Doseloop Beta

Apalutamide

medication Under review

A second-generation androgen receptor inhibitor used to treat certain types of prostate cancer by blocking testosterone effects.

Research summary

AI-Generated Content: This summary was created by AI and may contain errors. Always verify with peer-reviewed sources.

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 Iโ€“III 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

Reported Side Effects

Research (4 studies)

RCT

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.

The Oncologist • 2023 • n=1052

Chi KN, Chowdhury S, Oudard S, et al.

RCT

Apalutamide for the Treatment of Nonmetastatic Castration-Resistant Prostate Cancer

Urologic Oncology (review of SPARTAN) • 2021 • n=1207

Hussain M, Fizazi K, Saad F, et al.

RCT

Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer.

New England Journal of Medicine • 2018 • n=1207

Smith MR, Saad F, Chowdhury S, et al.

RCT

Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509) in Nonmetastatic Castration-Resistant Prostate Cancer

Clinical Cancer Research • 2017 • n=51

Smith MR, Antonarakis ES, Ryan CJ, et al.

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At a glance

Users tracking 0
Linked studies 4
Researched benefits 1
Side effects noted 2