Prostate cancer is the most common cancer among men in the United States. According to the American Cancer Society, more than 160,000 men in the United States are diagnosed with prostate cancer annually and more than 28,000 of them die from prostate cancer each year.
Apalutamide, marketed as Erleada, was approved by the FDA Feb. 14, 2018 for treating men who have an earlier form of prostate cancer called nonmetastatic castration-resistant prostate cancer.
Clinical Trial Result
The phase 3 clinical trial for Erleada was conducted at 332 locations in 26 countries, with 1,207 patients who had a rapidly rising prostate specific antigen and whose CT scans showed no evidence that the cancer had spread beyond the prostate—806 of whom were given 240 milligrams daily of Erleada and 401 of whom were given a placebo.
The data supporting Erleada’s effectiveness and safety were so strong that the FDA decided to end the trial a couple of years ahead of schedule (after slightly more than three years).
The phase three trial for Erleada showed that, after 16 months, on average, men taking the placebo had their cancer spread from the prostate to other areas—such as the bones, lymph nodes or brain—while for those men taking Erleada, the time before the prostate cancer began to spread was extended to more than 40 months, on average. This result was observed in men in all age groups.
Erleada can be taken before men show any spread of the cancer, when their prostate specific antigen level is high. PSA is a biomarker for prostate cancer; the higher the PSA level, the more cancer there is. Seventy percent of men older than 70 get prostate cancer, but it is usually very slow-growing, and men typically die with the cancer, not from it.
Side effects from Erleada and Xtandi, such as fatigue and rash, are not very severe, according to the researchers.