NCT06959433|Not Yet RecruitingPhase 3
Lu-177 PSMA Treatment in Cell Renal Carcinoma
Safety and Efficacy of Lu-177 PSMA Treatment in Metastatic Clear Cell Renal Carcinoma
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Safety and Efficacy of Lu-177 PSMA Treatment in Metastatic Clear Cell Renal Carcinoma
Sponsor study identifier
interventional
20
0 countries
N/A
Study Start
May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 28, 2025
Actual (reported)May 6, 2025
Actual (reported)May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
toxicity analysis
Therapy associated toxicity will be evaluated according to CTCAE V5.0 criteria.
1-36 months
efficacy analysis
1-36 months
Patients who will received Lu-177 PSMA treatment for metastatic RCC
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.
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First Submitted
April 28, 2025
First Posted
May 6, 2025
Study Start
May 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma
Contact the study team to confirm eligibility.
Primary Completion
February 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 27, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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