Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)
Condition: Prostatic Cancer, Castration-Resistant
MeSH terms: Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant
Intervention: Darolutamide (Nubeqa, BAY1841788); Enzalutamide
Intervention description: 600mg, twice daily; 160mg, once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Researchers in this study want to compare the effects of drug darolutamide and drug
      enzalutamide on physical function, including balance and daily activity, in patients with
      castration-resistant prostate cancer (CRPC). Both darolutamide and enzalutamide are approved
      AR inhibitors used for the treatment of patients with CRPC. AR inhibitor is a substance that
      keeps androgens (male sex hormones) from binding to proteins called androgen receptors, which
      are found in normal prostate cells, some prostate cancer cells, and in some other cells.
      Preventing this binding blocks the effects of these hormones in the body and therefore keeps
      prostate cancer cells from growing. Patients participating this study will receive either
      darolutamide or enzalutamide tablets. To evaluate the physical function, patients will be
      asked to make some movements like rising from a chair, walking three meters, etc.
      Additionally, researchers also want to find out the survival of patients and if patients have
      fatigue (feeling tired), cognitive (learning and thinking) problems, or other medical
      problems during the trial. Brand name of darolutamide is Nubeqa; brand name of enzalutamide
      is Xtandi.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be 18 years of age inclusive or older at the time of signing the
             informed consent.

          -  Participants who have:

               -  Histologically or cytologically confirmed adenocarcinoma of prostate, CRPC
                  (Castration-resistant prostate cancer) defined by disease progression despite ADT
                  (Androgen deprivation therapy) and may present as either a confirmed rise in
                  serum PSA (Prostate-specific antigen) levels (as defined by PCWG3 (Prostate
                  Cancer Working Group)), the progression of pre-existing disease, and/or the
                  appearance of new metastases. Metastatic and non-metastatic CRPC patients will be
                  eligible.

               -  KPS (Karnofsky Performance Scale) performance status of ≥80

               -  Blood counts at screening: hemoglobin ≥9.0 g/dL, absolute neutrophil count
                  ≥1500/μL, platelet count ≥100,000/μL

               -  Screening values of serum alanine aminotransferase (ALT) and/or aspartate
                  aminotransferase (AST) ≤2.5 × upper limit of normal (ULN), total bilirubin ≤1.5 ×
                  ULN, creatinine ≤2.0 × ULN

               -  Life expectancy of at least 1 year

          -  Sex: Male

        Exclusion Criteria:

          -  Symptomatic local-regional disease that requires medical intervention including
             moderate/severe urinary obstruction or hydronephrosis with abnormal renal function due
             to prostate cancer. Participants with visceral metastasis will be excluded.

          -  Past (within 6 months before the start of study intervention) or concurrent stroke,
             myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery
             bypass graft, and/or congestive heart failure (New York Heart Association Class III or
             IV)

          -  Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of the 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 3 years before the start of study intervention and from which the
             participant has been disease free

          -  Prior or concurrent central nervous system disease, such as epilepsy, Parkinson's
             disease, Alzheimer's disease, dementia, or multiple sclerosis

          -  Non-ambulatory participants who need a wheelchair. Other assistive devices (e.g., cane
             or walker) are permitted.

          -  Clinically significant limitations in cognitive function and/or physical function,
             such as >20 seconds in the TUG assessment

          -  Prior treatment with any of the following:

               -  Second-generation AR inhibitors, such as enzalutamide, apalutamide, or
                  Darolutamide

               -  Other investigational AR inhibitors

               -  Progression on abiraterone acetate and discontinuation within 6 months before
                  signing the ICF for the study

               -  For mCRPC participants: any chemotherapy, and/or >2 prior lines of systemic
                  anticancer treatment. Treatment with an LHRH agonist, LHRH antagonists, or
                  orchidectomy is not counted as systemic treatment with regard to this exclusion
                  criterion.

          -  Use of immunotherapy within 28 days before the start of study intervention

          -  Treatment with radiotherapy/radiopharmaceuticals within 12 weeks before the start of
             study intervention

          -  Previous participation in other clinical studies within 28 days before the start of
             study treatment or 5 half-lives of the investigational treatment of the previous
             study, whichever is longer Diagnostic assessments