prostate cancer
Conditions
Interventions
Patients are switched from GnRH agonist to GnRH antagonist degarelix. Degarelix is administered subcutaneously at an initial dose of 240mg followed by maintenance doses of 80mg every 4 weeks. Treatmen
Sponsors
Tokai Urological Clinical Trial Group
Nagoya University National Hospital Organization Nagoya Medical Center Social Insurance Chukyo Hospital Okazaki City Hospital Chubu Rosai Hospital Japanese Red Cross Nagoya Daiichi Hospital Japanese Red Cross Nagoya Daini Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. histologically confirmed adenocarcinoma of the prostate 2. receiving combined androgen blockade with GnRH agonist and a non-steroidal antiandrogen (bicalutamide or flutamide) 3. two consecutive increases in PSA at a minimum of 1-week intervals and PSA value >= 2.0ng/ml 4. castrate testosterone levels (<=0.5ng/ml) 5. ECOG performance status 0-1 6. laboratory requirements Hb >= 8.0g/dl WBC >= 3,000/mm3 platelet >= 100,000/mm3 both AST and ALT <= 2.5 x upper limit of normal serum creatinine <= 2.0 x upper limit of normal 7. Signed informed consent is obtained prior to the entry to this clinical study.
Exclusion criteria
Exclusion criteria: 1. receiving chemotherapeutic agents (including estramustine), corticosteroids, hormone agents except for GnRH agonist and non-steroidal antiandrogens, or investigational drugs 2. patients who never responded to CAB 3. patients with active multiple cancers 4. patients with clinical symptoms such as bone pain and nerve injury as a result of a spinal cord compression 5. prior treatment with local therapy (radical prostatectomy or radiotherapy) 6. patients with severe hepatic dysfunction (Child-Pugh class C) 7. patients with HIV or chronic active hepatitis B/C 8. history of acute myocardial infarction, severe or unstable angina, coronary or peripheral arterial revascularization, symptomatic congestive heart failure, cerebral vascular disease, transient ischemic attacks, or pulmonary embolism within 6 months before registration 9. patients with interstitial pneumonia or past history of interstitial pneumonia 10. patients with a brain tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the percentage of patients showing decreasing or stable PSA (relative change from baseline of less than 10%) after 12 weeks of GnRH antagonist treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. the percent change of PSA from baseline at 12 weeks and the maximal change at any time 2. PSA progression-free survival (PSA PFS) (PSA progression was defined as an increase in PSA of >=25% and >=2ng/ml above the nadir.) 3. radiographic progression-free survival (radiographic PFS) (progression in soft-tissue lesions was defined using RECIST criteria, and progression in bone was defined as the appearance of a minimum of two new lesions on bone scan.) 4. overall survival 5. changes in testosterone, LH, FSH, TRACP-5b and ICTP levels 6. safety (adverse events) 7. QOL (FACT-P) | — |
Countries
Japan
Contacts
Public ContactHiroki Hirabayashi
Komaki City Hospital Urology
Outcome results
None listed