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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT05322356
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years
* Patient to be treated with brachytherapy
* Patient with low or favorable intermediate risk prostate adenocarcinoma ISUP 1 and 2, G6 (3+3) or G7 (3+4)
* Life expectancy of more than 10 years
* PSA (prostate-specific antigen) \< 15 ng/ml
* cT1c or cT2a or cT2b
* Prostate volume ≤ 60 cc
* ECOG Performance status 0-2
* Patient is affiliated to a health insurance system
* Patient who has signed consent form
Exclusion Criteria:
* Patient with urinary function disorders IPSS\> 14
* Prostate volume \> 60cc.
* Gleason 7(4+3) or Gleason score ≥8
* PSA ≥ 15 ng/ml
* Patient with metastases
* Hormone therapy with antiandrogen or LHRH analogue
* History of abdominopelvic irradiation
* Inflammatory digestive disease (haemorrhagic rectocolitis, Crohn's disease)
* Interventional study in progress that may interfere with the present study
* Protected persons (patient concerned by articles L1121-5, L1121-6, L1121-8 of the French public health code)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05322356
Study Brief:
Protocol Section:
NCT05322356