RESUMO
INTRODUCTION: In 2014, the incidence of prostate cancer in the Russian Federation was 116.4 per 100,000 population. It is noteworthy that from 2004 to 2014, the proportion of patients with stage I-II prostate cancer increased from 35.5% to 52.5%, while that of patients with stages III and IV disease decreased from 38.4% to 29% and from 22.7% to 16.5%, respectively. All of this allows an increasing number of prostate cancer patients to be treated with radical treatment - low dose-rate brachytherapy. For the first time in this country, we report a clinical trial of low dose-rate brachytherapy for prostate cancer using domestically manufactured I-125 seeds. The successful results of this clinical trial are presented in this article. The aim of this work was to show the clinical efficacy and safety of domestically manufactured I-125 seeds for low dose-rate prostate cancer brachytherapy. MATERIALS AND METHODS: The clinical trial comprised 36 patients with stage T1-T2 prostate cancer. Patients were randomly assigned according to the risk of cancer progression. Low and intermediate risk groups comprised 30 (83.3%) and 6 (16.7%) patients, respectively. Patients of low risk group underwent brachytherapy alone with the minimum therapeutic dose of 145 Gy. I-125 seeds of two activities, 0.55 and 0.35 mCi per seed were used for implantation. Depending on the prostate volume, from 40 to 80 seeds, 57 on average were implanted. Mean implantation time was 85 minutes. In patients of the intermediate risk group brachytherapy was performed in combination with laparoscopic pelvic lymphadenectomy which was carried out 4-5 weeks prior to brachytherapy. RESULTS: Follow-up examination at 6 months after implantation showed that PSA decreased in all patients on average by 87% from the baseline. No adverse events were reported. CONCLUSION: The findings of the clinical trials of domestically manufactured I-125 seeds showed they are effective, safe and comply with international standards.