Enzalutamide and Quality of Life in Biochemically Recurrent Prostate Cancer

Area of Science:

• Oncology
• Clinical Trials
• Patient-Reported Outcomes

Background:

• The EMBARK trial previously demonstrated that enzalutamide plus leuprolide or enzalutamide monotherapy improved metastasis-free survival in high-risk biochemically recurrent prostate cancer.
• Health-related quality of life (HRQoL) data from this trial have not yet been reported.

Purpose of the Study:

• To report patient-reported outcomes (PROs) from the EMBARK trial.
• To evaluate the time to clinically meaningful deterioration in pain and HRQoL for patients receiving enzalutamide combination, enzalutamide monotherapy, or leuprolide alone.

Main Methods:

• Patients with high-risk biochemically recurrent prostate cancer were randomized to enzalutamide plus leuprolide, leuprolide alone, or enzalutamide monotherapy.
• PROs were collected at baseline and every 12 weeks, assessing pain and HRQoL using validated measures.
• Time to first and confirmed clinically meaningful deterioration (TTFD/TTCD) was the primary endpoint.

Main Results:

• All treatment groups reported high HRQoL at baseline.
• Median TTFD for worst pain was 19.35 months (leuprolide alone), 13.93 months (combination), and 16.59 months (monotherapy).
• Median TTCD for Functional Assessment of Cancer Therapy–Prostate total score was 36.53 months (leuprolide alone), 38.77 months (combination), and 30.55 months (monotherapy).

Conclusions:

• Enzalutamide combination and monotherapy preserved high HRQoL in patients with high-risk biochemically recurrent prostate cancer.
• PROs support the oncologic benefits of enzalutamide-based treatments while maintaining patient quality of life.