Investigation of efficacy and safety of Sequence treatment of Cabazitaxel administation after 3 courses of Docetaxel for castration-resistant prostate cancer
- Conditions
- CRPCcastration-resistant prostate cancer
- Registration Number
- JPRN-jRCTs031220683
- Lead Sponsor
- Taguchi Satoru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 20
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of peripheral neuropathy during treatment period
- Secondary Outcome Measures
Name Time Method (1) Duration of total chemotherapy<br>(2) Overall survival (OS)<br>(3) Progression-free survival (PFS)<br>(4) Incidence of peripheral neuropathy at 1 year<br>(5) Time to onset of peripheral neuropathy<br>(6) Change of QOL during treatment period