Bayer HealthCare and Orion Corporation (a Finnish pharmaceutical company) have announced that they have begun enrollment in a randomized Phase III clinical trial of a new investigational treatment for men with advanced prostate cancer. ODM-201 is a novel, oral androgen receptor inhibitor.
The trial named ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial and has been designed to evaluate the efficacy and safety of ODM-201 in men with castration-resistant prostate cancer (CRPC) who have rising PSA levels and no detectable metastases. The trial is designed to determine the effects of ODM-201 on men’s metastasis-free survival.
The trial has been designed to enroll 1,500 men. As with many phase III trials, it will have a 2 to 1 ration so that 1,000 men will be treated with the investigational drug, ODM-201 (at a dose of 600 mg twice a day) and the other 500 will receive a matching placebo.
Malecare’s clinical trial enrollment page,
More information in advance of the trial opening for enrollment can find more about it at: http://clinicaltrials.gov/ct2/show/NCT02200614.
According to ClinicalTrials.gov the trial has not yet started to enroll in the United States so you will need to check back to see when enrollment status changes.
Metastasis-free survival is defined as the time from entry into the trial to evidence of metastasis or death from any cause.
Secondary endpoints of this study include overall survival, time to a first symptomatic skeletal event (SSE), time to initiation of first cytotoxic chemotherapy, and time to pain progression.
Joel T Nowak, M.A., M.S.W.
Even with a 2:1 ratio drug to placebo who in their right mind is going to risk being put in a placebo arm? I was in that space then tried Nilutamide then I became metastatic. If I did had not already done Fereheme scans which found suspicious nodes (radiated) prior that becoming bone metastatic I would have gone the C11 route and in the hope that something actionable was found. I am all for betterment of science but IMHO these true placebo arms have to go in advanced disease.