prostate cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed prostate cancer with T4 2. No previous cytotoxic intravenous systemic chemotherapy 2. No evidence of clinical progression with 6 months primary androgen depriation therapy 3. >=40 years old 4. able to take oral medications 5. Life expectancy >6 months 6. ECOG PS 0-3 7.a-g WBC>=3000/mm3, Hb>=9g/dl, Plt>=75000/mm3, Serum creatinine <=3.0mg/dl, Total bilirubin <=1.8mg/dl, aspartate aminotransferase <=90 IU/l, alanine aminotransferase<=100 IU/l, 8. Obtained infromed consent with document
Exclusion criteria
Exclusion criteria: 1.No previous radiation therapy for prostate cancer 2.Allergy for androgen deprivation therapy 3. Patients who were judged unfit for enrollment by physicians in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local progression-related events free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)PSA response rate 2)PSA-progression-free survival 3)Overall survival 4)Progression-free survival 5)Time to Treatment for local events 6)QOL assessment (SF12, FACT-P) 7)CTCAE ver4.0 | — |
Countries
Japan
Contacts
Sapporo Medical University School of Medicine Department of Urology