According to a media release issued by Algeta this week, the company has completed patient enrollment into a large, Phase III trial evaluating radium-223 chloride in treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) in which metastases are clearly evident in bone.
The ALSYMPCA study is a double-blind, randomized, placebo-controlled, Phase III clinical trial designed to evaluate the efficacy and safety of Algeta’s radium-223-based, injectable form of radiation therapy (brand name Alpharadin). The study has a primary efficacy endpoint of overall survival; however, it is also designed to provide appropriate data on the safety profile of Alpharadin in clinical practice and its impact on quality of life.
Bone metastases are a primary cause of disability and death in patients with mCRPC. About 90 percent of men with this stage of prostate cancer have radiological evidence of bone metastasis. Older types of injectable radiation therapy, based on strontium-89 (Metastron) and samarium-153 (Quadramet), have been available as palliative therapy for patients with mCRPC in the USA and elsewhere around the world for about 15 years. However, neither of these products has ever been shown to extend survival compared to a placebo.
The ALSYMPCA trial began in June 2008. Target enrollment was 900 patients at more than 140 clinical centers worldwide, including 14 centers in the U.S. Results of the trial are expected some time in 2012. If trial results are positive, Algeta has stated that they would hope to file for regulatory approval of Alpharadin in the same year.