Lu177-EB-PSMA617 Radionuclide Treatment in Patients With Metastatic Castration-resistant Prostate Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1.11GBq of 177Lu-EB-PSMA-617 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. |
Drug: 1.11GBq of 177Lu-EB-PSMA-617
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.
|
| Experimental: 2.00 GBq of 177Lu-EB-PSMA-617 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. |
Drug: 2.00 GBq of 177Lu-EB-PSMA-617
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.
|
| Experimental: 3.70GBq of 177Lu-EB-PSMA-617 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. |
Drug: 3.70GBq of 177Lu-EB-PSMA-617
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.
|
Outcome Measures
Primary Outcome Measures
- Change of the PSA and standardized uptake value of 68Ga-PSMA before and after the treatment in mCRPC [1 year]
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake in lesions will be measured.
Secondary Outcome Measures
- Adverse events collection [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.]
Adverse events after the treatment of patients will be followed and assessed
Eligibility Criteria
Criteria
Inclusion Criteria:
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progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy.
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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:
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a serum creatinine level of more than 150μmol per liter,
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a hemoglobin level of less than 10.0 g/dl,
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a white-cell count of less than 4.0× 109/L,
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a platelet count of less than 100 × 109/L,
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a total bilirubin level of more than 3 times the upper limit of the normal range,
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a serum albumin level of more than 3.0 g per deciliter,
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cardiac insufficiency including carcinoid heart valve disease,
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a severe allergy or hypersensitivity to radiographic contrast material,
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claustrophobia, and pregnancy or breastfeeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | China |
Sponsors and Collaborators
- Peking Union Medical College Hospital
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
- Study Chair: Zhaohui Zhu, MD,PHD, Peking Union Medical College Hospital, Chinese Academy of Medical Science
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PekingUMCH-NM019