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About Xofigo®▼ (radium-223 dichloride) in mCRPC
For adult patients with metastatic castration-resistant prostate cancer (mCRPC)
Xofigo (+ best standard of care) is the first targeted alpha therapy to improve overall survival and slow down the decline of quality of life during on treatment period vs placebo + best standard of care (BSC) in mCRPC patients with symptomatic bone metastases and no known visceral metastases.
- The most frequently observed adverse reactions (≥ 10%) in patients receiving Xofigo were diarrhoea, nausea, vomiting, thrombocytopenia and bone fracture
- The most serious adverse reactions were thrombocytopenia and neutropenia
- Xofigo increases the risk of bone fractures. In clinical studies, concurrent use of bisphosphonates or denosumab reduced the incidence of fractures in patients treated with Xofigo
- Chemotherapy may be used after Xofigo*
- Low incidence of Grade 3–4 vomiting
- Can be administered without the need for steroids†
Xofigo is fully funded throughout the UK
Approved by NICE
Xofigo is NICE recommended as an option for treating patients with hormone-relapsed prostate cancer with 2 or more symptomatic bone metastases and no known visceral metastases if they have experienced disease progression after at least 2 lines of prior systemic therapy (other than LHRH analogues) or are ineligible for available systemic therapy options.
SMC accepted
For the treatment of adults with CRPC, symptomatic bone metastases and no known visceral metastases
To find out more, see Guidelines
mCRPC patients with symptomatic bone metastases should be treated early with Xofigo (prior to visceral metastases)
Introduce Xofigo for your mCRPC patients who have progressed on two lines of systemic therapy (other than LHRH analogues) or if ineligible for systemic therapy.
Identifying the right patients for treatment with Xofigo
Inclusion criteria for Xofigo following 2 prior lines or ineligible for systemic therapy
Xofigo is not recommended in patients with a low level of osteoblastic bone metastases.
How Xofigo may fit in to your treatment sequence
These are illustrative algorithms based on the revised EU indication for Xofigo. Not all potential treatment options are shown. Concurrent use of bone health agents to treat osteoporosis or for patients with bone metastases is recommended. Sequential use of abiraterone and enzalutamide (or vice versa) is not considered as an option due to likely futility of treatment. Consider clinical trials or best supportive care after all available systemic therapies have been administered.
Use Xofigo while there is an opportunity for action before the development of visceral metastases
Xofigo + BSC significantly extended median OS vs placebo + BSC
In the phase 3 ALSYMPCA trial, an updated analysis showed that
Median OS
Adapted from Parker C et al. 2013. ALSYMPCA was a double-blind, randomised, placebo-controlled, phase 3 study in 921 symptomatic mCRPC patients with 2 or more bone metastases. Patients were randomised 2:1 to receive 6 injections (one every 4 weeks) of Xofigo + BSC (n=614) or placebo + BSC (307). BSC included local EBRT or treatment with bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine, or ketoconazole. The primary endpoint was overall survival.
Xofigo + BSC significantly delays time to first symptomatic skeletal event (SSE) vs placebo + BSC
In the phase 3 ALSYMPCA trial, an updated analysis of secondary endpoints showed that
Median time to first SSE
Adapted from Parker C et al. 2013. ALSYMPCA was a double-blind, randomised, placebo-controlled, phase 3 study in 921 symptomatic mCRPC patients with bone metastases. Patients were randomised 2:1 to receive 6 injections (one every 4 weeks) of Xofigo + BSC (n=614) or placebo + BSC (307). BSC included local EBRT or treatment with bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine, or ketoconazole. SSEs were defined as EBRT for pain relief, spinal cord compression, tumour-related orthopaedic surgical interventions, bone fractures. The primary endpoint was overall survival.
Improved survival with Xofigo + BSC is accompanied by a slower decline in quality of life vs placebo + BSC
A post hoc analysis of the phase 3 ALSYMPCA trial showed that
In addition,
Patients with a meaningful improvement in FACT-P total score and EQ-5D utility score
Adapted from Nilsson S et al. 2016. ALSYMPCA was a double-blind, randomised, placebo-controlled, phase 3 study in 921 symptomatic mCRPC patients with bone metastases. Patients were randomised 2:1 to receive 6 injections (one every 4 weeks) of Xofigo + BSC (n=614) or placebo + BSC (307). BSC included local EBRT or treatment with bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine, or ketoconazole. The primary endpoint was overall survival. A post hoc analysis looked at health-related quality of life using two validated instruments: the general EQ-5D and the disease-specific FACT-P. Meaningful improvement defined as increase in FACT-P total score of ≥10 from baseline or an increase in EQ-5D utility score of ≥0.1 from baseline, at Week 16 and/or Week 24.
Safety profile of Xofigo + BSC was comparable to placebo + BSC
In the phase 3 ALSYMPCA trial, the rates of AEs were similar with Xofigo + BSC vs placebo + BSC.
ALSYMPCA was a double-blind, randomised, placebo-controlled, phase 3 study in 921 symptomatic mCRPC patients with bone metastases. The safety population included 600 patients in the Xofigo + BSC group and 301 patients in the placebo + BSC group.
For the full list of AEs, please refer to the SMPC link below:
Treatment considerations
*The haematological safety profiles for patients receiving chemotherapy after Xofigo were similar to those seen in patients receiving chemotherapy after placebo.
Patient considerations
†Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone. Concomitant use of steroids may further increase the risk of fracture.
Xofigo has a fixed course of treatment
Xofigo is administered as a 1-minute IV injection every 4 weeks for 6 injections.
Help your patients experience the benefits of Xofigo
Use of Xofigo is not recommended in patients with low levels of osteoblastic bone metastases.
PP-XOF-GB-0648 | April 2025
- 1Xofigo® Summary of Product Characteristics.
- 2Parker C, et al. Prostate Cancer Prostatic Dis. 2018;21(1):37-47.
- 3Parker C, et al. N Engl J Med. 2013;369(3):213-223.
- 4Nilsson S, et al. Ann Oncol. 2016;27(5):868-874.
- 5Suominen MI, et al. Clin Cancer Res. 2017;23(15):4335-4346.
- 6Nilsson S, et al. Ann Oncol. 2016;27(5):868-874. Supplementary data.
- 7NHS England. Cancer Drugs Fund List. Available from: https://www.england.nhs.uk/cancer/cdf/cancer-drugs-fund-list (Accessed April 2025).
- 8Scottish Medicines Consortium. Advice 1077/15. 2015. Available at: https://www.scottishmedicines.org.uk/medicines-advice/radium-223-xofigo-fullsubmission-107715/ (Last Accessed April 2025).
- 9National Comprehensive Cancer Network. NCCN Guidelines® Version 4.2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf (Last Accessed April 2025).
- 10Parker C, et al. Ann Oncol. 2015;26(suppl 5):v69-v77.
- 11O’Sullivan JM, et al. Eur Urol Oncol. 2019; doi:10.1016/j.euo.2019.02.007.
- 12Shore ND. Urology. 2015;85(4):717-724.
- 13Saad F, et al. Can Urol Assoc J. 2015;9(3-4):90-96.
- 14Cookson MS, et al. J Urol. 2015;193(2):491-499.
- 15Sartor O, et al. Prostate. 2016;76:905–916.
- 16Data on File. XOF-001. Bayer. 2016.