Clinical trial · Interventional
177Lu-PSMA-EB-01 in Patients With Metastatic Castration-resistant Prostate Cancer
Safety and Dosimetry of 177Lu-PSMA-EB-01 in Patients With Metastatic Castration-resistant Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pilot study to assess the safety and measure image-based absorbed dose of 177Lu-PSMA-EB-01, a new PSMA-specific radiopharmaceutical, in patients with metastatic castration resistant prostate cancer (mCRPC) who will undergo radioligand therapy (RLT). All patients underwent 68Ga-PSMA and 18F-FDG PET/CT for selection and were randomly divided into three groups of 3 people each.The three groups received an approximately 1.11 GBq (30mCi), 1.85 GBq (50 mCi) and 2.59 GBq (70mCi) of 177Lu-PSMA-EB-01 up to 2 cycles, respectively.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01 | Drug | — | UNRESOLVED |
| 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01 | Drug | — | UNRESOLVED |
| 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01
- description
- All patients were intravenous injected with single dose 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.
- interventionNames
- Drug: 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01
- type
- EXPERIMENTAL
- label
- 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01
- description
- All patients were intravenous injected with single dose 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.
- interventionNames
- Drug: 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * progressive metastatic castration-resistant prostate cancer * tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT Exclusion Criteria: * a serum creatinine level of more than 150 μmol per liter * a hemoglobin level of less than 10.0 g/dl * a white-cell count of less than 4.0× 109/L * a platelet count of less than 100 × 109/L * a total bilirubin level of more than 3 times the upper limit of the normal range * a serum albumin level of more than 3.0 g per deciliter * cardiac insufficiency
References
Publications (1)
- DERIVEDZang J, Wang G, Zhao T, Liu H, Lin X, Yang Y, Shao Z, Wang C, Chen H, Chen Y, Zhu Z, Miao W, Chen X, Zhang J. A phase 1 trial to determine the maximum tolerated dose and patient-specific dosimetry of [177Lu]Lu-LNC1003 in patients with metastatic castration-resistant prostate cancer. Eur J Nucl Med Mol Imaging. 2024 Feb;51(3):871-882. doi: 10.1007/s00259-023-06470-3. Epub 2023 Oct 21. PMID 37864592