Erleada (apalutamide) is an oral therapy developed by Janssen Pharmaceuticals to treat some types of prostate cancer.

The therapy is approved in the U.S. and Europe to treat metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT), and to treat non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease. Metastatic prostate cancer refers to prostate cancer that has spread from the prostate to other areas of the body.

How does Erleada work?

The prostate is a small gland in the groin that is important for the production of seminal fluid. Androgens are male sex hormones that play a critical role in the development and function of the prostate. In cancer, androgen signaling promotes cancer growth.

The first line of treatment for prostate cancer is usually ADT. However, nearly all patients progress to a more aggressive, castration-resistant cancer type, which has abnormal androgen-receptor signaling. This is because the cancerous cells are producing more of the androgen receptor or more androgens to activate the receptors.

Erleada contains a small molecule called apalutamide, which binds to androgen receptors — preventing them from signaling and making the receptors unavailable to bind to androgens.

Erleada in clinical trials

A Phase 3 clinical trial (NCT02489318) called TITAN is testing Erleada plus ADT versus ADT alone in patients with mHSPC. Patients are treated until disease progression or the occurrence of treatment-related toxicity. The primary outcomes of the study are overall survival and progression-free survival.

Preliminary results from the trial, which were published in The New England Journal of Medicine, revealed that Erleada plus ADT therapy significantly improved overall survival compared to ADT alone with a 33% reduction in the risk of death. The two-year overall survival rates, after a median follow-up of 22.7 months, were 82% for Erleada plus ADT compared to 74% for ADT alone.

The safety of Erleada plus ADT was consistent with previous studies; 42% of patients who received Erleada plus ADT experienced grade 3 or 4 adverse events, compared to 41% for patients receiving only ADT. The most common adverse events were high blood pressure and skin rash. Eight percent of patients in the Erleada group discontinued treatment due to adverse events, compared with 5% in the ADT-only group.

The trial is still ongoing and expected to be completed in July 2021.

Several clinical trials are recruiting prostate cancer patients now, or in the near future, to further test the effects of Erleada treatment in different populations and in combination with other therapies.


Last updated: Jan. 31, 2020


Prostate Cancer News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.