Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCentre Hospitalier Universitaire de la Guadeloupe
About this trial
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 .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Standard care
Other interventionExtra 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
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Patients prostate cancerOther 1 intervention
Trial outcomes
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
Time frame
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).
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Universitaire de la Guadeloupe
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Source ClinicalTrials.gov