1. Perma Permanent Brachytherapy Medical Events: Experiences of Pennsylvania Frank Costello Organization of Agreement States August 28, 2012 Milwaukee, Wisconsin

2. Prostate Seed Implants Permanent placement of radioactive seeds directly into the prostate gland Seeds are tiny welded titanium canisters Primarily I-125, Cs-131, and Pd-103

3. Prostate Implant Image Guided Seed Implantation Using Trans-rectal Ultrasound

4. Seed Implantation

5. What are the Rules? 10 CFR 35.40 – Written Directives 10 CFR 35.41 – Procedures  Replaced QM Rule 10 CFR 35.3045 – Medical Events

6. 10 CFR 35.40 Written Directives AU Signature, Date, & Patient Name Before Implantation  Radionuclide  Treatment Site  Dose After Implantation  Radionuclide  Treatment site  Number of sources and total strength  Exposure time or total dose

7. 10 CFR 35.41 Procedures Licensee shall develop, implement, and maintain written procedures to provide high confidence:  Patient identity verified before administration  Administration in accordance with WD  Check Computer and Manual Dose Calculations  Verify computer dose calculations correctly transferred to therapeutic medical unit console

8. 10 CFR 35.41 Procedures Trained and qualified personnel Appropriate equipment and treatment planning systems, e.g. VariSeed program Image guided procedures Post Treatment Fluoroscopy 30 Day CT

9. 10 CFR 35.3045 Medical Events Dose differs from prescribed dose  5 rem Effective Dose Equivalent  50 rem to an organ or tissue  50 rem Shallow Dose Equivalent, AND Total dose differs from prescribed dose by 20% or more AND/OR Dose to other than Treatment Site* >50 rem to organ or tissue >50% of expected dose *Excluding permanent implant seeds that were implanted correctly, but migrated outside the treatment site

10. Variables affect delivered dose Changes in anatomy from pre-planning to implant date to post-implant CT or MRI date (shrinkage from hormone treatment, swelling/shrinkage from tissue trauma). Differences in image contrast mechanisms cause prostate to appear differently on ultrasound vs. CT vs. MRI. Seed migration. As a result, post-implant dosimetry calculations are estimates rather than precise determinations of delivered dose.

11. PA Permanent Brachytherapy Events Date: June 11, 2009 (not reported) Licensee A Prescribed Dose: 145 gray Administered Dose: 92 gray Comment: Patient sent to another cancer center for additional brachytherapy treatment to “cold spots” in prostate. Licensee then changed process (Foley catheter bulb).

12. PA Permanent Brachytherapy Events Date: October 5, 2009 (not reported) Licensee B Prescribed Dose: 144 gray Administered Dose: 81.96 gray Comment: Unreported because it was an underdose and licensee completed treatment with external-beam therapy.

13. PA Permanent Brachytherapy Events Date: January 21, 2010 (reported) Licensee A Prescribed Dose: 145 gray Administered Dose: 0.5 gray Comment: No seeds were placed in prostate. Penile bulb received 161 gray. Doctor’s unfamiliarity with new ultrasound unit may have contributed to event.

14. PA Permanent Brachytherapy Events Date: November 2, 2010 (reported) Licensee C Prescribed Dose: 85 gray Administered Dose: 114 gray Comment: Incorrect dose was entered into the VariSeed program. Licensee did not compare written directive with printed treatment plan.

15. PA Permanent Brachytherapy Events Date: January 20, 2012 (reported) Licensee D Prescribed Dose: 110 gray Administered Dose: 75 gray Comment: Possibly caused by prostate edema

16. So, What are the Lessons Learned? Understand that the determination of medical events for prostate brachytherapy is difficult. D90 isn’t the sole consideration.

17. So, What are the Lessons Learned? Under the current rule, licensees in good faith may struggle to know if a given event is reportable.

18. So, What are the Lessons Learned? Inspection Techniques  Ask if there have been any medical events?  Spot check the 35.41 procedures  How would the licensee identify a medical event?  Review a sample of written directives  Talk to RSO, medical physicist, radiation oncologist, etc.

19. So, what are the Lessons Learned? Medical staff may take position that ultrasound guided implants may meet 10 CFR 35.41 requirement to provide high confidence that treatment is IAW Treatment Plan/WD, and that a 30 day CT not necessary. Patients may not return for 30 day CT due to long distance or lack of motivation.

20. So, What are the Lessons Learned? If you identify cases  Where the D90 is less than 80% of the prescribed dose, and/or,  Where less than 80% of the seeds are inside the prostate Collect the data and bring it back to the office for further review.

21. Current Rulemaking Rulemaking on permanent implant brachytherapy has been in progress for a long time. Included in current ongoing Part 35 rulemaking. Dose-based rule? Activity-based rule? Combination? Hard to achieve consensus.

22. Modest Suggestions Recognize that licensees have a day to make this report after identifying a medical event. Avoid notification of patients when their treatment was actually acceptable. Create rule that is clear, unambiguous, and acknowledged by the medical community as identifying unacceptable treatments. New rule does not have to be consistent with the conclusions of the VA-Philadelphia inspection and enforcement action.

23. Looking to the Future… Similar issues have been identified in PA associated with the use of microspheres in radiation therapy. Future presentation…

24. Questions?

25. Frank Costello DEP Radiation Health Physicist fcostello@pa.gov www.depweb.state.pa.us 484-250-5833 fcostello@pa.gov www.depweb.state.pa.us