NCT06242509Recruiting
Intestinal Akkermansia Muciniphila in Prostate Cancer
Impact of Intestinal Enrichment in Akkermansia Muciniphila by Next-generation Hormonal Therapies on Castration Resistant-prostate Cancer Response
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
Prostate cancer has the highest incidence and is the second leading cause of cancer death in men in western countries. Androgen deprivation therapy is the backbone treatment. However, after a latency hormone sensitive prostate cancer (HSPC) usually progresses to castration-resistant prostate cancer (CRPC) requiring treatments including next generation hormonal therapies with Abiraterone Acetate (AA). This, with limited survival. A particularly challenging area of interest to improve outcome in cancer is the interaction between the microbiome and anti-cancer therapies. Emerging data demontrate in pre-clincal studies that prostate cancer alters the microbiota, with loss of diversity and depletion of beneficial bacteria including A. muciniphila. In the other hand, Androgen deprivation therapy, reverses these effects. Specifically, in advanced disease with castration-resistant prostate cancer (CRPC), it has been shown in small studies that Abiraterone Acetate, can modulate patient-associated gastro-intestinal microbiota through promoting the growth of A. muciniphila. The goal of our study is to confirm that AA could promote fecal Akkermansia muciniphila growth and to use the enrichment of fecal Akkermansia muciniphila as a minimally invasive biomarker of response to AA in first line metastatic CRPC.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 52 (estimated)
- First submitted
- 29 Jan 2024
- Start date
- 20 Nov 2024
- Primary completion date
- 20 Jan 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Prostate cancer
- NCT number
- NCT06242509
What you commit to
- Study type: Observational
- Planned participants: 52
- From 20 Nov 2024 to the primary completion date, 20 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- CRPC patients who were previously treated with any next generation hormonal therapies in a metastatic CRPC setting
Other
- Person under legal protection
- Inability to obtain the non-opposition
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Saint Louis - AP-HP Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.