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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT00082134
Eligibility Criteria:
Inclusion Criteria:
* Patient has hormone-refractory prostate cancer (HRPC) as evidenced by PSA progression or progression of measurable disease.
* Patient has greater than 25% increase in 2 consecutive tests in which the first increase in PSA should occur a minimum of 1 week apart.
* Patients on androgen deprivation treatment and will continue on androgen deprivation treatment during study participation except for patients who are post orchiectomy.
* Patient has evidence of metastatic disease by positive bone scan or evidence of progressive metastatic disease by CT scan.
* Patient has been treated with at least 1 prior hormone therapy or is post orchiectomy.
* Patient has been previously treated at a minimum for an 8-week treatment period on a docetaxel-based regimen for metastatic HRPC.
* Patient has PSA at least 5 ng/mL or greater.
* Patient has testosterone less than 50 ng/dL.
* Patient ECOG performance status of 0 or 1.
* Patient has life expectancy of greater than 8 weeks.
* Patient meets lab values: A. Absolute neutrophil count at least 1,500/mm\^3 or greater; B.Platelet count at least 100,000/mm\^3 or greater; C. Serum creatinine at least 1.5 mg/dL or less or creatinine clearance at least 60 mL/min or greater; D. Bilirubin less than 2.0 mg/dL. E. AST and ALT less or equal to 2.5 times upper limit of normal
* Any chemotherapy, major surgery, or irradiation must be completed at least 4 weeks prior to study drug.
* Patient recovered from clinically significant toxicities from prior treatment.
Exclusion Criteria:
* Prior treatment with 2 or more prior chemotherapy regimens.
* Concurrent treatment with an estrogen-containing agent including diethylstilbestrol (DES).
* Prior flutamide (Eulexin) within past 4 weeks, prior bicalutamide (Casodex) within past 6 weeks, or prior nilutamide (Nilandron) within past 6 weeks.
* Prior strontium or samarium or other radioisotope therapy.
* Prior radiation therapy to greater than 25% of the bone marrow (e.g., no whole pelvic irradiation is allowed).
* Uncontrolled congestive heart failure or angina, patients with a history of myocardial infarction within 2 months of enrollment.
* Patients with uncontrolled hypertension.
* Pre-existing cardiac, pulmonary, neurologic or other disease that would preclude study participation.
* Documented untreated central nervous system (CNS) metastases. However, patients with treated CNS metastases that have been stable are eligible.
* Any significant concurrent disease or illness, or psychiatric disorders or alcohol or chemical abuse that would preclude study participation.
* Active secondary malignancy except non-melanoma skin cancers.
* Known, active infection, or known HIV positive or presence of an AIDS related illness.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
19 Years
Study:
NCT00082134
Study Brief:
Protocol Section:
NCT00082134