Akkermansia muciniphila in the gut of men with advanced prostate cancer
Official title: Impact of Intestinal Enrichment in Akkermansia Muciniphila by Next-generation Hormonal Therapies on Castration Resistant-prostate Cancer Response
Run by Assistance Publique - Hôpitaux de Paris · NCT06242509 · Data updated 2026-11-12
This research will test whether levels of the gut bacterium Akkermansia muciniphila are linked to treatment response in men with metastatic castration‑resistant prostate cancer who are starting abiraterone or similar hormone therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | Men only |
| Enrollment | 52 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | November 20, 2024 |
| Main results expected | January 20, 2027 |
| Study ends | January 20, 2027 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT06242509 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 18 or older with histologically confirmed prostate adenocarcinoma, metastatic castration‑resistant disease with castrate‑level testosterone, who are starting abiraterone or another next‑generation hormonal therapy within 15 days and are affiliated with French social security.
✕Probably not a fit
Patients previously treated with any next‑generation hormonal therapies in the metastatic CRPC setting, those not starting abiraterone or similar therapy, or those unable to provide consent or attend visits are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study enrolling men with histologically confirmed metastatic castration‑resistant prostate cancer who are initiating abiraterone acetate or another next‑generation hormonal therapy. Participants provide biological samples for microbiome analysis, with a focus on measuring Akkermansia muciniphila abundance. The study correlates microbiome features with clinical status and treatment timing without altering standard cancer care. Data will be used to characterize how disease and therapy relate to gut bacterial changes.
Why it matters
Potential benefit: If successful, the study could identify microbiome markers that help predict who responds to abiraterone and point to new ways to improve outcomes.
How similar studies have gone: Preclinical work and small clinical reports suggest prostate cancer and abiraterone can alter the gut microbiome including A. muciniphila, but larger clinical confirmation is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be willing and not opposed to the study * Be ≥ 18 years of age at the time of inclusion. * Histologically or cytologically documented adenocarcinoma of the prostate. * Have metastatic castration-resistant prostate cancer with castrate-level testosterone (\<50 ng/dL) during the study * Initiation of abiraterone acetate therapy or any other next-generation hormonal therapies within 15 days after inclusion * Participants must be able and willing to comply with the study visit schedule and study procedures * Affiliated with French social security Exclusion Criteria: * CRPC patients who were previously treated with any next generation hormonal therapies in a metastatic CRPC setting * Person under legal protection * Inability to obtain the non-opposition
Where it's running
-
Hôpital Saint Louis AP-HP
Paris, France Recruiting
Study contacts
- Study coordinator: Safae Terrisse, Dr
- Email: safae.terrisse@aphp.fr
- Phone: +33142499783
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.