The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)
Official Title: A Randomized, Open-label, Multicenter, Phase 2b Study to Evaluate Physical Function, Including Balance and Daily Activity, in Participants With Castration-resistant Prostate Cancer Treated With Darolutamide or Enzalutamide
Study ID: NCT04157088
Brief Summary: Researchers in this study want to compare the effects of drug darolutamide and drug enzalutamide on physical function, including balance and daily activity, in patients with castration-resistant prostate cancer (CRPC). Both darolutamide and enzalutamide are approved AR inhibitors used for the treatment of patients with CRPC. AR inhibitor is a substance that keeps androgens (male sex hormones) from binding to proteins called androgen receptors, which are found in normal prostate cells, some prostate cancer cells, and in some other cells. Preventing this binding blocks the effects of these hormones in the body and therefore keeps prostate cancer cells from growing. Patients participating this study will receive either darolutamide or enzalutamide tablets. To evaluate the physical function, patients will be asked to make some movements like rising from a chair, walking three meters, etc. Additionally, researchers also want to find out the survival of patients and if patients have fatigue (feeling tired), cognitive (learning and thinking) problems, or other medical problems during the trial. Brand name of darolutamide is Nubeqa; brand name of enzalutamide is Xtandi.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Oregon Health and Science University, Portland, Maine, United States
New Jersey Urology, LLC, Voorhees, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
MidLantic Urology - Bala Cynwyd, Bala-Cynwyd, Pennsylvania, United States
Bon Secours St. Francis Hospital, Greenville, South Carolina, United States
Carolina Urological Research Center, Myrtle Beach, South Carolina, United States