Recent Advances in the Management of High-Risk Localized Prostate Cancer: Local Therapy, Systemic Therapy, and Biomarkers to Guide Treatment Decisions.
Rana R McKay, Felix Y Feng, Alice Y Wang...
https://pubmed.ncbi.nlm.nih.gov/32412803Actively Recruiting
Early Phase 1
Age: 18Years +
MALE
ID05802121
The Role of Akkermansia Muciniphilia in Combating the Metabolic Effects of Androgen Deprivation Therapy in Men With Metastatic Prostate Cancer
Led by Western University · Updated on 2025-08-20
30
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying men with metastatic castration-sensitive prostate cancer to see if taking oral acetate can increase the amount of a gut bacterium called Akkermansia muciniphila. The trial aims to confirm this increase compared to standard care and to assess how well patients tolerate oral acetate. The study also explores whether higher levels of this bacterium relate to better metabolic health and bone strength. This is an early phase 1 clinical trial sponsored by Western University. Participants are randomly assigned to one of two groups. One group takes an apple cider vinegar caplet daily, containing 143 mg with 36% acetic acid, for three months. The other group receives standard care without supplementation. The study includes follow-up periods lasting up to six months to monitor changes and side effects. Throughout the study, stool samples will be collected at multiple time points to measure Akkermansia muciniphila levels. Researchers will also evaluate various metabolic markers such as blood sugar, cholesterol, and insulin resistance, plus bone health indicators. Side effects and tolerability will be checked after three months. Participants are monitored over six months to assess both primary and secondary outcomes related to metabolism and bone health.
CONDITIONS
Brief Title
Akkermansia Muciniphilia and Metabolic Side Effects of ADT
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Men aged 18 years or older
- Histologically confirmed metastatic castration-sensitive prostate adenocarcinoma
- Planned to receive androgen deprivation therapy (ADT)
- Must have baseline imaging with CT abdomen and pelvis plus bone scan or PSMA PET scan
You will not qualify if you...
- Age less than 18 years
- Primary neuroendocrine prostate cancer
- Treatment with ADT within the year before enrollment
- Planned or current use of chromium supplements during study
- Planned or current use of apple cider vinegar supplements during study
- Unable to provide informed consent or understand/read English without interpreter
- Liver function more than twice the upper limit of normal
- Any condition or lifestyle factor posing significant risk or affecting study completion
- Use of antibiotics that cannot be stopped and remain off during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants take one apple cider vinegar caplet daily for 3 months or are observed under standard care.
Monthly visits during treatment
Follow-up
Duration - 3 months
Participants are monitored for metabolic parameters and fecal Akkermansia muciniphilia counts after treatment ends.
Visits at 4 and 6 months post-enrollment
Trial Site Locations
Total: 1 location
1
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada, N6A5W9
Actively Recruiting
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Research Team
K
Kaydee Connors
S
Stephen Mardell
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Changes in body composition during androgen deprivation therapy for prostate cancer.
Matthew R Smith, Joel S Finkelstein, Francis J McGovern...
https://pubmed.ncbi.nlm.nih.gov/11836291Impact of androgen deprivation therapy on weight gain differs by age in men with nonmetastatic prostate cancer.
Narhari Timilshina, Henriette Breunis, Shabbir M H Alibhai
https://pubmed.ncbi.nlm.nih.gov/23083859Metabolic syndrome in men with prostate cancer undergoing long-term androgen-deprivation therapy.
Milena Braga-Basaria, Adrian S Dobs, Denis C Muller...
https://pubmed.ncbi.nlm.nih.gov/16921050Weight gain on androgen deprivation therapy: which patients are at highest risk?
Daniel M Seible, Xiangmei Gu, Andrew S Hyatt...
https://pubmed.ncbi.nlm.nih.gov/24726149A population-based study of cardiovascular disease mortality risk in US cancer patients.
Kathleen M Sturgeon, Lei Deng, Shirley M Bluethmann...
https://pubmed.ncbi.nlm.nih.gov/31761945Androgen deprivation therapy increases cardiovascular morbidity in men with prostate cancer.
Christopher S Saigal, John L Gore, Tracey L Krupski...
https://pubmed.ncbi.nlm.nih.gov/17657815Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer.
Nancy L Keating, A James O'Malley, Matthew R Smith
https://pubmed.ncbi.nlm.nih.gov/16983113Androgen-deprivation therapy in treatment of prostate cancer and risk of myocardial infarction and stroke: a nationwide Danish population-based cohort study.
Christina G Jespersen, Mette Nørgaard, Michael Borre
https://pubmed.ncbi.nlm.nih.gov/23433805Influence of androgen suppression therapy for prostate cancer on the frequency and timing of fatal myocardial infarctions.
Anthony V D'Amico, James W Denham, Juanita Crook...
https://pubmed.ncbi.nlm.nih.gov/17557956