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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 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.

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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.

Conditions Studied

Prostate Cancer

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

FieldValue
Enrollment Target 700 participants
Start Date 2023-08-14
Est. Completion 2033-07-21
Phase Phase 4

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05803941

The ClinicalTrials.gov registry entry for NCT05803941 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (15% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 17 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.