Evaluation and Predictive Value of Genetic Polymorphisms in the Management of Hormonal Treatment of Prostate Cancer (Feel+)

October 17, 2016 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
      • Aalst, Belgium, 9300
        • Recruiting
        • ASZ Aalst
        • Contact:
          • Bernard RAPPE, MD
      • Antwerpen, Belgium, 2020
      • Brussels, Belgium, 1070
      • Brussels, Belgium, 1200
      • Brussels, Belgium, 1000
        • Recruiting
        • CHU Saint Pierre
        • Contact:
          • Kim Entezari, MD
      • Dendermonde, Belgium, 9200
      • Hasselt, Belgium, 3500
      • Ieper, Belgium, 8900
        • Withdrawn
        • Jan Ypermanziekenhuis
      • La Louviere, Belgium, 7100
      • Liege, Belgium, 4000
      • Malle, Belgium, 2390
        • Withdrawn
        • AZ Sint Jozef
      • Merksem, Belgium, 2170
      • Mouscron, Belgium, 7700
      • Namur, Belgium, 5004
      • Oostende, Belgium, 8400
      • Roeselare, Belgium, 8800
        • Recruiting
        • AZ DELTA
        • Contact:
          • Lieven GOEMAN, MD
      • Turnhout, Belgium, 2300
      • Vilvoorde, Belgium, 1800
        • Recruiting
        • AZ Jan Portaels
        • Contact:
      • Yvoir, Belgium, 5530

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gonadoliberin antagonist treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aging Males Symptoms questionnaire
Time Frame: 0 months
0 months
Aging Males Symptoms questionnaire
Time Frame: 3 months
3 months
Aging Males Symptoms questionnaire
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Bertrand TOMBAL, MD, PhD, Cliniques Universitaires Saint Luc, Brussels

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

April 30, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B403201317385

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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