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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT00667069
Eligibility Criteria:
Inclusion criteria:
1. Patient must have undergone curative surgery for a localized adenocarcinoma of the prostate
2. pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV)
3. PSA ≤0.1 ng/mL after prostatectomy (confirmed at 1 month)
4. May receive treatment within 6 months after surgery
5. Positive margins (tumoral glands in contact with contour ink) on the surgical specimen
6. pN0 or pNx (lymph nodes resected during negative prostatectomy or lymph nodes not resected)
7. No current clinical or biochemical progressive disease
8. Life expectancy ≥10 years
9. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
10. Patient must be affiliated to the social security system
11. Patient must have received the information sheet and signed the consent form
Exclusion criteria:
1. Patient with prostate cancer other than adenocarcinoma
2. Gleason score ≥8 and with seminal vesicles involved
3. pN1 disease (Histologically confirmed nodal invasion during initial lymph node resection)
4. pT2 disease
5. Prior surgical or chemical castration
6. Prior hormonal therapy
7. Prior radiotherapy within 3 months after radical prostatectomy
8. Prior pelvic radiotherapy
9. No history of cancer (except basal cell skin cancer) within 5 years of surgery
10. No known severe hypertension uncontrolled by appropriate therapy (≥160 mm Hg systolic and/or ≥90 mm Hg diastolic)
11. Known hypersensitivity to gonadotropin-releasing hormone or its analogs
12. Contraindication to intramuscular injection
13. Concurrent participation in another interventional study
14. Patients under protective custody or guardianship, unable to comply with the specific requirements of the study or unable to understand the purpose of the study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00667069
Study Brief:
Protocol Section:
NCT00667069