Actively Recruiting
Microbiome Molecular Charaterisation
Led by Institute of Cancer Research, United Kingdom · Updated on 2024-05-24
1000
Participants Needed
1
Research Sites
779 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Preclinical models of prostate cancer have proved to be poorly predictive of the behaviour of the disease in patients. This protocol describes the acquisition of prostate cancer tissue or cells from patients with treatment naïve/hormone-sensitive and castration-resistant prostate cancer or patients undergoing diagnostic or follow up investigations. The knowledge gained will improve the investigators' understanding of the steps leading to the development of castration resistance and identify new molecular targets for treatment. The human microbiome has been under investigation in a range of human diseases (i.e. metabolic disease/obesity, neurological disorders, cardiovascular disease, mental disorders, autoimmune disease, asthma and allergies) and cancer. The human microbiota can have direct (e.g. via direct genotoxicity, induction of chronic inflammation, etc.) and/or indirect (e.g. effects on tumour effects on tumour development or progression exerted through microbial communities that exist at a site distant to the tumour) effects on the disease. Emerging data supports the influence of the gut microbiota on the efficacy of anti-cancer treatments, including immunotherapy. To date, the impact of the gut microbiome on prostate cancer therapies is virtually unexplored. Based on the evidence to date, the investigators hypothesize that the gut flora may be altered by certain treatments for advanced prostate cancer, and that the composition of the microbiome in the gastrointestinal tract may be used to predict therapeutic efficacy or therapy-related toxicities; as well as prevent treatment toxicity and/or enhance treatment response. Furthermore, the purpose is to investigate the association between gut flora and treatment response and related toxicities/morbidities in advanced prostate cancer.
CONDITIONS
Official Title
Microbiome Molecular Charaterisation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- ECOG performance status of 0 to 2
- Undergoing investigation for diagnosis or with confirmed prostate cancer undergoing further investigation or clinical trial participation
- Tumour suitable for fresh biopsy and medically fit for biopsy or surgery to acquire tumour tissue
- Willing and able to comply with sample collection requirements including fresh tumour biopsy
- Capable of understanding and complying with protocol and has given written informed consent
- Record of PSA levels within the last 3 months
You will not qualify if you...
- Presence of any blood disorders or coagulation problems that contraindicate biopsy
- Psychiatric illness or social situations limiting study compliance
- Any condition or situation that may pose significant risk, confound study results, or interfere with participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institute of Cancer Research/Royal Marsden NHS FT
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
O
Omobola Fadahunsi
CONTACT
S
Sasha Gayle
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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