Apalutamide
medication Under reviewA second-generation androgen receptor inhibitor used to treat certain types of prostate cancer by blocking testosterone effects.
Research summary
Clinical research on apalutamide is extensive but almost entirely confined to men with various stages of prostate cancer, typically in combination with androgen-deprivation therapy. Large phase III randomized controlled trials such as SPARTAN and TITAN have shown that apalutamide significantly improves metastasis-free survival, radiographic progression-free survival, and overall survival compared with placebo plus androgen-deprivation therapy in high-risk nonmetastatic castration-resistant and metastatic castration-sensitive prostate cancer populations. These benefits are consistent across age groups and disease volume subgroups, and real-world observational studies largely corroborate trial findings. Safety data from phase IโIII trials and post-marketing experience indicate that apalutamide is generally tolerable in the prostate cancer setting but associated with a distinct adverse effect profile, including fatigue, rash, falls, fractures, hypothyroidism, and cardiovascular events. Because all controlled human data come from patients with cancer undergoing intensive hormonal manipulation, there is no evidence base supporting any beneficial use of apalutamide in healthy humans. Its pharmacology (potent androgen receptor blockade) makes it inappropriate and potentially harmful for non-cancer, non-hypogonadal populations.
Reported Benefits
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Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509) in Nonmetastatic Castration-Resistant Prostate Cancer
Smith MR, Antonarakis ES, Ryan CJ, et al.
Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer.
Smith MR, Saad F, Chowdhury S, et al.
Apalutamide plus androgen deprivation therapy in clinical subgroups of patients with metastatic castration-sensitive prostate cancer: A subgroup analysis of the randomised clinical TITAN study.
Chi KN, Chowdhury S, Oudard S, et al.
Apalutamide for the Treatment of Nonmetastatic Castration-Resistant Prostate Cancer
Hussain M, Fizazi K, Saad F, et al.
Reported Side Effects
No reports yet
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Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509) in Nonmetastatic Castration-Resistant Prostate Cancer
Smith MR, Antonarakis ES, Ryan CJ, et al.
Apalutamide for the Treatment of Nonmetastatic Castration-Resistant Prostate Cancer
Hussain M, Fizazi K, Saad F, et al.
No reports yet
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Apalutamide for the Treatment of Nonmetastatic Castration-Resistant Prostate Cancer
Hussain M, Fizazi K, Saad F, et al.
Research (4 studies)
Apalutamide plus androgen deprivation therapy in clinical subgroups of patients with metastatic castration-sensitive prostate cancer: A subgroup analysis of the randomised clinical TITAN study.
Chi KN, Chowdhury S, Oudard S, et al.
Apalutamide for the Treatment of Nonmetastatic Castration-Resistant Prostate Cancer
Hussain M, Fizazi K, Saad F, et al.
Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer.
Smith MR, Saad F, Chowdhury S, et al.
Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509) in Nonmetastatic Castration-Resistant Prostate Cancer
Smith MR, Antonarakis ES, Ryan CJ, et al.
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