February 19, 2018

Erleada is The First Treatment for Non-metastatic Castration-resistant Prostate Cancer


CancerConnect News:  Men who are being treated with androgen deprivation therapy (ADT) and see their prostate specific antigen (PSA) levels begin to increase have a new treatment option. The U.S. Food and Drug Administration (FDA) has approved Erleada (Apalutamide) for the treatment of non-metastatic castration-resistant prostate cancer (CRPC).1  There were previously no FDA-approved treatments for non-metastatic CRPC, and patients typically continued to receive ADT, despite its diminishing benefit.

About Castration-Resistant Prostate Cancer

Prostate cancer is the second most common cancer in men worldwide.  More than 164,000 men in the United States are estimated to be newly diagnosed with prostate cancer in 2018.2,3 Castration-resistant prostate cancer refers to the subset of men whose prostate cancer progresses despite castration levels of testosterone.4 Non-metastatic CRPC means there is no clinically detectable evidence of the cancer spreading to other parts of the body (metastases), and there is a rising prostate-specific antigen (PSA) level.5   Many men with non-metastatic CRPC and a rapidly rising PSA level go on to develop metastatic CRPC.6   The relative 5-year survival rate for patients with distant stage prostate cancer is 30 percent and therapies that can delay the onset of metastasis in these patients is needed.

About Erleada ™

Erleada™ is an androgen receptor (AR) inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer that works by binding directly to the ligand-binding domain of the AR. Erleada™ inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription.

The FDA approval is based the results of a pivotal clinical trial presented last week at the 2018 ASCO Genitourinary Cancers Symposium. The trial evaluated 1,207 non-metastatic CRPC patients with a rapidly rising PSA (PSA doubling time of 10 months or less) and no evidence of distant metastatic cancer.  Half the individuals received Erleada in addition to whatever treatment they were already receiving (mostly ADT) and were compared to those not offered Erleada.

Erleada treated patients experienced a delay in the time to metastatic disease of 40.5 months compared to only 16.2 months for those not receiving the medication. This represents a 72% reduction in risk of metastasis or death.1


  1. https://www.pcf.org/news/fda-approves-apalutamide-erleada/?utm_source=pcflist&utm_medium=email&utm_campaign=20180214fda
  2. American Cancer Society. Cancer Facts & Figures 2018. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-….
  3. European Commission. Epidemiology of Prostate Cancer in Europe. https://ec.europa.eu/jrc/en/publication/epidemiology-prostate-cancer-europe.
  4. Urology Care Foundation. Advanced Prostate Cancer Patient Guide. urologyhealth.org/educational-materials.
  5. Luo J, Beer T, Graff J. Treatment of Non-metastatic Castration Resistant Prostate Cancer. Oncology. April 2016, 30(4):336-344.
  6. Smith MR, Kabbinavar F, Saad F, Hussain A et al. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. J Clin Oncol 2005; 23: 2918–2925.

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Tags: Apalutamide, Erleada, News, non-metastatic castration-resistant prostate cancer, Prostate Cancer, rising psa, treatment, Uncategorized