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:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT02165020
Eligibility Criteria:
Inclusion Criteria:
* age superior or equal to 18 years and inferior to 80 years.
* patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation.
* prostate cancer histologically proven.
* life expectancy superior to 10 years.
* Karnofsky performance status ≥ 60% (performance status ECOG 0-2).
* the patient has to be the beneficiary of a social security system or other insurance (order n° 2006-477 from April 26th 2006).
* the signed consent form.
Exclusion Criteria:
* age inferior to 18 years and ≥ 80 years;
* history of rectal surgery;
* patient who can't cooperate during the treatment;
* history of pelvic irradiation;
* history of inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;
* other current neoplasia or history of neoplasia dating from less than 5 months, excepting basal-cell carcinomas;
* patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect);
* patients receiving anticoagulant treatment or PLAVIX;
* other undergoing study that may interfere with the present study;
* patient under legal protection measure.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02165020
Study Brief:
Protocol Section:
NCT02165020