castration-resistant prostate cancer
Conditions
Interventions
cabazitaxel
docetaxel
Sponsors
Sapporo Medical University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed prostate cancer with progression and serum testosterone level of <50 ng/dL during androgen deprivation therapy 2. After docetaxel treatment (docetaxel, predonisolone) of 4 cycles 3. PSA response rate of less than 50% and no radiographic progression 4. Age from 40 to 80 years old 5. Able to take oral medications 6. Life expectancy >6 months 7. ECOG PS 0-2 8. Preserved hematologic function within 4 weeks as follows; a) WBC>=3000/mm3 b) Hb >=9g/dl c) Plt >=75000/mm3 d) serum creatinine <=3.0 mg/dl e) total bilirubin <=1.8mg/dl f) aspartate aminotransferase <=90 IU/l g) alanine aminotransferase <=100 IU/l 9. Obtained informed consent with document
Exclusion criteria
Exclusion criteria: 1. No previous cabazitaxel treatment 2. Active concomitant malignancy in 3 years except for prostate cancer 3. Difficult to control severe complications except for malignancy 4. Seizure to be treated with anticonvulsant 5. Severe liver dysfunction 6. Allergy for cabazitaxel, docetaxel and predonisolone 7. Neither ability nor will to cooperate the study 8. Unfit for enrollment by physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival 2) Progression-free survival 3) PSA progression-free survival 4) QOL assessment: FACT-P 5) Safety: CTCAE ver4.0 | — |
Countries
Japan
Contacts
Public ContactKohei Hashimoto
Sapporo Medical University School of Medicine Urology
Outcome results
None listed