metastatic hormone naive prostate cancer prostate cancer, hormone naive, metastatic
Conditions
Interventions
patients are assigned to the three groups including ADT, ADT+abiraterone, and ADT+docetaxel according to the patient's preference.
Sponsors
Narita Shintaro
Habuchi Tomonori
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 *N*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 |
|---|---|
| Metastatic free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete serologic response rate, cancer specific survival, overall survival, adverse event, pain score and frequency of skeltal related event, QOL | — |
Contacts
Public ContactShintaro Narita
Akita University School of Medicine
Outcome results
None listed