Intestinal Akkermansia Muciniphila in Prostate Cancer

NCT06242509 | Recruiting

• 1 other identifier: APHP221176
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Relative abundance of Akkermansia muciniphila

  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.

  At 1 month

Secondary Outcomes (17)

• Relative variation of the relative abundance of Akkermansia muciniphila

  At 3 months

• Relative variation in PSA

  At 1 month

• Receiver Operating curve (ROC)

  At 1 month

• Receiver Operating curve (ROC)

  At 3 months

• PSA progression-free (PSA-PFS) survival

  At 3 months

Study Arms (1)

Metastatic castration resistant prostate cancer (CRPC) receiving next generation hormonal therapy

Diagnostic Test: Biological samples

Interventions

Biological samples DIAGNOSTIC_TEST

Plasma sampling ans stool sampling * at inclusion * at 1 month * at 3 months * at progression within the 3 months

Metastatic castration resistant prostate cancer (CRPC) receiving next generation hormonal therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic CRPC receiving next generation hormonal therapy

You may qualify if:

• Be willing and not opposed to the study
• Histologically or cytologically documented adenocarcinoma of the prostate.
• Have metastatic castration-resistant prostate cancer with castrate-level testosterone (\<50 ng/dL) during the study
• Participants must be able and willing to comply with the study visit schedule and study procedures
• Affiliated with French social security

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint Louis AP-HP

Paris, France

RECRUITING

Central Study Contacts

Safae Terrisse, Dr

CONTACT

+33142499783; safae.terrisse@aphp.fr

Jérôme Lambert, Pr

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 5, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

FR (1)