Prostate Cancer Clinical Trial
Official title:
Therapeutic Efficiency and Response to 2.0 GBq (55mCi) 177Lu-EB-PSMA in Patients With mCRPC
In recent years, quite a few studies have demonstrated the possibility of 177Lu-PSMA-617 therapy as a viable treatment option in metastatic castration resistant prostate cancer (mCRPC), which has been shown desired effect. To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, we conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA) and labeled it with 177Lu. This study is designed to assess the efficiency and response to 177Lu-EB-PSMA (55 mCi) in patients with mCRPC.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - All the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy; - Distant metastases with high PSMA expression were confirmed on 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA. Exclusion Criteria: - The exclusion criteria were 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 and 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Therapeutic effect: PSA Response | The serum PSA response was documented monthly until 8 weeks after the last treatment therapy, which can effectively reflect the treatment effect of prostate cancer. Biochemical 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 1 month | |
Primary | Therapeutic effect: 68Ga-PSMA PET/CT Response | 68Ga-PSMA-617 wholebody PET/CT acquisitions 8 weeks after each cycle of treatment. The molecular response was classified according to adapted modified PERSIST 1.0 criteria. Complete response (CR) was complete resolution of 68Ga-PSMA-617 uptake in the target lesions. Partial response (PR) was defined as =30% decrease in the SUVmax of the target lesions and total Lesions PSMA from the baseline scan, and = 30% increase in the SUVmax value of the target lesions and total Lesions PSMA from the baseline scan was taken as progressive disease (PD). Neither CR, PR nor PD was considered stable disease (SD) that was <30% decrease or <30% increase of the target lesion. Changes of SUV (?SUV) between pre- and post-therapeutic PET were calculated. | through study completion, an average of 2 months | |
Secondary | Adverse events collection: Blood tests | Blood tests including hematologic status, liver function, and renal function were performed before and every two weeks after each cycle of treatment for a period of 8 weeks. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0. | through study completion, an average of 1 month |
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