Clinical Trials Detalhe

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

General Information

Gender

MALE

Age

N/A

Phase

PHASE3

Study Type

INTERVENTIONAL

Location

Guimarães, Portugal

Almada, Portugal

Matosinhos Municipality, Portugal

Braga, Portugal

Lisbon, Portugal

Porto, Portugal

Clinicaltrial.gov

https://classic.clinicaltrials.gov/ct2/show/NCT02200614

Summary

The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.

Conditions

Prostate Cancer Non-Metastatic

Castration-Resistant

Eligibility

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features. * Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone. * Prostate-specific Antigen (PSA) doubling time of ≤ 10 months and PSA \> 2ng/ml. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl. * Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN. * Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment. Exclusion Criteria: * History of metastatic disease at any time or presence of detectable metastases. * Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation. * Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor. * Use of estrogens or 5-α reductase inhibitors or AR inhibitors. * Prior chemotherapy or immunotherapy for prostate cancer. * Use of systemic corticosteroid. * Radiation therapy within 12 weeks before randomisation. * Severe or uncontrolled concurrent disease, infection or co-morbidity. * Treatment with bisphosphonate or denosumab within 12 weeks before randomisation. * Known hypersensitivity to the study treatment or any of its ingredients. * Major surgery within 28 days before randomisation. * Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV. * Uncontrolled hypertension. * Prior malignancy. * Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment. * Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease. * Treatment with any investigational drug within 28 days before randomisation. * Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.