Akkermansia Muciniphilia and Metabolic Side Effects of ADT

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Western University
• Treatments: Acetic Acid

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 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:

1. Age less than 18

2. Primary neuroendocrine prostate cancer

3. Treatment with ADT within the year leading up to enrolment

4. Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter)

5. Inadequate liver function