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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00225420
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed adenocarcinoma of the prostate with any of following clinical features:
A) T3 or T4 B) T1-2 + Gleason Score 8-10 C) T1-2 + Gleason Score 7 + Prostate Specific Antigen (PSA) \>10 ng/mL D) T1-2 + Any Gleason Score + PSA \>20 ng/mL
2. No evidence of metastatic disease on chest x-ray, bone scan or CT scan of abdomen/pelvis.
3. Age \> 18
4. The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
5. Peripheral neuropathy: must be \< grade 1
6. Hematologic parameters A) Absolute neutrophil count \> 1,500/mm3 B) Hemoglobin \> 8.0 g/dL C) Platelet count \> 100,000/mm3.
7. Hepatic parameters / Renal function A) Total Bilirubin must be ≤ 1.2 mg/dL B) Transaminases (AST and ALT) must be \< 1.5 x upper limit of normal (ULN) C) Alkaline phosphatase must be \< 2.5 x ULN D) Creatinine \< 1.5 x ULN ( \< 2.1 mg/dL)
8. No prior pelvic or prostate radiation or chemotherapy for prostate cancer. Androgen ablation therapy with one of the luteinizing hormone-releasing hormone (LH-RH) agonists prior to enrollment is acceptable as long as protocol treatment with radiotherapy and chemotherapy is started within 3 months of the initiation of androgen ablation.
9. Patient must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Exclusion Criteria:
1. Documented metastases on staging studies
2. Life expectancy \<10 years secondary to co-morbid illness
3. Myocardial infarction or significant change in anginal pattern within one year prior to study entry or current congestive heart failure (New York Heart Association Class 2 or higher)
4. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
5. History of invasive malignancy within the last five years prior to study entry except for carcinoma in situ or nonmelanoma skin cancer.
6. Psychiatric conditions which would prevent compliance with treatment or adequate informed consent.
7. Patients receiving another investigational agent during chemo- and radiotherapy
8. Uncontrolled intercurrent illness or other conditions that limit compliance with protocol treatment
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00225420
Study Brief:
Protocol Section:
NCT00225420