Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide; Flutamide; Androgen deprivation therapy
Intervention description: Oral Capsule; Oral tablet; All subjects must undergo continuous Androgen deprivation therapy with GnRH agonist/antagonist or bilateral orchiectomy during the study period.
Intervention MeSH terms: Flutamide; Androgens
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: Male
Minimum age: 20 Years
Healthy volunteers: No
Keywords: enzalutamide; Xtandi; Prostate Cancer

Summary:

      The objective of this study was to compare the efficacy and safety of the combination therapy
      with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with
      flutamide + ADT in patients with castration resistant prostate cancer who had relapsed during
      combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study also
      investigated the order of alternative antiandrogen therapy (AAT) by changing the 1st line
      medication after relapse of prostate-specific antigen (PSA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of
             the prostate without neuroendocrine differentiation or small-cell histology.

          -  Subject on continuous ADT with Gonadotropin Releasing Hormone (GnRH)
             agonist/antagonist or bilateral orchiectomy.

          -  Serum testosterone level below the target level at screening visit.

          -  Subject with asymptomatic or mildly symptomatic prostate cancer.

          -  Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Subject has progression of the disease as defined by rising PSA levels or progressive
             soft tissue or bony disease during CAB therapy in combination of bicalutamide and ADT.

          -  A sexually active male subject and the subject's female partner who is of childbearing
             potential must use 2 acceptable birth control methods from screening to 3 months after
             the last dose of the study drug.

          -  Subject must agree not to donate sperm from screening to 3 months after the last dose
             of the study drug.

        Exclusion Criteria:

          -  Subject with severe concurrent diseases, infections, or complications.

          -  Subject with confirmed or suspected brain metastasis or active leptomeningeal
             metastasis.

          -  Subject with a history of malignant tumor other than prostate cancer in the past 5
             years.

          -  Subject hypersensitive to the ingredients of enzalutamide capsules or flutamide
             tablets.

          -  Subject with a history of convulsive attack, or prone to convulsive attack.

          -  Subject with liver disorder such as viral hepatitis and hepatic cirrhosis, or subject
             with Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) at screening
             visit higher than the upper limit of normal.

          -  Subject received treatment for prostate cancer with cytocidal chemotherapy that
             includes anti androgenic agents other than bicalutamide, abiraterone, or estramustine.