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NCT Number: NCT05803941

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

The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other AAA617 causally related serious adverse event(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Linz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent must be obtained prior to participation in the study
  • Must have received at least one dose of AAA617 within an interventional, Phase I-IV Novartis sponsored clinical trial in prostate cancer and have fulfilled the trial's requirements that allows them to participate in this study.

Exclusion criteria

  • Inability to complete the needed investigational examinations due to any reason.

Treatment and study plan

AAA617

Drug

Long-term follow-up (LTFU) safety study of adult participants with prostate cancer that have received at least one dose of AAA617 from parent interventional Novartis sponsored clinical trials.

Other names: lutetium (177Lu) vipivotide tetraxetan, [177Lu]Lu-PSMA-617, 177Lu-PSMA-617

Primary outcomes

  1. Number and percentage of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study

    Selected adverse events (AEs) include xerostomia, xerophtalmia, myelosupression, renal toxicity and second primary malignancy and their complication. Only SAEs considered causally related to previous treatment with AAA617 will be considered.

Secondary outcomes

  1. Number and percentage of participants who have died

    Time frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study

    The number and percentage of participants who die during the long-term follow-up will be summarized.

  2. Absorbed radiation dose in kidney or other selected organs and number of AEs

    Time frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study

    Correlation between absorbed radiation dose in kidney or selected organs and safety of AAA617 for participants with dosimetry estimates collected in the parent treatment study.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

1-888-669-6682

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Apr 7, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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