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Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression. (KP-CARAIBES)

Primary Purpose

Prostatic Neoplasm, Adenocarcinoma, Neoplasm Recurrence

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Standard care
Sponsored by
Centre Hospitalier Universitaire de Pointe-a-Pitre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostatic Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • CHU of Rennes
  • CHU of GuadeloupeRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients prostate cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

association between determinants (independent variables) and health events linked to disease progression (dependent variables)
dependent variables: These are mainly criteria relating to :Discharge from active surveillance, Biological recurrence,Radiological, loco-regional or distant progression, Independant variables. These are mainly criteria relating to : Date of initial treatment and dates of successive treatments, Gleason score (ISUP) at diagnosis Gleason score (ISUP) on surgical specimen pTNM stage after surgery Body mass index [kg/m²], percentage of fat mass, % of water mass, % of bone mass estimated by bio-impedance. Metabolic syndrome (3 of the following 5 criteria): triglycerides > 1.7 mmo

Secondary Outcome Measures

association between determinants (independent variables) and health events other than those linked to disease progression (dependent variables).
Dependent variables Adverse events (disease-related or treatment-related) rated according to CTCAE grades (Common Terminology Criteria for Adverse Events) Micturition disorders estimated by the International Prostate Symptom Score (IPSS) Erectile function estimated by the IIEF5 score (International Index of Erectile Function) Quality of life estimated by the FACT-P score (Functional Assessment of Cancer Therapy-Prostate) Independent variables These are the same as those indicated for the primary endpoints.

Full Information

First Posted
September 14, 2023
Last Updated
September 14, 2023
Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT06046131
Brief Title
Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.
Acronym
KP-CARAIBES
Official Title
Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
February 28, 2039 (Anticipated)
Study Completion Date
February 28, 2039 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Pointe-a-Pitre
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm, Adenocarcinoma, Neoplasm Recurrence, Neoplasm Metastasis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Any patient with a histologically confirmed incident case of prostate cancer will be included in the study
Masking
None (Open Label)
Allocation
N/A
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients prostate cancer
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care
Other Intervention Name(s)
Extra blood collection, urine collection and saliva collection, questionnaire.
Intervention Description
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
Primary Outcome Measure Information:
Title
association between determinants (independent variables) and health events linked to disease progression (dependent variables)
Description
dependent variables: These are mainly criteria relating to :Discharge from active surveillance, Biological recurrence,Radiological, loco-regional or distant progression, Independant variables. These are mainly criteria relating to : Date of initial treatment and dates of successive treatments, Gleason score (ISUP) at diagnosis Gleason score (ISUP) on surgical specimen pTNM stage after surgery Body mass index [kg/m²], percentage of fat mass, % of water mass, % of bone mass estimated by bio-impedance. Metabolic syndrome (3 of the following 5 criteria): triglycerides > 1.7 mmo
Time Frame
At the start of the study, at 1,2,5 and 10 years after the inclusion and after starting treatment.
Secondary Outcome Measure Information:
Title
association between determinants (independent variables) and health events other than those linked to disease progression (dependent variables).
Description
Dependent variables Adverse events (disease-related or treatment-related) rated according to CTCAE grades (Common Terminology Criteria for Adverse Events) Micturition disorders estimated by the International Prostate Symptom Score (IPSS) Erectile function estimated by the IIEF5 score (International Index of Erectile Function) Quality of life estimated by the FACT-P score (Functional Assessment of Cancer Therapy-Prostate) Independent variables These are the same as those indicated for the primary endpoints.
Time Frame
: At the start of the study, at 1,2,5 and 10 years after the inlcusion and after starting treatment.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie HAMONY-SOTER
Phone
+590 590 93 46 77
Email
valerie.soter@chu-guadeloupe.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Eunice NUBRET
Phone
+590 590 93 46 86
Email
eunice.nubret@chu-guadeloupe.fr
Facility Information:
Facility Name
CHU of Rennes
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie Hamony Soter
Phone
+590 590 93 46 77
Email
valerie.soter@chu-guadeloupe.fr
First Name & Middle Initial & Last Name & Degree
Romain MATHIEU
Phone
+33 (0)6 63 69 70 30
Email
romain.mathieu@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Romain MATHIEU
Facility Name
CHU of Guadeloupe
City
Pointe-à-Pitre
ZIP/Postal Code
97159
Country
Guadeloupe
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie Hamony Soter
Phone
+590 590 93 46 77
Email
valerie.soter@chu-guadeloupe.fr
First Name & Middle Initial & Last Name & Degree
Laurent BRUREAU

12. IPD Sharing Statement

Learn more about this trial

Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.

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