Understanding the role of the microbiome in prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect prostate cancer tissue or cells from patients with treatment-naïve, hormone-sensitive, and castration-resistant prostate cancer. By analyzing these samples, researchers hope to gain insights into the development of castration resistance and identify new molecular targets for treatment. The study also explores the impact of the human microbiome on cancer progression and treatment response, leveraging recent findings that suggest a link between microbiota composition and therapeutic efficacy. Participants will undergo fresh biopsies to provide the necessary samples for sequencing and analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male \>=18 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2.
3. Undergoing investigation for diagnosis, or with a proven diagnosis of prostate cancer and undergoing further investigation or clinical trial participation.
4. 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.
5. Willing and able to comply with the requirements of the sample collection including fresh tumour biopsy.
6. The subject is capable of understanding and complying with the protocol requirements and has given written informed consent.
7. A record of PSA levels within last 3 months.

Exclusion Criteria:

1. The presence of any haematological disorders, including coagulation disorders, which would be a contraindication if patient were to undergo a biopsy.
2. Any psychiatric illness/social situations that would limit compliance with study requirements.
3. 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.

Where it's running

• Institute of Cancer Research/Royal Marsden NHS FT
  Sutton, Surrey, United Kingdom Recruiting

Study contacts

• Principal investigator: Johann De-Bono — The Royal Marsden NHS FT\The Institute of Cancer Research
• Study coordinator: Omobola Fadahunsi
• Email: bola.fadahunsi@icr.ac.uk
• Phone: 0203 437 3500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.