Castration resistant prostate cancer (CRPC)
Conditions
Interventions
None listed
Sponsors
Osaka University Graduate School Of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Patients with histologically or cytologically confirmed prostate cancer. 2)Patients who are receiving or received continuous androgen deprivation therapy using both gonadotropin-releasing hormone(GnRH)agonist and antagonist(medical castration), or both testicles removal by surgery (surgical castration). 3)Castration resistant prostate cancer(CRPC) patients who are observed disease progression after castration treatment and implied the treatment resistant. 4)CRPC patients who conducted anti-androgen alternating therapy as shown below 1) and are observed one or more of disease progression shown as below 2)during or after the therapy and decided to administer enzalutamide. Note 1)anti-androgen alternating therapy is defined as the therapy of flutamide administration after bicalutamide. Note 2)Disease progression criteria during or after anti-androgen alternating therapy 1. PSA progression during or after anti-androgen alternating therapy: PSA increased more than 25% compare to the lowest test results after initial dose of anti-androgen alternating therapy(flutamide)and the increasing is more than 2 ng/ml. 2. Confirmed disease progression of soft tissue lesion defined as RECIST v1.1. 3.Confirmed disease progression of bone lesion defined as 2 or more of new appearance of bone lesion on bone scintigraphy. 5)Patients with the Eastern Cooperative Oncology Group(ECOG)performance status 0-2 6)Patients who have signed written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1)Patients who is administering or have administration history of enzalutamide, abiraterone, docetaxel or cabazitaxel 2)Patients with history of seizure or predisposing disease of seizure 3)Patients with severe liver dysfunction 4)Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study 5)Patients who considered to be inappropriate for the study participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)PSA-PFS (prostate specific antigen)-(progression-free survival) 2) Progression-free survival (PFS) 3) Time to treatment failure (TTTF) 4) Time-to-PSA-progression (TTPP) 5) PSA response rate 6)Time to first symptomatic skeletal event (TTFS) (or Time to First SSE) 7) medication adherence 8) Safety assessment by the incidence and severity of adverse events as assessed by Japanese version of CTCAE v4.00) | — |
Countries
Japan
Contacts
Public ContactMotohide Uemura
Osaka University Graduate School Of Medicine Department of Urology
Outcome results
None listed