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Blood and urine samples, serial PET\/CT, planar, and SPECT\/CT scans were collected post-administration of [\n                      <jats:sup>68<\/jats:sup>\n                      Ga]Ga-PSMA-11 (111\u2013259\u00a0MBq) at screening and [\n                      <jats:sup>177<\/jats:sup>\n                      Lu]Lu-PSMA-617 (7.4\u00a0GBq\u2009\u00b1\u200910%) during cycle 1. External radiation exposure in medical personnel and family members was measured once in each cycle from cycle 1 to 6, excluding the cycle where dosimetry was performed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 35 patients included, 3 patients each had evaluable data for PK\/dosimetry of [\n                      <jats:sup>68<\/jats:sup>\n                      Ga]Ga-PSMA-11 and [\n                      <jats:sup>177<\/jats:sup>\n                      Lu]Lu-PSMA-617. Both [\n                      <jats:sup>68<\/jats:sup>\n                      Ga]Ga-PSMA-11 and [\n                      <jats:sup>177<\/jats:sup>\n                      Lu]Lu-PSMA-617 showed a bi-exponential decline in blood concentrations post-dosage, with an initial rapid phase followed by a slower phase. For [\n                      <jats:sup>68<\/jats:sup>\n                      Ga]Ga-PSMA-11, terminal half-life (T\n                      <jats:sub>1\/2<\/jats:sub>\n                      ; geometric mean) was 3.93\u00a0h, total systemic clearance (CL) was 5.52 L\/hr, and an apparent volume of distribution (V\n                      <jats:sub>z<\/jats:sub>\n                      ) was 31.3 L. For [\n                      <jats:sup>177<\/jats:sup>\n                      Lu]Lu-PSMA-617, these values were 28.9\u00a0h, 1.71 L\/hr, and 71.2 L, respectively. For [\n                      <jats:sup>68<\/jats:sup>\n                      Ga]Ga-PSMA-11 dosimetry, kidneys received the largest absorbed doses (0.23\u2009\u00b1\u20090.14\u00a0mGy\/MBq), and effective dose was 0.030\u00a0mSv\/MBq. For a full six-cycle cumulative injected activity of 44.4\u00a0GBq of [\n                      <jats:sup>177<\/jats:sup>\n                      Lu]Lu-PSMA-617, the lacrimal glands received the largest estimated absorbed dose of 90\u2009\u00b1\u200945\u00a0Gy. The mean absorbed dose to the kidneys (critical organ) was 0.34\u00a0Gy\/GBq, resulting in a cumulative absorbed dose of 15\u00a0Gy for the full six-cycles. The radiation exposure was evaluated among 13 medical personnel, 8 who participated in administration, and family members. Measurements were taken at 8 sites including patients\u2019 home. External radiation exposure to medical personnel and family members was minimal, with 0 \u03bcSv in 6\/7 patients and 60 \u03bcSv in 1 patient.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      This is the first prospective Japanese study to demonstrate the use of [\n                      <jats:sup>68<\/jats:sup>\n                      Ga]Ga-PSMA-11 and [\n                      <jats:sup>177<\/jats:sup>\n                      Lu]Lu-PSMA-617 in patients with mCRPC. The absorbed doses in various organs for both radiopharmaceuticals were consistent with previously reported data. Minimal radiation exposure observed for medical personnel and caregivers highlights the safety of [\n                      <jats:sup>177<\/jats:sup>\n                      Lu]Lu-PSMA-617 during treatment, ensuring a secure treatment environment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      This study is a prospective, open-label, multicenter, single-arm, phase 2 trial of [\n                      <jats:sup>177<\/jats:sup>\n                      Lu]Lu-PSMA-617 in patients with progressive PSMA\u2009+\u2009mCRPC in Japan (NCT05114746). The trial was initiated on 25-Jan-2022 (first patient first visit), with a primary analysis data cut-off on 8-Dec-2023. The study is ongoing. A total of 35 patients were screened and received [\n                      <jats:sup>68<\/jats:sup>\n                      Ga]Ga-PSMA-11, of whom 30 were included for efficacy and safety assessments of [\n                      <jats:sup>177<\/jats:sup>\n                      Lu]Lu-PSMA617 across Part 1 (safety run-in), Part 2 (post-taxane), and Part 3 (pre-taxane). Additionally, 3 patients each had evaluable data for PK and dosimetry assessments of [\n                      <jats:sup>68<\/jats:sup>\n                      Ga]Ga-PSMA-11 and [\n                      <jats:sup>177<\/jats:sup>\n                      Lu]Lu-PSMA-617. Informed consent was obtained from all participants before conducting any study-specific procedures.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s12149-025-02079-8","type":"journal-article","created":{"date-parts":[[2025,7,10]],"date-time":"2025-07-10T10:16:18Z","timestamp":1752142578000},"page":"1201-1212","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Pharmacokinetics and dosimetry of [177Lu]Lu-PSMA-617 and [68Ga]Ga-PSMA-11 in Japanese patients with PSMA-positive mCRPC"],"prefix":"10.1007","volume":"39","clinical-trial-number":[{"clinical-trial-number":"nct05114746","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4289-6250","authenticated-orcid":false,"given":"Shoko","family":"Takano","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anri","family":"Inaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Hirata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard B.","family":"Sparks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiko","family":"Sato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Nomura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toru","family":"Hattori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroya","family":"Kambara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quyen","family":"Nguyen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tohru","family":"Shiga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seigo","family":"Kinuya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makoto","family":"Hosono","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,7,10]]},"reference":[{"key":"2079_CR1","unstructured":"Cancer Information Service, National Cancer Center, Japan (Vital Statistics of Japan, Ministry of Health, Labour and Welfare) (n.d.) 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Anri Inaki received research funding from Peptidream Inc., Telix Pharmaceuticals Japan K.K., and Hitachi, Ltd. Kenji Hirata received research funding from GE HealthCare Japan Corporation, Sumitomo Heavy Industries, Ltd., and Nihon Medi-Physics Co., Ltd. Richard B. Sparks received consulting funding from Novartis through Imaging Endpoints for the dosimetry analysis. Masahiko Sato, Satoshi Nomura, Toru Hattori, and Hiroya Kambara are employees of Novartis Pharma K.K. Quyen Nguyen is an employee of Novartis Pharma AG. Tohru Shiga received research funding from Sumitomo Heavy Industries, Ltd. and AMS Planning. Makoto Hosono received honoraria from Novartis Pharma K.K. Seigo Kinuya has no conflict of interest to declare. No other potential conflict of interest relevant to this article was reported.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All human studies have been approved by the ethics committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and all subsequent revisions. This article does not contain any studies with animals performed by any of the authors. Evaluation of data was approved by the Independent Ethics Committee or Institutional Review Board for each center in accordance with the Declaration of Helsinki.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval and consent to participate"}},{"value":"All participants provided their informed consent prior to their inclusion in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}