Prostate Cancer Clinical Trial
Official title:
Evaluation and Predictive Value of Genetic Polymorphisms in the Management of Hormonal Treatment of Prostate Cancer
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.
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. ;
Observational Model: Case-Only, Time Perspective: Prospective
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