Prostate CancerCHLOECAPANCT06773806
CHLORDECONE EXPOSURE AND PROSTATE CANCER IN THE FRENCH REGION OF MARTINIIQUE
An observational study of Prostate Cancer, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in Martinique.
Trial summary
Prostate cancer is the most common male cancer in industrialized countries, including France, with over 60,000 new cases each year, and represents the third leading cause of cancer-related death in men. The only known risk factors are age, ethnic origin and family history of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- How many people
- 3,600 participants
- Where
- 2 sitesMartinique
- Study dates
- 15 Apr 2026to Apr 2031
- Phase
- Observational
- 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 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants will be selected from the Martinican male population under the age of 80.
Who may be able to join
- To take part in this research, participants must meet the following criteria:
- Patients/cases :
- All men newly diagnosed with Prostate Cancer in Martinique during a three-year given period in all public and private services caring for patients with Prostate Cancer, identified via multidisciplinary consultation meetings.
- Male adults under 75 years of age
- Resident in Martinique for at least 6 months
- Histologically confirmed (inclusion possible as soon as the result is known by the urologist)
Show all 25Show fewer
- Affiliated to a social security scheme or equivalent
- Have signed a free and informed consent form
- Biopsy-negative" controls (Group 1 controls):
- All men with a negative prostate biopsy following elevated Prostate Specific Antigen (PSA) assay (> 2.5 ng/ml) within a 3-year period in all public and private services in Martinique identified via urologists or pathologists.
- Male adults under 75 years of age
- Resident in Martinique for at least 6 months
- Frequency matched on age (+/- 5 years) to patients
- Affiliated to a social security scheme or equivalent
- Signed free and informed consent
- PSA-negative" controls (Group 2 controls):
- All men with a PSA ⩽ 2.5 ng/ml within a 3-year period and less than 3 months identified via a survey institute
- Male adults under 75 years of age
- Resident in Martinique for at least 6 months
- Frequency matched on age (+/- 5 years) against patients
- Frequency matched on socio-professional category against men of the same age in Martinique (INSEE data)
- NON INCLUSION CRITERIA
- To take part in this research, participants must not meet the following criteria:
- Be subject to a legal protection measure (safeguard of justice, curatorship or guardianship).
- Inability to consent because does not speak French or Creole.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Martinique2 sites, 2 recruiting
- Not yet recruiting
The private clinic "Clinique Saint-Paul"
Fort-de-France, 97200
Gabin N AGOUA, MD, docteuragoua.urologie@orange.fr
- Recruiting
University Hospital of Martinique (CHUM)
Fort-de-France, 97261
Clarisse JOACHIM-CONTARET, MD, PhD, HDR, clarisse.joachim@chu-martinique.fr
About this study
Official title: LIEN ENTRE EXPOSITION A LA CHLORDECONE ET CANCER DE LA PROSTATE EN MARTINIQUE
Prostate cancer is the most common male cancer in industrialized countries, including France, with over 60,000 new cases each year, and represents the third leading cause of cancer-related death in men.
The only known risk factors are age, ethnic origin and family history of prostate cancer. Indeed, there are considerable ethnic disparities in prostate cancer risk, with an incidence rate 60% higher in African-American men than in European-American men (Evans 2008). Similarly, in the French West Indies, where over 90% of the population is of Afro-Caribbean origin, the incidence of prostate cancer is twice as high as in mainland France. In 2015, the annual incidence was 88.5 cases per 100,000 in mainland France (Defossez 2021), while it was 184.1 cases per 100,000 in Guadeloupe, over the period 2008-2013 (Desloumeaux 2017), and 161.1 cases per 100,000 in Martinique, over the period 2005-2014 (Joachim 2019). The incidence rates observed in the French West Indies are of the same order as those observed in Afro-Caribbean populations in the UK and African-American populations in the USA (Ben Schlomo 2008, Evans 2008).
Read more
The reasons for these ethnic disparities in incidence are still poorly understood, but the role of genetic factors has been suggested. Indeed, certain genetic polymorphisms have been associated with an increased individual risk of prostate cancer in men of sub-Saharan African origin (Conti 2021; Karunamuni 2021; Marlin 2021). In addition, certain environmental factors (in the broadest sense) such as obesity, chronic inflammation, diet and certain environmental pollutants, including persistent organic pollutants (POPs) such as certain organochlorine pesticides, are also strongly suspected.
Among the suspected organochlorine pesticides is chlordecone, an insecticide used in the French West Indies until 1993, strongly suspected of playing a role in the occurrence of prostate cancer, particularly in the West Indies. Indeed, the Kannari study (Dereumeaux and Saoudi 2018), supported by Santé publique France, assessed the exposure of the West Indian population (Martinique and Guadeloupe) in 2013-2014 to chlordecone and certain organochlorine compounds , measured by serum levels, and quantified the determinants of this impregnation. The results of the study show that 90% of the West Indian population is indeed exposed to chlordecone, and demonstrate that chlordecone is still present in the environment (water and soil) and in food products, despite the cessation of its use in the West Indies in 1993.
To date, only one epidemiological study has explored the link between chlordecone exposure and the occurrence of prostate cancer, the Karuprostate study, a case-control study carried out between 2004 and 2007 in Guadeloupe, including 623 prostate cancer cases and 671 controls (Multigner 2010). Chlordecone exposure was measured by serum levels with an initial detection limit of 0.25 μg/L (Multigner 2010), then improved to 0.06 μg/L (Emmeville 2015). The authors highlighted a significant association between chlordecone exposure and prostate cancer, with a positive dose-response relationship (OR=1.77; 95% CI, 1.21 to 2.58 for the highest tercile). This association was more specifically observed in subjects with a family history of prostate cancer and in men who had lived in a Western country, requiring further investigation. The Karuprostate study also showed that serum levels of dichlorodiphenyldichloroethylene (DDE), the main and most stable metabolite of DDT, were significantly associated with the occurrence of CaP (Emmeville 2015). These results underline the interest of assessing, along with chlordecone, co-exposure to other persistent organic or organochlorine pollutants.
Furthermore, DDE exhibits anti-androgenic effects and has been shown to repress the production of Prostatic-Specific Antigen (PSA) (target gene of the androgen receptor) by human prostate cancer cell lines (Wong 2015). The supposed effect of other organochlorines such as chlordecone on androgen receptors and thus on PSA levels could thus have important repercussions in terms of prostate cancer diagnosis. Individual screening for prostate cancer is based on serum PSA levels, followed in cases of elevated PSA (> 3-4 ng/ml) by multiparametric Magnetic Resonance Imaging (mpMRI). A recent study showed that performing pre-biopsy mpMRI, regardless of PSA level, could lead to more men being diagnosed with clinically significant prostate cancer (Eldred-Evans 2021).
Finally, there is a lack of preclinical studies to investigate the distribution of chlordecone in blood and tissues, as well as the link between chlordecone and markers of prostate cancer aggressiveness.
We therefore propose a case-control study in the general population of Martinique. This study will enable us to understand the nature of the link between chlordecone and prostate cancer.
- Conditions
- Prostate Cancer
- Keywords
- Epidemiology, Case-control study, Prostate cancer, Chlordecone, Pesticides
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer patients | The "prostate cancer patients" group consists of : * Adult men under 75 years of age, * who are resident in Martinique for at least 6 months * who have been newly diagnosed with histologically confirmed prostate cancer in Martinique during a given three-year period in all public and private services caring for prostate cancer patients. | |
| Controls Group 1 | The 1st control group also called "negative biopsy group" consists of : * Adult men under 75 years of age, * who are resident in Martinique for at least 6 months * who have had a negative prostate biopsy following elevated PSA (> 2.5 ng/ml) in all public and private services in Martinique identified via urologists or pathologists, during the same given 3-year period as patients, * whose the frequency matched on age (+/- 5 years) versus patients | |
| Controls Group 2 | The second control group, also called "PSA negative group", is composed of : * Adult men under 75 years of age, * who are residing in Martinique for at least 6 months * who have had a PSA test less than or equal to the threshold value of 2.5 ng/ml, during the same 3-year period as the patients, identified by a survey institute. * whose frequency is age-matched (+/- 5 years) to patients. * with quotas defined on socio-professional category in relation to men of the same age residing in Martinique (based on INSEE data). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure : Measure of association between chlordecone exposure and the risk of prostate cancer.
Chlordecone exposure will be measured using several complementary methods, combining serum chlordecone assays, an assessment of chlordecone exposure based on questionnaire data (occupational, residential and dietary), and the use of job-exposure or culture-exposure matrices.
Measured: The blood sample required for chlordecone measurement and the study questionnaire will be taken for each participant during the single inclusion visit. Analysis of the study outcomes will take place at the end of the 36 months recruitment phase.
Secondary outcomes (4)
Primary secondary outcome measure : Measurement of the association between exposure to chlordecone and other environmental pollutants and serum Prostate-Specific Antigen levels in cases and controls.
The association between chlordecone (and other persistent organic pollutants) and PSA levels will be measured using blood tests for these different pollutants.
Measured: From the blood sampling to the statistical analyses it will take about 36 months.
Secondary secondary outcome measure : Number of significant cancers and aggressive cancers diagnosed on targeted mpMRI biopsies versus number of significant cancers and aggressive cancers diagnosed by systematic biopsies.
Significant cancer is defined by an ISUP score of 2 or more, and aggressive cancer by an ISUP score > 3 and/or clinical stage T2c or T3.
Measured: It will take around 36 months from recovery of ISUP clinical data to statistical analysis.
Third secondary outcome measure: Distribution of chlordecone in blood, adipose and prostate tissue. Validation of a molecular signature, previously identified in vitro, on the cases' tumour tissues.
Chlordecone distribution will be investigated by measuring chlordecone levels in blood, periprostatic adipose tissue and prostate tissue from cases treated by radical prostatectomy. A molecular signature associated with chlordecone exposure will be defined in vitro on prostate cancer cell cultures and organotypic cultures of human prostate cancers. This in vitro identified molecular signature will then be validated on tumor tissue from prostate biopsies of the cases, and compared to chlordecone exposure in these patients.
Measured: It will take around 36 months from blood sampling and recovery of the various prostate tissues to analysis of chlordecone distribution and validation of the molecular signature.
Fourth secondary outcome measure : Genotyping of genetic variants from blood samples using a genome-identity chip.
Genetic polymorphisms associated with an increased risk of prostate cancer will be sought and taken into account in the various analyses.
Measured: It will take at least 36 months from blood sampling to genotyping.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start15 Apr 2026
- Primary completionApr 2030 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Direction Générale de la Santé, France, LABERCA - Laboratoire d'Etude des Résidus et Contaminants dans les Aliments, National Cancer Institute, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773806
- Sponsor's protocol ID
- C22-52
- Other IDs
- 2023-A00160-45
- Acronym
- CHLOECAPA
- Status last verified
- Apr 2026
- First submitted
- 19 Dec 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIEN ENTRE EXPOSITION A LA CHLORDECONE ET CANCER DE LA PROSTATE EN MARTINIQUE
- ClinicalTrials.gov ID
- NCT06773806
- Acronym / sponsor ID
- CHLOECAPA / C22-52
- Conditions
- Prostate Cancer
- Keywords
- Epidemiology, Case-control study, Prostate cancer, Chlordecone, Pesticides
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Direction Générale de la Santé, France, LABERCA - Laboratoire d'Etude des Résidus et Contaminants dans les Aliments, National Cancer Institute, France
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 14 Jan 2025 (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.
Prostate cancer is the most common male cancer in industrialized countries, including France, with over 60,000 new cases each year, and represents the third leading cause of cancer-related death in men.
The only known risk factors are age, ethnic origin and family history of prostate cancer. Indeed, there are considerable ethnic disparities in prostate cancer risk, with an incidence rate 60% higher in African-American men than in European-American men (Evans 2008). Similarly, in the French West Indies, where over 90% of the population is of Afro-Caribbean origin, the incidence of prostate cancer is twice as high as in mainland France. In 2015, the annual incidence was 88.5 cases per 100,000 in mainland France (Defossez 2021), while it was 184.1 cases per 100,000 in Guadeloupe, over the period 2008-2013 (Desloumeaux 2017), and 161.1 cases per 100,000 in Martinique, over the period 2005-2014 (Joachim 2019). The incidence rates observed in the French West Indies are of the same order as those observed in Afro-Caribbean populations in the UK and African-American populations in the USA (Ben Schlomo 2008, Evans 2008).
The reasons for these ethnic disparities in incidence are still poorly understood, but the role of genetic factors has been suggested. Indeed, certain genetic polymorphisms have been associated with an increased individual risk of prostate cancer in men of sub-Saharan African origin (Conti 2021; Karunamuni 2021; Marlin 2021). In addition, certain environmental factors (in the broadest sense) such as obesity, chronic inflammation, diet and certain environmental pollutants, including persistent organic pollutants (POPs) such as certain organochlorine pesticides, are also strongly suspected.
Among the suspected organochlorine pesticides is chlordecone, an insecticide used in the French West Indies until 1993, strongly suspected of playing a role in the occurrence of prostate cancer, particularly in the West Indies. Indeed, the Kannari study (Dereumeaux and Saoudi 2018), supported by Santé publique France, assessed the exposure of the West Indian population (Martinique and Guadeloupe) in 2013-2014 to chlordecone and certain organochlorine compounds , measured by serum levels, and quantified the determinants of this impregnation. The results of the study show that 90% of the West Indian population is indeed exposed to chlordecone, and demonstrate that chlordecone is still present in the environment (water and soil) and in food products, despite the cessation of its use in the West Indies in 1993.
To date, only one epidemiological study has explored the link between chlordecone exposure and the occurrence of prostate cancer, the Karuprostate study, a case-control study carried out between 2004 and 2007 in Guadeloupe, including 623 prostate cancer cases and 671 controls (Multigner 2010). Chlordecone exposure was measured by serum levels with an initial detection limit of 0.25 μg/L (Multigner 2010), then improved to 0.06 μg/L (Emmeville 2015). The authors highlighted a significant association between chlordecone exposure and prostate cancer, with a positive dose-response relationship (OR=1.77; 95% CI, 1.21 to 2.58 for the highest tercile). This association was more specifically observed in subjects with a family history of prostate cancer and in men who had lived in a Western country, requiring further investigation. The Karuprostate study also showed that serum levels of dichlorodiphenyldichloroethylene (DDE), the main and most stable metabolite of DDT, were significantly associated with the occurrence of CaP (Emmeville 2015). These results underline the interest of assessing, along with chlordecone, co-exposure to other persistent organic or organochlorine pollutants.
Furthermore, DDE exhibits anti-androgenic effects and has been shown to repress the production of Prostatic-Specific Antigen (PSA) (target gene of the androgen receptor) by human prostate cancer cell lines (Wong 2015). The supposed effect of other organochlorines such as chlordecone on androgen receptors and thus on PSA levels could thus have important repercussions in terms of prostate cancer diagnosis. Individual screening for prostate cancer is based on serum PSA levels, followed in cases of elevated PSA (> 3-4 ng/ml) by multiparametric Magnetic Resonance Imaging (mpMRI). A recent study showed that performing pre-biopsy mpMRI, regardless of PSA level, could lead to more men being diagnosed with clinically significant prostate cancer (Eldred-Evans 2021).
Finally, there is a lack of preclinical studies to investigate the distribution of chlordecone in blood and tissues, as well as the link between chlordecone and markers of prostate cancer aggressiveness.
We therefore propose a case-control study in the general population of Martinique. This study will enable us to understand the nature of the link between chlordecone and prostate cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer patients | – | –The "prostate cancer patients" group consists of : * Adult men under 75 years of age, * who are resident in Martinique for at least 6 months * who have been newly diagnosed with histologically confirmed prostate cancer in Martinique during a given three-year period in all public and private services caring for prostate cancer patients. |
| Controls Group 1 | – | –The 1st control group also called "negative biopsy group" consists of : * Adult men under 75 years of age, * who are resident in Martinique for at least 6 months * who have had a negative prostate biopsy following elevated PSA (> 2.5 ng/ml) in all public and private services in Martinique identified via urologists or pathologists, during the same given 3-year period as patients, * whose the frequency matched on age (+/- 5 years) versus patients |
| Controls Group 2 | – | –The second control group, also called "PSA negative group", is composed of : * Adult men under 75 years of age, * who are residing in Martinique for at least 6 months * who have had a PSA test less than or equal to the threshold value of 2.5 ng/ml, during the same 3-year period as the patients, identified by a survey institute. * whose frequency is age-matched (+/- 5 years) to patients. * with quotas defined on socio-professional category in relation to men of the same age residing in Martinique (based on INSEE data). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from the Martinican male population under the age of 80.
Key inclusion criteria (25 listed)
- All men newly diagnosed with Prostate Cancer in Martinique during a three-year given period in all public and private services caring for patients with Prostate Cancer, identified via multidisciplinary consultation meetings.
- Male adults under 75 years of age
- Resident in Martinique for at least 6 months
- Histologically confirmed (inclusion possible as soon as the result is known by the urologist)
- Affiliated to a social security scheme or equivalent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome Measure : Measure of association between chlordecone exposure and the risk of prostate cancer.
Time frame: The blood sample required for chlordecone measurement and the study questionnaire will be taken for each participant during the single inclusion visit. Analysis of the study outcomes will take place at the end of the 36 months recruitment phase.
Chlordecone exposure will be measured using several complementary methods, combining serum chlordecone assays, an assessment of chlordecone exposure based on questionnaire data (occupational, residential and dietary), and the use of job-exposure or culture-exposure matrices.
4 secondary outcomes
Primary secondary outcome measure : Measurement of the association between exposure to chlordecone and other environmental pollutants and serum Prostate-Specific Antigen levels in cases and controls.
Time frame: From the blood sampling to the statistical analyses it will take about 36 months.
Secondary secondary outcome measure : Number of significant cancers and aggressive cancers diagnosed on targeted mpMRI biopsies versus number of significant cancers and aggressive cancers diagnosed by systematic biopsies.
Time frame: It will take around 36 months from recovery of ISUP clinical data to statistical analysis.
Third secondary outcome measure: Distribution of chlordecone in blood, adipose and prostate tissue. Validation of a molecular signature, previously identified in vitro, on the cases' tumour tissues.
Time frame: It will take around 36 months from blood sampling and recovery of the various prostate tissues to analysis of chlordecone distribution and validation of the molecular signature.
Fourth secondary outcome measure : Genotyping of genetic variants from blood samples using a genome-identity chip.
Time frame: It will take at least 36 months from blood sampling to genotyping.
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 4 May 2026.
- Individual participant dataSharing planned: Undecided
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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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in Martinique.
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 25 inclusion and 0 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 4 May 2026. 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 Martinique. 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 Florence MENEGAUX, MD, PhD (+33 1 45 59 51 53, florence.menegaux@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure : Measure of association between chlordecone exposure and the risk of prostate cancer. (time frame: The blood sample required for chlordecone measurement and the study questionnaire will be taken for each participant during the single inclusion visit. Analysis of the study outcomes will take place at the end of the 36 months recruitment phase.). 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 4 May 2026.