A recent article published in the New England Journal of Medicine reports a study showing the benefit of a new hormonal medication in reducing the development of prostate cancer metastases. About 1200 men from 26 countries throughout the world were enrolled in the study. About 800 men took an orally administered drug called apalutamide, while about 400 took a placebo pill (2:1 randomization). All men had prior treatment, mostly prostatectomy and/or radiation therapy, and had developed a rising PSA despite androgen deprivation therapy (using methods you may be familiar with, including Lupron or degarelix injections, or castration). This situation is called “castrate-resistant” prostate cancer and, as you can surmise, is a bad sign. All the men in the study had a PSA doubling time of less than 10 months (an indicator of an aggressive recurrence), but no evidence of metastases on CT scan or bone scan.
The results of the study showed that apalutamide delayed the development of prostate cancer metastases by about 2 years (metastasis-free survival was 40.5 months vs. 16.2 months) compared to placebo. The time to the development of any recurrence, local or distant, and the time to the development of symptoms from progression of prostate cancer was also longer in the apalutamide group. The most common side effects from the drug were fatigue and rash.
Despite improvements in surgery, radiation therapy and other primary treatments for prostate cancer, some patients do have recurrences and have to go through androgen deprivation therapy (ADT). Eventually ADT stops working and one enters the “castrate resistant” phase of disease. Apalutamide provides another tool in the tool box in our quest to stop the spread of prostate cancer and buy more time to develop new treatments for this difficult situation.