NCT05802121RecruitingEarly phase 1
Akkermansia Muciniphilia and Metabolic Side Effects of ADT
The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer
Source: ClinicalTrials.gov · Last updated 20 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 with metastatic, castration-sensitive prostate cancer compared to a standard of care arm. 2. To confirm tolerability and assess for side effects of oral acetate supplementation. 2. Secondary outcomes: 1. To determine if increased counts of A. muciniphilia correlate with improved metabolic parameters and improved bone health.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 12 Mar 2023
- Start date
- 2 Jul 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- Western University
- Diseases
- Prostate cancer, Obesity
- NCT number
- NCT05802121
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 30
- From 2 Jul 2025 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre · Victoria Hospital Coordinator of this site? Confirm its status | London | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.