Clareo Health | Abiraterone Acetate in Combination With Docetaxel After Disease Progression to Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Spanish Oncology Genito-Urinary Group
With
Janssen, LP
Apices Soluciones S.L.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
