PeptiDream Inc., PDRadiopharma Inc. — a wholly owned subsidiary of PeptiDream — and Curium Group, a global leader in nuclear medicine, have announced the initiation of a registrational Phase 2 clinical trial in Japan for 64Cu-PSMA-I&T, a novel PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells. The trial, registered as jRCT: 2031250225, marks an important milestone in the advancement of precision radiopharmaceuticals for prostate cancer diagnosis and treatment in Japan.
Advancing Dual Diagnostic and Therapeutic Radiopharmaceuticals
64Cu-PSMA-I&T is a positron emission tomography (PET) imaging agent labeled with the radioisotope Copper-64, designed to target PSMA, a protein overexpressed on prostate cancer cells. It is being developed alongside its therapeutic counterpart, 177Lu-PSMA-I&T, which utilizes the radioisotope Lutetium-177 for targeted radiotherapy. This “theranostic” pairing enables a dual approach — using 64Cu-PSMA-I&T for precise imaging and diagnosis, and 177Lu-PSMA-I&T for delivering localized radiation therapy to cancerous tissue.
The development of both agents is being conducted under a strategic collaboration between PDRadiopharma and Curium, with the shared goal of expanding access to innovative radiopharmaceuticals for prostate cancer patients in Japan.
Details of the Phase 2 Registrational Trial
The ongoing study is an open-label, single-arm Phase 2 clinical trial evaluating the sensitivity, specificity, and safety of 64Cu-PSMA-I&T in Japanese patients. The trial aims to enroll approximately 70 participants who have been newly diagnosed with unfavorable intermediate, high, or very high-risk prostate cancer and are scheduled to undergo prostatectomy with pelvic lymph node dissection.
The trial is being conducted as a registrational study in Japan and will leverage bridging data from Curium’s global clinical trials of the same compound. This approach is expected to accelerate regulatory review and potential approval, aligning Japanese clinical data with the company’s ongoing international development program.
In parallel, plans are underway to initiate a clinical trial for 177Lu-PSMA-I&T to assess its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC) — an advanced stage of the disease that remains challenging to treat with conventional therapies.
Executive Perspectives on the Collaboration
Patrick C. Reid, President and CEO of PeptiDream, highlighted the growing impact of radiopharmaceuticals on modern oncology.
“Targeted radiopharmaceuticals are rapidly revolutionizing how we diagnose and treat cancer. At PeptiDream and PDRadiopharma, we are committed to expanding our pipeline of targeted therapies. Partnering with Curium allows us to accelerate those efforts and bring next-generation prostate cancer treatments to patients in Japan,” Reid said.
Masato Murakami, President of PDRadiopharma and Chief Medical Officer of PeptiDream, emphasized the strong clinical demand for PSMA-based PET imaging in Japan.
“We are thrilled to begin the development of 64Cu-PSMA-I&T locally. Both 64Cu-PSMA-I&T and 177Lu-PSMA-I&T have the potential to transform how we diagnose and treat PSMA-expressing prostate cancers. Many urologists in Japan have expressed a desire to incorporate PSMA PET imaging into their clinical practice. Through our collaboration with Curium, we aim to meet this need and deliver novel radiopharmaceutical solutions that improve patient outcomes.”
Renaud Dehareng, CEO of Curium Group, underscored the importance of the partnership in bringing global innovations to Asia.
“Conducting these registrational trials with PeptiDream and PDRadiopharma marks a significant milestone in expanding access to cutting-edge radiopharmaceuticals across Asia. By combining Curium’s global development expertise with PDRadiopharma’s strong local infrastructure, we are well-positioned to deliver transformative solutions to prostate cancer patients in Japan.”
Global Progress of the PSMA-I&T Program
Curium’s development of the PSMA-I&T theranostic pair represents one of the most advanced global efforts in targeted prostate cancer radiopharmaceuticals.
- 177Lu-PSMA-I&T has been evaluated in the global Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier: NCT05204927). The study successfully met its primary endpoint, demonstrating a statistically significant and clinically meaningful benefit for patients with metastatic castration-resistant prostate cancer (mCRPC). These results reinforce its potential as a therapeutic standard in PSMA-targeted treatment.
- For 64Cu-PSMA-I&T, Curium has launched multiple global clinical studies, including:
- SOLAR RECUR Trial (NCT06235099), assessing the agent’s ability to detect biochemical recurrence of prostate cancer.
- SOLAR STAGE Trial (NCT06235151), evaluating its diagnostic performance in newly diagnosed patients with unfavorable intermediate to very high-risk prostate cancer undergoing surgery.
- SOLAR Phase 1/2 Study, the first-in-human trial, which achieved its co-primary endpoints — region-level correct localization rate and patient-level correct detection rate — in patients with histologically confirmed metastatic prostate cancer.
These global studies provide a robust foundation of safety and efficacy data that support the Japanese registrational trial, helping to expedite clinical adoption and regulatory approval.
Expanding the Role of Radiopharmaceuticals in Oncology
The PSMA-I&T program underscores a broader transformation within cancer diagnostics and therapy — the convergence of molecular imaging and precision medicine. By integrating diagnostic and therapeutic capabilities within a single target framework, radiopharmaceuticals like 64Cu-PSMA-I&T and 177Lu-PSMA-I&T exemplify the promise of personalized oncology, allowing clinicians to identify, monitor, and treat prostate cancer more effectively and with fewer side effects.
Japan’s adoption of these innovative modalities marks a significant step toward broadening access to precision radiopharmaceuticals in Asia. As prostate cancer remains one of the most prevalent malignancies among men, new diagnostic and therapeutic options such as PSMA-targeted agents offer the potential to improve survival outcomes and enhance quality of life for thousands of patients.
