Prostate Cancer, Metabolic Syndrome, Obesity, Cardiovascular Morbidity, Bone Diseases, Hyperlipidemias, Diabetes
Conditions
Keywords
prostate cancer, metabolic syndrome, androgen deprivation therapy, microbiome, Akkermansias muciniphilia, cardiovascular disease
Brief 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 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.
Interventions
Each patient will be instructed to take 1 caplet (equivalent of 143 mg/caplet containing 36% acetic acid) per day for 3 months (NPN: 80078433) https://www.jamiesonvitamins.com/products/apple-cider-vinegar-chromium?srsltid=AfmBOoqdVBFe83\_5JM9BmkomQM1LqsJYSFTiP\_78cnmehfzVg-4T4Z6o
Sponsors
Western University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This will be a single-institution, randomized 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 either conventional imaging (CT and BS) or PSMA PET scan. Patients will be randomized 1:1 to receive acetate supplementation or observation. 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 imaging with 1) CT of the abdomen, and pelvis and bone scan or 2) PSMA PET 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Akkermansia muciniphilia counts | 1 week | Counts of Akkermansia muciniphilia in participant stool samples at 1 week following the intervention will be compared to baseline counts. |
| Side effects and tolerability | 3 months | We will record side effects reported by the participants and the rate of Discontinuation of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic parameters: HbA1c | 6 months | HbA1c (%) |
| Metabolic parameters: triglycerides | 3 months | Triglycerides (mmol/L) |
| Metabolic parameters: LDL cholesterol | 3 months | LDL cholesterol (mmol/L) |
| Metabolic parameters: HDL cholesterol | 3 months | HDL cholesterol (mmol/L) |
| Metabolic parameters: total cholesterol | 3 months | Total cholesterol (mmol/L) |
| Metabolic parameters: PSA | 6 months | PSA (ng/mL) |
| Metabolic parameters: hemoglobin | 3 months | Hemoglobin (g/L) |
| Metabolic parameters: fasting plasma glucose | 3 months | Fasting plasma glucose (mmol/L) |
| Metabolic parameters: serum calcium | 3 months | Serum calcium (µmol/L) |
| Metabolic parameters: alanine transferase | 3 months | Alanine transferase (U/L) |
| Metabolic parameters: aspartate aminotransferase | 3 months | Aspartate aminotransferase (U/L) |
| Metabolic parameters: Insulin resistance index (HOMA IR) | 3 months | Insulin resistance index (HOMA IR) |
| Metabolic parameters: HOMA IR | 6 months | Insulin resistance index (HOMA IR) |
| Bone health: dp-ucMGP levels | 3 months | Circulating plasma dp-ucMGP levels (surrogate for vitamin K2 levels) from baseline |
| Bone health: Vitamin K2 | 3 months | Vitamin K2 levels |
| Metabolic parameters: serum creatinine | 3 months | Serum creatinine (µmol/L) |
| Metabolic parameters: HbA1C | 3 months | HbA1c (%) |
Countries
Canada
Contacts
Primary ContactKaydee Connors
Backup ContactStephen Mardell
Outcome results
None listed