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Intestinal Akkermansia Muciniphila in Prostate Cancer (AkkPRO)

A

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Metastatic Castration-resistant Prostate Cancer

Treatments

Diagnostic Test: Biological samples

Study type

Observational

Funder types

Other

Identifiers

NCT06242509
APHP221176

Details and patient eligibility

About

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.

Enrollment

52 estimated patients

Sex

Male

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

52 participants in 1 patient group

Metastatic castration resistant prostate cancer (CRPC) receiving next generation hormonal therapy
Treatment:
Diagnostic Test: Biological samples

Trial contacts and locations

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Central trial contact

Safae Terrisse, Dr; Jérôme Lambert, Pr

Data sourced from clinicaltrials.gov

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