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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT01284920
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Ongoing androgen deprivation therapy with a GnRH analogue or a bilateral orchiectomy
* Progressive disease after prior androgen deprivation therapy (medical or surgical castration)
* For Expansion Cohort, the patient has no more than two prior chemotherapy regimens with at least one regimen containing docetaxel
* For Expansion Cohort, the patient must have measurable lesions by RECIST
Exclusion Criteria:
* Metastases in the brain
* History of another malignancy except for adenocarcinoma of the prostate within the previous 5 years
* Use of bicalutamide within 6 weeks prior to study
* Radiation therapy within 12 weeks prior to study
* Evidence of serious drug hypersensitivity
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT01284920
Study Brief:
Protocol Section:
NCT01284920