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NCT05803941 · ClinicalTrials.gov registry record · Phase 4
Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
A Phase 4 study of Prostate Cancer, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 700
- Enrollment target
- 20
- Study locations
NCT05803941: Recruiting Phase 4 study of Prostate Cancer, sponsored by Novartis Pharmaceuticals.
NCT05803941 is a Phase 4 study of Prostate Cancer that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 700 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05803941, a Phase 4 study of Prostate Cancer, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 700 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG AAA617
Study Locations (20)
California
- St. Joseph Hospital - Orange
- Providence Saint Johns Health Ctr - Santa Monica
Louisiana
- Tulane Cancer Center - New Orleans
- Ochsner Clinic Foundation - New Orleans
Nebraska
- Urology Cancer Center PC - Omaha
- Nebraska Cancer Specialists - Omaha
Arizona
- Mayo Clinic Arizona - Scottsdale
Colorado
- University of Colorado - Aurora
Connecticut
- Hartford Hospital - Hartford
District of Columbia
- VA Medical Center - Washington D.C.
Florida
- Mayo Clinic Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2023-08-14 |
| Est. Completion | 2033-07-21 |
| Phase | Phase 4 |
What NCT05803941 shows while recruiting
NCT05803941 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (15% higher).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which AAA617 is the first listed.
NCT05803941 names 20 study sites across 17 states, led by California, Louisiana, Nebraska.
Frequently Asked Questions
What is clinical trial NCT05803941 about?
NCT05803941 is a clinical study titled "Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in 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...
What is the current status of trial NCT05803941?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 700 participants. The study started on 2023-08-14. Estimated completion is 2033-07-21.
What conditions does trial NCT05803941 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT05803941?
The interventions under investigation include: AAA617 (DRUG).
Who is sponsoring clinical trial NCT05803941?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05803941 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05803941's enrollment target sits among peer trials
700 90th of 735 higher than 645 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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