Gut bacteria changes in men with advanced prostate cancer on abiraterone
Studies stool samples for Akkermansia muciniphila in men with prostate cancer taking abiraterone.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Registry title
- Intestinal Akkermansia Muciniphila in Prostate Cancer
- Status
- Recruiting
- People taking part
- 52 people, planned
- Started
- 20 Nov 2024
- Expected to end
- 20 Jan 2027
- Type of study
- Observational
- Treatments tested
- Biological samples
- Record updated
- 27 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men aged 18 or older with prostate cancer that has spread and no longer responds to hormone-lowering treatment. They are about to start abiraterone acetate or a similar newer hormone treatment.
- Age
- 18 Years to 100 Years
- Sex
- Men only
- Disease stage
- Adenocarcinoma of the prostate that has spread (metastatic) and is castration-resistant, with testosterone below 50 ng/dL during the study.
- Earlier treatment
- Must start abiraterone acetate or another next-generation hormonal therapy within 15 days after joining. Cannot have had such a therapy before for metastatic castration-resistant disease.
- Biomarker or test result
- Prostate adenocarcinoma confirmed by tissue or cell examination; testosterone at castrate level (<50 ng/dL).
Main reasons for not taking part
- Previous next-generation hormonal therapy for metastatic castration-resistant prostate cancer
- Person under legal protection
- Not able to give non-opposition to the study
- Not able or willing to follow the study visits and procedures
- Not affiliated with French social security
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Where in France
- Hôpital Saint Louis - AP-HPParis, FranceContact: Safae TerrisseTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Metastatic castration resistant prostate cancer (CRPC) receiving next generation hormonal therapy
Treatment: Biological samples
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of Intestinal Enrichment in Akkermansia Muciniphila by Next-generation Hormonal Therapies on Castration Resistant-prostate Cancer Response
- Plain-language title
- Gut bacteria changes in men with advanced prostate cancer on abirateroneGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06242509, who can take part
- Record updated
- 27 April 2026