Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer

This is a global, prospective, multi-center, long-term follow-up (LTFU) safety study of

adult participants with prostate cancer that have received at least one dose of AAA617

from interventional, Phase I-IV Novartis sponsored clinical trials.

There will be no study treatment administered to participants in this study. Participants

will have visits every 6-8 months for monitoring of selected AEs and laboratory

parameters. The study periods include a Baseline and Follow-up Period (up to 10 years

after first dose of AAA617 in parent treatment study).

Participants should enroll into the LTFU study after parent treatment study requirements

are fulfilled (refer to the parent treatment study protocol for requirements, including

any additional requirements after participant enters this LTFU safety study).

The schedule of activities for this LTFU study is designed to start from date of informed

consent for this LTFU study. Participants should be followed every 6 to 8 months for up

to a total of 10 years starting from first dose of AAA617 in the parent treatment study.

Participants entering the LTFU study will have already completed a variable portion of

the required 10-year follow-up within the parent treatment study. The specific number of

visits required in this LTFU study will depend upon the time of enrollment into this LTFU

study following the first dose of AAA617 in the parent treatment study.

The total number of participants to be enrolled and the duration of this LTFU study will

depend upon the total number treated in the parent treatment studies and their duration.