castration-resistant prostate cancer CRPC
Conditions
Interventions
Cabazitaxel 20 mg/m2 I.V., every 3 weeks after 3 courses of docetaxel
Sequential treatment including early administration of cabazitaxel
Sponsors
Taguchi Satoru
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Diagnosed with metastatic castrate-resistant prostate cancer (2) Scheduled to take docetaxel (3) Male, aged 18 years and above at the time of informed consent (4) Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation (5) Able to attend all scheduled visits
Exclusion criteria
Exclusion criteria: (1) With chemotherapy intolerance (2) With a history of taking docetaxel or cabazitaxel (3) With severe liver failure, renal failure, or cardiac disease (judged by CTCAE v5.0-JCOG grade 3) (4) With severe myelosuppression (judged by CTCAE v5.0-JCOG grade 3) (5) With systemic infection (6) Suspected of infectious disease with fever (7) Suspected of intestinal pneumonia (8) With a history of severe allergy to docetaxel, cabazitaxel, or drugs containing polysorbate 80 (9) With malignancy other than prostate cancer (10) With a history of severe drug allergy including anaphylactic shock, or a history of severe side effects (11) Judged as ineligible by clinical investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of peripheral neuropathy during treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Duration of total chemotherapy (2) Overall survival (OS) (3) Progression-free survival (PFS) (4) Incidence of peripheral neuropathy at 1 year (5) Time to onset of peripheral neuropathy (6) Change of QOL during treatment period | — |
Contacts
Public ContactTaketo Kawai
International University of Health and Welfare Ichikawa Hospital
Outcome results
None listed