Androgen Blockade Intensification Shows No Impact on Quality of Life in Patients With Prostate Cancer

A new analysis from the phase 3 PRESTO trial revealed that intensified androgen receptor blockade in patients with high-risk biochemically relapsed castration-sensitive prostate cancer does not negatively impact health-related quality of life (HRQOL). This finding adds further support to the use of intensified androgen blockade for improving clinical outcomes in these patients.

Led by Ronald C. Chen, MD, MPH, of the University of Kansas Medical Center in Kansas City, Kansas, the PRESTO trial investigated the effects of intensified androgen receptor blockade on patients with biochemically relapsed prostate cancer following radical prostatectomy. These patients had a prostate-specific antigen (PSA) doubling time of 9 months or less and no evidence of metastatic disease on conventional imaging. Previous findings from the trial indicated that a 52-week regimen of androgen deprivation therapy (ADT) combined with apalutamide, or ADT plus apalutamide and abiraterone acetate with prednisone, extended PSA progression-free survival (PFS) compared with ADT alone.

This analysis, presented at the 2024 American Society of Clinical Oncology Annual Meeting, focuses on the HRQOL outcomes from the trial, assessing whether the intensified treatment regimens adversely affected patients’ daily lives.

The study included 504 randomized patients whose HRQOL was evaluated using several measures: the Hot Flash Related Daily Interference Scale (HFRDIS), the Expanded Prostate Cancer Index Composite (EPIC)-26 Sexual domain, the PROMIS Fatigue Short Form, and the EQ-5D-5L, which assesses overall HRQOL. Minimal important difference thresholds for these measures are well established in clinical research: HFRDIS (1.66 points), EPIC-26 Sexual (10-12 points), PROMIS Fatigue (3-5 points), and EQ-5D-5L (0.06 points).

General linear mixed modeling was used to estimate the mean differences in HRQOL between treatment arms according to an intent-to-treat approach.

The study’s results showed mean changes from baseline to the end of treatment for each HRQOL measure. The data indicated no statistically significant mean differences between the intensified androgen receptor blockade groups (ADT plus apalutamide, and ADT plus apalutamide and abiraterone acetate) and the ADT alone group in any HRQOL measure. Additionally, numerical differences across treatment arms for all HRQOL measures were below the published thresholds for minimal clinically important differences.

The HRQOL results from the PRESTO trial indicate that intensified androgen receptor blockade with apalutamide or apalutamide/abiraterone acetate in addition to 52 weeks of ADT improves PSA PFS without negatively affecting QOL for patients with high-risk biochemically recurrent prostate cancer. These findings provide further support for the use of intensified androgen blockade in this patient population.