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

Sponsor
Chinese University of Hong Kong
Study ID
NCT04409288
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    Androgen receptor inhibitor.
  • Enzalutamide — DRUG
    Androgern receptor inhibitor

Study Details

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 objective is to investigate whether there is any difference in patient preference between apalutamide and enzalutamide in patients with recurrent or metastatic hormone-sensitive prostate cancer.

Key Dates

Start date
Jul 20, 2020
Status verified
Jan 2024
Primary completion
Oct 16, 2023
Completion
Oct 16, 2023

Study Design

Enrollment
74 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    Apalutamide followed by Enzalutamide Study participants will receive 12 weeks of oral apalutamide (240mg) daily, followed by five weeks of washout period, and then 12 weeks of oral enzalutamide (160mg) daily.
  • Experimental: Group B
    Enzalutamide followed by Apalutamide Study participants will receive 12 weeks of oral enzalutamide (160mg) daily, followed by five weeks of washout period, and then 12 weeks of oral apalutamide (240mg) daily.

Primary Outcome Measure

Patient Preference Questionnaire [ Time Frame: Week 29 (at the end of second treatment) ]

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