A Phase 2 study of 64Cu-PSMA-I&T with Prostate Cancer Patients

A Phase 2, Multicenter, Open-label study to Test the Diagnostic Performance of 64Cu-PSMA-I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection in Japan

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250225

Enrollment

Registered

2025-07-09

Start date

2025-09-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Interventions

A single intravenous dose of 296 MBq (10%) of R-241B will be administered to patients with poor prognosis intermediate-risk, high-risk or very high-risk first prostate cancer who are scheduled for pro

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Patients with histologically proven prostate adenocarcinoma. 2. Planned prostatectomy with pelvic lymph node dissection. 3. Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.

Exclusion criteria

Exclusion criteria: 1. Patients who have received androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any treatment under development for prostate adenocarcinoma. 2. Patients participating in other clinical trials within 90 days prior to the date of consent. 3. Patients who are planned to have an x-ray contrast within 24 hours or other PET scan with other tracers within 24 hours prior to administration of R-241B. If Barium contrast is administered this should be cleared before the PET scan. 4. Patients who have received radiopharmaceuticals labeled with 131I within 60 days prior to administration of R-241B. 5. Patients who are allergic to any of the active ingredients or additives of the investigational drug. 6. Male patients with a female partner of childbearing potential who cannot agree to use contraception for 1 week after R-241B administration.

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of PET/CT with R-241B for pathologically confirmed positive pelvic lymph nodes	—

Secondary

Measure	Time frame
Efficacy: Inter-reader agreement for subject-specific reading results of R-241B PET/CT, read in an independent, blinded fashion Safety: adverse events, clinical test, vital signs, 12-lead ECG and self-assessment findings	—

Contacts

Public ContactSatoshi Miki

PDRadiopharma Inc.

s-clinicaltrial-info@pdradiopharma.com+81-3-6263-0454

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026