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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT02036060
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide written informed consent
* Male aged 18 years and above
* Histologically or cytologically confirmed adenocarcinoma of the prostate.
* Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI.
* Prostate cancer progression to previous castration treatment documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria or bone scan progression
* Asymptomatic or mildly symptomatic from prostate cancer
* Surgically or medically castrated, with testosterone levels of \< 50 ng/dL (\< 2.0 nM).
* Previous anti-androgen therapy and progression after withdrawal.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Hemoglobin \>= 10.0 g/dL independent of transfusion
* Platelet count \>= 100,000/µL
* Serum albumin \>= 3.5 g/dL
* Serum creatinine \< 1.5 x ULN or a calculated creatinine clearance \>= 60 mL/min
* Serum potassium \>= 3.5 mmol/L
* Liver function: a. Serum bilirubin \< 1.5 x ULN (except for patients with documented Gilbert's disease) b. AST or ALT \< 2.5 x ULN
* Life expectancy of at least 6 months
* Patients who have partners of childbearing potential must be willing to use a method of birth control
Exclusion Criteria:
* Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
* Any chronic medical condition requiring a higher dose of corticosteroid than 10mg prednisone/prednisolone daily.
* Pathological finding consistent with small cell carcinoma of the prostate
* Liver or visceral organ metastasis
* Known brain metastasis
* Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
* Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
* Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day
* Radiation or radionuclide therapy for treatment of metastatic CRPC
* Previously treated with ketoconazole for prostate cancer for greater than 7 days
* Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
* Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1
* Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of Cycle 1 Day 1
* Uncontrolled hypertension (systolic BP \>= 160 mmHg or diastolic BP \>= 95 mmHg).
* Active or symptomatic viral hepatitis or chronic liver disease
* History of pituitary or adrenal dysfunction
* Clinically significant heart disease
* Atrial Fibrillation, or other cardiac arrhythmia requiring therapy
* Other malignancy, except non-melanoma skin cancer, with a \>= 30% probability of recurrence within 24 months
* Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1
* Any condition which, in the opinion of the investigator, would preclude participation in this trial.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02036060
Study Brief:
Protocol Section:
NCT02036060