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NOT YET RECRUITING
NCT06959433
PHASE3

Lu-177 PSMA Treatment in Cell Renal Carcinoma

Sponsor: Ankara University

View on ClinicalTrials.gov

Summary

Summary Renal Cell Carcinoma (RCC) consists of 2% of all malignencies. RCCs are generally divided to histopathological subtypes as clear cell and non-clear cell variants. Clear cell variant responsible for the 75-80% of all RCCs. It is reported that 20-30% of RCCs are metastatic at the diagnosis and 5 years survival is approximately is 10-20% in this group of patients. Moreover, 60% of patients who are not metastatic at the diagnosis, develop metastates within 2-3 years. 2nd and 3th line effective treatment option in metastatic RCCs patients has been a subject of interest. PSMA (protatate specific membrane antigen) with the other name glutamate carboxypeptidase, is a transmembrane protein and overexpresses in prostate adenocarcinomas and neoangiogenesis spots of endothelium of other several tumor types. It infronts as a target for theranostic consept for mainly prostate cancer in nuclear medicine. As a radionuclide treatment option, Lu-177 PSMA treatment is proved as safe and effective treatment option in castration resistant prostata cancer patients. After its widely use in prostate cancer, it is reported that PSMA molecule can be used for imaging of RCC patients and PSMA uptake is higher than 18F-FDG. For this reason, Lu-177 PSMA treatment can be a systemic treatment option in RCC patients who have progress afer 1st cycle treatment. In this study we aimed to safety and efficacy of Lu-177 PSMA treatment in metastatic RCC patients as systemic radionuclide treatment option.

Official title: Safety and Efficacy of Lu-177 PSMA Treatment in Metastatic Clear Cell Renal Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-05-01

Completion Date

2028-08-01

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DRUG

Lu-177 PSMA-617

Included patients will receive 4 cycles of 7.4GBq Lu-177 PSMa therapy every 6 weeks. If any toxicity develops after the first cycle, dose reduction will be performed for the other cycles. At 1. And 4. Cycles of therapy, whole body planar and SPECT/CT imaging will be performed at 4. And 24. Hours and any time at 4-7.days of injection. On these images , kindey, liver and salivary gland doses will be calculated. Mean tumor dose will also be calculated by measurinf the tumoral uptake. In the follow up, patients will be controlled at 9. And 24. Weeks and every 12 months then after.