Recruiting

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

Sponsor:

Novartis Pharmaceuticals

Code:

NCT05803941

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AAA617

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT05803941

Start date

Aug 14, 2023

Status verified date

Jun, 2026

Completion date

Jul 21, 2033

Anticipated

Primary completion date

Jul 20, 2033

Anticipated

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

700 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111 novartis.email@novartis.com

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

480-301-8300

Principal Investigator:

Cassandra Moore

St. Joseph Hospital

Recruiting

Orange, California, United States, 92686

Principal Investigator:

Timothy Byun

Providence Saint Johns Health Ctr

Recruiting

Santa Monica, California, United States, 90404

Principal Investigator:

Przemyslaw Twardowski

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Muthiah Nachiappan

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Principal Investigator:

Andrew Salner

VA Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20422

Contacts

202-745-8457

Principal Investigator:

Frank Liu

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Principal Investigator:

Winston Tan

University Cancer and Blood Center LLC

Recruiting

Athens, Georgia, United States, 30607

Contacts

706-353-2990

Principal Investigator:

Petros Nikolinakos

Parkview Research Center

Recruiting

Fort Wayne, Indiana, United States, 46845

Principal Investigator:

Brian Chang

Tulane Cancer Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

504-585-6077

Principal Investigator:

Brian Lewis

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

504-842-6044

Principal Investigator:

Stephen Bardot

Corewell Health William Beaum Hosp

Recruiting

Royal Oak, Michigan, United States, 48073-6769

Principal Investigator:

Andrew Thompson

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Brian Costello

University of Mississippi Med Ctr

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

+1 601 815 5374

Principal Investigator:

John Clark Henegan

Wash U School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Lindsey Mayer

lindseymayer@wustl.edu

Principal Investigator:

Hyun Kim

Urology Cancer Center PC

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

402-697-2229

Principal Investigator:

Luke Nordquist

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68154

Principal Investigator:

Ralph Hauke

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Principal Investigator:

Benjamin A Gartrell

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Daniel J George

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

216-444-0441

Principal Investigator:

Shilpa Gupta

Univ of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Principal Investigator:

Leonard Appleman

Univ of Texas Southwest Med Center

Recruiting

Dallas, Texas, United States, 75390-9034

Principal Investigator:

Kevin Courtney

UT Health Science Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Bo Chen

Onco Hemato Asso of SW Virginia

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

540-774-8660

Principal Investigator:

David Buck

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H2X 1R9

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

Prostate Cancer
Long-Term Safety Follow-Up
177Lu-PSMA-617
[177Lu]Lu-PSMA-617
lutetium (177Lu) vipivotide tetraxetan
AAA617
parent treatment study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-06-04.