Metastatic prostate cancer without initial treatment
Conditions
Interventions
High-risk group (two of the following risk factors: Gleason score of more than equal 8, number of bone metastasis of more than equal 3,pretreatment visceral metastasis): patients receive androgen-dep
Sponsors
Department of Urology, Akita University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients who meet the criteria as described below will be included: 1.Historically confirmed prostate cancer 2.Metastatic disease on radiographic examinations without any initial treatment 3.20 years and older 4.ECOG performance status 0-2 5.Plan to receive androgen-deprivation therapy including leuteinizing hormone-releasing hormone (LHRH) agonist, LHRH antagonist, surgical castration with and without bicalutamide 6.Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following criteria *Leukocyte counts >= 3,000/mm3 *Platelets >= 750,000/mm3 *Hemoglobin concentration >= 9.0 g/dL *AST <= 90IU *ALT <= 100IU *Total bilirubin <=2.0mg/dL. *Serum creatinine, <= 3.0mg/dL 7.Agree with the protocol with signed informed consent
Exclusion criteria
Exclusion criteria: Patients who meet the criteria below will be excluded: 1.Severe cardiovascular disease and diabetes mellitus 2.Chronic pulmonary disease 3.Allergy to taxanes 4. Active concomitant malignancy 5. Difficulty of understanding of the trial because of mental disease 6.Inappropriate patients for this study judged by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease specific survival, overall survival, safety, QOL, pain score, symptomatic skeletal event | — |
Countries
Japan
Contacts
Public ContactShintaro Narita
Akita Univerisity Guraduate School of Medicine Urology
Outcome results
None listed