Deferred combined androgen blockade therapy using antiandrogen in metastatic prostate cancer patients treated with GnRH antagonist, degarelix
Not Applicable
- Conditions
- Metastatic prostate cancer (Untreated)
- Registration Number
- JPRN-UMIN000013668
- Lead Sponsor
- Department of Urooncology, Saitama Medical University International Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 70
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.