Cedar-Sinai Cancer researchers have identified two new promising treatment options for men diagnosed with aggressive and recurrent prostate cancer. This study is part of an international Phase III clinical trial and has been published in the New England Journal of Medicine. These treatments, if approved by the FDA, would provide additional methods of fighting metastasis-free prostate cancer patients improving survival rates and quality of life.
Men diagnosed with prostate cancer and their families will welcome this news since approximately 288,300 additional men will receive a diagnosis of prostate cancer in 2023, according to the American Cancer Society. It’s important to note that most men diagnosed with this disease have a very slow-growing form of prostate cancer that may never require treatment. However, some men will have a more aggressive and deadly form of the disease that will require surgery or radiation therapy. Unfortunately, within ten years, about one-third of those men will experience cancer recurrence.
When men experience a recurrence of aggressive prostate cancer, the recommended treatment is to put them on androgen deprivation therapy (ADT). This type of hormone therapy is used to decrease the production of testosterone, as it fuels the growth of prostate cancer cells and helps them to spread. ADT is designed to minimize the growth of these cancer cells by reducing the growth-stimulating effects of testosterone.
While ADT does help reduce blood levels of testosterone preventing growth of cancer cells, it still has drawbacks. One drawback is it does not completely eliminate the hormone, which may stimulate tumor growth. Additionally, not all patients like this treatment method due to its potential side effects, such as loss of sex drive, weight gain, fatigue, loss of muscle mass, and osteoporosis.
The study consisted of close to 1100 men with prostate cancer from 244 sites in 17 countries. The men were divided into three groups: One-third received ADT plus a medication called enzalutamide (Xtandi), which helps block the effects of testosterone and prevents any remaining blood testosterone from stimulating cancer cell growth. Another one-third of study participants received enzalutamide by itself. Researchers wanted to study the drug’s ability to block testosterone’s effect even though the patients’ blood levels of the hormone were not reduced. The final one-third of study participants received the standard treatment of using ADT alone.
Results from the study showed that men given the combination of ADT plus enzalutamide reduced risk of metastasis and death by 58% over using ADT alone. The men who were given only enzalutamide had a 37% reduction of metastasis risk or death. The men in these two groups also were able to maintain quality of life in comparison to men who were given only ADT.
Researchers with the study stated that while the therapy that offered the best risk reduction – men who used a combination of ADT and enzalutamide – there likely will be some men who prefer using enzalutamide by itself to avoid the side effects of ADT.
With the results from this clinical trial, makers of enzalutamide will be applying for FDA approval in order to provide an improved course of therapy for patients and providers to use when fighting aggressive, recurrent prostate cancer.
Dr. David Samadi is the Director of Men’s Health and Urologic Oncology at St. Francis Hospital in Long Island. He’s a renowned and highly successful board certified Urologic Oncologist Expert and Robotic Surgeon in New York City, regarded as one of the leading prostate surgeons in the U.S., with a vast expertise in prostate cancer treatment and Robotic-Assisted Laparoscopic Prostatectomy. Dr. Samadi is a medical contributor to NewsMax TV and is also the author of The Ultimate MANual, Dr. Samadi’s Guide to Men’s Health and Wellness, available online both on Amazon and Barnes & Noble. Visit Dr. Samadi’s websites at robotic oncology and prostate cancer 911.