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

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

Sponsors

Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborator: Ferring Pharmaceuticals

Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.

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.

Overall Status Unknown status
Start Date April 2013
Completion Date September 2017
Primary Completion Date September 2017
Study Type Observational
Primary Outcome
Measure Time Frame
Aging Males Symptoms questionnaire 0 months
Aging Males Symptoms questionnaire 3 months
Aging Males Symptoms questionnaire 6 months
Enrollment 250
Condition
Intervention

Intervention Type: Genetic

Intervention Name: Saliva sample collection for genetic analyses

Description: 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.

Arm Group Label: Gonadoliberin antagonist treatment

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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.

Gender: Male

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Bertrand TOMBAL, MD, PhD Principal Investigator Cliniques Universitaires Saint Luc, Brussels
Overall Contact

Last Name: Bertrand TOMBAL, MD, PhD

Phone: 003227641409

Email: [email protected]

Location
Facility: Status: Contact:
ASZ Aalst | Aalst, 9300, Belgium Recruiting Bernard RAPPE, MD
OLV Aalst | Aalst, 9300, Belgium Recruiting Peter SCHATTEMAN, MD [email protected]
ZNA Middelheim | Antwerpen, 2020, Belgium Recruiting Tibaut DEBACKER, MD [email protected]
CHu Saint Pierre | Brussels, 1000, Belgium Recruiting Kim Entezari, MD
Hopital Erasme | Brussels, 1070, Belgium Recruiting Thierry ROUMEGUERE, MD [email protected]
Cliniques Universitaires Saint Luc | Brussels, 1200, Belgium Recruiting Bertrand TOMBAL, MD, PhD 003227641409 [email protected]
AZ Sint Blasius | Dendermonde, 9200, Belgium Recruiting Dieter OST, MD [email protected]
JESSA Ziekenhuis | Hasselt, 3500, Belgium Recruiting Kris VEKEMANS, MD [email protected]
Jan Ypermanziekenhuis | Ieper, 8900, Belgium Withdrawn
CHU Tivoli | La Louviere, 7100, Belgium Recruiting Thierry WILDSCHUTZ, MD [email protected]
CHR Citadelle | Liege, 4000, Belgium Recruiting Hubert NICOLAS, MD [email protected]
AZ Sint Jozef | Malle, 2390, Belgium Withdrawn
ZNA Jan Palfijn | Merksem, 2170, Belgium Recruiting Peter DE JONGE, MD [email protected]
CH Mouscron | Mouscron, 7700, Belgium Recruiting Philippe FRANCOIS, MD [email protected]
Clinique Saint Luc Bouge | Namur, 5004, Belgium Recruiting Luc DE VISSCHER, MD [email protected]
AZ Damiaan | Oostende, 8400, Belgium Recruiting Pieter MATTELAER, MD [email protected]
AZ Delta | Roeselare, 8800, Belgium Recruiting Lieven GOEMAN, MD
AZ St Jozef | Turnhout, 2300, Belgium Recruiting Koen Ackaert, MD [email protected]
AZ Jan Portaels | Vilvoorde, 1800, Belgium Recruiting Geert Martens, MD [email protected]
CHU Mont-Godinne | Yvoir, 5530, Belgium Recruiting Francis LORGE, MD [email protected]
Location Countries

Belgium

Verification Date

October 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Gonadoliberin antagonist treatment

Description: Single arm study, all patients are treated the same way. Saliva sample collection for genetic analyses.

Acronym Feel+
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov