PLACE LABEL HERE

INFORMED CONSENT FOR

XOFIGO Ra-223 DICHLORIDE

Nuclear Medicine

(This form is designed to comply with the Georgia Informed Consent Law O.C.G.A. 31-9-6.1)

PATIENT NAME: ______DATE: ______TIME: ______

The diagnosis requiring this procedure is: Castration-resistant (cancer that is no longer responding to hormone therapy) prostate cancer with metastases to the bone.

The nature of the procedure is: Intravenous Xofigo Ra-223 dichloride therapy

The purpose of this procedure is:To destroy cancer cells in the bone, potentially delaying the progression of cancer andpossibly relieving the pain associated with cancer in the bone.

Potential side effects of Xofigo Ra-223 dichloride therapy:

Most common adverse reactions from Xofigo include (greater than 10%)

  • Nausea and Vomiting
  • Diarrhea
  • Peripheral edema (swelling of the extremities)
  • Infection or bleeding from lowering of blood counts (anemia, lymphocytopenia, leucopenia, thrombocytopenia, and neutropenia)

Less likely side effects (less than 10%)

  • Dehydration
  • Injection site reactions (redness, pain and swelling at the injection site)
  • Increased future cancer risk due to radiation exposure
  • Bone marrow failure and death

The likelihood of success of this procedure is: good  fair  poor

THE PRACTICAL ALTERNATIVES TO THIS PROCEDURE ARE: Analgesics (pain relieving medications), chemotherapy or other medical therapies, palliative radiation therapy, participation in a clinical trial.

If I choose not to have the above procedure, my prognosis (future medical condition) is: Uncertain.

I understand that the practice of medicine is not an exact science and that NO GUARANTEES OR ASSURANCES HAVE BEEN MADE TO ME concerning the results of this procedure.

I have read this consent for or it has been read to me. I have had the opportunity to have all of my questions answered to my satisfaction. I know that I can call my physician or the GHS Nuclear Medicine department with any questions that might arise. I hereby voluntarily request and consent for Dr. ______, as my physician, and any other physician(s), and such associates, assistants or other medical personnel involved in performing such procedure(s), to perform the procedure(s) described or referred to herein.

______

Date Time Person giving consent Relationship to patient

Patient unable to sign due to: ______

Responsible Practitioner’s Statement:

I have reviewed the contents of this form, including the risks, benefits and alternatives to the proposed procedure, with the patient or the patient’s decision-maker, and have provided the patient/decision-maker with an opportunity to ask questions.

______

Date Time Physician Signature PID Number

*1-37785* FORM 1-37785 REV. 12/2016 Page 1 of 1