New Study Shows Benefits of Apalutamide in Prostate Cancer Treatment
Introduction to the Study:
The integration of apalutamide with androgen deprivation therapy (ADT) has been found to extend prostate-specific antigen (PSA) progression-free survival in patients with biochemically recurrent prostate cancer, either with or without abiraterone acetate plus prednisone. This approach has shown promising results in enhancing survival in nonmetastatic castration-resistant prostate cancer and metastatic castration-sensitive disease.
The PRESTO trial, a phase 3 study, involved 503 patients who had undergone radical prostatectomy and had biochemical recurrence with a minimum PSA level of 0.5 ng/mL and PSA doubling time of 9 months or less. These patients were randomly assigned to receive ADT alone, ADT plus apalutamide, or ADT plus apalutamide, abiraterone acetate, and prednisone. The primary focus was on PSA progression-free survival during a 1-year treatment period, with secondary outcomes including PSA progression-free survival in the subgroup that achieved testosterone recovery and safety assessments.
After a median follow-up of 21.5 months, it was observed that ADT plus apalutamide significantly prolonged median PSA progression-free survival compared to ADT monotherapy (24.9 vs 20.3 months; hazard ratio [HR], 0.52). Furthermore, the combination of ADT plus apalutamide, abiraterone acetate, and prednisone exhibited an improved median PSA progression-free survival compared to ADT alone (26 vs 20.3 months; HR, 0.48). The time to testosterone recovery to > 50 ng/dL did not significantly differ between groups.
In Practice Recommendations:
Despite the positive outcomes in terms of PSA progression-free survival, experts advise caution in treating biochemical recurrence in asymptomatic men, as the potential toxicity of therapy may exacerbate underlying comorbidities and increase the risk of non-prostate cancer-related mortality.
Conclusion and Source:
The study was led by Rahul Aggarwal, MD, from the University of California San Francisco and published in the Journal of Clinical Oncology on January 23, 2024. It is essential to note the limitations of using PSA progression-free survival as a surrogate for overall survival, given the evolving nature of advanced imaging techniques.
For further details on the study findings, please visit the source link provided.