Chronic Radiation Induced Bowel Toxicity Study
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorThe Christie NHS Foundation Trust
About this trial
In the UK over 22,000 people undergo pelvic radiotherapy treatment per year, for several types of cancers including prostate cancer. The investigators want to investigate whether there are any differences in the bacteria in the bowel in patients with prostate cancer and whether these change during treatment.
The aim of this study is to analyse the bacteria from the stool of patients undergoing radiotherapy for prostate cancer. The investigators will also look for any changes in the urine, blood and using rectal swabs that might be a surrogate for what is happening in the gut at the same time. They will collect food frequency/ food diary information for each patient alongside health questionnaires.
The investigators aim to recruit approximately 50 patients diagnosed with prostate cancer due to undergo radiotherapy over a two year period. Patients will be recruited across 2 sites (Rosemere Cancer Centre, Lancashire Teaching Hospitals Trust and The Christie NHS Foundation Trust).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Newly diagnosed patients with prostate cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Procedure - blood, urine and stool sample collection
Procedure/SurgerySamples will be collected (blood, urine, stool and optional rectal swab) at baseline (prior to the start of radiotherapy), weekly during radiotherapy for 4 weeks, 6-8 weeks and 12 weeks from start of radiotherapy, and at 6-month and 12-month follow-up appointments
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Feasibility of obtaining longitudinal blood, urine and stool samples
Feasibility of obtaining longitudinal blood, urine and stool samples from patients with newly diagnosed prostate cancer undergoing standard of care radiotherapy. Samples will be collected at baseline (prior to the start of radiotherapy), weekly during radiotherapy for 4 weeks, 6-8 weeks and 12 from the start of radiotherapy, and at 6-month and 12-month follow-up appointments.
Time frame
From enrolment until 12 months post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Christie NHS Foundation Trust
Lead sponsor
University of Manchester
Collaborator
Lancashire Teaching Hospitals NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov