{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T09:33:15Z","timestamp":1787045595467,"version":"build-2736575974"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:00:00Z","timestamp":1787011200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:00:00Z","timestamp":1787011200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Sichuan Science and Technology Program","award":["2024NSFSC0668"],"award-info":[{"award-number":["2024NSFSC0668"]}]},{"name":"Research and development project of Affiliated Hospital of North Sichuan Medical College","award":["2022LC004"],"award-info":[{"award-number":["2022LC004"]}]},{"name":"the Opening Project of Medical Imaging Key Laboratory of Sichuan Province","award":["MIKL202409"],"award-info":[{"award-number":["MIKL202409"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur Radiol Exp"],"abstract":"Abstract<\/jats:title>\n \n Objective<\/jats:title>\n \n Metastatic castration-resistant prostate cancer (mCRPC) remains associated with poor long-term outcomes, and survival under current treatment is modest. Prostate-specific membrane antigen (PSMA)-targeted alpha therapy using\n 225<\/jats:sup>\n Ac exhibits superior cytotoxicity compared with beta-emitting radiopharmaceuticals; however, dose-limiting xerostomia from salivary gland accumulation restricts clinical application.\n 225<\/jats:sup>\n Ac-PSMA-CY313 is a next-generation radioligand designed to reduce off-target salivary uptake while maintaining tumor-targeting efficacy. We evaluated the safety and preliminary efficacy of\n 225<\/jats:sup>\n Ac-PSMA-CY313 in heavily pretreated mCRPC patients.\n <\/jats:p>\n <\/jats:sec>\n \n Materials and methods<\/jats:title>\n \n This prospective, open-label, single-arm study enrolled 16 patients with progressive mCRPC refractory to standard therapies. Patients received\n 225<\/jats:sup>\n Ac-PSMA-CY313 (200\u2009\u03bcCi intravenously every 8 weeks). The primary endpoint was treatment-related toxicity per NCI-CTCAE v5.0. Secondary endpoints included \u2265\u200950% PSA decline (PSA50) and radiographic response per RECIST 1.1\/PCWG3.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Xerostomia occurred in 75% of patients, predominantly grade-1 (68.8%), with one grade-2 case. Hematologic toxicities were mild-to-moderate: anemia 68.8% (grade 3: 6.3%), leukopenia 25.0% (all grade 1\u20132). No grade 4 toxicities or treatment-related deaths occurred. Significant laboratory changes included hemoglobin\u00a0 decrease (117.7\u2009\u00b1\u200919.2\n versus<\/jats:italic>\n 105.0\u2009\u00b1\u200919.7\u2009g\/L,\n p<\/jats:italic>\n \u2009=\u20090 .012). PSA50 response was 37.5% (95% confidence interval [CI]: 15.2%\u201364.6%), with a median PSA change of 18.1% (range: -143.0% to 100.0%). Radiographic response was 31.3% (95% CI: 11.0\u201358.7%), and the disease control (partial response\u2009+\u2009stable disease) rate was 62.5% (95% CI: 35.4\u201384.8%).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n In this first-in-human study of 16 patients,\n 225<\/jats:sup>\n Ac-PSMA-CY313 showed a manageable safety profile with predominantly low-grade xerostomia, a\u00a0PSA50 response of 37.5%, and\u00a0an image-based response of 31.3%. Conclusions regarding efficacy and comparative safety require validation in larger prospective trials.\n <\/jats:p>\n <\/jats:sec>\n \n Clinical trial registration<\/jats:title>\n \n Chinese Clinical Trial Registry: ChiCTR2400083275, Registered 19 April 2024.\n https:\/\/www.chictr.org.cn<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>\n \n Key Points<\/jats:title>\n \n \n \n \n Question<\/jats:bold>\n What are the safety and efficacy outcomes of the novel alpha-emitting radiopharmaceutical\n 225<\/jats:sup>\n Ac-PSMA-CY313 in advanced mCRPC?\n <\/jats:p>\n <\/jats:list-item>\n \n \n Findings<\/jats:bold>\n This first-in-human study demonstrates that \u00b2\u00b2\u2075Ac-PSMA-CY313 produces high PSA response rates with predominantly mild to moderate reversible adverse events.\n <\/jats:p>\n <\/jats:list-item>\n \n \n Relevance statement<\/jats:bold>\n 225<\/jats:sup>\n Ac-PSMA-CY313 showed promise as a next-generation PSMA-targeted \u03b1-therapy with a favorable safety-efficacy profile for advanced prostate cancer patients with limited therapeutic options, supporting its further clinical development.\n <\/jats:p>\n <\/jats:list-item>\n <\/jats:list>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1186\/s41747-026-00782-3","type":"journal-article","created":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T09:15:27Z","timestamp":1787044527000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluation of the safety and efficacy of 225Ac-PSMA-CY313 in metastatic castration-resistant prostate cancer: preliminary results"],"prefix":"10.1186","volume":"10","author":[{"given":"Hao","family":"Zhang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yekuan","family":"Shi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanqin","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zongxi","family":"He","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fei","family":"Luo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yue","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tielong","family":"Tang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daiyuan","family":"Ma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9702-4265","authenticated-orcid":false,"given":"Suping","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,8,18]]},"reference":[{"key":"782_CR1","doi-asserted-by":"publisher","first-page":"2635","DOI":"10.1007\/s10147-025-02881-4","volume":"30","author":"T Oishi","year":"2025","unstructured":"Oishi T, Fujita N, Kawashima Y et al (2025) Cross-resistance among novel androgen receptor signaling inhibitors in non-metastatic castration-resistant prostate cancer. 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Approval was granted by the Ethics Committee of the Affiliated Hospital of North Sichuan Medical College (Date 22\/03\/2024\/ No.2024ERJ89-1). Informed consent was obtained from all individual participants included in the study.","order":1,"name":"Ethics","label":"Ethics approval and consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors affirm that human research participants provided informed consent for publication of the images in Fig.\u00a0\n \n .","order":2,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors have no relevant financial or non-financial interests to disclose.","order":3,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"116"}}