BOSTON, MA, June 11, 2026
Curium Group, in collaboration with PeptiDream Inc. and PDRadiopharma Inc., has announced the completion of patient dosing in the registrational Phase 2 clinical trial of 64Cu-PSMA-I&T in Japan, marking a significant milestone in the development of advanced PSMA-targeted PET imaging agents for prostate cancer. The study is evaluating the diagnostic performance and safety of 64Cu-PSMA-I&T, a novel radiopharmaceutical labeled with Copper-64, designed to identify prostate cancer lesions through targeted imaging of prostate-specific membrane antigen (PSMA). With patient enrollment and dosing now complete, data analysis is underway to support a future regulatory submission in Japan, potentially expanding access to next-generation precision diagnostics for one of the country’s most prevalent cancers.
Phase 2 Trial Advances Precision Imaging for Prostate Cancer
The completed Phase 2 study is an open-label, single-arm registrational trial designed to assess the sensitivity, specificity, and safety of 64Cu-PSMA-I&T in Japanese patients newly diagnosed with unfavorable intermediate, high-risk, or very high-risk prostate cancer who are scheduled to undergo prostatectomy with pelvic lymph node dissection. The radiopharmaceutical leverages the expression of PSMA on prostate cancer cells, enabling highly targeted PET imaging that may improve disease detection and staging accuracy.
The trial forms part of a strategic collaboration between Curium and PDRadiopharma, a wholly owned subsidiary of PeptiDream, aimed at bringing innovative radiopharmaceutical technologies to the Japanese market. The resulting data, combined with findings from Curium’s ongoing international clinical programs, are expected to provide the foundation for future regulatory filings and potential commercialization in Japan.
Expanding a Theranostic Platform with Diagnostic and Therapeutic Agents
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The advancement of 64Cu-PSMA-I&T is part of a broader theranostic strategy that combines diagnostic imaging and targeted radiotherapy to improve prostate cancer management. Alongside the diagnostic program, Curium is also advancing 177Lu-PSMA-I&T, a therapeutic radiopharmaceutical that delivers targeted radiation directly to PSMA-expressing cancer cells. Earlier this year, Curium announced progress in a registrational clinical trial evaluating 177Lu-PSMA-I&T in patients with metastatic castration-resistant prostate cancer (mCRPC).
The company’s global Phase 3 ECLIPSE trial reported that its primary endpoint was successfully achieved, demonstrating a statistically significant and clinically meaningful benefit for patients. Together, the diagnostic and therapeutic agents create a comprehensive precision medicine approach that has the potential to improve disease detection, treatment selection, and patient outcomes across multiple stages of prostate cancer.
Strategic Collaboration Strengthens Radiopharmaceutical Development in Japan
The partnership between Curium, PeptiDream, and PDRadiopharma combines global radiopharmaceutical expertise with deep local development and commercialization capabilities. Under the collaboration agreement, the companies are jointly responsible for clinical development activities related to both 64Cu-PSMA-I&T and 177Lu-PSMA-I&T in Japan. PDRadiopharma will lead regulatory submissions, manufacturing, commercialization, and distribution within the country, while Curium continues to oversee global development and provide technology transfer support for establishing local manufacturing infrastructure, including a high-throughput Copper-64 production platform. The collaboration comes at a critical time, as prostate cancer remains one of the most common malignancies in Japan, with approximately 90,000 to 100,000 new cases diagnosed annually.
Company executives emphasized that completing patient dosing in the Phase 2 trial represents a major step toward delivering innovative diagnostic solutions and expanding access to cutting-edge radiopharmaceutical technologies for patients across Japan and the broader Asia-Pacific region. As data analysis progresses, stakeholders will closely watch for results that could pave the way for regulatory approval and wider adoption of PSMA-targeted imaging in clinical practice.
Source: Curium Group press release
