CAAA617A12202 (Phase II)

Investigator physician: Pr Pierre OLIVIER

Etude visant à évaluer le lutécium (¹⁷⁷Lu) vipivotide tétraxétan chez des patients atteints de cancer de la prostate métastatique progressif, résistant à la castration (CPRCm) et présentant une insuffisance rénale modérée ou sévère ou une fonction rénale normale

Patients atteints de cancer de la prostate métastatique, progressif, résistant à la castration, positif pour l’antigène membranaire spécifique de la prostate (PSMA pour prostate-specific membrane antigen), et présentant une :
- Insuffisance rénale modérée
-Insuffisance rénale sévère
- Fonction rénale normale

The aim of this study is to respond to a post-marketing request from the Health Authorities to determine the biodistribution, dosimetry and safety of AAA617 in patients with moderate to severe renal impairment. In addition, the efficacy of AAA617 and its potential effect on the QTcF interval will be evaluated.
Patients will receive AAA617 at a dose of 7.4 GBq (± 10%) every 6 weeks for 6 cycles for Cohorts A and B, and for 3 cycles (and 3 additional cycles) for Cohort C.
Patient recruitment for Cohort C (severe renal failure) will begin at the same time as for Cohorts A (normal renal function) and B (moderate renal failure). Comparisons between Cohorts C and A (severe renal failure versus normal renal function) and between Cohorts B and A (moderate renal failure versus normal renal function) will be made using descriptive statistics, and will be based on visual analysis of box plots (overlap, inter-patient variability). No formal statistical tests will be used for comparison.

Traitement : ¹⁷⁷Lu-PSMA-617
Study status: En cours d'inclusion
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Funding: