Prostate cancer
Conditions
Interventions
None listed
Sponsors
Department of Urology, Chiba University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.pathologically diagnosed as prostate cancer. (neuroendocrine cancer or small cell cancer were excluded.) 2.gnrH agonist resistance. 3.adminstration of gnrh agonist during the study, in case the patients have not received surgical castration. 4.serum testosterone < 0.50 ng/ml 5.serum psa > 2.5 ng/ml 6.If zoledronic acid hydrate is administered, there is no change of dose at least four weeks before dosage of degarelix. 7.psa is greater than 2.5 ng/ml within six months. the rise of psa has to be at least 50% over nadir and has to be confirmed by a second psa at least two weeks later. 8.as for the patients who had received systemic chemotherapy, patients received no more than two regimens including at least one course of docetaxel therapy. 9.performance status(ps; eastern co-operative oncology group) 0-1.(the patients whose ps are 2 due to bone pain are permitted.) 10.age more than 17 11.written informed consent was obtained. 12.the patients can prevent pregnancy by appropriate methods (a condom or a pessary) from the start of study to at least three months after the last dose.
Exclusion criteria
Exclusion criteria: 1. receive radiation therapy within twelve weeks before dosage of degarelix. 2. when the investigator thinks the patient is ineligible. 3. other systemic disease which is severe or uncontrollable. 4. severe allergy to degarelix.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA response. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total prostate volume, Serum testosterone, LH, FSH, BAP, IPSS, safety (CTCAE ver. 4.0), QOL | — |
Countries
Japan
Contacts
Public ContactShinichi Sakamoto
Chiba University Hospital Urology
Outcome results
None listed