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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT01795703
Eligibility Criteria:
Inclusion Criteria:
* In-patients or out-patients with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
* Have surgically or medically castrated, with testosterone levels of less than 50 nanogram per deciliter
* Have Prostate Specific Antigen (PSA) level of at least 5 nanogram per milliliter
* Be under PSA progression according to Prostate-Specific Antigen Working Group (PSAWG) eligibility criteria or objective progression by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria for participants with measurable disease after androgen deprivation
* Have been used at least 1 but not more than 2 cytotoxic chemotherapy regimens for Metastatic Castration-Resistant Prostate Cancer (mCRPC). At least 1 regimen must have contained docetaxel. If docetaxel-containing chemotherapy was used more than once, those of regimens containing docetaxel would be considered as 1 regimen in total
Exclusion Criteria:
* Has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels or any systemic corticosteroid within 4 weeks prior to Cycle 1 Day 1 or has received ketoconazole for prostate cancer
* Has received radiotherapy, chemotherapy (including estramustine) or immunotherapy (including provenge) within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1
* Has had surgery or local prostatic intervention within 4 weeks prior to Cycle 1 Day 1. In addition, any clinically relevant sequel from the surgery must have resolved prior to Cycle 1 Day 1
* Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart Association (NYHA) Class 3 to 4 heart disease or cardiac ejection fraction measurement of less than 50 percent within 6 months prior to Cycle 1 Day 1
* Has uncontrolled hypertension (systolic blood pressure greater than or equal to 160 millimeter of mercury or diastolic blood pressure greater than or equal to 95 millimeter of mercury)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Study:
NCT01795703
Study Brief:
Protocol Section:
NCT01795703