Intestinal Akkermansia Muciniphila in Prostate Cancer

Официальное название

Impact of Intestinal Enrichment in Akkermansia Muciniphila by Next-generation Hormonal Therapies on Castration Resistant-prostate Cancer Response

Обзор

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.

Вмешательства

• Диагностический тест Biological samples
  Plasma sampling ans stool sampling * at inclusion * at 1 month * at 3 months * at progression within the 3 months

Первичные конечные точки

• Relative abundance of Akkermansia muciniphila [Срок оценки: At 1 month]

Вторичные конечные точки (12)

• Relative variation of the relative abundance of Akkermansia muciniphila [Срок оценки: At 3 months]
• Relative variation in PSA [Срок оценки: At 1 month]
• Receiver Operating curve (ROC) [Срок оценки: At 1 month]
• Receiver Operating curve (ROC) [Срок оценки: At 3 months]
• PSA progression-free (PSA-PFS) survival [Срок оценки: At 3 months]
• Anti- Akkermansia muciniphila IgG levels [Срок оценки: At baseline]
• Anti- Akkermansia muciniphila IgG levels [Срок оценки: At 1 month]
• Anti- Akkermansia muciniphila IgG levels [Срок оценки: At 3 months]
• Anti- Akkermansia muciniphila IgA levels [Срок оценки: At baseline]
• Anti- Akkermansia muciniphila IgA levels [Срок оценки: At 1 month]
• Anti- Akkermansia muciniphila IgA levels [Срок оценки: At 3 months]
• Alpha diversity [Срок оценки: At baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Hôpital Saint Louis AP-HP — Paris

Идентификаторы

NCT: NCT06242509 · APHP221176

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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