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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.
Prostate cancer is the most frequent malignant tumor in men worldwide. Prostate-specific membrane antigen (PSMA), is a surface molecule specifically expressed by prostate tumors which was shown to be a valid target for radiotherapy. 177Lu-PSMA-617, a urea-based compound, provide an effective target for the treatment of metastatic castration-resistant prostate cancer. However, a major problem in the therapeutic use of 177Lu-PSMA-617 has been its short half-life and fast rate of clearance. The investigators designed and synthesized a new radiopharmaceutical, named 177Lu-PSMA-EB-01. EB（Evans Blue）can bind to albumin to slow down its plasma clearance rate, thereby increasing tumor accumulation and reducing the total dosage of Lu-177. Hence, EB-PSMA-01 may be an option for consideration due to limited supply of Lu-177, by which more patients may be benefited by this version of 177Lu-EB-PSMA-01. This study was designed to investigate the safety, dosimetry and preliminary effects of 177Lu-EB-PSMA-01 in patients with metastatic castration resistant prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01 | Experimental | 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. |
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| 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01 | Experimental | 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. |
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| 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01 | Experimental | All patients were intravenous injected with single dose 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dosimetry of normal organs and tumors | The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-PSMA-EB-01. The dose delivered to normal organs and tumors will be recorded. | through study completion, an average of 4 weeks |
| Hematologic adverse events collection | Hematologic status were performed before and every 2 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0 | through study completion, an average of 6 months |
| Hepatic and renal toxic events collection | Liver function, and renal function were performed before and 4 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0. | through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PSA Response | The serum PSA response was documented semimonthly until 6 weeks after the administration of 177Lu-PSMA-EB-01. PSA response was classified as the following: partial response (PR) if PSA decrease ≥50%, progressive disease (PD) if PSA increase ≥ 25% and stable disease (SD) if PSA increase <25% or PSA decrease <50%. | through study completion, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaohui Zhu, MD | Contact | 86-13611093752 | 13611093752@163.com | |
| Guochang Wang, MD | Contact | 86-18516822732 | guochang1007@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaohui Zhu Zhu, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37864592 | Derived | Zang 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. |
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| 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01 | Drug | 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. |
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| 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01 | Drug | All patients were intravenous injected with single dose 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection. |
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