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, liver, soft tissue) greater than 1 cm.
5. The man has no brain metastases.
6. The man has not had any chemotherapy since the last Xofigo treatment cycle.
The trial will have as its primary outcomes (results):
• Evaluating the number of men with either treatment-related AEs (adverse events) or SAEs (serious adverse events) [ Time Frame: Up to 7 months ] [ Designated as safety issue: Yes ]
• NEvaluating the number of participants with Radium-223 dichloride-related SAEs in the active follow-up period [ Time Frame: Up to 2 years after last treatment ] [ Designated as safety issue: Yes ]
• Any changes in complete blood count [ Time Frame: Up to 2.5 years ] [ Designated as safety issue: Yes ]
• The total number of participants who discontinue Radium-223 dichloride treatment due to treatment emergent AEs or death [ Time Frame: Up to 7 months ] [ Designated as safety issue: Yes ]
To read more about the trial go to: Xofigo Re-treat Trial
ClinicalTrials.gov Identifier: NCT01934790
If you believe that you are qualified (having had Xofigo over 30 days prior) and would be interested in participating you should contact:
Dr. Oliver Sartor, Tulane University
Contact: Patrick Cotogno, email@example.com, (504) 988-6542
Joel T. Nowak, M.A., M.S.W.