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PCRI's Executive Director, Mark Scholz, MD, describes a clinical trial (NCT03834519) of interest to men with advanced prostate cancer who have failed to respond to treatment with either Zytiga (abiraterone) or Xtandi (enzalutamide) (but not both) and to chemotherapy. The study is assessing whether there is a survival benefit to combining Keytruda (pembrolizumab) and Lynparza (olaparib) versus the status quo of switching from Zytiga plus prednisone to Xtandi or vice versa (depending on previous treatment). 0:12 Background on clinical trials — Clinical trials are an important part of expanding treatment options for men with prostate cancer, and they are generally designed to address an unmet need. In this case, the unmet need is men with advanced prostate cancer who have failed to respond to either Xtandi or Zytiga (but not both) and to chemotherapy. Men in this situation have limited options moving forward. 1:10 Control (or status quo) arm of the study — The status quo for men in this situation has been to switch to whatever 2nd generation hormone therapy the patient has not yet taken; however, this is usually ineffective. This is the form of therapy that will be given in the control arm of this study 1:45 Experimental arm of the study — Merck pharmaceuticals is evaluating the efficacy of the combined use of two of its drugs, Lynparza and Keytruda, to compare against the control arm of the study. Both medicines are FDA--approved to treat other forms of cancer. 2:36 Background on the agents used in this study, Lynparza — Lynparza and Keytruda have both been shown to have activity in prostate cancer. Lynparza is especially useful in men with BRCA mutation, however, a BRCA mutation is not necessary to participate in the study. Lynparza has side effects similar to chemotherapy (fatigue, low blood counts) except without hair loss. It comes in the form of a pill and is taken twice a day. Patients on Lynparza need to be monitored as if they were undergoing chemotherapy. 3:37 Background on the agents used in this study, Keytruda — Keytruda is an immune medication that "takes the brakes" off the entire immune system. It is an infusion every three weeks. It is usually well-tolerated but around 20% of men will experience side effects due to overactivity of the immune system (asthma, diarrhea, rashes). 4:10 Lynparza and Keytruda are both potent agents and side effects will be an issue, but men who are in the situation to qualify for this trial do not have many other options. Don’t know your stage? Take the quiz: Visit http://www.prostatecancerstaging.org To learn more about prostate cancer visit http://www.pcri.org To download the free Staging Guide visit http://www.pcri.org/prostate-cancer-s... Who we are: The Prostate Cancer Research Institute (PCRI) is a 501(c)(3) not-for-profit organization that is dedicated to helping you research your treatment options. We understand that you have many questions, and we can help you find the answers that are specific to your case. All of our resources are designed by a multidisciplinary team of advocates and expert physicians, for patients. We believe that by educating yourself about the disease, you will have more productive interactions with your medical professionals and receive better individualized care. Feel free to explore our website or call our free helpline at 1 (800) 641-7274 with any questions that you have. Our Federal Tax ID # is 95-4617875 and qualifies for maximum charitable gift deductions by individual donors. The information on the Prostate Cancer Research Institute's YouTube channel is provided with the understanding that the Institute is not engaged in rendering medical advice or recommendation. The information provided in these videos should not replace consultations with qualified health care professionals to meet your individual medical needs. #ProstateCancer #Prostate #MarkScholzMd