Clinical trial · Interventional
Lu177-EB-PSMA617 Radionuclide Treatment in Patients With Metastatic Castration-resistant Prostate Cancer
Lu177-EB-PSMA617 Prostate-Specific Membrane Antigen Inhibitor Therapy in Patients With 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)
In prior studies, the investigators synthesized 177Lu-EB-PSMA-617 by conjugating a truncated Evans Blue (EB) molecule and DOTA chelator onto PSMA-617 and labeled it with 177Lu to increase the tumor accumulation and retention for radioligand therapy，and then the investigators evaluated the dosimetry of 177Lu-EB-PSMA-617 and response to single low-dose treatment in patients with metastatic castration-resistant prostate cancer(mCRPC). This study was performed to evaluate the safety and therapy response to 177Lu-EB-PSMA-617 in patients with mCRPC. This is an open-label, randomized study. Different groups with doses of 1.11GBq (30 mCi), 2.00 GBq (54 mCi) and 3.7GBq (100 mCi)of 177Lu-EB -PSMA617 will be injected intravenously. All patients will undergo 68Ga-PSMA PET/CT scans before and after the treatment.
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 |
|---|---|---|---|
| 1.11GBq of 177Lu-EB-PSMA-617 | Drug | — | UNRESOLVED |
| 2.00 GBq of 177Lu-EB-PSMA-617 | Drug | — | UNRESOLVED |
| 3.70GBq of 177Lu-EB-PSMA-617 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1.11GBq of 177Lu-EB-PSMA-617
- description
- The patients were intravenously injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-PSMA617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.
- interventionNames
- Drug: 1.11GBq of 177Lu-EB-PSMA-617
- type
- EXPERIMENTAL
- label
- 2.00 GBq of 177Lu-EB-PSMA-617
- description
- The patients were intravenously injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.
- interventionNames
- Drug: 2.00 GBq of 177Lu-EB-PSMA-617
- type
- EXPERIMENTAL
- label
- 3.70GBq of 177Lu-EB-PSMA-617
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 that did not respond to androgen-suppression therapy and/or systemic chemotherapy. * Distant metastases with high PSMA expression confirmed by 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA-617. Exclusion Criteria: * a serum creatinine level of more than 150μmol 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 including carcinoid heart valve disease, * a severe allergy or hypersensitivity to radiographic contrast material, * claustrophobia, and pregnancy or breastfeeding.
References
Publications (1)
- DERIVEDChen X, Peng Y, Zheng Q, Lai Y, Cheng H, Zhu Z, Wang G, Zang J. The Prognostic Value of 68Ga-PSMA and 18F-FDG PET/CT in Metastatic Castration-Resistant Prostate Cancer Treated with 177Lu-EB-PSMA. Ann Nucl Med. 2026 Jul 1. doi: 10.1007/s12149-026-02250-9. Online ahead of print. PMID 42384311