Medical Radiology and Radiation Safety. 2025. Vol. 70. № 2

DOI:10.33266/1024-6177-2025-70-2-113-118

P.V. Sychev1, Yu.D. Udalov1, 2

Results of Evaluation of Four Cycles of Radionuclide Therapy with a Domestic Radiopharmaceutical Based on Radium-223 Chloride for the Treatment of Bone Metastases

1 Federal Scientific Clinical Center for Medical Radiology and Oncology, Dimitrovgrad, Russia

2 A.I. Burnazyan Federal Medical Biophysical Center, Moscow, Russia

Contact person: Petr Vladimirovich Sychev, e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

ABSTRACT

Purpose: The evaluation of the efficacy and safety of a domestic radiopharmaceutical drug based on Radium-223 chloride in patients with bone metastases in comparison with the original drug.

Material and methods: In the period from 2022 to 2023, a study was conducted that included 36 patients diagnosed with metastatic castration–resistant prostate cancer in the absence of visceral metastases, who underwent planar osteoscintigraphy in the whole body mode and PET/CT with 18F-PSMA. In all patients included in the study, the fact of metastatic skeletal lesions and the absence of visceral metastases were confirmed by diagnostic studies before inclusion in the study. The effectiveness was assessed by comparing the data of planar osteoscintigraphy and PET/CT before the start of treatment and after cycle 4, as well as by assessing the pain syndrome. The safety of the drug was monitored by assessing hematological toxicity in dynamics before and after each cycle. In the study group, 22 patients (84.6 %), and in the control group, 14 patients (93.3 %) received 4 cycles of treatment. The fatal outcome was found in the research group in 3 people (11.5 %), in the control group in 1 patient (6.7 %) with a diagnosis of Covid-19. The general condition of the patients at the time of the fourth treatment cycle was satisfactory, there were no side effects in the form of redness at the injection site, nausea and vomiting.

Results: There was a deviation from the lower limits of normal in the study group in terms of hemoglobin level in 9 patients (35 %), in the control group in 6 patients (40 %), in neutrophil levels in 1 patient in the study group (3.8 %), in platelet level in 6 patients in the study group (23 %), in 5 patients in the control group (33.3 %), in the level of lymphocytes in 6 patients in the study group (23 %), which is associated with the underlying disease. The minimum values ​of the indicators did not require correction.

Conclusions: The first results of therapy with a domestic drug based on radium-223 chloride are comparable with the original drug.

Keywords: castration-resistant prostate cancer (CRPC), bone metastases, radionuclide therapy, radium-223 chloride, single-photon emission computed tomography, positron emission tomography

For citation: Sychev PV, Udalov YuD. Results of Evaluation of Four Cycles of Radionuclide Therapy with a Domestic Radiopharmaceutical Based on Radium-223 Chloride for the Treatment of Bone Metastases. Medical Radiology and Radiation Safety. 2025;70(2):113–118. (In Russian). DOI:10.33266/1024-6177-2025-70-2-113-118

 

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Conflict of interest. The authors declare no conflict of interest.

Financing. The study had no sponsorship.

Contribution. Article was prepared with equal participation of the authors.

Article received: 20.12.2024. Accepted for publication: 25.01.2025.