Prostate cancer
Conditions
Interventions
Bicalutamide (AstraZeneca, Tokyo, Japan) 80mg administered orally on Day 1 and every day, goserelin acetate (AstraZeneca, Tokyo, Japan) 10.8mg administered subcutaneously on Day 8 and every 12 weeks,
Sponsors
Kinki University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Treatment-naive male patients with histologically confirmed adenocarcinoma of the prostate. Radiologic evidence of bone metastasis. Eastern Cooperative Oncology Group performance status of 0 or 1. Adequate bone marrow, hepatic, and renal function: White blood cell count >4.0x103/mm3 Platelet count >100x103/ mm3 Hemoglobin >10.0 g/dL Serum bilirubin <1.5 times the upper limit of normal Aspartate and alanine aminotransferase levels <2.5 times the ULN Creatinine clearance >60mL/min ECOG performance status of 2 due to bone disease was permitted.
Exclusion criteria
Exclusion criteria: Symptomatic central nervous system metastases. Coagulation disorders. Infection requiring intravenous antibiotics. Radiologically proved interstitial pneumonitis. Clinically significant cardiovascular disease. Pleural or pericardial effusion Dental problem requiring invasive treatment. History of bisphosphonate. History of another malignancy within the preceding 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skeleton-related event-free survival at 24 month after the introduction of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, time to first SRE, overall survival, decrease of the extent of bone diseases, improvement of pain, and safety | — |
Countries
Japan
Contacts
Public ContactMasahiro Nozawa
Kinki University Department of Urology
Outcome results
None listed