NCT06242509

Intestinal Akkermansia Muciniphila in Prostate Cancer

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 52 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Biological samples	Plasma sampling ans stool sampling * at inclusion * at 1 month * at 3 months * at progression within the 3 months

Timeline

• Start date: 2024-02-15
• Primary completion: 2025-09-15
• Completion: 2025-11-15
• First posted: 2024-02-05
• Last updated: 2024-02-05