Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
Public ClinicalTrials.gov record NCT05803941. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05803941
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 700 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 13, 2023
- Primary completion
- Jul 19, 2033
- Completion
- Jul 20, 2033
- Last update posted
- Jun 3, 2026
2023 – 2033
United States locations
- U.S. sites
- 24
- U.S. states
- 20
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | Recruiting |
| St. Joseph Hospital | Orange | California | 92686 | Recruiting |
| Providence Saint Johns Health Ctr | Santa Monica | California | 90404 | Recruiting |
| University of Colorado | Aurora | Colorado | 80045 | Recruiting |
| Hartford Hospital | Hartford | Connecticut | 06102 | Recruiting |
| VA Medical Center | Washington D.C. | District of Columbia | 20422 | Recruiting |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | Recruiting |
| University Cancer and Blood Center LLC | Athens | Georgia | 30607 | Recruiting |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | Recruiting |
| Tulane Cancer Center | New Orleans | Louisiana | 70112 | Recruiting |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | Recruiting |
| Corewell Health William Beaum Hosp | Royal Oak | Michigan | 48073-6769 | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | Recruiting |
| University of Mississippi Med Ctr | Jackson | Mississippi | 39216 | Recruiting |
| Wash U School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Urology Cancer Center PC | Omaha | Nebraska | 68130 | Recruiting |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68154 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10467 | Recruiting |
| Duke University Medical Center | Durham | North Carolina | 27710 | Recruiting |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Recruiting |
| Univ of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| Univ of Texas Southwest Med Center | Dallas | Texas | 75390-9034 | Recruiting |
| UT Health Science Center | Houston | Texas | 77030 | Recruiting |
| Onco Hemato Asso of SW Virginia | Roanoke | Virginia | 24014 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05803941, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 3, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05803941 live on ClinicalTrials.gov.