From the Guidelines
Apalutamide is a medication primarily used to treat prostate cancer, specifically approved for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), with a recommended dosage of 240 mg taken orally once daily, with or without food, in conjunction with a gonadotropin-releasing hormone (GnRH) analog or after surgical castration to maintain low testosterone levels 1.
Key Points
- Apalutamide works by blocking the action of androgens by binding to androgen receptors in cancer cells, preventing these hormones from stimulating cancer growth 1.
- Common side effects include fatigue, rash, falls, fractures, decreased appetite, and hot flashes 1.
- The medication is part of a class called androgen receptor inhibitors and represents an important treatment option for men with advanced prostate cancer, particularly when the cancer continues to progress despite low testosterone levels from other treatments 1.
Clinical Evidence
- The double-blind phase III TITAN clinical trial demonstrated that apalutamide plus ADT improved radiographic progression-free survival and overall survival in patients with metastatic, castration-sensitive prostate cancer 1.
- The SPARTAN trial showed that apalutamide significantly reduced the risk of distant metastasis or death in patients with non-metastatic CRPC 1.
- The ASCO guideline update recommends apalutamide with ADT as the regimen for men with metastatic noncastrate prostate cancer, with high evidence quality and a strong strength of recommendation 1.
Treatment Considerations
- Patients taking apalutamide should be monitored for adverse events, including rash, hypothyroidism, and ischemic heart disease 1.
- Health-related quality of life should be maintained during treatment, and patients should be educated on the potential side effects and benefits of apalutamide therapy 1.
From the FDA Drug Label
ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1) non-metastatic castration-resistant prostate cancer. ( 1) ERLEADA is a prescription medicine used for the treatment of prostate cancer: that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone, OR that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone
The use of apalutamide (Erleada) is for the treatment of:
- Metastatic castration-sensitive prostate cancer
- Non-metastatic castration-resistant prostate cancer 2
From the Research
Use of Apalutamide (Erleada)
- Apalutamide is a novel androgen signalling inhibitor used in combination with continuous androgen deprivation therapy (ADT) for the treatment of patients with advanced prostate cancer 3.
- It is used to treat non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC) 3, 4, 5.
- Apalutamide in combination with ADT has been shown to significantly extend overall survival compared to the standard of care in patients with nmCRPC and mHSPC 3, 6.
- It can be used in a broad patient population, including patients with high and low volume/risk mHSPC, patients with de novo metastatic disease or metastases following treatment for localized disease, as well as older patients 3.
- Apalutamide is well tolerated, with manageable side effects that do not impact health-related quality of life compared to ADT alone 3, 7.
Efficacy of Apalutamide
- Apalutamide has demonstrated efficacy in extending metastasis-free survival (MFS) and overall survival (OS) in patients with nmCRPC 4, 6.
- A matching-adjusted indirect comparison of apalutamide and enzalutamide showed that apalutamide may have a higher probability of a more favorable MFS and OS in patients with nmCRPC 4.
- Apalutamide has also shown benefit in patients with metastatic hormone-naive prostate cancer, making it a valuable addition to the treatment options for prostate cancer 7.
Clinical Practice
- Expert opinion recommends the use of apalutamide in combination with ADT in patients with mHSPC and patients with nmCRPC who are at risk of developing metastatic disease 3.
- Practical considerations such as patient selection, monitoring, and management of side effects are important in the real-world setting 3.
- Real-world experience with apalutamide supports the efficacy and safety findings reported by clinical trials 3.