Impact of Intestinal Enrichment in Akkermansia Muciniphila by Next-generation Hormonal Therapies on Castration Resistant-prostate Cancer Response
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- Relative abundance of Akkermansia muciniphila
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Relative abundance of Akkermansia muciniphila
时间窗: At 1 month
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.
次要结局
- PSA progression-free (PSA-PFS) survival(At 3 months)
- Relative variation in PSA(At 1 month)
- Relative variation of the relative abundance of Akkermansia muciniphila(At 3 months)
- Receiver Operating curve (ROC)(At 3 months)
- Anti- Akkermansia muciniphila IgG levels(At 3 months)
- Anti- Akkermansia muciniphila IgA levels(At 3 months)
- Alpha diversity(At 3 months)
- Beta diversity(At 3 months)