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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT00705835
Eligibility Criteria:
Inclusion Criteria:
* Non-castrate metastatic patients must have biochemically progressive disease as defined by serial changes in PSA (with a serum testosterone \> or = to 180 ng/mL)following definitive primary therapy such as prostatectomy or radiation. Castrate metastatic patients must have biochemically progressive disease in the absence of radiographic evidence of disease progression with rising PSA values despite castrate (\<50 ng/mL) levels of testosterone following an adequate course of hormonal therapy. An adequate course of hormonal therapy is treatment with an LH-RH analog (with or without an anti-androgen) or orchiectomy.
* Prostate cancer must be histologically confirmed by the Department of Pathology at MSKCC.
* Karnofsky performance status \>70%.
* Patients must have adequate organ function as defined by:
* WBC \> or = to 3000/mm3, neutrophils \> or = to1000/mm3, platelet count \> or = to l00,000 mm3
* Bilirubin \<2.0 mg/dl
* Alkaline Phosphatase and SGOT \<3.0 times the upper limit of normal
* Creatinine \< or = to 2.0 mg/dl
* Hemoglobin \>9.0 g/dl
* ALT \<2.5 times the upper limit of normal
* Patients must be at least 18 years of age
* Expected survival must be \>6 months
* Patients must sign informed consent.
* Non-castrate metastatic patients must have a serum testosterone \>180 ng/mL.
Exclusion Criteria:
* Radiographic evidence of disease progression.
* Clinically significant cardiac disease (New York Heart Association Class III/IV or severe debilitating pulmonary disease).
* Active CNS or epidural tumor.
* An infection requiring antibiotic treatment.
* Lymphopenia defined by lymphocytes \<1000/mm3.
* Cancer related pain requiring the use of opioid containing analgesics.
* Positive stool guaiac, excluding hemorrhoids or documented radiation-induced proctitis.
* Concurrent treatment with nutritional or herbal supplements (e.g., PC SPES or similar agents) which could potentially confound the interpretation of study results.
* History of an active secondary malignancy except for non-melanoma skin cancer.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00705835
Study Brief:
Protocol Section:
NCT00705835