Prostatic NeoplasmKP-CARAIBESNCT06046131
Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.
A study of Prostatic Neoplasm and Adenocarcinoma, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm, Adenocarcinoma, Neoplasm Recurrence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Feb 2023to 28 Feb 2039
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Physical or mental health judjed by the investigator as precluding participation in the research Protected adults (guardianship, curatorship, safeguard of justice).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
France1 site, 1 recruiting
- Not yet recruiting
CHU of Rennes
Rennes, Ille-et-Vilaine, 35000
Valérie Hamony Soter, +590 590 93 46 77, valerie.soter@chu-guadeloupe.fr
Romain MATHIEU, +33 (0)6 63 69 70 30, romain.mathieu@chu-rennes.fr
Guadeloupe1 site, 1 recruiting
- Recruiting
CHU of Guadeloupe
Pointe-à-Pitre, Guadeloupe, 97159
Valérie Hamony Soter, +590 590 93 46 77, valerie.soter@chu-guadeloupe.fr
Laurent BRUREAU
About this study
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 .
Read the 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.
- Being tested
- Standard care
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Also called Extra blood collection, urine collection and saliva collection, questionnaire.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: : At the start of the study, at 1,2,5 and 10 years after the inlcusion and after starting treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start28 Feb 2023
- Primary completion28 Feb 2039 (estimated)
- Study completion28 Feb 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Any patient with a histologically confirmed incident case of prostate cancer will be included in the study
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046131
- Sponsor's protocol ID
- PAP_RIPH2_2020/26
- Acronym
- KP-CARAIBES
- Status last verified
- Nov 2025
- First submitted
- 14 Sep 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.
- ClinicalTrials.gov ID
- NCT06046131
- Acronym / sponsor ID
- KP-CARAIBES / PAP_RIPH2_2020/26
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 28 Feb 2039 (estimated)
- Study completion
- 28 Feb 2039 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Any patient with a histologically confirmed incident case of prostate cancer will be included in the study
| Arm | Type | Receives |
|---|---|---|
| Patients prostate cancer | Other | Other: Standard carePatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Physical or mental health judjed by the investigator as precluding participation in the research Protected adults (guardianship, curatorship, safeguard of justice).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard careAlso: Extra blood collection, urine collection and saliva collection, questionnaire.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 | Other | Patients prostate cancer |
Primary outcome
association between determinants (independent variables) and health events linked to disease progression (dependent variables)
Time frame: At the start of the study, at 1,2,5 and 10 years after the inclusion and after starting treatment.
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
1 secondary outcome
association between determinants (independent variables) and health events other than those linked to disease progression (dependent variables).
Time frame: : At the start of the study, at 1,2,5 and 10 years after the inlcusion and after starting treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Prostatic Neoplasm and Adenocarcinoma, run by Centre Hospitalier Universitaire de la Guadeloupe at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie HAMONY-SOTER (+590 590 93 46 77, valerie.soter@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association between determinants (independent variables) and health events linked to disease progression (dependent variables) (time frame: At the start of the study, at 1,2,5 and 10 years after the inclusion and after starting treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.