At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Procedure - blood, urine and stool sample collection (procedure)
- How long the study runs
- Study runs about 32 months (dates as stated)
- About the drug or intervention
- Procedure - blood, urine and stool sample collection — procedure: 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
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by The Christie NHS Foundation Trust, is looking at men with localised intermediate to high-risk prostate cancer who are having a type of radiotherapy called intensity-modulated radiotherapy (IMRT). The study focuses on bowel side effects that can happen after radiotherapy. The trial team can tell you more about what the study is testing.
Who can take part
- Men aged 18 or over, with no upper age limit, who can give informed consent
- Newly diagnosed prostate cancer confirmed by tissue tests, that is localised and classed as intermediate to high-risk (T2b-T4a N0 M0)
- Due to be treated with curative radiotherapy to the prostate (IMRT, 60 Gy in 20 sessions over a 4-week plan)
- Good enough general health and activity levels (performance status ECOG 0-2)
Who may not be able to
- Antibiotics by injection or mouth in the 2 months before joining
- Chemotherapy or immunotherapy, or other drugs that suppress the immune system, in the 6 months before joining
- Large daily doses of shop-bought probiotics (108 colony-forming units or more per day) in the 12 months before joining
- Diagnosed inflammatory bowel disease or coeliac disease
- Previous bowel (colorectal) cancer
- Surgery to remove all or part of the bowel (colectomy)
- A history of diverticulitis (mild diverticular disease without problems is allowed)
What taking part involves
- • Radiotherapy to the prostate using IMRT (intensity-modulated radiotherapy), giving a total dose of 60 Gy in 20 treatment sessions over 4 weeks, with the aim of curing the cancer
Time commitment: Treatment involves 20 radiotherapy sessions over 4 weeks; details of extra study visits, tests or follow-up are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 50
- Started
- 2024-11-19
- Last checked
- 2024-12
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer
- • Clinical study - 50 participants
- • In the UK over 22,000 people undergo pelvic radiotherapy treatment per year, for several types of cancers including prostate cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer
- • Male only
Where?
- • Manchester - Christie NHS Foundation Trust
- • Preston - Lancashire Teaching Hospitals NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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).
More detail
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: 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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
- How fit you need to be: ECOG 0 or better
What the study is looking for
- ✓Male, aged ≥ 18; no upper age limit and able to give agreement to take part.
- ✓Newly diagnosed patients with, confirmed by a biopsy, localised, intermediate to high-risk prostate cancer (T2b...
- ✓Patients to be treated with prostate radical radiotherapy IMRT (60Gy in 20# with curative intent) 4-week regimen.
- ✓Performance status - ECOG 0-2.
Who cannot take part
- ✗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 drug treatment or...
- ✗Had consumed large doses of commercial probiotics (greater or equal to 108 CFU per day) within 12 months of...
- ✗Patients with diagnosed inflammatory bowel disease or coeliac disease
- ✗Patients with previous colorectal cancer
See the full criteria
Where Is This Study? (2 UK sites)
Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston PR2 9HT, United Kingdom
How to Get in Touch
Lois Gardner, PhD
Sponsor contactCONTACT
Eleanor Cheadle, PhD
Sponsor contactCONTACT