Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.

NCT06046131 | Recruiting

• 1 other identifier: PAP_RIPH2_2020/26
• Study Type: interventional
• Target: 3,000
• Locations: 2 countries
• Sites: 2

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 .

Conditions

Prostatic Neoplasm; Adenocarcinoma; Neoplasm Recurrence; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• 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

  At the start of the study, at 1,2,5 and 10 years after the inclusion and after starting treatment.

Secondary Outcomes (1)

• association between determinants (independent variables) and health events other than those linked to disease progression (dependent variables).

  : At the start of the study, at 1,2,5 and 10 years after the inlcusion and after starting treatment.

Study Arms (1)

Patients prostate cancer

OTHER

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.

Other: Standard care

Interventions

Standard care 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

Also known as: Extra blood collection, urine collection and saliva collection, questionnaire.

Patients prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

CHU of Rennes

Rennes, Ille-et-Vilaine, 35000, France

NOT YET RECRUITING

CHU of Guadeloupe

Pointe-à-Pitre, Guadeloupe, 97159, Guadeloupe

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Recurrence; Neoplasm Metastasis

Interventions

Standard of Care; Urine Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Central Study Contacts

Valérie HAMONY-SOTER

CONTACT

+590 590 93 46 77; valerie.soter@chu-guadeloupe.fr

Eunice NUBRET

CONTACT

+590 590 93 46 86; eunice.nubret@chu-guadeloupe.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Any patient with a histologically confirmed incident case of prostate cancer will be included in the study

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: February 28, 2023
• Primary Completion (Estimated): February 28, 2039
• Study Completion (Estimated): February 28, 2039
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (1); GU (1)