non-metastatic prostate cancer
Conditions
Interventions
Darolutamide
Sponsors
Department of Urology, Gunma University Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1 male, age >= 20 years old 2 hitologically proven prostate cancer 3 castrated state 4 castration resistant prostate cancer 5 ECOG PS 0 -2 6 Patients with no distant metastases on imaging 7 obtain by written consent 8 No history of chemotherapy treatment 9 Patients who have written consent for participation in this study
Exclusion criteria
Exclusion criteria: 1 Epileptic state patients 2 Brain damage, apoplexy, brain metastatis, active epidural metastatis of cranium 3 Hypersensitivity to darolutamide or its component 4 Severe liver dysfunction 5 Severe kidney function 6 Cases with distant metastases at the first visit 7 Impropriate state judged by charged doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will verify the time to treatment failure from the starting of dalorutamide administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Overall survival, (2)Usefulness of sex hormone level as prognostic and efficacy predictors, (3)Usefulness of novel PSA-related markers as prognostic and efficacy predictors, (4) Searching for prognostic and efficacy predictors from pre-treatment patient background, (5) Searching for prognostic factors and efficacy predictive factors from PSA dynamics after dalorutamide administration, (6) Investigation on adverse event occurrence after dalorutamide administration | — |
Countries
Japan
Contacts
Public ContactYoshiyuki Miyazawa
CRPC-TRG: castration resistant prostate cancer treatment research group Department of Urology, Gunma University Graduate School of Medicine
Outcome results
None listed