Status:
RECRUITING
Akkermansia Muciniphilia and Metabolic Side Effects of ADT
Lead Sponsor:
Western University
Conditions:
Prostate Cancer
Metabolic Syndrome
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The overriding objectives of this study are: 1. Primary outcomes: 1. To confirm that administration of oral acetate increases the proportion of A. muciniphilia in the stool samples of patients wi...
Eligibility Criteria
For inclusion in this study, patients must fulfill all of the following criteria:
- Men ≥18 years of age with histologically-proven metastatic castration-sensitive prostate adenocarcinoma planned to receive ADT (TNM stage Tany, Nany, M1) (see Appendix I).
- Must have baseline imaging with 1) CT of the abdomen, and pelvis and bone scan or 2) PSMA PET scan
Patients fulfilling any of the following criteria are NOT eligible for participation in this study:
- Age less than 18
- Primary neuroendocrine prostate cancer
- Treatment with ADT within the year leading up to enrolment
- Planned or concurrent use of chromium supplementation for the study duration
- Planned or concurrent use of apple cider vinegar supplementation for the study duration
- Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter)
- Inadequate liver function (>2x upper limit of normal)
- Any other condition, chronic disease, or lifestyle factor, that, in the opinion of the Qualified Investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
- Use of antibiotics that cannot be discontinued for a washout period and remain off them for the duration of the trial
Key Trial Info
Start Date :
July 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05802121
Start Date
July 2 2025
End Date
June 1 2027
Last Update
August 20 2025
Active Locations (1)
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1
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada, N6A5W9