Lu-177 PSMA Treatment in Cell Renal Carcinoma

Phase 3

Not yet recruiting

• Conditions: Metastatic Renal Cancer
• Interventions: Drug: Lu-177 PSMA-617

• Registration Number: NCT06959433
• Lead Sponsor: Ankara University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study First Posted: 2025-05-06
• Last Update Posted: 2025-05-06
• Study Start: 2025-08-01
• Primary Completion: 2028-02-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age >18
• Progression after at least 2 lines of systemic therapy or existence of a contraindication to systemic therapies
• At least 3 years of life expectancy
• ECOG performance status ≤ 2
• Ability to sign informed consent

Exclusion Criteria

• Age<18
• Not having received any systemic therapies
• History of a secondary malignancy
• ECOG performance status > 2
• Any contraindication for radionuclide therapy (pregnancy, lactation, organ disfunction, metastatic lesions with a risk of compression
• Previous history of any radionuclide therapies
• Inability to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lu-PSMA treatment arm	Lu-177 PSMA-617	Patients who will received Lu-177 PSMA treatment for metastatic RCC

Primary Outcome Measures

Name	Time	Method
toxicity analysis	1-36 months	Therapy associated toxicity will be evaluated according to CTCAE V5.0 criteria.

Secondary Outcome Measures

Name	Time	Method
efficacy analysis	1-36 months	Therapy response will be evaluated according to RECIST 1.1 criteria