NCT06242509 Intestinal Akkermansia Muciniphila in Prostate Cancer
| NCT ID | NCT06242509 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Metastatic Castration-resistant Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2027-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 52 participants in total. It began in 2024-11-20 with a primary completion date of 2027-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06242509 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 100 Years, studying Metastatic Castration-resistant Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06242509 currently recruiting?
Yes, NCT06242509 is actively recruiting participants. Contact the research team at safae.terrisse@aphp.fr for enrollment information.
Where is the NCT06242509 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06242509 clinical trial?
NCT06242509 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 52 participants.
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