Trial Search Results
ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
The use of docetaxel combined with the androgen deprivation therapy (ADT) is now becoming a new standard of treatment for patients with advanced hormone-sensitive prostate cancer. The purpose of this study is to find out if ODM-201 is effective at keeping cancer under control when given in addition to standard treatment which includes ADT and docetaxel chemotherapy for six cycles. ODM-201 may help to slow down the growth of tumors when given in addition to ADT and docetaxel chemotherapy.
Stanford is currently not accepting patients for this trial.
Collaborator: Orion Corporation, Orion Pharma
- Drug: BAY1841788 / darolutamide (ODM-201)
- Drug: Standard ADT (androgen deprivation therapy)
- Drug: Docetaxel
- Drug: Placebo
- 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
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study