Akkermansia Muciniphilia and Metabolic Side Effects of ADT

Trial Title: Akkermansia Muciniphilia and Metabolic Side Effects of ADT

NCT ID: NCT05802121

Condition: Prostate Cancer
Metabolic Syndrome
Obesity
Cardiovascular Morbidity
Bone Diseases
Hyperlipidemias
Diabetes

Conditions: Official terms:
Prostatic Neoplasms
Bone Diseases
Metabolic Syndrome
Hyperlipidemias
Acetic Acid

Conditions: Keywords:
prostate cancer
metabolic syndrome
androgen deprivation therapy
microbiome
Akkermansias muciniphilia
cardiovascular disease

Study type: Interventional

Study phase: Early Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: 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.

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

Intervention:

Intervention type: Drug
Intervention name: Apple Cider Vinegar
Description: 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/
Arm group label: Apple Cider Vinegar

Intervention type: Drug
Intervention name: Placebo
Description: Each patient will be instructed to take 6 placebo capsules per day for 3 months
Arm group label: Placebo

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.

Criteria for 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. 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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: June 2023

Completion date: June 2026

Lead sponsor:
Agency: Western University
Agency class: Other

Source: Western University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05802121