Now that Radium-223 Dichloride (Xofigo) has been approved by the FDA for use in men with castrate resistant prostate cancer with bone metastases we will begin to see the actual treatments happening. The next question in the process that will arise is whether or not it is safe and effective to re-treat an individual with additional rounds of the drug once it has failed.
In many of the other treatments we use for advanced prostate cancer we have found that it is possible to go back after a treatment failure and re-institute the treatment and see a positive result. Will this work with Xofigo and given that it is radiation is it safe to retreat a man?
To begin to answer these questions there will be a new phase 1-2 clinical trial to evaluate the potential of Xofigo retreatment. The trial whch is scheduled to begin in November (this month) still has not formerly begun.
It is expected to enroll 40 men who meet the following criteria:
1. The man has already received the full 6 treatments of Xofigo.
2. The man has finished the initial treatment cycle (6 injections) more than 30 days ago.
3. The man has no enlarged lymph nodes greater than 6 cm.
4. The man has no visceral metastases (lung,