A multicenter randomized Phase III trial of enzalutamide versus abiraterone as a first-line endocrine therapy for castration-resistant prostate cancer

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2014
INTERVENTION: enzalutamide 160mg abiraterone 1000mg CONDITION: castration‐resistant prostate cancer PRIMARY OUTCOME: Time to PSA progression; TTPP SECONDARY OUTCOME: Overall survival, radiographic progression‐free survival, time to cytotoxic chemotherapy initiation, time to stage‐up of ECOG performance status, time to opioid analgesic initiation, PSA response rate INCLUSION CRITERIA: 1. Pathologically or cytologically confirmed castration‐resistant prostate cancer defined as total testosterone <50 ng/dl and two consecutive PSA elevatoin with 1week interval and the PSA judged is at least 2ng/ml higher than nadir. 2. No previous cytotoxic intravenous systemic chemotherapy 3. >=20 years old 4. ECOG PS 0‐2 5. Total bilirubin <=1.5xUpper Limit of Normal (ULN), aspartate transaminase <=2.5xULN (<=5.0xULN in patients with liver metasiasis), alanine transaminase <=2.5xULN (<=5.0xULN in patients with liver metasiasis), no ascites, and no hepatic encephalopathy 6. Serum creatinine <=2.0xULN 7. Life expectancy >3months 8. Obtained infromed consent with document
Epistemonikos ID: 06f9247cc8e19f8f8d8be0b0b5c3f6419c3689cd
First added on: Aug 22, 2024