MICROBIOME MOLECULAR CHARACTERISATION (MMC)
Research type
Research Study
Full title
MICROBIOME MOLECULAR CHARACTERISATION (MMC): COLLECTION OF CLINICAL MATERIAL FROM PATIENTS WITH PROSTATE CANCER OR UNDERGOING INVESTIGATION FOR DIAGNOSTIC OR FOLLOW-UP PURPOSES FOR MOLECULAR CHARACTERISATION AND MICROBIOME ANALYSIS.
IRAS ID
326155
Contact name
Johann De Bono
Contact email
Sponsor organisation
Institute of Cancer Research
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
The study is a prospective, observational, multi-centre non-interventional study.
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 our 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 [3, 5-6]. 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, we 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, our purpose is to investigate the association between gut flora and treatment response and related toxicities/morbidities in advanced prostate cancer.Patient will also be followed up every 6 months via medical notes review or telephone for survival and anti-cancer treatment data.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0181
Date of REC Opinion
11 Oct 2023
REC opinion
Further Information Favourable Opinion