Actively Recruiting

Age: 18Years +
MALE
NCT06423976

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

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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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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