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Intestinal Akkermansia Muciniphila in Prostate Cancer

RECRUITINGSponsored by Assistance Publique - Hôpitaux de Paris
Actively Recruiting
SponsorAssistance Publique - Hôpitaux de Paris
Started2024-11-20
Est. completion2027-01-20
Eligibility
Age18 Years – 100 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06242509

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

Age: 18 Years – 100 YearsSex: MALEHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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

Conditions2

CancerMetastatic Castration-resistant Prostate Cancer

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