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ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
||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
||Paul Mathew, MD
||Jessika E Silva
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
- 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
- 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)
Subjects will be evaluated every 12 weeks during the treatment period, and one month after the last dose of study drug. Active follow-up visits will occur every 12 weeks for up to 1 year. Patients can consent to an option pharmacogenetic study which will require whole blood. PK samples will be collected at the first visit and every 12 weeks thereafter. Plasma for genetic and non-genetic biomarkers will be collected one week prior to randomization, at day 1, every 12 weeks, and at the end of treatment visit. Screening CT/MRI will be performed, as well as at disease progression.