Long-Term Safety Study of Lutetium (177Lu) Vipivotide Tetraxetan in Prostate Cancer Patients

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05803941

Provider View

This study is monitoring the long-term safety of a treatment called Lutetium (177Lu) Vipivotide Tetraxetan in men with prostate cancer who have already received this treatment in previous clinical trials.

Patient Parameters

Program Overview

The aim of this study is to observe the long-term effects and any potential risks of a prostate cancer treatment known as Lutetium (177Lu) Vipivotide Tetraxetan, also called AAA617. This study is for men who have already received at least one dose of this treatment in earlier clinical trials sponsored by Novartis. The study will track any serious side effects over time.

Description

This is a worldwide study that will follow men with prostate cancer who have previously received the treatment AAA617 in earlier clinical trials. The study will not provide any new treatment but will involve regular check-ups every 6 to 8 months to monitor for any side effects or health changes. The study will last up to 10 years from the first time the treatment was given in the original trial.

Participants will join this long-term follow-up study after completing the requirements of their original treatment study. The number of visits each participant will need to attend depends on when they join this follow-up study, based on when they first received the treatment.

The total number of participants and the length of this follow-up study will depend on how many people were treated in the original studies and how long those studies lasted.

Eligibility Criteria

Inclusion Criteria

  • Must have signed a consent form agreeing to participate in the study.
  • Must have received at least one dose of the treatment AAA617 in a previous Novartis clinical trial for prostate cancer and completed the trial's requirements to join this study.
  • If sexually active, must agree to use a condom during intercourse for up to 14 weeks after the last dose of AAA617 from the original study.

Exclusion Criteria

  • Unable to complete the necessary study examinations for any reason.

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