Clinical trial NCT06242509: Intestinal Akkermansia Muciniphila in Prostate Cancer
Official title: Impact of Intestinal Enrichment in Akkermansia Muciniphila by Next-generation Hormonal Therapies on Castration Resistant-prostate Cancer Response
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metastatic Castration-resistant Prostate Cancer
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic CRPC receiving next generation hormonal therapy

Brief 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 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

Primary outcomes:
measure: Relative abundance of Akkermansia muciniphila
timeFrame: At 1 month
Secondary outcomes:
measure: Relative variation of the relative abundance of Akkermansia muciniphila
timeFrame: At 3 months
measure: Relative variation in PSA
timeFrame: At 1 month
measure: Receiver Operating curve (ROC)
timeFrame: At 1 month
measure: Receiver Operating curve (ROC)
timeFrame: At 3 months
measure: PSA progression-free (PSA-PFS) survival
timeFrame: At 3 months
measure: Anti- Akkermansia muciniphila IgG levels
timeFrame: At baseline
measure: Anti- Akkermansia muciniphila IgG levels
timeFrame: At 1 month
measure: Anti- Akkermansia muciniphila IgG levels
timeFrame: At 3 months
measure: Anti- Akkermansia muciniphila IgA levels
timeFrame: At baseline
measure: Anti- Akkermansia muciniphila IgA levels
timeFrame: At 1 month
measure: Anti- Akkermansia muciniphila IgA levels
timeFrame: At 3 months
measure: Alpha diversity
timeFrame: At baseline
measure: Alpha diversity
timeFrame: At 1 month
measure: Alpha diversity
timeFrame: At 3 months
measure: Beta diversity
timeFrame: At baseline
measure: Beta diversity
timeFrame: At 1 month
measure: Beta diversity
timeFrame: At 3 months
Other outcomes:
Locations:
Study officials:
References: