Metastatic Castration-resistant Prostate CancerAkkPRONCT06242509
Intestinal Akkermansia Muciniphila in Prostate Cancer
An observational study of Metastatic Castration-resistant Prostate Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Biological samples
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2024to 20 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic CRPC receiving next generation hormonal therapy
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Saint Louis AP-HP
Paris
Safae Terrisse, +331 42 49 42 47 ext. +33, safae.terrisse@aphp.fr
About this study
Official title: Impact of Intestinal Enrichment in Akkermansia Muciniphila by Next-generation Hormonal Therapies on Castration Resistant-prostate Cancer Response
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.
- Being tested
- Biological samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplesDiagnostic test
Plasma sampling ans stool sampling
- at inclusion
- at 1 month
- at 3 months
- at progression within the 3 months
| Study group | Role | What they receive |
|---|---|---|
| Metastatic castration resistant prostate cancer (CRPC) receiving next generation hormonal therapy | Not described Receives: Diagnostic Test: Biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 month
Secondary outcomes (17)
Relative variation of the relative abundance of Akkermansia muciniphila
Between baseline and Month 3 of AA treatment, compared between responders versus non responders
Measured: At 3 months
Relative variation in PSA
Relative variation in PSA between baseline PSA and nadir value, according to fecal Akkermansia muciniphila enrichment
Measured: At 1 month
Receiver Operating curve (ROC)
Receiver Operating curve (ROC) of the baseline relative abundance of fecal Akkermansia muciniphila to predict PSA response
Measured: At 1 month
Receiver Operating curve (ROC)
Receiver Operating curve (ROC) of the baseline relative abundance of fecal Akkermansia muciniphila to predict PSA response
Measured: At 3 months
PSA progression-free (PSA-PFS) survival
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.
Measured: At 3 months
Anti- Akkermansia muciniphila IgG levels
Measured: At baseline
Anti- Akkermansia muciniphila IgG levels
Measured: At 1 month
Anti- Akkermansia muciniphila IgG levels
Measured: At 3 months
Anti- Akkermansia muciniphila IgA levels
Measured: At baseline
Anti- Akkermansia muciniphila IgA levels
Measured: At 1 month
Anti- Akkermansia muciniphila IgA levels
Measured: At 3 months
Alpha diversity
Assessed by Shannon index (Microbial Richness)
Measured: At baseline
Alpha diversity
Assessed by Shannon index (Microbial Richness)
Measured: At 1 month
Alpha diversity
Assessed by Shannon index (Microbial Richness)
Measured: At 3 months
Beta diversity
Assessed by Bray-Curtis dissimilarity (Microbial Diversity)
Measured: At baseline
Beta diversity
Assessed by Bray-Curtis dissimilarity (Microbial Diversity)
Measured: At 1 month
Beta diversity
Assessed by Bray-Curtis dissimilarity (Microbial Diversity)
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start20 Nov 2024
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242509
- Sponsor's protocol ID
- APHP221176
- Acronym
- AkkPRO
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intestinal Enrichment in Akkermansia Muciniphila by Next-generation Hormonal Therapies on Castration Resistant-prostate Cancer Response
- ClinicalTrials.gov ID
- NCT06242509
- Acronym / sponsor ID
- AkkPRO / APHP221176
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic castration resistant prostate cancer (CRPC) receiving next generation hormonal therapy | – | Diagnostic Test: Biological samples |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic CRPC receiving next generation hormonal therapy
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samplesPlasma sampling ans stool sampling * at inclusion * at 1 month * at 3 months * at progression within the 3 months | Diagnostic test | Metastatic castration resistant prostate cancer (CRPC) receiving next generation hormonal therapy |
Primary outcome
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.
17 secondary outcomes
Relative variation of the relative abundance of Akkermansia muciniphila
Time frame: At 3 months
Relative variation in PSA
Time frame: At 1 month
Receiver Operating curve (ROC)
Time frame: At 1 month
Receiver Operating curve (ROC)
Time frame: At 3 months
PSA progression-free (PSA-PFS) survival
Time frame: At 3 months
Anti- Akkermansia muciniphila IgG levels
Time frame: At baseline
Anti- Akkermansia muciniphila IgG levels
Time frame: At 1 month
Anti- Akkermansia muciniphila IgG levels
Time frame: At 3 months
Anti- Akkermansia muciniphila IgA levels
Time frame: At baseline
Anti- Akkermansia muciniphila IgA levels
Time frame: At 1 month
Anti- Akkermansia muciniphila IgA levels
Time frame: At 3 months
Alpha diversity
Time frame: At baseline
Alpha diversity
Time frame: At 1 month
Alpha diversity
Time frame: At 3 months
Beta diversity
Time frame: At baseline
Beta diversity
Time frame: At 1 month
Beta diversity
Time frame: At 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration-resistant Prostate Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Safae Terrisse, Dr (+33142499783, safae.terrisse@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of Akkermansia muciniphila (time frame: At 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.