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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT00024232
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed prostate cancer
* Disease progression after prior castration
* At least 3 rising PSA levels at least 1 week apart OR 2 rising levels at least 4 weeks apart
* New osseous lesions on bone scan and/or more than 25% increase in bidimensionally measurable soft tissue disease or appearance of new sites of disease by CT scan or MRI
* Testosterone no greater than 50 ng/mL
* Medical therapy (e.g., gonadotropin-releasing hormone analogues) to maintain castrate level of testosterone should continue in the absence of surgical orchiectomy
* Progression of disease after discontinuation of prior anti-androgen therapy
* No requirement for palliative therapy within the past 12 weeks
* No active CNS or epidural primary tumor OR active CNS or epidural metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 3,500/mm3
* Platelet count greater than 100,000/mm3
Hepatic:
* Bilirubin less than 1.5 mg/dL
* Gamma-glutamyl-transferase less than upper limit of normal (ULN)
* AST less than ULN
* PT less than 14 seconds
* No prior autoimmune hepatitis
Renal:
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No clinically significant cardiac disease (New York Heart Association class III or IV)
Pulmonary:
* No severe debilitating pulmonary disease
Other:
* Fertile patients must use effective contraception
* No active uncontrolled infection or infection requiring IV antibiotics
* No prior autoimmune disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior murine protein for diagnostic or therapeutic purposes
* No other concurrent anticancer immunotherapy
Chemotherapy:
* At least 4 weeks since prior chemotherapy and recovered
* No concurrent anticancer chemotherapy
Endocrine therapy:
* See Disease Characteristics
* No concurrent anticancer hormonal therapy
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
* Concurrent radiotherapy to localized sites of disease (e.g., bone) allowed if the site does not contain sole measurable lesion
Surgery:
* See Disease Characteristics
* No concurrent surgery
Other:
* Recovered from all prior therapy
* At least 4 weeks since prior therapeutic investigational anticancer drugs
* At least 4 weeks since prior participation in therapeutic clinical trial with an experimental drug
* No prior diagnostic ProstaScint, Myoscint, or Oncoscint scans
* No other concurrent therapeutic investigational anticancer agents
* No concurrent participation in other therapeutic clinical trial with an experimental drug
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00024232
Study Brief:
Protocol Section:
NCT00024232