Stephen J. Freedland, MD Ceasing treatment with enzalutamide (Xtandi)-containing regimens did not have a significant impact on global quality of life (QOL) in patients with biochemically recurrent (BCR) nonmetastatic hormone-sensitive prostate cancer (nmHSPC) who responded to these therapies, according to findings from a post-hoc analysis of the phase 3 EMBARK trial (NCT02319837) presented during the 2024 ASCO Annual Meeting . 1 The pivotal EMBARK trial was a double-blind, placebo-controlled study that included 1068 adult patients with nmHSPC with high-risk BCR.
2 Patients had all progressed following surgery or radiation and had a rapid PSA doubling time (<9 months). Patients were randomized in a 1:1:1 fashion to receive either oral enzalutamide monotherapy at a dose of 160 mg once daily (n = 355), enzalutamide 60 mg once daily in combination with intramuscular or subcutaneous leuprolide at a dose of 22.5 mg once every 12 weeks (n = 355), or placebo plus intramuscular or subcutaneous leuprolide at a dose of 22.
5 mg once every 12 weeks (n = 358). “One of the unique aspects, of EMBARK, however, is that patients got the treatment that they were originally assigned to for 37 weeks and then PSA was measured. If the patient had a good PSA response, defined as less than 0.
2 ng/mL, treatment was actually stopped, and they stayed off therapy until the PSA rose to ≥2.0 ng/mL for those who had had radical prostatectomy (RP) or ≥5.0 ng/mL for those who had not had RP.
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