Clinical Trials Search
Clinical Trial 18885
Cancer Type: Genitourinary
Interventions:ODM-201; Placebo; Taxotere (docetaxel); docetaxel
Study Type: Treatment
Phase of Study: Phase III
- Jingsong Zhang
A Randomized, Double-Blind, Placebo-Controlled Phase III Study of ODM-201 Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients with Metastatic Hormone-Sensitive Prostate Cancer
The purpose of the study is to assess the efficacy and safety of BAY1841788 (ODM-201) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
The Primary Objective of this study is: - To demonstrate the superiority in overall survival (OS) of ODM-201 in addition to standard ADT and docetaxel, over placebo in addition to standard ADT and docetaxel. The Secondary Objectives of this study are to evaluate: - Time to castration-resistant prostate cancer. - Time to initiation of subsequent antineoplastic therapy. - Symptomatic skeletal event free survival (SSE-FS). - Time to first symptomatic skeletal event (SSE). - Time to initiation of opioid use for >= consecutive days. - Time to pain progression. - Time to worsening of physical symptoms of disease based on functional assessment of cancer therapy / National Comprehensive Cancer Network prostate cancer symptom index 17 item questionnaire (NCCN-FACT FPSI-17). - Safety. The Exploratory Objectives of this study include: - Quality of life. - Medical resource use. - Prostate-specific antigen (PSA) assessments. - Pharmacokinetics and exposure-response analysis. - Evaluate biomarkers to investigate the drug (i.e., mode-of-action-related effect and / or safety) and / or the pathomechanism of the disease.