Akkermansia Muciniphilia and Metabolic Side Effects of ADT
Prostate Cancer, Metabolic Syndrome, Obesity
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer, metabolic syndrome, androgen deprivation therapy, microbiome, Akkermansias muciniphilia, cardiovascular disease
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 conventional imaging with CT of the abdomen, and pelvis and bone scan. Exclusion Criteria: 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 Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter) Inadequate liver function
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Apple Cider Vinegar
Placebo
Webbers Natural apple cider vinegar pills (NPN: 80021269), enteric coated. Each patient will be instructed to take 6 enteric slow-release acetate capsules (equivalent of 500 mg/ capsule containing 25 mg acetate x 6 capsules) per day for 3 months.
Placebo pills will be provided by our hospital pharmacy, and patients will be given the same instructions as in the treatment arm.