Metastatic prostate cancer (Untreated)
Conditions
Interventions
Degarelix monotherapy. Bicalutamide will be added in case of recurrence. Bicalutamide will be replaced with Flutamide in case of second recurrence.
Sponsors
Department of Urooncology, Saitama Medical University International Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Patients that histologically proven prostate can. 2)Patients that treatment of the prostate cancer haven't got before. 3)Patients that has metastasis(in the TNM classification N1 and M1). 4)Patients that duration of survival is anticipated more than six months. 5)Patients that an agreement of the participation in this study is provided in a document
Exclusion criteria
Exclusion criteria: 1)Patients that correspond to the taboo of the use drug. 2)Patients that had orchidectomy before. 3)Patients younger than 20 years. 4)Active multiple cancer(synchronous multiple cancer/multifocal cancer and metachronous multiple cancer/multifocal cancer with disease free survival is within 5 years except for carcinoma in situ considered as healed or lesion equal to mucosal carcinoma) 5)Active infection requiring systemic therapy 6)Body temperature >=38 degrees Celsius at registration 7)Concomitant psychiatric disease or symptom 8)Continuous systemic steroids or immunosuppressive medication(oral or intravenous) 9)Considered as inadequate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemical recurrence is defined as a >=25% or >= 2ng/mL increase from minimum value in PSA which is lowered by degarelix monotherapy. After antiandrogen is initiated, the efficacy of those is considered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Firstly bicalutamide will be administrated, then, in case of no efficacy or biochemical recurrence, flutamide will be administrated and efficacy of this therapy will be reevaluated. If flutamide shows no efficacy, this research will be discontinued. | — |
Countries
Japan
Contacts
Public ContactMasayuki Ishii
Saitama Medical University International Medical Center Clinical Research Support Center
Outcome results
None listed