Metastatic castration resistant prostate cáncer MedDRA version: 16.1 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ZYTIGA
Product Name: acetato de abiraterona
Pharmaceutical Form: Tablet
INN or Proposed INN: ABIRATERONE ACETATE
CAS Number: 154229-18-2
Other descriptive name: ABIRATERONE ACETATE
Concent
Sponsors
SOGUG - Spanish Oncology Genitourinary Group
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Part I 1. Willing and able to provide written informed consent 2. Male aged 18 years and above 3. Histologically or cytologically confirmed adenocarcinoma of the prostate. 4. Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI. 5. 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 6. Asymptomatic or mildly symptomatic from prostate cancer 7. Surgically or medically castrated, with testosterone levels of = 10.0 g/dL independent of transfusion 11. Platelet count >= 100,000/?L 12. Serum albumin >= 3.5 g/dL 13. Serum creatinine = 60 mL/min 14. Serum potassium >= 3.5 mmol/L 15. Liver function: a. Serum bilirubin = 10.0 g/dL 4. Platelet count >= 100,000/?L 5. Serum albumin >= 3.5 g/dL 6. Serum creatinine = 60 mL/min 7. Serum potassium >= 3.5 mmol/L 8. Liver function: i. Serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 69
Exclusion criteria
Exclusion criteria: Part I 1. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated 2. Any chronic medical condition requiring a higher dose of corticosteroid than 10mg prednisone/prednisolone daily. 3. Pathological finding consistent with small cell carcinoma of the prostate 4. Liver or visceral organ metastasis 5. Known brain metastasis 6. Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1 7. Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC 8. Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day 1 9. Radiation or radionuclide therapy for treatment of metastatic CRPC 10. Previously treated with ketoconazole for prostate cancer for greater than 7 days 11. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1 12. Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 13. Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of Cycle 1 Day 1 14. Uncontrolled hypertension (systolic BP >= 160 mmHg or diastolic BP >= 95 mmHg). 15. Active or symptomatic viral hepatitis or chronic liver disease 16. History of pituitary or adrenal dysfunction 17. Clinically significant heart disease 18. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy 19. Other malignancy, except non-melanoma skin cancer, with a >= 30% probability of recurrence within 24 months 20. Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1 21. Any condition which, in the opinion of the investigator, would preclude participation in this trial. Part II 1. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated 2. Any chronic medical condition requiring a higher dose of corticosteroid than 10mg prednisone/prednisolone daily. 3. Uncontrolled hypertension (systolic BP >= 160 mmHg or diastolic BP >= 95 mmHg). 4. Active or symptomatic viral hepatitis or chronic liver disease 5. History of pituitary or adrenal dysfunction 6. Clinically significant heart disease 7. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy 8. Other malignancy, except non-melanoma skin cancer, with a >= 30% probability of recurrence within 24 months 9. Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1 10. Any condition which, in the opinion of the investigator, would preclude participation in this trial. 11. ANC < 1.500 cells/mm3 12. Patients with severe hepatic insufficiency. 13. Any condition which, in the opinion of the investigator, would preclude participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 12 months radiologic progression free survival;Secondary Objective: Overall survival Radiologic progression free survival PSA progression free survival PSA response rate Objective response rate Quality of life (FACT-P) Time to skeletal-related event Time to opiate use for cancer pain Time to pain progression Safety and tolerability profile;Primary end point(s): 12 months radiographic progression-free survival (rPFS) 1. A patient is considered to have progressed by bone scan if: a. The first bone scan with ?2 new lesions compared to baseline is observed <12 weeks from randomization and is confirmed by a second bone scan taken ?6 weeks later showing ?2 additional new lesions (a total of ?4 new lesions compared to baseline); b. The first bone scan with ?2 new lesions compared to baseline is observed ?12 weeks from randomization and the new lesions are verified on the next bone scan ?6 weeks later (a total of ?2 new lesions compared to baseline). 2. Progression of soft tissue lesions measured by CT or MRI as defined in modified RECIST criteria. 3. Death from any cause;Timepoint(s) of evaluation of this end point: Every 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Radiologic progression free survival 2 PSA progression free survival 3 Overall survival 4 PSA response rate 5 Objective response rate 6 Quality of life (FACT-P) 7 Time to skeletal-related event 8 Time to opiate use for cancer pain 9 Time to pain progression 10 Safety and tolerability profile;Timepoint(s) of evaluation of this end point: 1 Every 12 weeks 2 Every 4 weeks 3 Every 12 weeks 4 Every 4 weeks 5 Every 12 weeks 6 Every 12 weeks 7 Every 12 weeks 8 Every 4 weeks 9 Every 4 weeks 10 Every 4 weeks | — |
Countries
Spain
Contacts
Public ContactClinical Operations Department
APICES SOLUCIONES, S.L.
Outcome results
None listed