Intestinal Akkermansia Muciniphila in Prostate Cancer

Recruiting now

Conditions studied: Metastatic Castration-resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06242509

Run by

Assistance Publique - Hôpitaux de Paris

People needed

52

Starts

2024-11-20

Expected to finish

2027-01-20

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Hôpital Saint Louis AP-HP — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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