Clinical Trial 18885

Cancer Type: Genitourinary
Interventions:ODM-201; Placebo; Taxotere (docetaxel); docetaxel

Study Type: Treatment
Phase of Study: Phase III

  • Jingsong Zhang


Study Title

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.

Inclusion Criteria

  • Histologically or cytologically confirmed adenocarcinoma of prostate.
  • Metastatic disease
  • Candidates for ADT and docetaxel. Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow, liver and renal function

  • Exclusion Criteria

  • Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, ODM-201; other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer, chemotherapy or immunotherapy for prostate cancer prior to randomization.
  • Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
  • Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
  • Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 5 years before randomization and from which the patient has been disease-free
  • Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment.
  • Inability to swallow oral medications