metastatic prostate cancer
Conditions
Interventions
Standard therapy + Operation or radiotherapy
Sponsors
Hirosaki University School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Histologically proven adenocarcinoma of the prostate Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation Clinical stage M1a (distant lymph node positive), or M1b (bone metastasis) If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET [positron emission tomography], bone scan and MRI, modality at the discretion of the treating physician) No previous local therapy for prostate cancer Give informed consent Prostate deemed resectable by surgeon Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Hemoglobin (HgB) >= 9 g/dL compatible for surgery Platelets > 80,000 compatible for surgery Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible for surgery
Exclusion criteria
Exclusion criteria: Refuses to give informed consent Deemed to have unresectable disease by surgeon Received ADT for more than 6 months prior to randomization Life expectancy of less than 6 months prior to randomization Known spinal cord compression M1c disease (solid organ metastasis) Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to randomization Previous local therapy for prostate cancer Previous chemotherapy for prostate cancer Patients who have chemotherapy, radiotherapy or oral antifungal agents (ketoconazole, itraconazole, fluconazole) within 3 weeks prior to entering the study or those who have not recovered (e.g. back to baseline or grade 1) from adverse events due to agents administered more than 3 weeks earlier Any drug interactions that are deemed to be medically significant would require a washout of 5-half-lives of the interaction agent before enrollment can occur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival PSA response Objective response | — |
Countries
Japan
Contacts
Public ContactShingo Hatakeyama
Hirosaki University School of Medicine Urology
Outcome results
None listed