Intestinal Akkermansia Muciniphila in Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological samples.
- Who it may be relevant to
- Registry conditions: Metastatic Castration-resistant Prostate Cancer. Basic parameters: 18 years — 100 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Intestinal Enrichment in Akkermansia Muciniphila by Next-generation Hormonal Therapies on Castration Resistant-prostate Cancer Response
Overview
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.
Interventions
- Diagnostic test Biological samples
Plasma sampling ans stool sampling * at inclusion * at 1 month * at 3 months * at progression within the 3 months
Primary outcome measures
- Relative abundance of Akkermansia muciniphila [Time frame: At 1 month]
Secondary outcome measures (12)
- Relative variation of the relative abundance of Akkermansia muciniphila [Time frame: At 3 months]
- Relative variation in PSA [Time frame: At 1 month]
- Receiver Operating curve (ROC) [Time frame: At 1 month]
- Receiver Operating curve (ROC) [Time frame: At 3 months]
- PSA progression-free (PSA-PFS) survival [Time frame: At 3 months]
- Anti- Akkermansia muciniphila IgG levels [Time frame: At baseline]
- Anti- Akkermansia muciniphila IgG levels [Time frame: At 1 month]
- Anti- Akkermansia muciniphila IgG levels [Time frame: At 3 months]
- Anti- Akkermansia muciniphila IgA levels [Time frame: At baseline]
- Anti- Akkermansia muciniphila IgA levels [Time frame: At 1 month]
- Anti- Akkermansia muciniphila IgA levels [Time frame: At 3 months]
- Alpha diversity [Time frame: At baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Saint Louis AP-HP — Paris
Identifiers
NCT: NCT06242509 · APHP221176