Microbiome Molecular Charaterisation

NCT06423976 | Recruiting

• 1 other identifier: CCR5856
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Microbiome composition in prostate cancer patients

  Describing the microbiome composition in prostate cancer patients using metagenomic and metabolomic studies.

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Prevalence of prostate cancer aberrations

  through study completion, an average of 1 year

• Patient clinical outcomes

  time to castration resistance, time to treatment progression and overall survival.

Interventions

Sequencing study OTHER

Sequencing of tumour samples for microbiome analysis and molecular charcterisation.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The sample size is not based on formal statistical power analyses but rather on pragmatic and feasibility considerations. Our experience with our previous MC study lets us assume that we will be able to recruit 200 patients per year (from 1-2 participating centres) over a recruitment period of five years. Thus, the total expected sample size will be 1000 patients. The expected study endpoint analysis will commence following the 5-year recruitment period but no longer than the overall 15-year end of study timeline.

You may qualify if:

• Male \>=18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2.
• Undergoing investigation for diagnosis, or with a proven diagnosis of prostate cancer and undergoing further investigation or clinical trial participation.
• Patients with tumour deemed by the designated investigator as safely suitable for fresh biopsy AND who are medically fit (according to local practice) to undergo a biopsy or surgical procedure to acquire tumour tissue.
• Willing and able to comply with the requirements of the sample collection including fresh tumour biopsy.
• The subject is capable of understanding and complying with the protocol requirements and has given written informed consent.
• A record of PSA levels within last 3 months.

You may not qualify if:

• The presence of any haematological disorders, including coagulation disorders, which would be a contraindication if patient were to undergo a biopsy.
• Any psychiatric illness/social situations that would limit compliance with study requirements.
• Presence of any concurrent condition or situation, which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (1)

Institute of Cancer Research/Royal Marsden NHS FT

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Johann De-Bono

  The Royal Marsden NHS FT\The Institute of Cancer Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omobola Fadahunsi

CONTACT

0203 437 3500; bola.fadahunsi@icr.ac.uk

Sasha Gayle

CONTACT

0208 722 4672; sasha.gayle@icr.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: May 21, 2024
• Study Start: October 23, 2023
• Primary Completion (Estimated): October 1, 2038
• Study Completion (Estimated): October 1, 2038
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

GB (1)