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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic Arizona, Scottsdale, Arizona, United States, 85259

Orange

St. Joseph Hospital, Orange, California, United States, 92686

Santa Monica

Providence Saint Johns Health Ctr, Santa Monica, California, United States, 90404

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Hartford

Hartford Hospital, Hartford, Connecticut, United States, 06102

Washington

VA Medical Center, Washington, District of Columbia, United States, 20422

Jacksonville

Mayo Clinic Jacksonville, Jacksonville, Florida, United States, 32224

Athens

University Cancer and Blood Center LLC, Athens, Georgia, United States, 30607

Fort Wayne

Parkview Research Center, Fort Wayne, Indiana, United States, 46845

New Orleans

Tulane Cancer Center, New Orleans, Louisiana, United States, 70112

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2033-07-21