Recent progress in treating advanced castration-sensitive prostate cancer (CSPC) has led to remarkable improvements in oncologic outcomes, with median overall survival (OS) approaching 60 months. This advancement is primarily attributed to enhanced androgen deprivation therapy (ADT) using docetaxel, next-generation androgen receptor pathway inhibitors (ARPIs), or a combination of chemotherapy and ARPIs. Although these treatments have improved cancer control, they also come with a higher risk of acute and chronic side effects that can negatively affect patients’ well-being and health-related quality of life (HRQOL).Â
The LACOG0415 a phase 2, randomized clinical trial was designed and coordinated by the genitourinary steering committee of the Latin American Cooperative Oncology Group (LACOG), and carried out at 14 sites in Brazil. This work was reviewed and approved by the institutional review board and conducted according to the Good Clinical Practices guidelines, and the declaration of Helsinki guidelines.
Written informed consent was obtained from all participants before any study procedures were carried out, the randomization of eligible patients was based on (1:1:1) equally into three groups to receive ADT + abiraterone acetate (1000 mg) + prednisone (5 mg twice), APA (240 mg/day) alone or abiraterone acetate (1000 mg) + prednisone (5 mg twice) + APA (240 mg/day). Randomization of subjects was done at the central level. HRQOL data was obtained from a patient-completed, self-administered FACT-P questionnaire at baseline and every four weeks to Week 25. The FACT-P is a 39-question tool validated to measure social well-being, emotional well-being, physical well-being, and functional well-being. It has a prostate cancer subscale. The scores range from 0-156, with higher scores indicating better HRQOL.Â
A total of 128 advanced CSPC patients were enrolled to evaluate treatment efficacy and HRQOL across three strategies: (1) ADT with abiraterone acetate and prednisone (42 patients), (2) apalutamide alone (42 patients), and (3) a combination of abiraterone acetate, prednisone, and apalutamide (44 patients). The median age ranged from 69.5 to 71 years across groups. Most patients had metastatic disease (74.2%), with smaller proportions presenting with high-risk biochemical recurrence (17.2%) or locally advanced disease (8.6%).Â
The three treatment arms demonstrated no differences in baseline mean FACT-P total scores or subscales, p = 0.69. During treatment, HRQOL was stable, and at 25 weeks, the mean FACT-P subscales and overall scores did not differ statistically significantly. When compared to the ADT plus AAP arm, neither the APA alone nor the AAP plus APA arms significantly improved HRQOL, except for emotional well-being. Specifically, the APA alone arm had a more favorable time to deterioration of emotional well-being (hazard ratio (HR) 0.37, p = 0.02), compared with the ADT plus AAP arm (hazard ratio 0.56, p = 0.13). Â
This secondary analysis of a randomized clinical trial evaluated HRQOL in patients with advanced CSPC undergoing different treatment regimens. HRQOL remained stable across three treatment options: ADT plus AAP, APA alone, and AAP plus APA. No significant difference was found in HRQOL between APA alone and AAP plus APA compared to ADT plus AAP. However, the observed difference in time to deterioration of the emotional well-being score between APA alone and ADT plus AAP should be explored in future research. Â
Reference:Â Bastos DA, Soares A, Schutz FAB, et al. Androgen receptor pathway inhibitor therapy for advanced prostate cancer: secondary analysis of a randomized clinical trial. JAMA Netw Open. 2025;8(1):e2454253. doi:10.1001/jamanetworkopen.2024.54253Â
