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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT00186420
Eligibility Criteria:
Inclusion Criteria:
* Patients who have undergone a radical prostatectomy (should have unmeasurable PSA) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following:
* Node positive disease post-operatively
* Capsule involvement
* Seminal Vesicles involvement
* Gleason score ≥ 8
* \>50% of core biopsies that are positive
* Clinical Stage T2c and T3
* Pre-op PSA \> 15 plus Gleason score of 7
* Age greater than 18
* ECOG Performance Status 0-1
* Serum creatinine \<= 1.5 mg/dl
* Granulocyte count \>= 1500/m3, Hemoglobin \> 8.0 g/dl, and platelet count \>= 100,000/m3
* Total bilirubin \<= ULN
* AST, ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
* Signed patient informed consent.
* Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter.
Exclusion Criteria:
* Peripheral neuropathy \> grade 1
* History of severe hypersensitivity to Taxotere® or other drugs formulated with polysorbate 80.
* Patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent.
* Active infection within 14 days of beginning treatment
* Patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection.
* Patients with a current malignancy. Patients with prior a history of in situ lobular carcinoma of the breast, basal or squamous cell skin cancer, are eligible.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00186420
Study Brief:
Protocol Section:
NCT00186420