Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT06640959
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06640959
Study Brief:
Protocol Section:
NCT06640959