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
- Conditions
- Prostatic Neoplasms
- Registration Number
- JPRN-jRCT2080223461
- Lead Sponsor
- Bayer Yakuhin, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 100
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
- 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
- Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment.
- Inability to swallow oral medications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Overall survival<br>Approximately 70 months<br>From date of randomization until death from any cause, during treatment and during active and long term follow-up
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Time to castration resistant prostate cancer <br>Time to initiation of subsequent antineoplastic therapy <br>Symptomatic skeletal event free survival (SSE-FS)<br> Time to first symptomatic skeletal event (SSE) <br>Time to initiation of opioid use <br>Time to pain progression<br>Time to worsening of physical symptoms of disease <br>Number of participants with adverse events as a measure of safety <br>Approximately 70 months