Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer (NCT05803941)
A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Arizona — Scottsdale, Arizona
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (54 Sites)
Showing the first 25 of 54 sites.
- Mayo Clinic Arizona — Scottsdale, Arizona
- St. Joseph Hospital — Orange, California
- Providence Saint Johns Health Ctr — Santa Monica, California
- University of Colorado — Aurora, Colorado
- Hartford Hospital — Hartford, Connecticut
- VA Medical Center — Washington D.C., District of Columbia
- Mayo Clinic Jacksonville — Jacksonville, Florida
- University Cancer and Blood Center LLC — Athens, Georgia
- Parkview Research Center — Fort Wayne, Indiana
- Tulane Cancer Center — New Orleans, Louisiana
- Ochsner Clinic Foundation — New Orleans, Louisiana
- Corewell Health William Beaum Hosp — Royal Oak, Michigan
- Mayo Clinic Rochester — Rochester, Minnesota
- University of Mississippi Med Ctr — Jackson, Mississippi
- Wash U School of Medicine — St Louis, Missouri
- Urology Cancer Center PC — Omaha, Nebraska
- Nebraska Cancer Specialists — Omaha, Nebraska
- Montefiore Medical Center — The Bronx, New York
- Duke University Medical Center — Durham, North Carolina
- Cleveland Clinic Foundation — Cleveland, Ohio
- Univ of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- Univ of Texas Southwest Med Center — Dallas, Texas
- UT Health Science Center — Houston, Texas
- Onco Hemato Asso of SW Virginia — Roanoke, Virginia
- Novartis Investigative Site — Linz,
📞 Contact the Study Coordinator
Phone: (888) 669-6682
Email: novartis.email@novartis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described — Homewood, Alabama
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Explore by condition: All Prostate Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.