Algeta Begins Phase III Clinical Study of Alpharadin in Men with Advanced Prostate Cancer
Algeta ASA has started patient recruitment in a pivotal phase III clinical study of its targeted therapeutic Alpharadin in advanced, hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton. This development follows the publication of phase II results showing that Alpharadin treatment provides a significant survival benefit in metastatic HRPC patients compared to placebo.
The ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study is a double-blind, randomised, 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 trial is overall survival. Patients will be randomized 2-to-1 in favor of Alpharadin, which will be given as six injections of 50 kBq/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 (PSA) and total alkaline phosphatase (ALP). In addition, the trial will monitor and evaluate both the acute and long-term safety profiles of Alpharadin treatment as well as its impact on quality of life.
The Co-ordinating Investigator for the ALSYMPCA study is Dr. Christopher Parker, a clinical oncologist and specialist in prostate cancer based at the Institute of Cancer Research and the Royal Marsden Hospital in Sutton, UK.
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