Enzalutamide and Prostate-Specific Antigen Levels in Metastatic Prostate Cancer: A Secondary Analysis of the ARCHES Randomized Clinical Trial
Abstract
IMPORTANCE: In men with metastatic hormone-sensitive prostate cancer (mHSPC), prostate-specific antigen (PSA) decline after treatment has been associated with improved survival. However, the data on PSA decline are limited in men with mHSPC after treatment with enzalutamide plus androgen deprivation therapy (ADT).
OBJECTIVE: To evaluate the association of enzalutamide plus ADT in men with mHSPC by PSA level at study enrollment in individuals with prior ADT and by degree of PSA reduction with clinical end points.
DESIGN, SETTING, AND PARTICIPANTS: This post hoc secondary analysis was performed on data collected from the ARCHES multinational, double-blind, phase 3 randomized clinical trial. In the ARCHES trial, men with mHSPC were randomized between March 21, 2016, and January 12, 2018. Analyses were performed in October 2018 (median follow-up, 14.4 months; IQR, 11.2-17.7 months) and May 2021 (median follow-up, 44.6 months; IQR, 41.3-48.6 months).
INTERVENTION: Patients were randomized 1:1 to enzalutamide (160 mg/d) plus ADT or placebo plus ADT. ADT received for 3 to 6 months before study enrollment was permitted.
MAIN OUTCOMES AND MEASURES: Radiographic progression-free survival (rPFS) and overall survival (OS) were correlated post hoc with PSA level at enrollment in patients with prior ADT and additionally with PSA decline at 6 months or undetectable PSA (<0.2 ng/mL) during study treatment.
RESULTS: A total of 1150 men (median age, 70 years; range, 46-92 years) were…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 1,150 participants or records.
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