Clinical trial · Observational
Intestinal Akkermansia Muciniphila in Prostate Cancer
Impact of Intestinal Enrichment in Akkermansia Muciniphila by Next-generation Hormonal Therapies on Castration Resistant-prostate Cancer Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological samples | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Metastatic castration resistant prostate cancer (CRPC) receiving next generation hormonal therapy
- interventionNames
- Diagnostic Test: Biological samples
Primary outcomes (1)
- measure
- Relative abundance of Akkermansia muciniphila
- timeFrame
- At 1 month
- description
- Between baseline and Month 1 of next-generation hormonotherapy (NGHT), compared between responders versus non-responders. The response is defined as an early PSA decrease \> 50% at one month of NGHT.
Secondary outcomes (17)
- measure
- Relative variation of the relative abundance of Akkermansia muciniphila
- timeFrame
- At 3 months
- description
- Between baseline and Month 3 of AA treatment, compared between responders versus non responders
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available