Radium-223 has been studied in comparison with other treatment modalities ( 19). There were no clinically significant differences in hematologic adverse events with radium-223 treatment ( 4).Ĭurrent treatment guidelines for mCRPC include hormonal agents like abiraterone acetate and enzalutamide, the chemotherapeutic agent cabazitaxel, the immunotherapeutic agent sipuleucel-T, and radium-223 ( 19, 21).
#RADIUM 223 TREATMENT TRIAL#
The trial also showed delayed development of skeletal complications and a significant reduction of the risks of spinal cord compression and requirement for external beam radiation therapy ( 4). Testing a total of six injections of radium-223 per patient, the trial showed a significant improvement in overall survival rates and improved quality of life with treatment ( 20). The ALSYMPCA trial, which concluded in 2013, was a randomized, double-blind, multinational phase 3 trial. Two additional randomized, double-blinded phase 2 trials were conducted (BC1-03 and BC1-04) before starting the ALSYMPCA (ALpharadin in SYMPtomatic Prostate Cancer) trial ( 19). This study showed that adverse events, including serious adverse events, were more common when patients were not treated with radium-223 ( 18). It was a randomized double-blind placebo-controlled multicenter phase 2 trial.
The BC1-02 was the second clinical study conducted in 2002. They concluded that radium-223 was tolerated well at therapeutic dosages, with pain relief and positive effects on serum markers as indications of its anticancer effect ( 17). The first-in-human trial was conducted in 2000 by Nilsson et al to study the safety and tolerability of radium-223. Complications include significant bone pain, skeletal-related complications such as pathologic fractures, malignant hypercalcemia, bone marrow suppression, and spinal cord compression ( 5– 7). When this disease presents with detectable macroscopic metastases, patients are considered to have metastatic CRPC (mCRPC), which has a poor prognosis and an expected survival of 18 to 20 months. However, there is inevitable progression to castration-resistant prostate cancer (CRPC), which develops despite castration levels of testosterone. Patients are initially treated with either chemical or surgical androgen deprivation therapies. Bone metastases can be present in more than 90% of patients with advanced prostate cancer, leading to significant morbidity and mortality ( 3, 4). About 85% of cases present with localized disease, but nearly 40% progress to metastatic cancer. In 2014, prostate cancer accounted for 24% and 27% of all new male cancer cases in Canada and the US, respectively ( 1, 2). Nearly 14% of men will be diagnosed with prostate cancer at some point in their life. Prostate cancer is the most common malignancy in men in the United States and Europe and is the third leading cause of cancer-related death in men.
0 kommentar(er)
