Hôpital Saint Louis AP-HP
Paris, France
Location status: Recruiting
NCT Number: NCT06242509
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.
Interested in participating?
Request Info18 year–100 year
Male
Observational
Paris, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Plasma sampling ans stool sampling
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.
Time frame: At 3 months
Between baseline and Month 3 of AA treatment, compared between responders versus non responders
Time frame: At 1 month
Relative variation in PSA between baseline PSA and nadir value, according to fecal Akkermansia muciniphila enrichment
Time frame: At 1 month
Receiver Operating curve (ROC) of the baseline relative abundance of fecal Akkermansia muciniphila to predict PSA response
Time frame: At 3 months
Receiver Operating curve (ROC) of the baseline relative abundance of fecal Akkermansia muciniphila to predict PSA response
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.
Time frame: At baseline
Time frame: At 1 month
Time frame: At 3 months
Time frame: At baseline
Time frame: At 1 month
Time frame: At 3 months
Time frame: At baseline
Assessed by Shannon index (Microbial Richness)
Time frame: At 1 month
Assessed by Shannon index (Microbial Richness)
Time frame: At 3 months
Assessed by Shannon index (Microbial Richness)
Time frame: At baseline
Assessed by Bray-Curtis dissimilarity (Microbial Diversity)
Time frame: At 1 month
Assessed by Bray-Curtis dissimilarity (Microbial Diversity)
Time frame: At 3 months
Assessed by Bray-Curtis dissimilarity (Microbial Diversity)
Contact information is provided by the study sponsor or research team.
Jérôme Lambert, Pr
CONTACT
Safae Terrisse, Dr
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Impact of Intestinal Enrichment in Akkermansia Muciniphila by Next-generation Hormonal Therapies on Castration Resistant-prostate Cancer Response
Acronym: AkkPRO
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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