Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-17 @ 3:10 AM
Study NCT ID:
NCT02440802
Status:
UNKNOWN
Last Update Posted:
2016-10-18
First Post:
2015-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation and Predictive Value of Genetic Polymorphisms in the Management of Hormonal Treatment of Prostate Cancer
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Study Overview
Official Title:
Evaluation and Predictive Value of Genetic Polymorphisms in the Management of Hormonal Treatment of Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Feel+
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: