Clinical trial NCT06046131: Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.
Official title: Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostatic Neoplasm
Adenocarcinoma
Neoplasm Recurrence
Neoplasm Metastasis
Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2023-09-21
Enrollment: 3000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Any patient with a histologically confirmed incident case of prostate cancer will be included in the study
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion 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).

Primary outcomes:
measure: association between determinants (independent variables) and health events linked to disease progression (dependent variables)
timeFrame: At the start of the study, at 1,2,5 and 10 years after the inclusion and after starting treatment.
Secondary outcomes:
measure: association between determinants (independent variables) and health events other than those linked to disease progression (dependent variables).
timeFrame: : At the start of the study, at 1,2,5 and 10 years after the inlcusion and after starting treatment.
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU of Rennes
state: Ille-et-Vilaine
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU of Guadeloupe
Study officials:
References: