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Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer

Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer

Recruiting
18 years and older
Male
Phase 3

This is a prospective, open-label, randomized, controlled, cross-over trial assessing patient preference for apalutamide versus enzalutamide in 146 male patients with recurrent or metastatic hormone-sensitive prostate cancer The primary outcome is patient preference, which serves as an indicator covering different aspects of treatment-related effects, and this would be most important in a patient's perspective. The quality of life, psychological and cognitive changes following apalutamide and enzalutamide in a comprehensive manner will be investigated.

Patient will receive two 12-weeks treatment periods with a 5-week wash-out period between the treatment periods. Patients will receive Apalutamide and Enzulutamide sequentially. Patient, physician and caregiver preferences will be assessed at the end of the second treatment period. Other secondary outcomes on health-related quality of life measures, psychological assessment scores and cognitive assessment scores shall be assessed before and the end of first treatment and second treatment period.

Study details
    Malignant neoplasm of prostate
    Prostatic disorder

NCT04409288

Chinese University of Hong Kong

19 February 2024

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