prostate cancer
Conditions
Interventions
docetaxel plus prednisolone
docetaxel
Sponsors
Kitasato University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Histological proof of prostate adenocarcinoma. 2) Patient with HRPC, which was confirmed by failure of 2nd line hormone therapy and disease progression even after withdrawal of anti-androgen. 3) Serum PSA higher than 2ng/ml. 4) Life expectancy of at least 3 Months. 5) Patients with Performance Status (ECOG) 0-2. 6) No previous chemotherapy of taxane. 7) adequate organ function a) WBC: larger or equal to 4,000/L and smaller or equal to 12,000/L b) Neutro: larger or equal to 2,000/L c) Plt: larger or equal to 100,000/L d) Hb: larger or equal to 9.5g/dL e) AST(GOT): smaller than 2.5x upper limit of normal f) ALT(GPT): smaller than 2.5x upper limit of normal g) Serum Cr: smaller than 1.5x upper limit of normal h) SPO2: larger or equal to 90% i) ECG: no evidence to need treatment 8) Patients must sign an informed consent indication that they are aware of the investigational nature of the study, in keeping with the policies of the institution.
Exclusion criteria
Exclusion criteria: 1. active infection 2. history of previous radiotherapy to pelvis, severe comorbidity, history of any other malignancy which includes synchronal double cancer 3. chest Xray shows obvious interstitial pneumonia and pulmonary fibrosis 4. patients who have been included in another clinical trial less than 6 months before agreement of this trial 5. patients who are judged as unsuitable for the trial by the doctor in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QOL (before administration of Docetaxel, every 3 weeks when chemotherapy is paused) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to failure, Adverse Events, Overall mortality | — |
Countries
Japan
Contacts
Public ContactKen-ichi Tabata
Kitasato University Urology
Outcome results
None listed