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NCT Number: NCT06242509

Intestinal Akkermansia Muciniphila in Prostate Cancer

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.

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Key information

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological samples

Diagnostic Test

Plasma sampling ans stool sampling

  • at inclusion
  • at 1 month
  • at 3 months
  • at progression within the 3 months

Primary outcomes

  1. Relative abundance of Akkermansia muciniphila

    Time frame: At 1 month

    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.

Secondary outcomes

  1. Relative variation of the relative abundance of Akkermansia muciniphila

    Time frame: At 3 months

    Between baseline and Month 3 of AA treatment, compared between responders versus non responders

  2. Relative variation in PSA

    Time frame: At 1 month

    Relative variation in PSA between baseline PSA and nadir value, according to fecal Akkermansia muciniphila enrichment

  3. Receiver Operating curve (ROC)

    Time frame: At 1 month

    Receiver Operating curve (ROC) of the baseline relative abundance of fecal Akkermansia muciniphila to predict PSA response

  4. Receiver Operating curve (ROC)

    Time frame: At 3 months

    Receiver Operating curve (ROC) of the baseline relative abundance of fecal Akkermansia muciniphila to predict PSA response

  5. PSA progression-free (PSA-PFS) survival

    Time frame: At 3 months

    According to fecal Akkermansia muciniphila baseline relative abundance. PSA-PFS will be defined as the time from treatment initiation to PSA progression as per PCWG3 (The Prostate Cancer Working Group 3) or death, whichever occurs first; patients without event at M3 will be treated as censored observations.

  6. Anti- Akkermansia muciniphila IgG levels

    Time frame: At baseline

  7. Anti- Akkermansia muciniphila IgG levels

    Time frame: At 1 month

  8. Anti- Akkermansia muciniphila IgG levels

    Time frame: At 3 months

  9. Anti- Akkermansia muciniphila IgA levels

    Time frame: At baseline

  10. Anti- Akkermansia muciniphila IgA levels

    Time frame: At 1 month

  11. Anti- Akkermansia muciniphila IgA levels

    Time frame: At 3 months

  12. Alpha diversity

    Time frame: At baseline

    Assessed by Shannon index (Microbial Richness)

  13. Alpha diversity

    Time frame: At 1 month

    Assessed by Shannon index (Microbial Richness)

  14. Alpha diversity

    Time frame: At 3 months

    Assessed by Shannon index (Microbial Richness)

  15. Beta diversity

    Time frame: At baseline

    Assessed by Bray-Curtis dissimilarity (Microbial Diversity)

  16. Beta diversity

    Time frame: At 1 month

    Assessed by Bray-Curtis dissimilarity (Microbial Diversity)

  17. Beta diversity

    Time frame: At 3 months

    Assessed by Bray-Curtis dissimilarity (Microbial Diversity)

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme Lambert, Pr

CONTACT

[email protected]

+33142499742

Safae Terrisse, Dr

CONTACT

[email protected]

+33142499783

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: AkkPRO

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2024
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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