A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of lutetium (177Lu) vipivotide tetraxetan in Adult Participants with Prostate Cancer

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503208-94-00

Acronym

CAAA617A12402

Enrollment

298

Registered

2023-11-27

Start date

2024-04-04

Completion date

Unknown

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Brief summary

Number and proportion of participants with selected AEs and serious adverse events (SAEs), changes in laboratory values

Detailed description

Number and proportion of participants who have died, Potential correlation between absorbed radiation dose in kidney or other selected organs and safety of AAA617 (if sufficient amount of dosimetry data is available from the parent treatment study)

Interventions

DRUGPluvicto 1 000 MBq/mL solution for injection/infusion

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number and proportion of participants with selected AEs and serious adverse events (SAEs), changes in laboratory values	—

Secondary

Measure	Time frame
Number and proportion of participants who have died, Potential correlation between absorbed radiation dose in kidney or other selected organs and safety of AAA617 (if sufficient amount of dosimetry data is available from the parent treatment study)	—

Countries

Austria, Belgium, Czechia, France, Germany, Netherlands, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026