Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.

NCT ID: NCT06046131

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2039-02-28

Brief Summary

The course and progression of prostate cancer is highly variable, depending on the individual characteristics, the aggressiveness of the disease at the time of diagnosis as well as the ethno-geographic origins of the individuals. The general objective of the project is to identify the clinical, genetic and environmental determinants (risk factors) of the evolution, progression and complications of the disease according to the treatment options. Identifying modifiable and non-modifiable prognostic determinants of disease progression is a major challenge. This knowledge will help guide treatment choices but also, especially in high-risk populations (high incidence of disease) to better tailor prevention policies and possibly screening .

Detailed Description

There is a lack of information to predict the course of prostate cancer following its initial diagnosis; in other words, why some are indolent and evolve very slowly and others are aggressive, evolve rapidly with an increased risk of metastasis development and death. In addition, these evolutions do not seem similar according to ethno-geographic origins. We therefore hypothesize that in addition to genetic susceptibility factors specific to individuals and / or linked to their ethno-geographic origins, medical, occupational and environmental factors can influence the course of the disease and the response to treatments. We will build two prospective cohorts of incident cases of prostate cancer, one in Guadeloupe (whose population is predominantly Afro-descendant) and one in Rennes (Brittany, whose population is mainly of Caucasian origin). Each patient will be subject to longitudinal follow-up over time. Structured questionnaires will be administered at the time of diagnosis and at regular times after the initial treatment or subsequent treatments. They will focus on socio-demographic data, places of residence, education levels, lifestyles (tobacco, alcohol), personal and family medical history, current treatments, current and past occupational activities. Anthropometric and blood pressure measurements will be made at the time of diagnosis and at regular times after treatment. Saliva, urine and blood samples will be obtained. Clinical data related to the disease will be collected continuously.

Conditions

Prostatic Neoplasm; Adenocarcinoma; Neoplasm Recurrence; Neoplasm Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients prostate cancer

Patient with a confirmed diagnosis of prostate cancer will be included before starting any treatment. Recruitment will be carried out by urologists from the urology departments of the CHU of Guadeloupe and the CHU of Rennes.

Group Type: OTHER

Standard care

Intervention Type: OTHER

Extra blood collection for dosages Urine collection for the dosage of non-persistent pollutants, isolation of extracellular vesicles released in urine, analysis of the microbiome, metagenomics to obtain a complete description of the bacterial functions represented as well as other microorganisms present, metabolome profiling and identification and/or assays of any other biological compound of interest strictly related to the specific objectives of the research.

Saliva collection for the extraction of the constitutional DNA. An interview using a structured questionnaire A quality of live auto-questionnaire

Interventions

Standard care

Extra blood collection for dosages Urine collection for the dosage of non-persistent pollutants, isolation of extracellular vesicles released in urine, analysis of the microbiome, metagenomics to obtain a complete description of the bacterial functions represented as well as other microorganisms present, metabolome profiling and identification and/or assays of any other biological compound of interest strictly related to the specific objectives of the research.

Saliva collection for the extraction of the constitutional DNA. An interview using a structured questionnaire A quality of live auto-questionnaire

Intervention Type: OTHER

Other Intervention Names

Extra blood collection, urine collection and saliva collection, questionnaire.

Eligibility Criteria

Inclusion Criteria

Adult patients with incident case of prostate cancer Patient consulting the University Hospital of Guadeloupe or the University Hospital of Rennes Patient who resides in the departments of Guadeloupe or Martinique or the community of Saint-Martin or in Britany Patient affiliated or beneficiary of the social security signed consent

Exclusion Criteria

Physical or mental health judjed by the investigator as precluding participation in the research Protected adults (guardianship, curatorship, safeguard of justice).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier Universitaire de la Guadeloupe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU of Rennes

Rennes, Ille-et-Vilaine, France

Site Status: NOT_YET_RECRUITING

CHU of Guadeloupe

Pointe-à-Pitre, Guadeloupe, Guadeloupe

Site Status: RECRUITING

Countries

France; Guadeloupe

Central Contacts

Valérie HAMONY-SOTER

Role: CONTACT

valerie.soter@chu-guadeloupe.fr

+590 590 93 46 77

Eunice NUBRET

Role: CONTACT

eunice.nubret@chu-guadeloupe.fr

+590 590 93 46 86

Facility Contacts

Valérie Hamony Soter

Role: primary

valerie.soter@chu-guadeloupe.fr

+590 590 93 46 77

Romain MATHIEU

Role: backup

romain.mathieu@chu-rennes.fr

+33 (0)6 63 69 70 30

Valérie Hamony Soter

Role: primary

valerie.soter@chu-guadeloupe.fr

+590 590 93 46 77

Other Identifiers

PAP_RIPH2_2020/26

Identifier Type: -

Identifier Source: org_study_id