hormone-sensitive Prostate cancer
Conditions
Interventions
You have an equal chance of being in either of these two treatment groups:
• Treatment 1
ODM-201 600 mg (2 x 300 mg tablets) twice daily for a total daily dose
of 1200 mg to be taken with food
• T
Metastatic hormone sensitive prostate cancer
Sponsors
Bayer AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
Exclusion criteria: - Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (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 subject has been disease-free - Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment. - Inability to swallow oral medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival approximately 70 months From date of randomization until death from any cause, during treatment and during active and long term follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to castration resistant prostate cancer approximately 70 months Approximately every 12 weeks (according to standard of care) up to the time of PSA progression by soft tissue lesion or progression by bone lesions, whatever come first. Time to initiation of subsequent antineoplastic therapy approximately 70 months Every 12 weeks up to the date of first subsequent antineoplastic therapy for prostate cancer. Symptomatic skeletal event free survival (SSE-FS) approximately 70 months Every 12 weeks up to the first occurrence of SSE or death from any cause, whatever comes first SSE is defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first. Time to first symptomatic skeletal event (SSE) approximately 70 months Every 12 weeks up to the first occurrence of SSE. SSE is defined as EBRT to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first. Time to initiation of opioid use approximately 70 months Every 12 weeks up to the opiod use. Time to pain progression approximately 70 months Every 12 weeks up to the first date a subject experiences a pain progression. Pain to be assessed with a patient reported questionaire. Time to worsening of physical symptoms of disease approximately 70 months Every 12 weeks up to the first date a subject experiences an increase in physical symptoms. Physical symptoms of disease to be assessed with a patient reported questionaire. Number of participants with adverse events as a measure of safety approximately 70 months | — |
Countries
Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Finland, France, Germany, Israel, Italy, Japan, Korea (the Democratic Peoples Republic of), Mexico, Netherlands, Poland, Russian Federation, Spain, Sweden, Taiwan (Province of China), United Kingdom, United States of America
Outcome results
None listed