Curium, PeptiDream and PDRadiopharma Complete Patient Dosing in Phase 2 Trial of 64Cu-PSMA-I&T PET Diagnostic for Prostate Cancer in Japan
核心洞察
Patient dosing has been completed in the registrational Phase 2 clinical trial of 64Cu-PSMA-I&T, a PET radiopharmaceutical targeting PSMA (搜索) on prostate cancer (搜索) cells, in Japan.
The open-label, single-arm study is evaluating sensitivity, specificity, and safety in Japanese patients newly diagnosed with unfavorable intermediate, high, or very high-risk prostate cancer (搜索).
Data analysis is now underway, with results expected to support a future regulatory submission in Japan alongside Curium's ongoing global clinical trials.
Curium Group (搜索), together with PeptiDream Inc. (搜索) and its wholly owned subsidiary PDRadiopharma Inc., announced on June 11, 2026, that patient dosing has been completed in the registrational Phase 2 clinical trial of 64Cu-PSMA-I&T in Japan. The trial (jRCT: 2031250225) is evaluating the investigational PET radiopharmaceutical as a diagnostic imaging agent for prostate cancer (搜索), with data analysis now underway to support a future regulatory submission.
64Cu-PSMA-I&T is a positron emission tomography (PET) radiopharmaceutical targeting prostate-specific membrane antigen (PSMA (搜索)), a cell-surface protein commonly highly expressed in prostate cancer (搜索) cells. The agent is labeled with the radioisotope Copper-64 and is being developed under a strategic collaboration between Curium and PDRadiopharma.
Trial Design and Objectives
The open-label, single-arm Phase 2 study is designed to evaluate the sensitivity, specificity, and safety of 64Cu-PSMA-I&T in Japanese patients newly diagnosed with unfavorable intermediate, high, or very high-risk prostate cancer (搜索) who are scheduled for prostatectomy with pelvic lymph node dissection. The results from this study, together with data from Curium's ongoing global clinical trials, are expected to support future regulatory submission in Japan.
A Theranostic Strategy in Parallel
In parallel, Curium announced in February 2026 that a registrational clinical trial of the therapeutic counterpart, 177Lu-PSMA-I&T, is being advanced. This agent, a PSMA (搜索)-targeting ligand conjugated with the radioisotope Lutetium-177, is being evaluated for efficacy and safety in patients with metastatic castration-resistant prostate cancer (搜索) (mCRPC), as part of a theranostic approach that pairs diagnostic imaging with targeted radiotherapy.
Curium's global pivotal Phase 3 ECLIPSE trial (NCT05204927) of 177Lu-PSMA-I&T has already reported that its primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.
Global Clinical Development Context
Curium is also conducting two global Phase 3 trials for 64Cu-PSMA-I&T: the SOLAR RECUR trial (NCT06235099), evaluating the agent for diagnosing biochemical recurrence of prostate cancer (搜索), and the SOLAR STAGE trial (NCT06235151), for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer electing to undergo surgery. The first-in-human Phase 1/2 SOLAR trial met its co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven prostate cancer.
Partnership Structure
Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of both 64Cu-PSMA-I&T and 177Lu-PSMA-I&T in Japan. PDRadiopharma will lead regulatory filing, manufacturing, commercialization, and distribution activities in Japan, while Curium will continue to lead global development and support PDRadiopharma through technology transfer, including the set-up of a high-throughput Copper-64 manufacturing line based on Curium's proprietary technology.
Executive Commentary
Renaud Dehareng, CEO of Curium Group (搜索), stated: "Conducting these trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer (搜索) across Asia. By combining Curium's global development expertise with PDRadiopharma's deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to patients with prostate cancer in Japan."
Patrick C. Reid, President & CEO of PeptiDream, commented: "The completion of patient dosing marks an important milestone in the development of 64Cu-PSMA-I&T in Japan. This program represents a key component of our growing radiopharmaceutical pipeline and our broader theranostics strategy. We would like to thank the patients, investigators and clinical sites for their participation and support."
Prostate Cancer (搜索) in Japan
Prostate cancer (搜索) continues to be widely prevalent in Japan, with approximately 90,000 to 100,000 new cases annually, according to the National Cancer Center Japan. The development of novel diagnostic and therapeutic radiopharmaceuticals addresses a significant unmet need in this patient population.