A New Treatment Method for Advanced Prostate Cancer with Xofigo (Radium-223)
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Bone Metastasis Treatment in Prostate Cancer: Xofigo (Radium-223)
Used when advanced prostate cancer has spread to the bones, Xofigo® (Radium-223), is a smart radiation treatment targeted at the atomic level that strikes cancer cells “from within.” By mimicking calcium, it settles in bone metastases and destroys the tumor with the alpha particles it emits. You can find all the details of this treatment below.
Drug Information
- Brand Name: Xofigo®
- Active Ingredient: Radium-223 dichloride
- Class: Radiopharmaceutical (Alpha-Particle Emitter)
- Category: Nuclear Medicine / Targeted Radionuclide Therapy
- Route of Administration: Intravenous (IV) Injection
- Manufacturer: Bayer
🇹🇷 Status in Türkiye (License, Price and SGK):
- License: It is licensed by the Ministry of Health but is not a “Pharmacy Medicine.” It is available only at hospitals licensed for Nuclear Medicine.
- Procurement: It is procured by the hospital. The patient cannot obtain it from a pharmacy with a prescription.
- Payment (SGK): Not covered.
- Price: The approximate cost of a single dose is approximately 140.000 TL - 170.000 TL (4.000$ - 5.000$) The total treatment consists of 6 doses.
Approved Indications
Xofigo was specifically developed for prostate cancer patients with bone metastases only. Its approved uses are as follows:
- Metastatic Castration-Resistant Prostate Cancer (mCRPC): Patients whose disease progresses despite hormone therapy (injections or pills).
- Symptomatic Bone Metastases: Patients with spread to the bones and associated pain or risk of fracture.
- Those Without Visceral Metastases: Suitable for patients without large metastases in organs such as the lungs or liver (or whose lymph nodes are smaller than 3 cm).
FDA Approval History
Xofigo is the first alpha-emitting drug proven to extend survival in prostate cancer:
- 15 May 2013 (Official Approval): The FDA approved the drug based on the results of the Phase 3 clinical study called ALSYMPCA.
- ALSYMPCA Study: This study demonstrated that Xofigo significantly prolonged overall survival compared with placebo (median 14.9 months versus 11.3 months) and delayed the time to the first skeletal event (such as a fracture).
What Is Xofigo and How Does It Work?
Xofigo is a very special molecule that acts like a biological “Trojan Horse.”
🔬 Mechanism of Action Details:
Because of its chemical structure, the Radium-223 molecule is mistaken for Calcium by the body:
- Calcium Mimicry: The body uses large amounts of calcium to repair damage in areas with bone metastases. When Xofigo enters the bloodstream, the body mistakes it for calcium and transports it directly to areas of bone containing tumors.
- Alpha Emission (Heavy Impact): Radium-223, which settles inside the tumor, begins emitting “alpha particles.” Alpha rays have very high energy but a very short range (only a few cell lengths).
- Double Effect: Thanks to this short range, it shreds the DNA of the cancer cell directly at the target site (double-strand breaks) while causing minimal damage to the healthy bone marrow immediately nearby.
Comparison: Xofigo (Alpha) vs. Other Radiation
The table below summarizes the difference between the alpha emitter Xofigo and older beta-emitting drugs (such as samarium):
| Feature | Xofigo (Radium-223) | Samarium-153 (Beta) | Lutetium-177 (PSMA) |
|---|---|---|---|
| Radiation Type | Alpha (α) - High Energy | Beta (β) - Low Energy | Beta (β) - Medium Energy |
| Range of Effect | Very Short (<0.1 mm) | Long (A few mm) | Medium (1-2 mm) |
| Bone Marrow Damage | Minimal | High | Medium |
| Contribution to Survival | Proven | Pain Relief Only | Proven |
Administration and Dosage
Xofigo treatment is administered on an outpatient basis in the Nuclear Medicine clinic:
- Who Administers It? Because it requires a license to use radioactive substances, the treatment may be administered only by a Nuclear Medicine Specialist Physician . Your oncology doctor plans the treatment, and Nuclear Medicine administers it.
- Dose Calculation: The dose is not standard; it is calculated according to the patient’s body weight . A dose of 55 kBq (Kilobecquerel) is administered per kilogram. (For example, the dose given that day to a 75 kg patient differs from the dose given that day to a 90 kg patient.)
- Treatment Schedule: A total of 6 doses is planned.
- Interval: An interval of 4 weeks (28 days) is observed between each injection.
- Administration: The drug is administered by slow intravenous (IV) injection (approximately 1 minutes).
- Is Hospitalization Required? No. Since alpha particles cannot even pass through a sheet of paper, the patient does not emit radiation into the surroundings and can return home immediately after treatment. There is no need to stay in a lead-lined room.
Precautions During Use
Because it is a radioactive treatment, certain special precautions must be taken:
- Hygiene (First 1 Week): The drug is largely excreted through the intestines. Great care should be taken with toilet hygiene, the toilet should be flushed twice, and hands should be washed thoroughly.
- Blood Counts: Blood tests are обязательно performed before every dose. If red blood cells, white blood cells, or platelets become too low, treatment may be delayed.
- Fluid Intake: Drinking plenty of water is recommended to facilitate elimination of the drug from the body.
- Concomitant Treatments: It is generally not administered at the same time as chemotherapy. However, hormone injections/pills (such as Zytiga and Xtandi) may be continued.
Side Effects
Xofigo generally has much milder side effects than chemotherapy:
- Common Effects:
- Diarrhea (%25): It is usually mild.
- Nausea (%36): It may occur on and after the day of treatment.
- Bone Pain: There may be a temporary increase in pain during the first few days after treatment (the “flare” effect), which indicates that the drug is working.
- Fatigue.
- Hematological Effects: Anemia, neutropenia (low immune cell count), or thrombocytopenia (risk of bleeding) may occur. Therefore, blood monitoring is critically important.
- Important: It does not cause hair loss.
References
- Parker C, Nilsson S, Heinrich D, et al. Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer. N Engl J Med. 2013;369:213-223. (ALSYMPCA Study)
- Bayer HealthCare. Xofigo (radium Ra 223 dichloride) injection: Prescribing Information.
- Sartor O, et al. Radium-223 in the treatment of metastatic castration-resistant prostate cancer. Oncologist. 2014.
Sources
Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369(3):213-223. doi: 10.1056/NEJMoa1213755
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