Intestinal Akkermansia Muciniphila in Prostate Cancer

Trial Title: Intestinal Akkermansia Muciniphila in Prostate Cancer

NCT ID: NCT06242509

Condition: Metastatic Castration-resistant Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Biological samples
Description: Plasma sampling ans stool sampling - at inclusion - at 1 month - at 3 months - at progression within the 3 months
Arm group label: Metastatic castration resistant prostate cancer (CRPC) receiving next generation hormonal therapy

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.

Criteria for eligibility:

Study pop:
Patients with metastatic CRPC receiving next generation hormonal therapy

Sampling method: Non-Probability Sample
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

Gender: Male

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: No

Start date: February 15, 2024

Completion date: November 15, 2025

Lead sponsor:
Agency: Assistance Publique - Hôpitaux de Paris
Agency class: Other

Source: Assistance Publique - Hôpitaux de Paris

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06242509