Akkermansia Muciniphilia and Metabolic Side Effects of ADT

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorWestern University

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:

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

Eligibility criteria

Qualifiers

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

Age less than 18

Primary neuroendocrine prostate cancer

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Apple Cider Vinegar

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators