ADT Intensification Prolongs PSA-PFS in Biochemically Recurrent Prostate Cancer

Intensification of androgen deprivation therapy (ADT) can prolong prostate-specific antigen (PSA) progression-free survival (PFS) in patients with biochemically recurrent prostate cancer, according to research published in the Journal of Clinical Oncology.

The trial showed that patients had longer PSA-PFS if they received apalutamide plus ADT than if they received ADT alone. However, the addition of abiraterone acetate plus prednisone (AAP) to apalutamide and ADT did not further improve PSA-PFS.

This phase 3 trial, PRESTO (ClinicalTrials.gov Identifier: NCT03009981), enrolled 503 patients with biochemically recurrent prostate cancer and a PSA doubling time of 9 months or less.

The patients were randomly assigned to 52-week treatment with ADT alone (n=166), ADT plus apalutamide (n=168), or ADT plus apalutamide and AAP (n=169).

At a median follow-up of 21.5 months, the median PSA-PFS was significantly longer with ADT-apalutamide than with ADT alone — 24.9 months and 20.3 months, respectively (hazard ratio [HR], 0.52; 95% CI, 0.35-0.77; P =.00047).

At a median follow-up of 21.3 months, the median PSA-PFS was significantly longer with ADT plus apalutamide and AAP than with ADT alone — 26.0 months and 20.0 months, respectively (HR, 0.48; 95% CI, 0.32-0.71; P =.00008).

However, there was no significant difference in PSA-PFS between the ADT-apalutamide arm and the ADT-apalutamide-AAP arm (HR, 0.95; 95% CI, 0.62-1.45).

The median time to testosterone recovery after treatment discontinuation was not significantly different across the treatment arms. It was 3.9 months with ADT alone, 3.8 months with ADT plus apalutamide (HR, 0.94; 95% CI, 0.68-1.29), and 4.7 months with ADT plus apalutamide and AAP (HR, 0.75; 95% CI, 0.54-1.03).

Treatment-emergent adverse events (AEs) occurred in 91% of patients treated with ADT alone, 91% of those who received ADT plus apalutamide, and 96% of those who received ADT plus apalutamide and AAP. Serious AEs occurred in 8%, 9%, and 17%, respectively.

The most common treatment-emergent AEs in the overall cohort were hot flashes (78%), fatigue (55%), injection site reactions (33%), hypertension (31%), insomnia (21%), arthralgia (15%), and hyperglycemia (14%). The most common serious AEs were hypertension (1%), dyspnea (0.6%), and fall (0.6%). There were no treatment-related deaths.

“Apalutamide plus ADT improved PSA-PFS compared with ADT alone without adversely affecting time to testosterone recovery after completion of a finite duration of treatment,” Michael A. Carducci, MD, associate editor of the journal, wrote in a comment on the study.

“The further addition of abiraterone acetate plus prednisone to apalutamide + ADT did not appear to provide additional benefit with respect to PSA-PFS and was associated with higher frequency of toxicity, particularly rates of hypertension.”

Disclosures: This research was partly supported by Janssen Scientific Affairs, LLC. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

This article originally appeared on Cancer Therapy Advisor