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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT01148069
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18,
* Prostate adenocarcinoma (histologically proven),
* Locally-advanced (T3a or Gleason \> 7 or PSA ≥ 20 ng/mL),
* Distal half of seminal vesicles unaffected on MRI,
* Non metastatic cancer: negative extension assessment (on prostatic and pelvic MRI and bone scintigraphy),
* Radiotherapy and hormonotherapy indication,
* Medical insurance affiliation,
* Written informed consent.
Non-inclusion criteria:
* Co-morbidity or medical history contraindicating surgery (pelvic lymphadenectomy and seminal vesicle ablation),
* Contraindication to pelvic irradiation,
* Hip prosthesis,
* History of cancer for the last 5 years (except baso-cellular epithelioma),
* History of pelvic irradiation,
* Person deprived of freedom or under guardianship,
* Participation in another biomedical research.
Exclusion Criteria:
* Surgery showing lymph nodes involvement (pelvic radiation indication)
* Surgery without ablation of seminal vesicles
* Surgery with positive margins in seminal vesicles
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01148069
Study Brief:
Protocol Section:
NCT01148069