Introduction

Radium-223 dichloride (trade name: Xofigo) was approved in November 2013 for the treatment of prostate cancer that has spread to the bones (bone metastases) in men for whom a standard hormone blocker is no longer effective. In September 2018, the approval status was changed. Since then, radium-223 dichloride is only an option for men who have prostate cancer that is progressing despite two previous systemic treatments or for whom systemic treatment is no longer possible.

If prostate cancer is at an advanced stage, the tumor has spread to other parts of the body and complete recovery is no longer possible. Then systemic treatment is used. This means that the treatment has an effect on the whole body. Using medication to block the production of testosterone is one way to slow down the progression of the cancer. If the cancer progresses despite treatment with these hormone blockers, it is referred to as "hormone refractory" or "castration-resistant" metastatic prostate cancer. Other treatments are then often used as well, such as chemotherapy.

Radium-223 dichloride has been approved for use in patients who have bone metastases that are causing symptoms, such as pain.

Radium-223 dichloride is radioactive and collects mostly in the bones. When applied from a nearby source, it is supposed to slow the growth of the bone metastases. If there are metastatic tumors in other organs as well, it shouldn't be used.

Application

Radium-223 dichloride is injected slowly into a vein using a syringe. The exact dose will depend on the patient's body weight. One course of treatment consists of six injections. The injections are given four weeks apart.

Other treatments

Patients who have prostate cancer and bone metastases, and have had at least two previous systemic treatments – or patients for whom systemic treatment is not an option – receive best supportive care (BSC). BSC should be tailored to the patient's individual needs. The aim is to relieve pain and other symptoms, and improve quality of life.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether radium-223 dichloride has any advantages or disadvantages in men who have advanced prostate cancer that is progressing despite previous systemic treatments or in men who can't have systemic treatment. The manufacturer didn't provide any suitable data with which to answer this question.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of radium-223 dichloride (Xofigo).