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

April 21, 2025 updated by: Novartis Pharmaceuticals

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Recruiting
        • Novartis Investigative Site
      • Wien, Austria, 1090
        • Recruiting
        • Novartis Investigative Site
  • Belgium
      • Gent, Belgium, 9000
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 1R9
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Olomouc, Czechia, 779 00
        • Recruiting
        • Novartis Investigative Site
      • Praha 5, Czechia, 150 06
        • Recruiting
        • Novartis Investigative Site
  • France
      • Lyon, France, 69373
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Essen, Germany, 45147
        • Recruiting
        • Novartis Investigative Site
      • Muenchen, Germany, 80377
        • Recruiting
        • Novartis Investigative Site
      • Rostock, Germany, 18057
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
      • Delft, Netherlands, 2625 AD
        • Recruiting
        • Novartis Investigative Site
      • Maastricht, Netherlands, 6229 HX
        • Recruiting
        • Novartis Investigative Site
      • Nijmegen, Netherlands, 6500HB
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28222
        • Recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46026
        • Recruiting
        • Novartis Investigative Site
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08036
        • Recruiting
        • Novartis Investigative Site
      • Hospitalet de LLobregat, Catalunya, Spain, 08907
        • Recruiting
        • Novartis Investigative Site
  • Sweden
      • Goteborg, Sweden, 413 45
        • Recruiting
        • Novartis Investigative Site
      • Stockholm, Sweden, 17176
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Recruiting
        • Novartis Investigative Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Novartis Investigative Site
      • Glasgow, United Kingdom, G12 0YN
        • Recruiting
        • Novartis Investigative Site
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • Novartis Investigative Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic Arizona
        • Principal Investigator:
          • Cassandra Moore
        • Contact:
          • Phone Number: 480-301-8300
    • California
      • Orange, California, United States, 92686
        • Recruiting
        • St. Joseph Hospital
        • Principal Investigator:
          • Timothy Byun
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Providence Saint Johns Health Ctr
        • Principal Investigator:
          • Przemyslaw Twardowski
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Principal Investigator:
          • Muthiah Nachiappan
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Principal Investigator:
          • Andrew Salner
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Recruiting
        • VA Medical Center
        • Principal Investigator:
          • Frank Liu
        • Contact:
          • Phone Number: 202-745-8457
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville
        • Principal Investigator:
          • Winston Tan
    • Georgia
      • Athens, Georgia, United States, 30607
        • Recruiting
        • University Cancer and Blood Center LLC
        • Principal Investigator:
          • PETROS NIKOLINAKOS
        • Contact:
          • Phone Number: 706-353-2990
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Research Center
        • Principal Investigator:
          • Brian Chang
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane Cancer Center
        • Contact:
          • Phone Number: 504-585-6077
        • Principal Investigator:
          • Brian Lewis
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
        • Principal Investigator:
          • Stephen Bardot
        • Contact:
          • Phone Number: 504-842-6044
    • Michigan
      • Royal Oak, Michigan, United States, 48073-6769
        • Recruiting
        • Corewell Health William Beaum Hosp
        • Principal Investigator:
          • Andrew Thompson
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Principal Investigator:
          • Brian Costello
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Med Ctr
        • Principal Investigator:
          • John Clark Henegan
        • Contact:
          • Phone Number: +1 601 815 5374
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Wash U School of Medicine
        • Contact:
        • Principal Investigator:
          • Hyun Kim
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Urology Cancer Center PC
        • Principal Investigator:
          • Luke Nordquist
        • Contact:
          • Phone Number: 402-697-2229
      • Omaha, Nebraska, United States, 68154
        • Recruiting
        • Nebraska Cancer Specialists
        • Principal Investigator:
          • Ralph Hauke
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Benjamin A Gartrell
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Daniel J. George
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Shilpa Gupta
        • Contact:
          • Phone Number: 216-444-0441
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • Univ of Pittsburgh Medical Center
        • Principal Investigator:
          • Leonard Appleman
    • Texas
      • Dallas, Texas, United States, 75390-9034
        • Recruiting
        • Univ of Texas Southwest Med Center
        • Principal Investigator:
          • Kevin Courtney
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Health Science Center
        • Principal Investigator:
          • Bo Chen
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Onco Hemato Asso of SE Virginia
        • Principal Investigator:
          • David Buck
        • Contact:
          • Phone Number: 540-774-8660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm

Participants will be followed until death, lost to follow-up, or up to 10 years from first dose of AAA617, whichever occurs first.

There will be no study treatment administered to participants while participating in this study.
Drug: AAA617
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:
  • [177Lu]Lu-PSMA-617
  • 177Lu-PSMA-617
  • lutetium (177Lu) vipivotide tetraxetan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every visit up to 10 years after 1st dose of AAA617 received in parent treatment study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every visit up to 10 years after 1st dose of AAA617 received in parent treatment study
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.
every visit up to 10 years after 1st dose of AAA617 received in parent treatment study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2023

Primary Completion (Estimated)

July 20, 2033

Study Completion (Estimated)

July 21, 2033

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAA617A12402
  • 2023-503208-94-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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