How does the Radium 223 treatment work?
Radium targets bone cancer cells. This is because it is similar to calcium, which is also absorbed by bone cells. The cancer cells in the bone take up radium 223 and it then releases radiation which travels a very short distance. This means that the cancer cells receive a high dose of radiation which can destroy them.
What is Xofigo (radium 223 therapy)?
Radium 223 therapy (Xofigo) Radium 223 is a type of internal radiotherapy treatment for cancer that began in the prostate and has spread to the bones.
What is Radium-223 dichloride used to treat?
Radium-223 dichloride is a calcium-mimetic agent that specifically targets bone lesions. Radium-223 dichloride has been approved for the treatment of metastatic castration-resistant prostate cancer with symptomatic bone metastases, without known visceral metastases.
Can radium-223 be used to treat bone metastases of prostate cancer?
Background. Several drugs have been approved by the Food and Drug Administration (FDA) to prevent pain and fractures in patients with bone metastases, but none of these drugs improves the survival of men with prostate cancer. Radium-223 dichloride (radium-223) is a radioactive isotope that emits low levels of alpha particle radiation.
How long does radium-223 extend life?
Evidence sinthesis: According to the ALSYMPCA study, Radium 223 significantly prolongs the overall survival of patients with castration resistant prostate cancer and bone metastases; approximately 3.6 months in comparison with patients who received placebo, which turns into a median life expectancy of 14.9 months, and ...
How many times can you have radium treatment?
You usually have radium 223 as an injection into the bloodstream through a small tube (cannula) put into a vein. The injection takes up to a minute. You normally have the injection repeated every 4 weeks. You usually have it 6 times.
How long does Xofigo extend life?
XOFIGO SIGNIFICANTLY EXTENDS OVERALL SURVIVAL (OS) Median OS was 14.0 months (95% CI: 12.1-15.8) for Xofigo + best standard of care (BSOC) vs 11.2 months for BSOC (95% CI: 9.0-13.2).
What happens after radium treatment?
Ask your care team about the side effects you might get.Sore skin. In some people, radiotherapy can make the skin sore and red (similar to sunburn), darker than normal or dry and itchy. ... Tiredness. ... Hair loss. ... Feeling sick. ... Problems eating and drinking. ... Diarrhoea. ... Stiff joints and muscles. ... Sex and fertility issues.More items...
Do tumors grow back after radiation?
Normal cells close to the cancer can also become damaged by radiation, but most recover and go back to working normally. If radiotherapy doesn't kill all of the cancer cells, they will regrow at some point in the future.
Does radium 223 lower PSA?
Radium-223 may also reduce PSA levels. As most know, PSA levels are an indicator of cancer progression, with higher PSA values corresponding to worse outcomes. A significantly larger proportion of the radium-223 patients experienced at least a 30% reduction in PSA levels compared to the men who received a placebo.
How effective is Xofigo?
Effectiveness for prostate cancer those treated with Xofigo were 30% less likely to die than those treated with a placebo (a treatment containing no active drug) at least 50% of those treated with Xofigo lived for 14.9 months. at least 50% of those treated with a placebo lived for 11.3 months.
Is Xofigo a chemotherapy?
Xofigo (Radium 223 Dichloride) Chemotherapy Drug Information.
How much does Xofigo cost?
One concern about these new treatments is their high cost — Xofigo costs $69,000 for six injections, Bayer said. "They're adding two to three months, for a huge cost.
What are the treatments after radiotherapy?
For most people, the cancer experience doesn't end on the last day of radiation therapy. Radiation therapy usually does not have an immediate effect, and it could take days, weeks or months to see any change in the cancer. The cancer cells may keep dying for weeks or months after the end of treatment.
How long can you live after radiation therapy?
Median follow-up time for this report was 41 months (range=14.6-59.0). Following treatment with stereotactic radiation, more than eight in ten patients (84%) survived at least 1 year, and four in ten (43%) survived 5 years or longer. The median overall survival (OS) time was 42.3 months.
How long does it take for a tumor to shrink after radiation?
At the same time, if a cell doesn't divide, it also cannot grow and spread. For tumors that divide slowly, the mass may shrink over a long, extended period after radiation stops. The median time for a prostate cancer to shrink is about 18 months (some quicker, some slower).
More About Radium 223 Dichloride
Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug.
Clinical Trials Accepting Patients
Find Clinical Trials for Radium Ra 223 Dichloride - Check for trials from NCI's list of cancer clinical trials now accepting patients.
When was Radium 223 approved?
On May 15, 2013, based on interim results from the ALSYMPCA trial, the FDA approved radium-223 for the treatment of men with castration-resistant prostate cancer with bone metastases that are causing symptoms.
How many patients were in the Alpharadin trial?
The Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial enrolled 921 patients with metastatic, castration-resistant prostate cancer. Men in the trial were randomly assigned to receive either radium-223 (six intravenous injections, one every 4 weeks) plus the best standard of care or a placebo plus the best standard of care.
How much radiation does a syringe emit?
Once the drug, which can be given intravenously, reaches bone, it emits very low levels of radiation that travel less than 100 microns, or approximately four one-thou sandths of an inch, limiting damage to the surrounding tissues.
Does Xofigo help prostate cancer?
Results from a phase III trial called ALSYMPCA show that radium-223 dichloride (Xofigo®) improves overall survival in men with advanced prostate cancer that has spread to their bones compared with a placebo.
What Is Prostate Cancer?
Prostate cancer is one of the most common cancers among men. Approximately 1 in 9 men will be diagnosed with prostate cancer in their lifetime, and it is the second leading cause of cancer-related death in men in the United States.
What to Expect Before Treatment With Radium-223 Therapy (Xofigo)?
Our doctor must confirm that you have prostate cancer through existing studies and tests. Once this is confirmed, our doctor typically requests a series of tests to assess your general health.
What Will My Radium-223 Therapy (Xofigo) Treatment Schedule Look Like?
Our treating doctor will explain the damage to your body caused by prostate cancer and the consequences of not being treated. They will also explain the program you must follow to achieve the best possible treatment outcome with Radium-223 Therapy (Xofigo).
What to Expect During Treatment With Radium-223 Therapy (Xofigo)?
The treatment program for Radium-223 Therapy (Xofigo) consists of intravenous administration (peripheral route in one arm) of the drug.
How Long Does Treatment With Radium-223 (Xofigo) Take?
Radium-223 Therapy (Xofigo) is a relatively quick procedure, which will take no more than half an hour. The application of the intravenous drug takes no more than a minute.
What to Expect After Treatment With Radium-223 Therapy (Xofigo)?
After Radium-223 Therapy (Xofigo) treatment, there will be low-grade radioactivity from the patient. Small amounts of radioactivity may be present in the urine and stools.
How Long Before I Can Be Discharged After Treatment With Radium-223 (Xofigo) Therapy?
As it is an outpatient procedure, discharge after intravenous application will be quick – it will not take more than a couple of hours for the first side effects to subside. Generally speaking, within 1-2 hours, you may be on your way home.
How Should I Use This Medicine
This medicine is for injection into a vein. It is given by a health care professional in a hospital or clinic setting.
Ra Mechanism Of Action
223Ra is a radioactive isotope that decays to stable lead after a complex disintegration path with several radioactive daughters that produce four alpha particles . 223Ra decay chain is as follows: 223Ra 219Rn 215Po 211Pb 211Bi 207Tl 207Pb .
Snmmi 201: Current And Future Role Of Radium 223 In Prostate Cancer
Phillip Koo, MD, Gandaglia G, Karakiewicz PI, Briganti A, et al. Impact of the Site of Metastases on Survival in Patients with Metastatic Prostate Cancer. European urology 2015 68: 325-34. Suominen MI, Fagerlund KM, Rissanen JP, et al.
Clinical Trials Of Radium 223 Dichloride
The FDA approval for Xofigo was based on the results of a Phase III clinical study known as ALSYMPCA . It was a randomised, double-blind, placebo controlled study. It enrolled 921 patients at more than 100 centres across 19 countries. The patients enrolled had castration-resistant prostate cancer with symptomatic bone metastases.
Discussions With The Patient And Their Caregiver At The Start Of Radium
The healthcare provider has a responsibility to explain to the patient and their caregiver all of the approved options that are available to treat mCRPC, the rationale for selecting radium-223, and what the patient might expect during treatment .
The Potential Of Radium
The majority of patients with metastatic castration-resistant prostate cancer have evidence of bone metastases. Among available bone-targeted therapies, only radium-223 dichloride , a targeted alpha emitter that binds to areas of increased bone turnover in metastases, has been shown to improve survival rates.
How Radium 223 Dichloride Works
There are two different types of radiation therapy, which are known as external beam radiation and brachytherapy . Radium 223 dichloride is a mildly radioactive form of the metal radium and it is one of the drugs used in brachytherapy.
When was radium 223 approved?
On May 15, 2013 the U.S. Food and Drug Administration (FDA) expedited approval for Radium-223 for the treatment of prostate cancer bone mets that are causing symptoms. A subsequent follow-up analysis confirmed that significant extension of survival for Radium-223 patients. Furthermore, there were fewer study related adverse events ...
What is the radiation that binds with prostate cancer?
A more recent entry into the field is Radium-223 which has unique clinical properties. [i] Because it selectively seeks bone and bone formation, it binds with prostate cancer’s tumor-forming activity. Radium-223 emits high-energy alpha-particle radiation that has a toxic effect on the DNA of tumor cells.
What are the elements that are used to treat prostate cancer?
Isotopes are elements that emit radiation. Certain isotopes have been used successfully with prostate cancer bone mets to control pain, improve quality of life, and to a lesser extent prolong survival. These include Strontium-89, Samarium-153, and Rhenium. A more recent entry into the field is Radium-223 which has unique clinical properties.
What is the purpose of the Phase III trial?
The purpose of this Phase III trial was to compare the effectiveness of a promising radioisotope with that of a placebo in controlling prostate cancer that had spread to the bones, and to track survival. Prostate cancer bone mets. When prostate cancer spreads to the bones, it is no longer able to be cured.
Is radium 223 radioactive?
The path of the radioactive particles (alpha particles) emitted by Radium-223 is extremely short, so there is little-to-no effect on neighboring healthy tissues. The ALSYMPCA study began enrolling patients in 2008, the goal being to enroll 900 prostate cancer patients with bone mets but no other identified metastases.
Summary
- Results from a phase III trial called ALSYMPCA show that radium-223 dichloride (Xofigo®) improves overall survival in men with advanced prostate cancer that has spread to their bones compared with a placebo.
Background
- In most men with metastatic castration-resistant prostate cancer—prostate cancer that no longer responds to hormone therapy—the cancer spreads (metastasizes) to the bones. Bone metastases can cause intense pain, weakness, and bone fractures, greatly impairing quality of life—and in some cases causing death. Several drugs have been approved by the Food and Drug Administra…
The Study
- The Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial enrolled 921 patients with metastatic, castration-resistant prostate cancer. Men in the trial were randomly assigned to receive either radium-223 (six intravenous injections, one every 4 weeks) plus the best standard of care or a placebo plus the best standard of care. The tria...
Results
- Median overall survival was 14.9 months for the men assigned to receive radium-223 and 11.3 months for those assigned to the placebo. An overall survival benefit with radium-223 was seen in all subgroups of men analyzed—for example, men benefited whatever the extent of their disease and regardless of whether they had previously received docetaxel or were currently being treate…
Limitations
- The trial investigators, led by Christopher Parker, MD, of the Royal Marsden National Health Service Foundation Trust and Institute of Cancer Research (Sutton, United Kingdom), wrote that the study findings are likely to be “generalizable to routine clinical practice.” They also noted a potential limitation to the study, which is that despite its otherwise broad eligibility the trial did n…
Comment
- “This well-executed study shows a clear survival benefit in patients who had received the treatments that were available when the study was conducted, including standard chemotherapy,” said Bhupinder Mann, MBBS, of NCI’s Division of Cancer Treatment and Diagnosis. Drs. Vapiwala and Glatstein agreed. “The real-world applicability is undeniable; these patients had symptomati…