This trial is evaluating whether Enzalutamide will improve 1 primary outcome and 46 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months).
This trial requires 1401 total participants across 2 different treatment groups
This trial involves 2 different treatments. Enzalutamide is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
"The signs of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) present in men with LUTS do not differ from patients with LUTS but without prostate cancer. The most useful sign of prostate cancer was an elevated PSA level. The decision to perform a prostate biopsy should be based on the PSA serum level." - Anonymous Online Contributor
"There is a large variability in the timing of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) in men with BPH. Men with BPH with early cancer may have a different profile of risk factors for prostate cancer than men with BPH with late cancer." - Anonymous Online Contributor
"Prostate cancer typically appears in men over the age of 50 and forms in the prostate. It often forms by the time a man reaches 50 and can form over 10 years. Prostate cancer is the number one cause of cancer related deaths. And while not curable, prostate cancer can be controlled. If a man has prostate cancer, his doctor should be notified within 6 months to prevent other complications." - Anonymous Online Contributor
"Enzalutamide is used to treat many types of testosterone-dependent androgen-inhibiting conditions, such as prostate cancer, hirsutism, and hyperandrogenism. These conditions have an increased risk of cardiovascular diseases. Enzalutamide prevents estrogen and androgen-induced breast and endometrium development and function. Additionally, because endometrial hyperplasia and polyps are frequent side effects of NSAAs and are associated with high morbidity and mortality, enzalutamide does not worsen these common adverse effects. Enzalutamide lowers blood glucose and cardiovascular risk by inhibiting certain aspects of the androgen synthesis pathway." - Anonymous Online Contributor
"Our analysis revealed that in patients taking enzalutamide, there was no statistically significant association in any adverse or serious adverse event with enzalutamide compared to placebo. Adverse reactions of the treatment were similar." - Anonymous Online Contributor
"Based on this small study, enzalutamide monotherapy appears to be effective enough in the treatment of metastatic castration-refractory prostate cancer (CRPC) without significant side effects. EPRS had only one patient in this small study, and the duration of response was 4.9 months, less than the 6 months' response seen with enzalutamide at 20 mg/d in a Phase I trial in 2007. EPRS demonstrated the longest duration of response reported to date in patients with CRPC. Further, enzalutamide was well tolerated in the majority of patients. More data are now required before using enzalutamide monotherapy in the treatment of CRPC." - Anonymous Online Contributor
"There is no convincing evidence that [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) can be cured or has been curable. Radical prostatectomy, external beam radiation, and hormone therapy are all palliative treatments that have been used to treat patients whose prostate cancer has progressed after radical prostatectomy. Radical prostatectomy is often combined with intraoperative pelvic radiation, pelvic lymphadenectomy or androgen deprivation therapy to treat localized or locally advanced disease. The use of this multimodal therapy approach after radical prostatectomy has increased since the mid 1990s. Radical prostatectomy alone has not been proven to confer a significant long term survival benefit in men with localized prostate cancer." - Anonymous Online Contributor
"The treatment paradigm for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) has shifted from a traditional, disease-fighting role of radical prostatectomy and definitive radiation therapy to a more personalized approach that focuses on alleviating the patient's symptoms while still allowing the disease to be treated if appropriate." - Anonymous Online Contributor
"It is estimated that a total of 13,250 men are diagnosed with PC in the U.S. each year. Estimates of the annual age-adjusted incidence of PC in the U.S. are the following: non-Hispanic blacks 6,970, non-Hispanic whites 16,200, Hispanics 21,400, men of other races 16,350, and unknown race, age 17, and unknown sex 19,100." - Anonymous Online Contributor
"Overall, no new treatments have been discovered that have been shown to increase mortality from [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), but clinical trials have been conducted for new cancer therapies that are currently in development for prostate cancer. These new treatments may decrease the use of external beam radiotherapy and/or hormonal therapy, and increase the use of brachytherapy treatment." - Anonymous Online Contributor
"Prostate cancer has historically been an extremely lethal disease, but survival rates have improved in recent years. In the present era, with better cancer treatment modalities and the increasing understanding of the mechanisms of prostate cancer, survival rates are greater now than they had been previously." - Anonymous Online Contributor
"In our study of patients with advanced prostate cancer treated with enzalutamide, it was observed that enzalutamide did not improve patient-reported physical and mental quality of life. These data may help physicians better counsel patients with their treatment options." - Anonymous Online Contributor