Clinical trial · Interventional
177Lu-PSMA-I＆T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer
NCT04188587CI-TRIAL-00042083unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the safety and efficacy of 177 Lu -labeled PSMA ligand(PSMA-I＆T) in the treatment of mCRPC in Asianethics.
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 |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177 Lu-PSMA-I&T | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 177Lu-PSMA-I&T
- description
- 177Lu-PSMA-I＆Tradioligand therapy with 2.0-8.0GBq in every circle were performed. And then 177Lu-PSMA post-therapy scans were performed at 24 h and 48 h respectively, and the fusion phenomenon was performed at the second day to pre evaluate the efficacy of the patients.
- interventionNames
- Drug: 177 Lu-PSMA-I&T
Primary outcomes (1)
- measure
- PSA
- timeFrame
- 2 months
- description
- Serum prostate specific antigen (PSA) levels was used as the main marker of efficacy evaluation, and the changes of PSA level were divided into decrease \> 50%, 30% \~ 50% and \< 30%.
Secondary outcomes (1)
- measure
- Adverse events collection
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Entry criteria 1. ECOG score: 0-1 point 2. Lymph and skeletal metastases or visceral metastases that cannot be removed surgically 3. The disease continues to progress after treatment with ADT, chemotherapy, radiotherapy, or abiraterone and emzaludine 4.68Ga PSMA-11 PET / CT showed that there was significant radioactivity uptake in tumor tissues and metastases \[SUVmax\> 7\], which was significantly higher than that in the liver. Exclusion criteria 1. Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed. 2. Hemoglobin\<80g/L;Hemameba\<2.5×109/L;Thrombocyte\<70g/L 3. Glomerular filtration rate\<50ml/min 4. Serum creatinine\>130umol/L;Total bilirubin\>2mg/L;Albumin\<30g/L. 5. International normalized ratio（INR）\>1,5 6. Alanine aminotransferase, aspartate aminotransferase is 5 times larger than normal value
References
Publications (0)
Data not yet available
No reference posted for this study.