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

NCT02440802 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2016-10-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Bertrand TOMBAL, MD, PhD · Cliniques Universitaires Saint Luc, Brussels

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02440802 on ClinicalTrials.gov