Erleada-ADT Combo Increases Survival of mCSPC Patients Without Affecting Quality of Life, Phase 3 Trial Shows

Erleada-ADT Combo Increases Survival of mCSPC Patients Without Affecting Quality of Life, Phase 3 Trial Shows
Adding Erleada (apalutamide) to standard androgen deprivation therapy (ADT) increases the survival and delays disease progression in men with metastatic castration-sensitive prostate cancer (mCSPC) — and does so without compromising their quality of life — a Phase 3 clinical trial shows. Those findings were presented in the poster, “Patient-reported outcomes (PROs) from TITAN: A phase III, randomized, double-blind study of apalutamide (APA) versus placebo (PBO) added to androgen deprivation therapy (ADT) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC),” at the European Society for Medical Oncology (ESMO) 2019 Congress, Sept. 27–Oct. 1 in Barcelona, Spain. The results also were published in The Lancet Oncology. Erleada, developed by Janssen, is a form of hormone therapy that is intended to prevent male hormones from sending chemical signals that stimulate cancer growth; it does so by blocking the activity of androgen receptors. ADT is a standard prostate cancer treatment that lowers the amount of male hormones in the body. The U.S. Food and Drug Administration (FDA) recently approved Erleada for treating men with metastatic castration-sensitive prostate cancer (mCSPC) whose cancer still responded to ADT. The decision was based on findings from the randomized, double-blind, placebo-controlled, TITAN Phase 3 clinical trial (NCT02489318). TITAN enrolled 1,052 adult men with mCSPC who were assigned randomly to receive either Erleada (four tablets of 60 mg, once-a-day) in combination with standard ADT, or a placebo in combination with ADT, in cycles of 28 days. Patients were included regardless of the extent of their disease, risk of progression and prior docetaxel use, and could be either newly diagnosed with mCSPC
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