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The treatment of men with metastatic castration-resistant prostate cancer (mCRPC) continues to evolve as new agents gain approval. Most recently, the alpha emitting radiopharmaceutical radium-223 (Xofigo) was approved for patients with bone metastatic prostate cancer. This agent was initially explored as a palliative option, explains Leonard G. Gomella, MD. However, the investigation quickly changed once it was discovered that the agent improved survival.
In the phase III ALSYMPCA trial, which was the basis for the FDA approval of radium-223, 921 patients who were either intolerant or ineligible for docetaxel were randomized in a 2:1 ratio to receive radium-223 or placebo. In the trial, treatment was administered by injection every 4 weeks for 6 cycles. The study found that radium-223, as compared with placebo, significantly improved overall survival by a median of 3.6 months. Additionally, treatment with raidum-223 resulted in low myelosuppression rates and fewer adverse events, Gomella notes.
The growing number of therapies for mCRPC adds a new level of complexity and challenges to the treatment of patients, notes moderator Raoul S. Concepcion, MD. Further adding to this challenge, is the difficulty of conducting trials examining sequencing, due to the lack of an adequate surrogate endpoint. As a result of these challenges, the importance of a multidisciplinary treatment approach is further emphasized.
In the community setting, Lawrence I. Karsh, MD, notes that his institution utilizes an advanced prostate cancer panel to guide treatment decisions. This panel includes radiation oncologists, medical oncologists, nurses, urologists, and a representative from the billing department.
Now that effective treatments are available for patients with metastatic disease, it is more important to detect early metastases, even before symptoms become apparent, states Mark C. Scholz, MD. As a result of the prolongation in survival with these agents, Scholz believes they should be utilized earlier in the treatment paradigm.
Another challenge that has surfaced with the approval of these agents is the question of sequencing, notes Gomella. This topic will likely take 3 to 5 years to fully explore. Additionally, with the many new mechanisms of action, patient education is essential, to promote an informed treatment decision.
The key to solving these challenges is teamwork, believes Evan Y. Yu, MD. The trick to this approach is to foster an environment that encourages this approach. Additionally, Karsh adds, enrolling patients on clinical trials provides an opportunity to further understand the optimal administration of these agents. The level of advancements made so far would not have been possible without patients volunteering for clinical trials.