Investigating bowel bacteria changes in prostate cancer patients undergoing radiotherapy

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 analyze the bacteria present in the stool of patients with prostate cancer who are undergoing pelvic radiotherapy. The researchers will collect stool, blood, urine, and optional rectal swab samples at various points during and after treatment to assess any changes in the microbiota and related immunological responses. Additionally, participants will complete food diaries and health questionnaires to provide further insights into their dietary habits and quality of life. The study will recruit approximately 50 patients across two sites over a two-year period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male, aged ≥ 18; no upper age limit and able to give informed consent.
* Newly diagnosed patients with, histologically confirmed, localised, intermediate to high-risk prostate cancer (T2b -T4a N0 M0).
* Patients to be treated with prostate radical radiotherapy IMRT (60Gy in 20# with curative intent) 4-week regimen.
* Performance status - ECOG 0-2.

Exclusion Criteria:

* Had received systemic antibiotics (intravenous, intramuscular, or oral) within 2 months before enrolment.
* Had received cytotoxic or immunosuppressive therapies within 6 months of enrolment, including chemotherapy or immunotherapy.
* Had consumed large doses of commercial probiotics (greater or equal to 108 CFU per day) within 12 months of enrolment (such as Actimint®, CranProBio®, ImmunoProBio®, among others).
* Patients with diagnosed inflammatory bowel disease or coeliac disease
* Patients with previous colorectal cancer
* Patients who have undergone colectomy (total or subtotal)
* Patients with a history of diverticulitis (uncomplicated diverticular disease permitted)

Where it's running

• Christie NHS Foundation Trust
  Manchester, Greater Manchester, United Kingdom Recruiting
• Lancashire Teaching Hospitals NHS Foundation Trust
  Preston, Lancashire, United Kingdom Recruiting

Study contacts

• Study coordinator: Lois Gardner, PhD
• Email: lois.gardner@manchester.ac.uk
• Phone: 01612008863

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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.