A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF ODM-201 IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

Gender: Male
Maximum age: 99
Minimum age: 18
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:
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 cm in short axis below the aortic bifurcation is allowed.
2.Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis due to prostate cancer
3.Acute toxicities of prior treatments and procedures not resolved to grade  1 or baseline before randomisation.
4.Prior treatment with:
?second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, ODM-201, other investigational AR inhibitors,
?CYP17 enzyme inhibitor such as abiraterone acetate, TAK-700 or
?oral ketoconazole longer than for 28 days.
5.Use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride) or AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate) within 28 days before randomisation.
6.Prior chemotherapy or immunotherapy for prostate cancer, except adjuvant/neoadjuvant treatment completed > 2 years before randomisation.