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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01133704
Eligibility Criteria:
Inclusion Criteria:
* Histologically documented adenocarcinoma of the prostate
* Metastatic disease as evidenced by soft tissue and/or bony metastases
* Prostate-specific antigen value of at least 5 ng/mL
* Tumor progression while on hormonal therapy
* Castration levels of testosterone (defined as less than 50 ng/dL)
* Life expectancy of at least 16 weeks
* Adequate hematologic, renal, and liver function
Exclusion Criteria:
* Visceral organ metastases
* Metastatic disease expected to be in need of radiation therapy within 4 months.
* Concurrent therapy with experimental agents
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01133704
Study Brief:
Protocol Section:
NCT01133704