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.

Lead Sponsor:

Bayer

Collaborator: Orion Corporation, Orion Pharma

Stanford Investigator(s):

Intervention(s):

  • Drug: BAY1841788 / darolutamide (ODM-201)
  • Drug: Standard ADT (androgen deprivation therapy)
  • Drug: Docetaxel
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - 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

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shermeen Poushnejad
650-724-7662
Not Recruiting