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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT00376792
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate meeting one of the following criteria after undergoing radical prostatectomy:
* pT2 with Gleason score 4+3 or 8-10 and positive margins in the radical prostatectomy specimen
* Any pT3a tumor with Gleason score ≥ 4+3
* pT3b tumor with Gleason score ≥ 7
* Negative lymph nodes at histological examination (N0)
* Patients with a preoperative prostate-specific antigen (PSA) ≥ 10.0 ng/mL should have undergone a lymph node dissection
* Postoperative PSA must be \< 0.5 ng/mL
* Considered at high risk for recurrent disease
* No metastatic (M0) disease
* Negative bone scan
PATIENT CHARACTERISTICS:
* WHO/ECOG performance status 0-1
* Hemoglobin ≥ 11.0 g/dL
* Neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 150,000/mm³
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin normal
* AST and ALT ≤ 1.5 times ULN
* Alkaline phosphatase \< 1.5 times ULN
* No active untreated infectious disease (e.g., tuberculosis or methicillin-resistant Staphylococcus aureus)
* No active gastric ulcer
* No known hypersensitivity to polysorbate 80
* No symptomatic peripheral neuropathy ≥ grade 2
* No myocardial infarction within the past 6 months
* No other unstable cardiovascular disease within the past 6 months
* No other serious illness or medical condition
* No altered psychological or physical state that would preclude study compliance
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior hormonal therapy (e.g., luteinizing hormone-releasing hormone analogues and/or antiandrogens) affecting prostate cancer cells
* No prior radiotherapy to the pelvis
* No prior chemotherapy
* More than 6 months since prior systemic corticosteroids
* No other concurrent anticancer therapy or investigational drugs
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00376792
Study Brief:
Protocol Section:
NCT00376792