Clinical trial · Interventional
Therapeutic Efficiency and Response to 2.0 GBq (55mCi) 177Lu-EB-PSMA in Patients With mCRPC
- 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 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.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2.0 GBq of 177Lu-EB-PSMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 2.0 GBq of 177Lu-EB-PSMA
- description
- The patients were intravenously injected with the dose about 2.0 GBq (55 mCi) of 177Lu-EB-PSMA and underwent 68Ga-PSMA PET/CT scans before and after the treatment.
- interventionNames
- Drug: 2.0 GBq of 177Lu-EB-PSMA
Primary outcomes (2)
- measure
- Therapeutic effect: PSA Response
- timeFrame
- through study completion, an average of 1 month
- description
- 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%.
- measure
- Therapeutic effect: 68Ga-PSMA PET/CT Response
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available