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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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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.
Prostate cancer (PC) is the second most common cancer worldwide in men, with persistently high numbers dying from this disease. Recent studies have demonstrated the possibility of 177Lu-PSMA-617 therapy as a viable treatment option in mCRPC. To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, the investigators conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA-617) and label it with 177Lu.
The study is open-label and patients will be divided into three groups and monitored throughout the 6 to 10-month treatment period for survival, disease progression, and adverse events to evaluate the safety and therapy response to the 177Lu-EB-PSMA-617.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.11GBq of 177Lu-EB-PSMA-617 | Experimental | 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. |
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| 2.00 GBq of 177Lu-EB-PSMA-617 | Experimental | 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. |
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| 3.70GBq of 177Lu-EB-PSMA-617 | Experimental | The patients were intravenously injected with the dose about 3.70GBq (100 mCi) of 177Lu-EB-PSMA617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.11GBq of 177Lu-EB-PSMA-617 | Drug | Patients were intravenous injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the PSA and standardized uptake value of 68Ga-PSMA before and after the treatment in mCRPC | The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake in lesions will be measured. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events collection | Adverse events after the treatment of patients will be followed and assessed | patients will be monitored throughout the whole treatment period. Patients will be followed up every 3 month until 1 year for a long-term follow-up period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Zang, MD | Contact | +86 10 69154196 | 15901495106@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaohui Zhu, MD,PHD | Peking Union Medical College Hospital, Chinese Academy of Medical Science | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42384311 | Derived | Chen 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. |
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| 2.00 GBq of 177Lu-EB-PSMA-617 | Drug | Patients were intravenous injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles. |
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| 3.70GBq of 177Lu-EB-PSMA-617 | Drug | Patients were intravenous injected with the dose about 3.70GBq (100 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles. |
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