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NCT05939414 · ClinicalTrials.gov registry record · Phase 3
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
A Phase 3 study of Oligometastatic Prostate Cancer (OMPC), sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT05939414 is a Phase 3 study of Oligometastatic Prostate Cancer (OMPC) that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 450 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT05939414, a Phase 3 study of Oligometastatic Prostate Cancer (OMPC), is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).
Conditions Studied
Interventions
- DRUG AAA617
Study Locations (20)
California
- VA Greater LA Healthcare System - Los Angeles
- VA Palo Alto Health Care System - Palo Alto
- Stanford University - Palo Alto
- UCSF - San Francisco
Florida
- Cancer Specialists of North Florida - Jacksonville
- Woodlands Medical Specialists - Pensacola
Illinois
- University of Chicago - Chicago
- The Cancer Institute of Alexian Brothers - Elk Grove
Louisiana
- Mary Bird Perkins Cancer Center - Baton Rouge
- East Jefferson Hospital - Metairie
Maryland
- University of Maryland Medical Ctr - Baltimore
- Johns Hopkins Kimmel Com Cancer Ctr - Baltimore
Massachusetts
- Dana Farber Cancer Institute - Boston
- Beth Israel Deaconess Med Ctr - Boston
Arkansas
- Highlands Oncology Group - Fayetteville
Colorado
- Rocky Mountain Cancer Centers - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2024-03-12 |
| Est. Completion | 2031-10-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05939414
The ClinicalTrials.gov registry entry for NCT05939414 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Oligometastatic Prostate Cancer (OMPC) appearing as the primary indexed condition, and to 1 intervention - of which AAA617 is the first listed.
NCT05939414 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05939414 about?
NCT05939414 is a clinical study titled "An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.". The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for th...
What is the current status of trial NCT05939414?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2024-03-12. Estimated completion is 2031-10-03.
What conditions does trial NCT05939414 study?
This clinical trial studies the following conditions: Oligometastatic Prostate Cancer (OMPC).
What interventions are being tested in trial NCT05939414?
The interventions under investigation include: AAA617 (DRUG).
Who is sponsoring clinical trial NCT05939414?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05939414 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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