziekenhuis
city: La Louviere
country: Belgium
facility: CHU Tivoli
city: Liege
country: Belgium
facility: CHR Citadelle
city: Malle
country: Belgium
facility: AZ Sint Jozef
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Mouscron
country: Belgium
facility: CH Mouscron
city: Namur
country: Belgium
facility: Clinique Saint Luc Bouge
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Roeselare
country: Belgium
facility: AZ Delta
city: Turnhout
country: Belgium
facility: AZ St Jozef
city: Vilvoorde
country: Belgium
facility: AZ Jan Portaels
city: Yvoir
country: Belgium
facility: CHU Mont-Godinne
Study officials:
affiliation: Cliniques Universitaires Saint Luc, Brussels
name: Bertrand TOMBAL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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