Adding Apalutamide Boosts PSA Control in Prostate Cancer

TOPLINE:

A new study revealed that the addition of apalutamide to androgen deprivation therapy (ADT), with or without abiraterone acetate plus prednisone, prolongs prostate-specific antigen (PSA) progression-free survival in patients with biochemically recurrent prostate cancer.

METHODOLOGY:

Intensification of androgen blockade is known to improve survival in nonmetastatic castration-resistant prostate cancer as well as metastatic castration-sensitive disease. This approach, when used for a finite duration, can also benefit patients with high-risk biochemically recurrent prostate cancer who are at a risk for distant metastases.In the open-label, phase 3 PRESTO trial, researchers evaluated 503 patients who had undergone radical prostatectomy and experienced biochemical recurrence with a minimum PSA level of 0.5 ng/mL and PSA doubling time of 9 months or less.The patients were randomly assigned 1:1:1 to receive ADT alone, ADT plus apalutamide, or ADT plus apalutamide, abiraterone acetate, and prednisone.The primary endpoint was PSA progression-free survival during a 1-year treatment duration.Secondary outcome measures included PSA progression-free survival in the testosterone-recovered population (a subgroup of patients who achieved serum testosterone to> 50 ng/dL during the study follow-up), medium time to testosterone recovery (a level> 50 ng/dL), and safety.

TAKEAWAY:

At a median follow-up of 21.5 months, ADT plus apalutamide significantly prolonged median PSA progression-free survival compared with ADT monotherapy (24.9 vs 20.3 months; hazard ratio [HR], 0.52). ADT plus apalutamide, abiraterone acetate, and prednisone improved median PSA progression-free survival compared with ADT alone (26 vs 20.3 months; HR, 0.48).Compared with ADT monotherapy, the time to testosterone recovery to> 50 ng/dL was not significantly different in the ADT plus apalutamide (3.9 vs 3.8 months, respectively). In the ADT plus apalutamide, abiraterone acetate, and prednisone group, there was longer time (4.7 months) to testosterone recovery, which did not meet statistical significance.Serious adverse events occurred in 8% of patients in the ADT monotherapy group, 9% in the ADT plus abiraterone group, and 17% in the ADT plus apalutamide, abiraterone acetate, and prednisone group, respectively. The most common were hypertension, dyspnea, and falls.

IN PRACTICE:

Despite finding that intensified ADT significantly improved PSA progression-free survival vs ADT alone, experts in an accompanying editorial cautioned that by treating biochemical recurrence, “we are treating largely asymptomatic men, many of whom will live for years without encountering any disease-related consequences and for whom the toxicity of therapy may exacerbate underlying comorbidities, potentially increasing the risk of nonprostate cancer death.”

SOURCE:

This research was led by Rahul Aggarwal, MD, from University of California San Francisco, and was published online on January 23, 2024, in the Journal of Clinical Oncology.

LIMITATIONS:

The primary endpoint of PSA progression-free survival is not a well-established surrogate for overall survival. This study was conducted before the adoption of advanced imaging techniques, potentially affecting the accurate identification and characterization of nonmetastatic patients with recurrent prostate cancer. Radiotherapy was not allowed during the treatment period.

DISCLOSURES:

This study was supported by Alliance Foundation Trials and Janssen Pharmaceuticals. Several authors reported financial affiliations with various organizations.

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