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Apalutamide (JNJ-56021927 formerly known as ARN 509) is a novel small-molecule androgen receptor antagonist similar to enzalutamide but with less central nervous system penetration, which could potentially result in reduced levels of fatigue and seizures. Curetoday.com has an article about 2 Phase 3 clinical trials of Apalutamide: the ATLAS trial (NCT02531516; learn more here); the SPARTAN study (NCT01946204; learn more here). The SPARTAN study is currently recruiting in Australia; the ATLAS study is not. For SPARTAN, eligible patients must show no signs of evident metastatic prostate cancer and must have a high risk for disease progression. A high risk for disease progression is defined as either a PSA doubling time (PSADT) of less than 10 months while on continuous ADT, or Castrate Resistant Prostate cancer demonstrated while on continuous ADT. PSADT is calculated using at least three PSA values during ADT.
JNJ-56021927 (formerly known as ARN-509) is an androgen receptor antagonist. Some prostate cancer cells require androgens for growth. JNJ-56021927 prevent androgens from binding to the prostate cancer cells’ androgen receptors. JNJ-56021927 is not as advanced in its development as enzalutamide (Brand name Xtandi). Results from initial clinical trials suggest that JNJ-56021927 may be more potent and effective than enzalutamide. A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer is being conducted. Details of this trial can be found by clicking on this link: https://clinicaltrials.gov/ct2/show/NCT02257736 This clinical trial is being conducted at a number of hospitals in most Australian states. I am aware that the Royal Melbourne Hospital has commenced recruitment of patients for this trial. I'm not aware of the recruitment status of the other Australian sites but I expect that these sites will commence recruitment shortly, if they are not already doing so. There will be 2 arms of the trial. Patients on the 1st arm will receive Abiraterone, Prednisone and JNJ-56021927. Patients on the 2nd arm will receive Abiraterone, Prednisone and a placebo.