An observational study in Prostate Cancer, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Status unknown at 20 sites in Belgium. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-18.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 250 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.
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Prostate cancer patients for which reimbursed androgen deprivation therapy with a gonadoliberin antagonist is indicated, for aperiod of at least 6 months.
Exclusion Criteria:
Single arm study, all patients are treated the same way. Saliva sample collection for genetic analyses.
Genetic: Saliva sample collection for genetic analyses
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.
Aging Males Symptoms questionnaire
Time frame: 0 months
Aging Males Symptoms questionnaire
Time frame: 3 months
Aging Males Symptoms questionnaire
Time frame: 6 months
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain