RecruitingNCT06242509

Intestinal Akkermansia Muciniphila in Prostate Cancer

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

52 participants

Start Date

Nov 20, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Inclusion Criteria7

  • 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

Exclusion Criteria3

  • 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

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Interventions

DIAGNOSTIC_TESTBiological 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

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NCT06242509


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