Akkermansia Muciniphilia and Metabolic Side Effects of ADT

Launched by WESTERN UNIVERSITY · Mar 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called oral acetate on men with a type of prostate cancer known as metastatic castration-sensitive prostate adenocarcinoma. The main goals are to see if taking oral acetate can increase the amount of a specific bacteria called Akkermansia muciniphilia in their stool and to check how well patients tolerate this supplement. Researchers also want to find out if having more of this bacteria is linked to better health, particularly in terms of metabolism and bone health.

To be eligible for this study, participants must be men aged 18 or older who have been diagnosed with the specific type of prostate cancer mentioned. They should also have certain imaging tests done to assess their condition. Unfortunately, men who have had certain types of treatments recently or have specific health issues will not be able to join this trial. If chosen to participate, men will be monitored for any side effects from the supplement and will help researchers learn more about how it impacts their health. The trial is not yet recruiting participants, but it represents an important step in understanding potential new treatments for prostate cancer and related health issues.

Gender

MALE

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 conventional imaging with CT of the abdomen, and pelvis and bone scan.
• 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. Planned or concurrent use of chromium supplementation for the study duration
• • 5. Planned or concurrent use of apple cider vinegar supplementation for the study duration
• • 6. Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter)
• • 7. Inadequate liver function (\>2x upper limit of normal)
• • 8. Any other condition, chronic disease, or lifestyle factor, that, in the opinion of the Qualified Investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
• • 9. Use of antibiotics that cannot be discontinued for a washout period and remain off them for the duration of the trial