Neoplasms

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Genital Neoplasms, Male

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Genital Diseases, Male

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Acetic Acid

Retinol acetate

Anti-Bacterial Agents

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.

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

https://www.webbernaturals.com/en-ca/apple-cider-vinegar-500-mg-capsules/

Apple Cider Vinegar

Each patient will be instructed to take 6 placebo capsules per day for 3 months

Placebo

Kaydee Connors

Nicole Phillips

Melissa Huynh, MD

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 placebo.
   2. To confirm tolerability and assess for side effects of delayed oral acetate supplementation.
2. Secondary outcomes:

   1. To determine if increased counts of A. muciniphilia correlate with improved metabolic parameters and improved bone health.

This will be a single-institution, randomized placebo-controlled trial involving men ≥18 years of age with metastatic castration-sensitive prostate cancer. This study will require histologic confirmation of prostate adenocarcinoma and radiographic evidence of metastatic disease on conventional imaging (CT or BS). Patients will be randomized 1:1 to receive acetate supplementation or placebo. Our institution sees approximately 200 new metastatic prostate cancer patients each year, therefore, the investigators do not anticipate encountering difficulties with recruitment into this study over a period of 2 years.

Both participants and investigators will be blinded to the intervention, either the apple cider vinegar pills vs. acetate.

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

Our study protocol and analyses can be shared, but individual data will not.

Counts of Akkermansia muciniphilia in participant stool samples at 1 week following the intervention will be compared to baseline counts.

Counts of Akkermansia muciniphilia in participant stool samples at 1 month following the intervention will be compared to baseline counts.

Counts of Akkermansia muciniphilia in participant stool samples at 3 months following the intervention will be compared to baseline counts.

Counts of Akkermansia muciniphilia in participant stool samples at 4 months following the intervention will be compared to baseline counts.

Counts of Akkermansia muciniphilia in participant stool samples at 6 months following the intervention will be compared to baseline counts.

We will record side effects reported by the participants and the rate of Discontinuation of the intervention.

Circulating plasma dp-ucMGP levels (surrogate for vitamin K2 levels) from baseline

Spots Global Cancer Trial Database for Akkermansia Muciniphilia and Metabolic Side Effects of ADT

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