Akkermansia Muciniphilia and Metabolic Side Effects of ADT
Recruiting
Early Phase 1
Interventional Study
Prostate Cancer
Metabolic Syndrome
Obesity
Cardiovascular Morbidity
Bone Diseases
Hyperlipidemias
Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 30 (estimated)
- Sponsor
- Western University · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
For inclusion in this study, patients must fulfill all of the following criteria:
1. 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).
2. Must have baseline imaging with 1) CT o…
Contacts