<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">clinicaloncology</journal-id><journal-title-group><journal-title xml:lang="ru">Клинический случай в онкологии</journal-title><trans-title-group xml:lang="en"><trans-title>Clinical Case in Oncology</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">3034-1477</issn><issn pub-type="epub">3034-4018</issn><publisher><publisher-name>ОНКОПРАКТИК</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.62546/3034-1477-2025-3-4-7-17</article-id><article-id custom-type="elpub" pub-id-type="custom">clinicaloncology-144</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>КЛИНИЧЕСКИЕ СЛУЧАИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>CASE REPORTS</subject></subj-group></article-categories><title-group><article-title>Даролуамид в сочетании с андроген-депривационной терапией как новый метод лечения метастатического гормоночувствительного рака предстательной железы</article-title><trans-title-group xml:lang="en"><trans-title>Daroluamid in combination with androgen-deprivation therapy as a new method of treatment of mHSPCa</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6276-1716</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Беркут</surname><given-names>М. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Berkut</surname><given-names>Maria V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Беркут Мария Владимировна,</p><p>Санкт-Петербург.</p></bio><bio xml:lang="en"><p>St. Petersburg.</p></bio><email xlink:type="simple">berkutv91@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-5275-482X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Заозерский</surname><given-names>О. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Zaozersky</surname><given-names>Oleg V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Заозерский Олег Вячеславович,</p><p>Санкт-Петербург.</p></bio><bio xml:lang="en"><p>St. Petersburg.</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0008-8245-6234</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Горлин</surname><given-names>П. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Gorlin</surname><given-names>Petr M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Горлин Петр Михайлович,</p><p>Санкт-Петербург.</p></bio><bio xml:lang="en"><p>St. Petersburg.</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0004-1819-2845</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кондратьева</surname><given-names>А. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Kondratyeva</surname><given-names>Anastasia G.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Кондратьева Анастасия Геннадьевна,</p><p>Санкт-Петербург.</p></bio><bio xml:lang="en"><p>St. Petersburg.</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-3850-7109</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Носов</surname><given-names>А. К.</given-names></name><name name-style="western" xml:lang="en"><surname>Nosov</surname><given-names>Alexander K.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Носов Александр Константинович,</p><p>Санкт-Петербург.</p></bio><bio xml:lang="en"><p>St. Petersburg.</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Национальный медицинский исследовательский центр онкологии им. Н. Н. Петрова</institution><country>Россия</country></aff><aff xml:lang="en"><institution>National Medical Research Center of Oncology named after N. N. Petrov</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>06</day><month>08</month><year>2026</year></pub-date><volume>3</volume><issue>4</issue><fpage>7</fpage><lpage>17</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Беркут М.В., Заозерский О.В., Горлин П.М., Кондратьева А.Г., Носов А.К., 2026</copyright-statement><copyright-year>2026</copyright-year><copyright-holder xml:lang="ru">Беркут М.В., Заозерский О.В., Горлин П.М., Кондратьева А.Г., Носов А.К.</copyright-holder><copyright-holder xml:lang="en">Berkut M.V., Zaozersky O.V., Gorlin P.M., Kondratyeva A.G., Nosov A.K.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.oncocase.ru/jour/article/view/144">https://www.oncocase.ru/jour/article/view/144</self-uri><abstract><p>Представлен клинический случай ведения пациента с метастатическим гормоночувствительным раком предстательной железы и высокой метастатической нагрузкой, получавшего терапию даролутамидом в сочетании с андрогенной депривационной терапией. Выбор схемы был обусловлен выраженной сопутствующей патологией и высоким риском межлекарственных взаимодействий, вследствие чего врачебная комиссия определила целесообразность применения препарата с благоприятным профилем безопасности. На фоне лечения отмечается существенный клинический эффект, включая достижение неопределяемого уровня простатспецифического антигена и частичный регресс метастатических очагов. Особое внимание уделено обсуждению значимости проблемы риска развития межлекарственных взаимодействий и роли даролутамида в терапии пациентов старшей возрастной группы с полипрагмазией.</p></abstract><trans-abstract xml:lang="en"><p>This clinical case report presents the management of a patient with high-volume hormone-sensitive metastatic prostate cancer treated with a combination of darolutamide and androgen deprivation therapy. The treatment choice was driven by significant comorbidities and a high risk of drug–drug interactions, supporting the rationale for selecting a therapy with a favorable safety and interaction profile. The patient achieved a marked clinical benefit, including an undetectable PSA level and partial regression of metastatic lesions. Special attention is given to the clinical relevance of drug–drug interactions and the role of darolutamide in managing elderly patients with polypharmacy.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>метастатический гормоночувствительный рак предстательной железы</kwd><kwd>ARANOTE</kwd><kwd>даролутамид</kwd><kwd>доцетаксел</kwd><kwd>андрогендепривационная терапия</kwd></kwd-group><kwd-group xml:lang="en"><kwd>metastatic hormone-sensitive prostate cancer</kwd><kwd>ARANOTE</kwd><kwd>darolutamide</kwd><kwd>docetaxel</kwd><kwd>androgen-deprivation therapy</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Каприн А.Д., Старинский В.В., Шахзадова А.О. Состояние онкологической помощи населению России в 2024 году / под ред. А.Д.Каприна. М.: МНИОИ им. П.А.Герцена филиал ФГБУ «НМИЦ радиологии» Минздрава России, 2025. 275 с. ISBN 978-5-85502-309-1; URL: https://glavonco.ru/upload/onco2024.pdf (дата обращения 17.12.2025).</mixed-citation><mixed-citation xml:lang="en">Kaprin A.D., Starinsky V.V., Shakhzadova A.O. The state of oncological care for the population of Russia in 2024. Ed. by A.D.Kaprin. Moscow: P.A.Herzen Moscow Oncology Research Institute branch of the Federal State Budgetary Institution «NMITs Radiology» of the Ministry of Health of the Russian Federation, 2025. 275 p. ISBN: 9785-85502-309-1; URL: https://glavonco.ru/upload/onco2024.pdf  (date of access 17.12.2025) (In Russ.).</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Siegel R.L., Miller K.D., Wagle N.S. et al. Cancer statistics, 2023 // CA: a cancer journal for clinicians. 2023. Vol. 73 (1). P. 17–48. doi: 10.3322/caac.21763.</mixed-citation><mixed-citation xml:lang="en">Siegel R.L., Miller K.D., Wagle N.S. et al. Cancer statistics, 2023 // CA: a cancer journal for clinicians. 2023. Vol. 73 (1). P. 17–48. doi: 10.3322/caac.21763.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Harris W.P., Mostaghel E.A., Nelson P.S. et al. Androgen deprivation therapy: progress in understanding mechanisms of resistance and optimizing androgen depletion. Nature clinical practice // Urology . 2009. Vol. 6 (2). P. 76–85. doi: 10.1038/ncpuro1296.</mixed-citation><mixed-citation xml:lang="en">Harris W.P., Mostaghel E.A., Nelson P.S. et al. Androgen deprivation therapy: progress in understanding mechanisms of resistance and optimizing androgen depletion. Nature clinical practice // Urology . 2009. Vol. 6 (2). P. 76–85. doi: 10.1038/ncpuro1296.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Leith A., Ribbands A., Kim J. et al. Impact of next-generation hormonal agents on treatment patterns among patients with metastatic hormone-sensitive prostate cancer: a real-world study from the United States, five European countries and Japan // BMC urology. 2022. Vol. 22 (1). P. e33. doi: 10.1186/s12894-022-00979-9.</mixed-citation><mixed-citation xml:lang="en">Leith A., Ribbands A., Kim J. et al. Impact of next-generation hormonal agents on treatment patterns among patients with metastatic hormone-sensitive prostate cancer: a real-world study from the United States, five European countries and Japan // BMC urology. 2022. Vol. 22 (1). P. e33. doi: 10.1186/s12894-022-00979-9.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Aly M., Leval A., Schain F. et al. Survival in patients diagnosed with castration-resistant prostate cancer: a population-based observational study in Sweden // Scandinavian journal of urology. 2020. Vol. 54 (2). P. 115–121. doi: 10.1080/21681805.2020.1739139.</mixed-citation><mixed-citation xml:lang="en">Aly M., Leval A., Schain F. et al. Survival in patients diagnosed with castration-resistant prostate cancer: a population-based observational study in Sweden // Scandinavian journal of urology. 2020. Vol. 54 (2). P. 115–121. doi: 10.1080/21681805.2020.1739139.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Kyriakopoulos C.E., Chen Y.H., Carducci M.A. et al. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial // Journal of clinical oncology. 2018. Vol. 36 (11). P. 1080–1087. doi: 10.1200/JCO.2017.75.3657.</mixed-citation><mixed-citation xml:lang="en">Kyriakopoulos C.E., Chen Y.H., Carducci M.A. et al. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial // Journal of clinical oncology. 2018. Vol. 36 (11). P. 1080–1087. doi: 10.1200/JCO.2017.75.3657.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Huggins С. Studies on prostatic cancer: The effects of castration on advanced carcinoma of the prostate gland // Archives of Surgery. 1941. Vol. 43 (2). P. 209–223. doi: 10.1001/archsurg.1941.01210140043004.</mixed-citation><mixed-citation xml:lang="en">Huggins С. Studies on prostatic cancer: The effects of castration on advanced carcinoma of the prostate gland // Archives of Surgery. 1941. Vol. 43 (2). P. 209–223. doi: 10.1001/archsurg.1941.01210140043004.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Clarke N.W., Ali A., Ingleby F.C. et al. Addition of docetaxel to hormonal therapy in lowand high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial // Annals of oncology . 2019. Vol. 30 (12). P. 1992–2003. doi: 10.1093/annonc/mdz396.</mixed-citation><mixed-citation xml:lang="en">Clarke N.W., Ali A., Ingleby F.C. et al. Addition of docetaxel to hormonal therapy in lowand high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial // Annals of oncology . 2019. Vol. 30 (12). P. 1992–2003. doi: 10.1093/annonc/mdz396.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Fizazi K., Tran N., Fein L. et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer // The New England journal of medicine. 2017. Vol. 377 (4). P. 352–360. doi: 10.1056/NEJMoa1704174.</mixed-citation><mixed-citation xml:lang="en">Fizazi K., Tran N., Fein L. et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer // The New England journal of medicine. 2017. Vol. 377 (4). P. 352–360. doi: 10.1056/NEJMoa1704174.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Davis I.D., Martin A.J., Stockler M.R. et al. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer // The New England journal of medicine . 2019. Vol. 381 (2). P. 121–131. doi: 10.1056/NEJMoa1903835.</mixed-citation><mixed-citation xml:lang="en">Davis I.D., Martin A.J., Stockler M.R. et al. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer // The New England journal of medicine . 2019. Vol. 381 (2). P. 121–131. doi: 10.1056/NEJMoa1903835.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Chi K.N., Agarwal N., Bjartell A. et al. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer // The New England journal of medicine. 2019. Vol. 381 (1). P. 13–24. doi: 10.1056/NEJMoa1903307.</mixed-citation><mixed-citation xml:lang="en">Chi K.N., Agarwal N., Bjartell A. et al. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer // The New England journal of medicine. 2019. Vol. 381 (1). P. 13–24. doi: 10.1056/NEJMoa1903307.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Saad F., Vjaters E., Shore N. et al. Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial // Journal of clinical oncology. 2024. Vol. 42 (36). P. 4271–4281. doi: 10.1200/JCO-24-01798.</mixed-citation><mixed-citation xml:lang="en">Saad F., Vjaters E., Shore N. et al. Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial // Journal of clinical oncology. 2024. Vol. 42 (36). P. 4271–4281. doi: 10.1200/JCO-24-01798.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Smith M.R., Hussain M., Saad F. et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer // The New England journal of medicine. 2022. Vol. 386 (12). P. 1132–1142. doi: 10.1056/NEJMoa2119115.</mixed-citation><mixed-citation xml:lang="en">Smith M.R., Hussain M., Saad F. et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer // The New England journal of medicine. 2022. Vol. 386 (12). P. 1132–1142. doi: 10.1056/NEJMoa2119115.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Fizazi K., Foulon S., Carles J. et al. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2×2 factorial design // Lancet. 2022. Vol. 399 (10336). P. 1695–1707. doi: 10.1016/S01406736(22)00367-1.</mixed-citation><mixed-citation xml:lang="en">Fizazi K., Foulon S., Carles J. et al. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2×2 factorial design // Lancet. 2022. Vol. 399 (10336). P. 1695–1707. doi: 10.1016/S01406736(22)00367-1.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">ASCO 2025: Phase III ARANOTE Post-hoc Analyses Presented on Health-Related Quality of Life and Pain Outcomes in Patients with Metastatic Castration-Sensitive Prostate Cancer Receiving NUBEQA® (darolutamide) plus ADT. URL: https://www.bayer.com/en/us/news-stories/nubeqa-androgen-receptor-inhibitor (date of access 10.12.2025). Text : electronic.</mixed-citation><mixed-citation xml:lang="en">ASCO 2025: Phase III ARANOTE Post-hoc Analyses Presented on Health-Related Quality of Life and Pain Outcomes in Patients with Metastatic Castration-Sensitive Prostate Cancer Receiving NUBEQA® (darolutamide) plus ADT. URL: https://www.bayer.com/en/us/news-stories/nubeqa-androgen-receptor-inhibitor (date of access 10.12.2025). Text : electronic.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Benzo R., Moreno P.I., Fox R.S. et al. Comorbidity burden and health-related quality of life in men with advanced prostate cancer // Research square. 2023. Vol. 3. P. e2572781 (electronic). doi: 10.21203/rs.3.rs-2572781/v1.</mixed-citation><mixed-citation xml:lang="en">Benzo R., Moreno P.I., Fox R.S. et al. Comorbidity burden and health-related quality of life in men with advanced prostate cancer // Research square. 2023. Vol. 3. P. e2572781 (electronic). doi: 10.21203/rs.3.rs-2572781/v1.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">Ibáñez C., Tourís-Lores M., Montesa M. et al. Drug-drug interactions in metastatic hormone-sensitive prostate cancer (mHSPC): practical considerations for treating men with androgen receptor pathway inhibitors and common medications in this stage // Expert opinion on drug metabolism &amp; toxicology. 2025. Vol. 21 (6). P. 625–636. doi: 10.1080/17425255.2025.2478167.</mixed-citation><mixed-citation xml:lang="en">Ibáñez C., Tourís-Lores M., Montesa M. et al. Drug-drug interactions in metastatic hormone-sensitive prostate cancer (mHSPC): practical considerations for treating men with androgen receptor pathway inhibitors and common medications in this stage // Expert opinion on drug metabolism &amp; toxicology. 2025. Vol. 21 (6). P. 625–636. doi: 10.1080/17425255.2025.2478167.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Ruplin A., Segal E., McFarlane T. Review of drug-drug interactions in patients with prostate cancer // Journal of oncology pharmacy practice. 2024. Vol. 30 (6). P. 1057–1072. doi: 10.1177/10781552241238198.</mixed-citation><mixed-citation xml:lang="en">Ruplin A., Segal E., McFarlane T. Review of drug-drug interactions in patients with prostate cancer // Journal of oncology pharmacy practice. 2024. Vol. 30 (6). P. 1057–1072. doi: 10.1177/10781552241238198.</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">Gravis G., Fizazi K., Joly F. et al. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial // The Lancet. Oncology. 2013. Vol. 14 (2). P. 149–158. doi: 10.1016/S1470-2045(12)70560-0.</mixed-citation><mixed-citation xml:lang="en">Gravis G., Fizazi K., Joly F. et al. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial // The Lancet. Oncology. 2013. Vol. 14 (2). P. 149–158. doi: 10.1016/S1470-2045(12)70560-0.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
