Algeta start enrollment in Ph III Alpharadin trial

Norwegian cancer therapeutics company Algeta has started patient recruitment in a pivotal Phase III clinical study of its monthly bolus injection Alpharadin (radium-223; Marketletters passim) in advanced, hormone-refractory prostate cancer that has metastasized to the skeleton.

The ALSYMPCA study is a double-blind, randomized, controlled trial that enrols symptomatic HRPC patients who will be randomized to receive Alpharadin plus best standard of care or placebo plus best standard of care. Approximately 750 patients are expected to be enrolled at more than 125 medical centers in Europe, Asia, South America and Canada.

The primary efficacy endpoint of the study is overall survival. Patients will be randomized two-to-one in favor of Alpharadin, which will be given as six injections of 50kBq/kg body weight, four weeks apart. Secondary endpoints include time to occurrence of specified disease-related events, and time to progression of certain key biomarkers indicative of disease status, including blood levels of serum prostate-specific antigen and total alkaline phosphatase. In addition, the trial is designed to monitor and evaluate both the acute and long-term safety profiles of Alpharadin treatment, as well as its impact on patient's quality of life.