Algeta Announces first US Patient Randomized in ALSYMPCA Phase III Study
News Dec 16, 2009
Algeta ASA announces that the first clinical center in the US, the Tulane Cancer Center, New Orleans, has started randomizing patients in the phase III clinical study of Alpharadin in men with castration-resistant (also known as hormone-refractory) prostate cancer (CRPC) that has metastasized to the skeleton.
The ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study is a double-blind, randomized, controlled trial that enrols patients with CRPC and symptomatic bone metastases who will be randomized to receive Alpharadin (radium-223 chloride) 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 worldwide. Algeta expects to enroll patients across up to 15 sites in the US. Global recruitment remains on schedule and is expected to be complete by the second half of 2010.
The Principal Investigator of the ALSYMPCA study in the US is Dr. Oliver Sartor, Piltz Professor of Cancer Research in the Departments of Medicine and Urology at Tulane University School of Medicine at the Tulane Cancer Center in New Orleans. The Tulane Cancer Center is one of the top cancer-focused medical centers in the US.