A multicentric, single arm, open-label, phase I/II study evaluating PSMA targeted radionuclide therapy in adult patients with metastatic clear cell renal cancer (PRadR).
177Lu-PSMA-1
PFS
Radiolabelled therapy
Renal cancer
mccRCC
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
01 Feb 2024
01 Feb 2024
Historique:
received:
24
11
2023
accepted:
30
11
2023
medline:
2
2
2024
pubmed:
2
2
2024
entrez:
2
2
2024
Statut:
epublish
Résumé
Despite advancements in managing metastatic clear cell renal carcinoma (mccRCC) through antiangiogenic tyrosine kinase inhibitors and immunotherapy, there remains a demand for novel treatments for patients experiencing progression despite the use of these medications. There is currently no established standard treatment for patients receiving third therapy line. Prostate Specific Membrane Antigen (PSMA) whose high expression has been demonstrated in metastatic aggressive prostate adenocarcinoma is also highly expressed in neovessels of various solid tumors including renal cell carcinoma (RCC): 86% of clear cell RCC, 61% of chromophobe RCC, and 28% of papillary RCC. Therefore, PSMA may be a target expressed in metastatic ccRCC for radionuclide therapy using PSMA ligands radiolabeled with Lutetium-177 (PRLT). This is a multicenter phase I/II study designed to assess the tolerability and effectiveness of 177Lu-PSMA-1 in individuals with PSMA-positive metastatic clear cell renal cell carcinoma (ccRCC), identified through 68Ga-PSMA PET, conducted in France (PRadR). 48 patients will be treated with 4 cycles of 7.4 GBq of Our prospective study may lead to new potential indications for the use of ClinicalTrials.gov: NCT06059014.
Sections du résumé
BACKGROUND
BACKGROUND
Despite advancements in managing metastatic clear cell renal carcinoma (mccRCC) through antiangiogenic tyrosine kinase inhibitors and immunotherapy, there remains a demand for novel treatments for patients experiencing progression despite the use of these medications. There is currently no established standard treatment for patients receiving third therapy line. Prostate Specific Membrane Antigen (PSMA) whose high expression has been demonstrated in metastatic aggressive prostate adenocarcinoma is also highly expressed in neovessels of various solid tumors including renal cell carcinoma (RCC): 86% of clear cell RCC, 61% of chromophobe RCC, and 28% of papillary RCC. Therefore, PSMA may be a target expressed in metastatic ccRCC for radionuclide therapy using PSMA ligands radiolabeled with Lutetium-177 (PRLT).
METHODS
METHODS
This is a multicenter phase I/II study designed to assess the tolerability and effectiveness of 177Lu-PSMA-1 in individuals with PSMA-positive metastatic clear cell renal cell carcinoma (ccRCC), identified through 68Ga-PSMA PET, conducted in France (PRadR). 48 patients will be treated with 4 cycles of 7.4 GBq of
DISCUSSION
CONCLUSIONS
Our prospective study may lead to new potential indications for the use of
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov: NCT06059014.
Identifiants
pubmed: 38302933
doi: 10.1186/s12885-023-11702-8
pii: 10.1186/s12885-023-11702-8
doi:
Banques de données
ClinicalTrials.gov
['NCT06059014']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
163Informations de copyright
© 2024. The Author(s).
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