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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT02123758
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Documentation of metastatic disease
* Prostate cancer progression
* Surgically or medically castrated, with testosterone levels of less than (\<) 50 nanogram per deciliter (ng/dL)
* Adequate bone marrow and organ function
Exclusion Criteria:
* Known brain metastases
* Pathological finding consistent with small cell carcinoma of the prostate
* Administration of an investigational agent within 4 weeks of Treatment Cycle 1, Day 1
* Chemotherapy, or immunotherapy for the treatment of prostate cancer within 4 weeks of Treatment Cycle 1, Day 1
* Therapies that must be discontinued or substituted prior to Treatment Cycle 1, Day 1 include the following: Medications known to lower the seizure threshold; Herbal and non-herbal products that may decrease prostate specific antigen (PSA) levels (that is, saw palmetto, pomegranates or pomegranate juice); Medications known to induce drug metabolizing enzymes such as dexamethasone, rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort, etc.; and, potent inhibitors of CYP3A4 or CYP2C8
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02123758
Study Brief:
Protocol Section:
NCT02123758