Радиолигандная терапия 177Lu-ПСМА при кастрационно-резистентном раке предстательной железы. Обзор литературы и серия клинических примеров

Волкова М.И., Крылов А.С., Носов Д.А., Алексеев Б.Я. Радиолигандная терапия ¹⁷⁷Lu-ПСМА при кастрационно-резистентном раке предстательной железы. Обзор литературы и серия клинических примеров. Современная Онкология. 2025;27(4):331–339. DOI: 10.26442/18151434.2025.4.203504

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Volkova MI, Krylov AS, Nosov DA, Alekseev BYa. Radioligand therapy with ¹⁷⁷Lu-PSMA in castration-resistant prostate cancer: A literature review and case series. Journal of Modern Oncology. 2025;27(4):331–339. DOI: 10.26442/18151434.2025.4.203504

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Аннотация

Гиперэкспрессия и лиганд-зависимая интернализация простатического специфического мембранного антигена (ПСМА) с последующим накоплением связывающей молекулы в клетках рака предстательной железы (РПЖ) делает данный гликопротеин удобной мишенью для таргетной терапии с использованием радионуклидов. В настоящее время единственным препаратом данной группы с эффективностью, доказанной в крупном рандомизированном клиническом исследовании при метастатическом кастрационно-резистентном РПЖ, является ¹⁷⁷Lu-ПСМА-617. В статье представлены обзор данных о механизме действия и результатах завершенных исследований радиолигандной терапии (РЛТ) ¹⁷⁷Lu-ПСМА при РПЖ, актуальных показаниях к данному виду лечения у пациентов с кастрационно-резистентной фазой заболевания, практические рекомендации по проведению РЛТ, включая ее планирование, проведение, мониторинг эффективности и меры радиационной защиты. Приведены клинические случаи пациентов с частичным ответом/стабилизацией заболевания на фоне РЛТ, выраженной положительной динамикой/полным ответом и прогрессированием РПЖ.

Ключевые слова: простатический специфический мембранный антиген, ПСМА, простатический специфический антиген, ПСА, кастрационно-резистентный рак предстательной железы, радиолигандная терапия, ¹⁷⁷Lu-ПСМА, радиофармпрепарат для ПСМА-направленной терапии

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Overexpression and ligand-dependent internalization of prostate-specific membrane antigen (PSMA), followed by its accumulation in prostate cancer (PCa) cells, make this glycoprotein a good target for radionuclide-based targeted therapy. Currently, the only drug in this group with efficacy proven in a large randomized clinical study in patients with metastatic castration-resistant PCa is ¹⁷⁷Lu-PSMA-617. The article presents an overview of the data on the mechanism of action and the results of completed studies of radioligand therapy (RLT) with ¹⁷⁷Lu-PSMA for PCa, the current indications for this type of treatment in patients with a castration-resistant phase of the disease, and practical guidelines for RLT, including its planning, implementation, monitoring of effectiveness, and radiation protection measures. Clinical cases of patients with partial response/stabilization of the disease during RLT, significant improvement/complete response, and progression of PCa are presented.

Keywords: prostate specific membrane antigen, PSMA, prostate specific antigen, PSA, castration-resistant prostate cancer, radioligand therapy, ¹⁷⁷Lu-PSMA, radiopharmaceutical for PSMA-directed therapy

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Список литературы

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4. Silver DA, Pellicer I, Fair WR, et al. Prostate-specific membrane antigen expression in normal and malignant human tissues. Clin Cancer Res. 1997;3(1):81-5.
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7. Prasad V, Huang K, Prasad S, et al. In Comparison to PSA, Interim Ga-68-PSMA PET/CT Response Evaluation Based on Modified RECIST 1.1 After 2(nd) Cycle Is Better Predictor of Overall Survival of Prostate Cancer Patients Treated With (177)Lu-PSMA. Front Oncol. 2021;11:578093:578093. DOI:10.3389/fonc.2021.578093
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30. Bian L, Li P, Wang X, et al. Dual-Tracer 18 F-FDG and 68 Ga-PSMA PET/CT Imaging of Heterogeneous Phenotypes of Metastatic Castration-Resistant Prostate Cancer for Predicting Response to Novel Hormone Therapy. Clin Nucl Med. 2025;50(2):143-4. DOI:10.1097/RLU.0000000000005587
31. Schuchardt C, Zhang J, Kulkarni HR, et al. Prostate-Specific Membrane Antigen Radioligand Therapy Using (177)Lu-PSMA I&T and (177)Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer: Comparison of Safety, Biodistribution, and Dosimetry. J Nucl Med. 2022;63(8):1199-207. DOI:10.2967/jnumed.121.262713
32. Mair C, Warwitz B, Fink K, et al. Radiation exposure after 177Lu-DOTATATE and 177Lu-PSMA-617 therapy. Ann Nucl Med. 2018;32(7):499-502. DOI:10.1007/s12149-018-1264-x
33. Handayani W, Chantadisai M, Phromphao B, et al. Comparative post-therapeutic dosimetry between 2D planar-based and hybrid-based methods for personalized Lu-177 treatment. Ann Nucl Med. 2024;38(11):884-93. DOI:10.1007/s12149-024-01960-2
34. Kafka M, Horninger A, di Santo G, et al. Real-world Outcomes and Predictive Biomarkers for (177)Lutetium Prostate-specific Membrane Antigen Ligand Treatment in Metastatic Castration-resistant Prostate Cancer: A European Association of Urology Young Academic Urologists Prostate Cancer Working Group Multi-institutional Observational Study. Eur Urol Oncol. 2024;7(3):421-2. DOI:10.1016/j.euo.2023.07.018
35. Hartrampf PE, Bundschuh RA, Weinzierl FX, et al. mCRPC patients with PSA fluctuations under radioligand therapy have comparable survival benefits relative to patients with sustained PSA decrease. Eur J Nucl Med Mol Imaging. 2022;49(13):4727-75. DOI:10.1007/s00259-022-05910-w
36. Gafita A, Djaileb L, Rauscher I, et al. Response Evaluation Criteria in PSMA PET/CT (RECIP 1.0) in Metastatic Castration-resistant Prostate Cancer. Radiology. 2023;308(1):e222148. DOI:10.1148/radiol.222148
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1. Kessel K, Bernemann C, Bögemann M, Rahbar K. Evolving Castration Resistance and Prostate Specific Membrane Antigen Expression: Implications for Patient Management. Cancers (Basel). 2021;13(14):3556. DOI:10.3390/cancers13143556
2. Nguyen DP, Xiong PL, Liu H, et al. Induction of PSMA and Internalization of an Anti-PSMA mAb in the Vascular Compartment. Mol Cancer Res. 2016;14(11):1045-103. DOI:10.1158/1541-7786.MCR-16-0193
3. Sweat SD, Pacelli A, Murphy GP, Bostwick DG. Prostate-specific membrane antigen expression is greatest in prostate adenocarcinoma and lymph node metastases. Urology. 1998;52(4):637-40. DOI:10.1016/s0090-4295(98)00278-7
4. Silver DA, Pellicer I, Fair WR, et al. Prostate-specific membrane antigen expression in normal and malignant human tissues. Clin Cancer Res. 1997;3(1):81-5.
5. 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):213-23. DOI:10.1056/NEJMoa1213755
6. Kwan TN, Spremo S, Teh AYM, et al. Performance of Ga-68 PSMA PET/CT for diagnosis and grading of local prostate cancer. Prostate Int. 2021;9(2):107-12. DOI:10.1016/j.prnil.2020.07.008
7. Prasad V, Huang K, Prasad S, et al. In Comparison to PSA, Interim Ga-68-PSMA PET/CT Response Evaluation Based on Modified RECIST 1.1 After 2(nd) Cycle Is Better Predictor of Overall Survival of Prostate Cancer Patients Treated With (177)Lu-PSMA. Front Oncol. 2021;11:578093:578093. DOI:10.3389/fonc.2021.578093
8. Seifert R, Emmett L, Rowe SP, et al. Second Version of the Prostate Cancer Molecular Imaging Standardized Evaluation Framework Including Response Evaluation for Clinical Trials (PROMISE V2). Eur Urol. 2023;83(5):405-12. DOI:10.1016/j.eururo.2023.02.002
9. Paschalis A, Sheehan B, Riisnaes R, et al. Prostate-specific Membrane Antigen Heterogeneity and DNA Repair Defects in Prostate Cancer. Eur Urol. 2019;76(4):469-78. DOI:10.1016/j.eururo.2019.06.030
10. Violet J, Sandhu S, Iravani A, et al. Long-Term Follow-up and Outcomes of Retreatment in an Expanded 50-Patient Single-Center Phase II Prospective Trial of (177)Lu-PSMA-617 Theranostics in Metastatic Castration-Resistant Prostate Cancer. J Nucl Med. 2020;61(6):857-65. DOI:10.2967/jnumed.119.236414
11. Hofman MS, Emmett L, Sandhu S, et al. [(177)Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial. Lancet. 2021;397(10276):797-804 (in English). DOI:10.1016/S0140-6736(21)00237-3
12. Hofman MS. Long-Term Follow-up and Outcomes of Retreatment in an Expanded 50-Patient Single-Center Phase II Prospective Trial of 177Lu-PSMA-617 Theranostics in Metastatic Castration-Resistant Prostate Cancer. J Nucl Med. 2020;61(6):857-65. DOI:10.2967/jnumed.119.236414
13. Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021;385(12):1091-103. DOI:10.1056/NEJMoa2107322
14. Morris MJ, Castellano D, Herrmann K, et al. (177)Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial. Lancet. 2024;404(10459):1227-29. DOI:10.1016/S0140-6736(24)01653-2
15. Khalaf DJ, Annala M, Taavitsainen S, et al. Optimal sequencing of enzalutamide and abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer: a multicentre, randomised, open-label, phase 2, crossover trial. Lancet Oncol. 2019;20(12):1730-79. DOI:10.1016/S1470-2045(19)30688-6
16. Chi KN, Saad F, Parulekar WR, et al. CCTG PR21: A randomized phase II study of [177lu]lu-PSMA-617 verus docetaxel in patients with metastatic castration-resistant prostate cancer and PSMA-positive disease (NCT04663997). JCO. 2022;40(Suppl. 16):TPS5110-P5110. DOI:10.1200/jco.2022.40.16_suppl.tps5110
17. Hammer S, Schlicker A, Zitzmann-Kolbe S, et al. Darolutamide Potentiates the Antitumor Efficacy of a PSMA-targeted Thorium-227 Conjugate by a Dual Mode of Action in Prostate Cancer Models. Clin Cancer Res. 2021;27(15):4367-38. DOI:10.1158/1078-0432.CCR-21-0342
18. Emmett L, Subramaniam S, Crumbaker M, et al. Overall survival and quality of life with [(177)Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): secondary outcomes from a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2025;26(3):291-9 (in English). DOI:10.1016/S1470-2045(25)00009-9
19. Azad A, Bressel M, Tan H, et al. LBA66 UpFrontPSMA: A randomised phase II study of sequential 177Lu-PSMA-617 and docetaxel (D) versus docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC). Annals of Oncology. 2024;35:S1255-156. DOI:10.1016/j.annonc.2024.08.2309
20. Eapen RS, Buteau JP, Jackson P, et al. Administering [(177)Lu]Lu-PSMA-617 Prior to Radical Prostatectomy in Men with High-risk Localised Prostate Cancer (LuTectomy): A Single-centre, Single-arm, Phase 1/2 Study. Eur Urol. 2024;85(3):217-26 (in English). DOI:10.1016/j.eururo.2023.08.026
21. National Center for Biotechnology Information. Available at: https://clinicaltrials.gov. Accessed: 16.09.2025.
22. Nosov DA, Volkova MI, Gladkov OA, et al. Rak predstatel’noi zhelezy. Prakticheskie rekomendatsii RUSSCO, chast’ 1.2. Zlokachestvennye opukholi. 2024;14(3s2):242-69 (in Russian).
23. Fizazi K, Gillessen S, ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Updated treatment recommendations for prostate cancer from the ESMO Clinical Practice Guideline considering treatment intensification and use of novel systemic agents. Ann Oncol. 2023;34(6):557-63. DOI:10.1016/j.annonc.2023.02.015
24. Lowrance W, Dreicer R, Jarrard DF, et al. Updates to Advanced Prostate Cancer: AUA/SUO Guideline (2023). J Urol. 2023;209(6):1082-100. DOI:10.1097/ju.0000000000003452
25. Cornford P, Tilki D, van den Bergh R.C.N, et al. EAU – EANM – ESTRO – ESUR – ISUP – SIOG Guidelines on Prostate Cancer. Available at: https://d56bochluxqnz.cloudfront.net/documents/full-guideline/EAU-EANM-ESTRO-ESUR-ISUP-SIOG-Guidelin.... Accessed: 29.09.2025.
26. NCCN clinical practice guidelines Prostate Cancer v. 2.2026 – sept 15, 2025. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed: 29.09.2025.
27. Kratochwil C, Fendler WP, Eiber M, et al. Joint EANM/SNMMI procedure guideline for the use of (177)Lu-labeled PSMA-targeted radioligand-therapy ((177)Lu-PSMA-RLT). Eur J Nucl Med Mol Imaging. 2023;50(9):2830-85. DOI:10.1007/s00259-023-06255-8
28. Mirzaei S, Schweighofer-Zwink G, Ofner H, et al. Use of (177)Lu prostate-specific membrane antigen therapy in metastatic castration-resistant prostate cancer: Joint statement of the Austrian Society of Nuclear Medicine and Theranostics and the Austrian Society of Urology and Andrology. Wien Klin Wochenschr. 2025;137(Suppl. 4):157-66. DOI:10.1007/s00508-025-02544-4
29. Kim J, Lee S, Kim D, et al. Combination of [(18)F]FDG and [(18)F]PSMA-1007 PET/CT predicts tumour aggressiveness at staging and biochemical failure postoperatively in patients with prostate cancer. Eur J Nucl Med Mol Imaging. 2024;51(6):1763-72 (in English). DOI:10.1007/s00259-023-06585-7
30. Bian L, Li P, Wang X, et al. Dual-Tracer 18 F-FDG and 68 Ga-PSMA PET/CT Imaging of Heterogeneous Phenotypes of Metastatic Castration-Resistant Prostate Cancer for Predicting Response to Novel Hormone Therapy. Clin Nucl Med. 2025;50(2):143-4. DOI:10.1097/RLU.0000000000005587
31. Schuchardt C, Zhang J, Kulkarni HR, et al. Prostate-Specific Membrane Antigen Radioligand Therapy Using (177)Lu-PSMA I&T and (177)Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer: Comparison of Safety, Biodistribution, and Dosimetry. J Nucl Med. 2022;63(8):1199-207. DOI:10.2967/jnumed.121.262713
32. Mair C, Warwitz B, Fink K, et al. Radiation exposure after 177Lu-DOTATATE and 177Lu-PSMA-617 therapy. Ann Nucl Med. 2018;32(7):499-502. DOI:10.1007/s12149-018-1264-x
33. Handayani W, Chantadisai M, Phromphao B, et al. Comparative post-therapeutic dosimetry between 2D planar-based and hybrid-based methods for personalized Lu-177 treatment. Ann Nucl Med. 2024;38(11):884-93. DOI:10.1007/s12149-024-01960-2
34. Kafka M, Horninger A, di Santo G, et al. Real-world Outcomes and Predictive Biomarkers for (177)Lutetium Prostate-specific Membrane Antigen Ligand Treatment in Metastatic Castration-resistant Prostate Cancer: A European Association of Urology Young Academic Urologists Prostate Cancer Working Group Multi-institutional Observational Study. Eur Urol Oncol. 2024;7(3):421-2. DOI:10.1016/j.euo.2023.07.018
35. Hartrampf PE, Bundschuh RA, Weinzierl FX, et al. mCRPC patients with PSA fluctuations under radioligand therapy have comparable survival benefits relative to patients with sustained PSA decrease. Eur J Nucl Med Mol Imaging. 2022;49(13):4727-75. DOI:10.1007/s00259-022-05910-w
36. Gafita A, Djaileb L, Rauscher I, et al. Response Evaluation Criteria in PSMA PET/CT (RECIP 1.0) in Metastatic Castration-resistant Prostate Cancer. Radiology. 2023;308(1):e222148. DOI:10.1148/radiol.222148
37. Yordanova A, Linden P, Hauser S, et al. Outcome and safety of rechallenge [(177)Lu]Lu-PSMA-617 in patients with metastatic prostate cancer. Eur J Nucl Med Mol Imaging. 2019;46(5):1073-00 (in English). DOI:10.1007/s00259-018-4222-x
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Авторы

М.И. Волкова*^1,2, А.С. Крылов³, Д.А. Носов⁴, Б.Я. Алексеев^5,6

¹Онкологический центр №1 ГБУЗ «Городская клиническая больница им. С.С. Юдина» Департамента здравоохранения города Москвы, Москва, Российская Федерация
²ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Российская Федерация
³ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России, Москва, Российская Федерация
⁴ФГБУ «Центральная клиническая больница с поликлиникой» Управления делами Президента РФ, Москва, Российская Федерация
⁵ФГБОУ ВО «Российский биотехнологический университет (РОСБИОТЕХ)», Москва, Российская Федерация
⁶ФГБУ «Национальный медицинский исследовательский центр радиологии» Минздрава России, Москва, Российская Федерация
*mivolkova@rambler.ru

________________________________________________

Maria I. Volkova*^1,2, Alexander S. Krylov³, Dmitry A. Nosov⁴, Boris Ya. Alekseev^5,6

¹Moscow State Budgetary Healthcare Institution "Oncological Center No. 1 of Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department", Moscow, Russian Federation
²Russian Medical Academy of Continuous Professional Education, Moscow, Russian Federation
³Blokhin National Medical Research Center of Oncology, Moscow, Russian Federation
⁴Central Clinical Hospital with Polyclinic, Moscow, Russian Federation
⁵Russian Biotechnological University, Moscow, Russian Federation
⁶National Medical Research Radiological Centre, Moscow, Russian Federation
*mivolkova@rambler.ru

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