CAAA617A12202 (Phase II)

Investigator physician: Pr Pierre OLIVIER

Study evaluating lutetium (¹⁷⁷Lu) vipivotide tetraxetan in patients with progressive metastatic castration-resistant prostate cancer (mCRPC) with moderate or severe renal impairment or normal renal function

Patients with progressive metastatic castration-resistant prostate cancer, positive for prostate-specific membrane antigen (PSMA), with:
- Moderate renal impairment
- Severe renal impairment
- Normal renal function

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.

Treatment: ¹⁷⁷Lu-PSMA-617
Study status: Recruiting
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Funding: