The Link Between Apalutamide and QOL in Non-Metastatic CRPC

Excerpt:

“Adding apalutamide to androgen deprivation therapy (ADT) does not appear to harm health-related quality of life (HRQOL) in men with nonmetastatic castration-resistant prostate cancer (CRPC), according to new research published in Lancet Oncology.

“Previous research has showed that men in this patient population who received apalutamide had longer metastasis-free survival and a longer time to symptomatic progression compared with those who received placebo. This new study found that adding apalutamide still preserves HRQOL. Specifically, the group mean patient-reported outcome scores over time demonstrated HRQOL was maintained from baseline (initiation of apalutamide), and it was similar over time among men receiving apalutamide versus placebo.”

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FDA Approves Enzalutamide for Nonmetastatic CRPC

Excerpt:

“The FDA has approved enzalutamide (Xtandi) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Pfizer and Astellas, the codevelopers of the antiandrogen agent.

“The approval is based on the phase III PROSPER trial, in which the combination of enzalutamide (Xtandi) and androgen deprivation therapy (ADT) reduced the risk of metastases or death by 71% compared with ADT alone for patients with nonmetastatic CRPC. In the double-blind study, the median metastasis-free survival (MFS) was 36.6 months with enzalutamide plus ADT versus 14.7 months with ADT alone (HR, 0.29; 95% CI, 0.24-0.35; P <.0001).”

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Apalutamide Reduces Risk of PSA Progression by 94% in Nonmetastatic CRPC

Excerpt:

“Apalutamide (Erleada) lowered the risk of PSA progression by 94% in patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to a posthoc analysis from the phase III SPARTAN trial presented at the 2018 American Urological Association (AUA) Annual Meeting.

“The median time to PSA progression was not reached in the apalutamide arm compared with 3.71 months in the placebo group (HR, 0.064; 95% CI, 0.052-0.080; <.0001). A separate retrospective cohort study presented at AUA underscored the significance of these apalutamide data by confirming prior observations of the link between faster PSA doubling time (PSADT) and poorer metastasis-free survival (MFS) and overall survival (OS).”

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FDA Approves New Treatment for a Certain Type of Prostate Cancer Using Novel Clinical Trial Endpoint

Excerpt:

“The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.”

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Astellas, Medivation Launch Phase III Prostate Cancer Trial

“Medivation Inc. and Astellas Pharma Inc. announced enrollment of the first patient in a global phase III clinical trial, known as PROSPER, which will evaluate the safety and efficacy of enzalutamide in patients with nonmetastatic (often referred to as M0) castration-resistant prostate cancer (CRPC). Currently no prescription medicine is specifically approved for the treatment of patients with nonmetastatic CRPC in the U.S.”