Recently FDA has approved Apalutamide for the treatment of the patient with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy. In the present study, researcher evaluated the efficacy of the drug in such cases. Study Design: A double-blind, placebo-controlled trial was conducted for men with castration-resistant prostate cancer who were at high risk for the development of metastasis.
The patients were having prostate-specific antigen doubling time of 10 months or less. A total of 1207 patient underwent randomization 806 were assigned to the apalutamide group and 401 to the placebo group All the patients were 18 years of age or older Patients with local or regional nodal disease were excluded from this trail Methods: Patients received daily dose of 240mg apalutamide or matched placebo until protocol-defined progression, adverse…
