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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT00122005
Eligibility Criteria:
Inclusion Criteria:
* Histologically diagnosed adenocarcinoma of the prostate
* Progressive disease
* ECOG performance status of 0 or 1
* Adequate bone marrow, renal and hepatic function
* Castrate levels of testosterone
* May have had local radiotherapy as part of their initial treatment or 28 days after palliative radiotherapy or one chemotherapy treatment for metastatic disease
Exclusion Criteria:
* Transitional cell, small cell or squamous cell prostate cancer
* Systemic steroid therapy within 10-days of enrollment
* Documented history of active autoimmune disease such as lupus, sarcoidosis, rheumatoid arthritis, glomerulonephritis or vasculitis
* Clinically significant active infections
* History of other malignancies over past 5-years (except non-melanoma skin cancer or controlled superficial bladder cancer)
* Uncontrolled medical problems (i.e. neurological, cardiovascular) considered high risk for investigational new drug treatment
* Prior treatment with an investigational drug within 30-days of study entry
* Seropositive for HIV, hepatitis B surface antigen or hepatitis C
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00122005
Study Brief:
Protocol Section:
NCT00122005