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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT00598858
Eligibility Criteria:
Inclusion Criteria:
* Patient must have a histological diagnosis of adenocarcinoma of the prostate which is measurable or evaluable Stage I or II.
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Patient must have a pre-study PSA within 28 days prior to start of therapy.
* Patients who have received prior radiotherapy are not eligible.
* Patient must have an adequate renal function
* Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
* Age \> 18
* Patients must be able to take oral medications
Exclusion Criteria:
* Patients with measurable metastatic diseases by a CT scan of the abdomen and pelvis within 28 days and by a bone scan within 42 days prior to start of therapy.
* Patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to start of therapy and must have recovered from toxicities of prior therapy to grade 1 or less with the exception of alopecia.
* Patients must not be treated with non-steroidal anti-androgens (flutamide, bicalutamide, nilutamide or ketoconazole).
* Patients must not take vitamins, herbs, or micronutrient supplement within 28 days prior to start of therapy.
* Patients may not have ongoing problems with bowel obstruction or short bowel syndrome characterized by grade 2 or greater diarrhea or malabsorptive disorders.
* Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* Patients should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol.
* Patients should not have any medical life-threatening complications of their malignancies
* Patients should not have a known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV).
* Patients should not have current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
* Patients with history of myocardial infarction, cerebrovascular accident, transient ischemic attack, or unstable angina within 6 months
* Patients with clinically significant peripheral vascular disease
* Patients with evidence of bleeding diathesis or coagulopathy
* Patients with central nervous system or brain metastases
* Patients who had major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
* Patients with minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
* Patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
* Patients with serious, non-healing wound, ulcer, or bone
* Patients who are diagnosed of any other malignancy except non-melanomatous skin cancer in the past 5 years
* Patients receiving anticoagulation therapy (e.g. Coumadin) prior to registration
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00598858
Study Brief:
Protocol Section:
NCT00598858