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:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT00043212
Eligibility Criteria:
Inclusion Criteria
* Hormone refractory prostate cancer (HRPC) \– progressive disease despite androgen deprivation and serum testosterone \<50ng/dL; progression defined as either:
1. Rising PSA over 6 months with at least a 50% increase between the 1st and 3rd measurement, and the 3rd measurement \>2.0 ng/ml; or
2. Progression of metastatic lesion on bone scan, or
3. Progression of lymph node metastasis by CT scan.
* Zubrod or ECOG performance status of 0-1.
* Three or fewer bone metastases on a bone scan with minimal symptoms.
* No lymph node lesions greater than 3.0 cm at longest diameter.
* Adequate hematological, hepatic and renal function.
Exclusion Criteria
* History of other active malignancy.
* Prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy for metastatic disease in previous 12 months.
* Strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones (e.g., Saw Palmetto, PC-SPES) within 1 month prior to enrollment.
* Brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases or other serious illness.
* Prior splenectomy.
* History of severe asthma, anaphylaxis, or other serious adverse reactions to vaccines or any of the antigens included in the skin test.
* History of moderate to severe lower limb lymphedema, or recent signs of deep venous thrombosis (DVT) or thrombo-embolic disease, or impending stroke.
* History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV.
* Impending untreated spinal cord compression or urinary outlet obstruction.
* Any medication that might affect immune function. (Exceptions: Nonprescription doses of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and H2 blockers).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00043212
Study Brief:
Protocol Section:
NCT00043212