Prostate cancer
Conditions
Interventions
Switch from Gn-RH agonistto degarelix. Degarelix is adoministred to the patients for 12 months. First time,degarelix(240mg/body)will be administered subcutaneously. After 4 weeks,degarelix(80mg/bod
Sponsors
Yokohama City University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Patient with histologically confirmed prostate cancer 2)Patient whose PSA level are rising more than 2 ng/ml consecutively twice 3)Testosterone levels which are measured within 28 days before the entry of this study are less than 50 ng/dl 4)Patients without AWS 5)Patients aged 20 or above 6)ECOG performance states 0-1 7)Laboratory requirements WBC is equal to or higher than 3000/mm3 Hb is equal to or higher than 10.0 g/dl PLT is equal to or higher than 100000/mm3 Serum Creatinine is equal to or less than 2.0mg/dl AST is equal to or less than 100U/l ALT is equal to or less than 100U/l 8)Patients who provide the documents of agreement for this study
Exclusion criteria
Exclusion criteria: Patients 1)who have a treatment history of degarelix 2)who have a treatment history of Enzalutamide or Abraterone 3)who are using steroid 4)who are using estrogen 5)who are using 5-alpha-reductase inhibitor 6)who have a serious cardiovascular disease 7)who have in active cancer except prostate cancer 8)have an allergy to degarelix 9)who are disqualified by a doctor in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA Responder rate at 12w | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Time to PSA increase by 25 % compared to PSA st starting this study in Responder 2)Time to PSA progression survival 3)Time to treatoment fairule 4)Time to overall survival 5)Time to cancer specific survival 6)Time to radiographic PFS 7)safty | — |
Countries
Japan
Contacts
Public ContactNarihiko Hayashi
Yokohama City University Department of urology
Outcome results
None listed