Actively Recruiting

Age: 18Years - 100Years
MALE
NCT06242509

Intestinal Akkermansia Muciniphila in Prostate Cancer

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-27

52

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intestinal Akkermansia Muciniphila in Prostate Cancer

Who Can Participate

Age: 18Years - 100Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Be willing and not opposed to the study
  • Be 65 18 years of age at the time of inclusion
  • Have histologically or cytologically confirmed adenocarcinoma of the prostate
  • Have metastatic castration-resistant prostate cancer with castrate-level testosterone (<50 ng/dL) during the study
  • Begin abiraterone acetate or other next-generation hormonal therapy within 15 days after inclusion
  • Be able and willing to comply with the study visit schedule and procedures
  • Be affiliated with French social security
Not Eligible

You will not qualify if you...

  • Previously treated with any next-generation hormonal therapies for metastatic CRPC
  • Under legal protection
  • Unable to provide non-opposition consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Saint Louis AP-HP

Paris, France

Actively Recruiting

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Research Team

S

Safae Terrisse, Dr

CONTACT

J

Jérôme Lambert, Pr

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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