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:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-26 @ 3:21 PM
NCT ID:
NCT01704027
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed adenocarcinoma of the prostate
2. High risk localized adenocarcinoma defined by at least one of the following criteria:
* Clinical stage T2c, T3 or T4
* Gleason score ≥ 8
* Prostate-specific antigen (PSA)≥ 20 ng/ml and ≤ 100 ng/ml
3. Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy)
4. No pelvic adenopathy ≥ 15 mm on CT or MRI,
5. Absence of bone and/or visceral metastasis
6. Androgen deprivation beginning no later than the day of radiotherapy and up to six months before irradiation
7. Absence of prior pelvic radiotherapy,
8. Absence of surgical treatment of prostate cancer except transurethral resection performed within 4 months minimum before radiotherapy,
9. Age ≥ 18 years and ≤ 85 years
10. ECOG performance status ≤ 1,
11. Estimated life expectancy \> 5 years
12. Membership of a social security system,
13. Signed informed consent.
Exclusion Criteria:
1. Prostate cancer histology other than adenocarcinoma,
2. pN1 patients (lymph node dissection after histologically proven)
3. PSA \> 100 ng/ml
4. History of cancer within 5 years prior to trial entry (with the exception of basal cell carcinoma skin)
5. Patient with severe hypertension uncontrolled by appropriate treatment (≥ 160 mm Hg systolic and / or ≥ 90 mm Hg diastolic)
6. Contra-indication for pelvic irradiation (eg scleroderma, chronic inflammatory disease of the digestive tract, etc ...)
7. Contra-indication to agonists or antagonists of LH-RH
8. Bilateral hip prosthesis,
9. Patients already included in another clinical trial with an experimental molecule,
10. Persons deprived of liberty or under guardianship
11. Unable to undergo medical test for geographical, social or psychological.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01704027
Study Brief:
Protocol Section:
NCT01704027