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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT04105920
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 to 80 years old.
* Patients over 75 years old must have a G8 score ≥ 14 or oncogeriatric assessment.The geriatrician's expertise will validate the brachytherapy treatment.
* Karnofsky performance status ≥ 60% (ECOG performance status 0-2)
* Patients diagnosed with histologically proven localized prostate adenocarcinoma
* Prostate cancer eligible for brachytherapy according to the following criteria:
* at. Low risk prostate cancer: Gleason score \<7 and PSA \<10 ng / ml AND cT1-cT2a
* Intermediate risk prostate cancers with on or two adverse factor: Gleason score = 7 (3 + 4) OR PSA 10-15ng / ml OR cT2b-cT2c / ml
* less than 50% positive biopsies
* Volume of the prostate \<60 cc
* No middle lobe
* IPSS \<15/35
* Initial IIEF5 score, no treatment, greater than or equal to 20/25
* Patient able to sign an informed consent form
* Patient benefiting from a social insurance system or similar system
Exclusion Criteria:
* Nodal or distant metastatic evolution
* History of abdominal or pelvic irradiation
* Anterior treatment for prostate cancer, including hormone therapy with LHRH analogue or GnRH antagonist.
* History of prostate resection, not allowing brachytherapy seeds implantation.
* Uncontrolled cancer (except basal cell skin cancer)
* Current clinical study that may interfere with this study
* Patient unable to complete a self-administered questionnaire and understand the ins and outs of the trial
* Major patients protected by law
* Allergy to hyaluronic acid
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04105920
Study Brief:
Protocol Section:
NCT04105920