PLACE LABEL HERE
INFORMED CONSENT FOR
XOFIGO Ra-223 DICHLORIDE
(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
- 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%)
- 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