{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T00:43:49Z","timestamp":1783039429981,"version":"3.54.6"},"reference-count":32,"publisher":"MDPI AG","issue":"14","license":[{"start":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T00:00:00Z","timestamp":1752537600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Novartis"},{"name":"Eckert &amp; Ziegler Radiopharma GmbH"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background: This Phase 2 trial evaluated the efficacy, tolerability, and safety of [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) in patients with \u22651 measurable lesion and progressive prostate-specific membrane antigen-positive (PSMA+) metastatic castration-resistant prostate cancer (mCRPC) in Japan. Methods: This study comprises four parts; data from three parts are presented here. Part 1 evaluated safety and tolerability; Parts 2 (post-taxane) and 3 (pre-taxane\/taxane-naive) assessed the overall response rate (ORR; primary endpoint), overall survival (OS), radiographic progression-free survival (rPFS), disease control rate (DCR), PFS, and safety; and Part 4 is the expansion part. Patients received 7.4 GBq (\u00b110%) 177Lu-PSMA-617 Q6W for up to six cycles. Results: Of the 35 patients who underwent a [68Ga]Ga-PSMA-11 (68Ga-PSMA-11) PET\/CT scan, 30 received 177Lu-PSMA-617 (post-taxane, n = 12; pre-taxane, n = 18). No dose-limiting toxicity was noted in Part 1 (n = 3). Post- and pre-taxane patients had a median of three and five cycles, respectively. The primary endpoint, ORR, met the pre-specified threshold, with the lower limit of the 90% confidence interval (CI) above the threshold of 5% for post-taxane and 12% for pre-taxane. Post- and pre-taxane patients had an ORR of 25.0% (90% CI: 7.2\u201352.7) and 33.3% (90% CI: 15.6\u201355.4), respectively. In post- and pre-taxane patients, the DCR was 91.7% and 83.3%, the median rPFS was 3.71 and 12.25 months, and the median PFS was 3.71 and 5.59 months, respectively. The median OS was 14.42 and 12.94 months in post- and pre-taxane patients, respectively. The most common adverse events were constipation, decreased appetite, decreased platelet count, anemia, and nausea. Conclusions: The primary endpoint (ORR) was met. The safety profile of 177Lu-PSMA-617 was consistent with the VISION and PSMAfore studies, with no new safety signals in the Japanese patients with mCRPC.<\/jats:p>","DOI":"10.3390\/cancers17142351","type":"journal-article","created":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T15:01:05Z","timestamp":1752591665000},"page":"2351","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["[177Lu]Lu-PSMA-617 in Patients with Progressive PSMA+ mCRPC Treated With or Without Prior Taxane-Based Chemotherapy: A Phase 2, Open-Label, Single-Arm Trial in Japan"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8480-9100","authenticated-orcid":false,"given":"Kouji","family":"Izumi","sequence":"first","affiliation":[{"name":"Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa 920-8640, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9363-9054","authenticated-orcid":false,"given":"Ryuji","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Department of Renal and Genitourinary Surgery, Hokkaido University, Sapporo 060-8638, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4325-7722","authenticated-orcid":false,"given":"Yusuke","family":"Ito","sequence":"additional","affiliation":[{"name":"Department of Urology, Yokohama City University Graduate School of Medicine, Yokohama 236-0004, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1545-1827","authenticated-orcid":false,"given":"Seiji","family":"Hoshi","sequence":"additional","affiliation":[{"name":"Department of Urology, Fukushima Medical University School of Medicine, Fukushima City 960-1295, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9203-4245","authenticated-orcid":false,"given":"Nobuaki","family":"Matsubara","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, National Cancer Center Hospital East, Kashiwa 277-8577, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3079-6033","authenticated-orcid":false,"given":"Toshinari","family":"Yamasaki","sequence":"additional","affiliation":[{"name":"Department of Urology, Kobe City Medical Center General Hospital, Kobe 650-0047, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8135-8746","authenticated-orcid":false,"given":"Takashi","family":"Mizowaki","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto 606-8501, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6350-3436","authenticated-orcid":false,"given":"Atsushi","family":"Komaru","sequence":"additional","affiliation":[{"name":"Prostate Center and Division of Urology, Chiba Cancer Center, Chiba 260-0801, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Nomura","sequence":"additional","affiliation":[{"name":"Novartis Pharma K.K., Tokyo 105-0001, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toru","family":"Hattori","sequence":"additional","affiliation":[{"name":"Novartis Pharma K.K., Tokyo 105-0001, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroya","family":"Kambara","sequence":"additional","affiliation":[{"name":"Novartis Pharma K.K., Tokyo 105-0001, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaheen","family":"Alanee","sequence":"additional","affiliation":[{"name":"Senior Clinical Development, RLT Prostate, Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8040-3245","authenticated-orcid":false,"given":"Makoto","family":"Hosono","sequence":"additional","affiliation":[{"name":"Department of Radiology, Kindai University, Osaka 577-8502, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seigo","family":"Kinuya","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, Kanazawa University Hospital, Kanazawa 920-8641, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,7,15]]},"reference":[{"key":"ref_1","unstructured":"SEER Cancer Stat Facts: Prostate Cancer, Available online: 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