None listed
Conditions
Interventions
Investigational product, dose and mode of administration: ODM-201 600 mg or placebo (2 x 300 mg tablets) bid orally with food.
Duration of treatment: Until confirmed metastasis or until death up to
Sponsors
BAYER HEALTHCARE AG,
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Among inclusion criteria are the following, please refer to the protocol for the rest of criteria: 1. Written informed consent obtained. 2. Males aged  18 years. 3. Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features. 4. Progressive castration-resistant prostate cancer is defined as 3 consecutive rising PSA level during androgen deprivation therapy (ADT) at least 1 week apart, resulting in 2 > 50% increases over nadir, with the last value  2 ng/ml despite castrate level of serum testosterone. If the patient has a history of antiandrogen use, the most recent PSA value must be obtained at least 4 weeks after antiandrogen withdrawal. 5. Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on gonadotropin releasing hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy. Patients who have not undergone bilateral orchiectomy must continue GnRH therapy during the study. 6. PSADT of  10 months and PSA  2 ng/ml at screening. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion criteria
Exclusion criteria: Among exclusion criteria are the following, please refer to the protocol for the rest of criteria: 1. History of metastatic disease or presence of detectable metastases by blinded central reading. Presence of pelvic lymph nodes 2 years before randomisation.
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea South, Latvia, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactRosa Chamorro
BAYER S.A.
Outcome results
None listed