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RECRUITING
NCT06242509

Intestinal Akkermansia Muciniphila in Prostate Cancer

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

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.

Official title: Impact of Intestinal Enrichment in Akkermansia Muciniphila by Next-generation Hormonal Therapies on Castration Resistant-prostate Cancer Response

Key Details

Gender

MALE

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

52

Start Date

2024-11-20

Completion Date

2027-01-20

Last Updated

2026-04-27

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Biological samples

Plasma sampling ans stool sampling * at inclusion * at 1 month * at 3 months * at progression within the 3 months

Locations (1)

Hôpital Saint Louis AP-HP

Paris, France