Phase 3 Trial Testing Darolutamide in Castration-resistant Prostate Cancer Expected to Conclude in September

Phase 3 Trial Testing Darolutamide in Castration-resistant Prostate Cancer Expected to Conclude in September
A Phase 3 clinical trial evaluating darolutamide (ODM-201) as a treatment for castration-resistant prostate cancer patients at high risk for metastasis is expected to conclude in September 2018, Orion, the therapy's maker, announced. Initiated in 2014, the ARAMIS trial (NCT02200614) is part of a collaboration between Orion and Bayer to develop the investigational androgen receptor inhibitor. This multicenter, randomized Phase 3 trial is evaluating darolutamide versus a placebo in non-metastatic castration-resistant prostate cancer patients at high risk for metastasis. The trial was designed to enroll 1,500 participants across 400 clinical centers worldwide. Patients will receive treatment twice daily until they develop metastasis or for up to six years. Patients must have not received prior second-generation androgen receptor inhibitors, CYP17 enzyme inhibitors (which prevents steroid synthesis), chemotherapy, or immunotherapy. Treatment with bisphosphonates or denosumab — therapies that prevent bone damage — in the 12 weeks prior to randomization were also excluding factors. The trial's primary goal is to determine if patients on darolutamide live longer without developing metastasis compared with those receiving placebo. Researchers will also assess if darolutamide extends patients' lives, delays symptomatic skeletal problems, and delays the need for chemotherapy. The amount of time to pain progression, along with the therapy's safety and tolerability, will also be evaluated. In laboratory studies, darolutamide showed a great affinity toward the androgen receptor, blocking its activity and preventing the growth of prostate cancer cells. In contrast with other androgen receptor inhibitors, the medicine showed minimal penetration of the blood-br
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