An observational study in Prostate Cancer, sponsored by The Christie NHS Foundation Trust. Recruiting at 2 sites in United Kingdom. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by The Christie NHS Foundation Trust · Observational
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).
This is a prospective, translational study which aims to investigate the radiation induced immunological changes in the bowel mucosa, blood and urine, and the role of the microbiota in acute and late bowel toxicity.
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:
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).
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →The Christie NHS Foundation Trust is the lead sponsor of 99 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Newly diagnosed patients with prostate cancer
Exclusion Criteria:
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
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 treatment
Plan to share: No
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The Christie NHS Foundation Trust