metastatic prostate cancer
Conditions
Interventions
Degarelix 240mg, sc at day 1. Degarelix 240mg, sc every 4 weeks. Bicalutamide 80mg daily(as deferred CAB therapy in the case of PSA recurrence)
Leuprorelin or goserelin: subcutaneous injection (acc
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histopathological confirmed prostate cancer patients. 2. Patients with metastatic prostate cancer (Stage D1,D2). 3. Patients' survival is expected more than six months. 4. Patients with written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with history of treatment or under treatment on prostate cancer. 2. Patients with active double cancer. Patients with history of malignant tumor within the past 5 years are regarded as having active double cancer. The basal cell carcinoma that radical treatment was taken or superficial squamous cell carcinoma are not included in active double cancer.) 3. Patients with less than 20 years of age on the enrollment day. 4. Any other patients who are regarded as unsuitable for this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to CAB Treatment Failure (TTF in the case of deferred CAB therapy in antagonist monotherapy group) 2. Overall Survival 3. Progression Free Survival in image diagnosis 4. Radiographic Progression Free Survival 5. Change of PSA 6. Effect on hormone dynamics 7. Change of bone metabolic markers 8. Effect on lipid metabolism 9. Adverse event | — |
Countries
Japan
Contacts
Public ContactAkira Yokomizo
HARASANSHIN Hospital Urology
Outcome results
None listed