Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-11-19
2027-07-31
Brief Summary
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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).
Detailed Description
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The investigators aim to recruit 50 patients newly diagnosed with (histologically confirmed) localised, intermediate to high-risk prostate cancer (T2b -T4a N0 M0), who are due to undergo standard of care radical radiotherapy (Intensity modulated radiotherapy (IMRT)) (60Gy in 20# with curative intent) 4-week regimen.
Eligible patients who have consented to the study will provide the following samples 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:
1. stool sample
2. blood sample (40mls) delegated nurse or research nurse.
3. mid-stream urine sample
4. optional rectal swab
5. quality of life health questionnaire
4-day diet diaries will be completed by the patients in the 4 days prior to providing their baseline stool samples and at follow-up appointments (6-8 weeks, 6 months, 12 months).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Procedure - blood, urine and stool sample collection
Samples 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
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
MALE
No
Sponsors
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University of Manchester
OTHER
Lancashire Teaching Hospitals NHS Foundation Trust
OTHER
The Christie NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, Lancashire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Catherine Trigwell
Role: primary
Claire Searle
Role: primary
Other Identifiers
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CFTsp225
Identifier Type: -
Identifier Source: org_study_id