Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Oligometastatic Prostate Cancer (OMPC), sponsored by Novartis Pharmaceuticals.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS) is defined as the time from randomization to first evidence of radiographically detectable bone or soft tissue distant metastasis by conventional imaging (i.e., Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) and bone scans) as assessed by BIRC using RECIST 1.1 or death due to any cause, whichever occurs first. Participants who are alive without distant metastasis at the analysis data cut-off or are lo
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 |
What NCT05939414 shows while recruiting
NCT05939414 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Oligometastatic Prostate Cancer (OMPC)
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 NCT05939414's enrollment target sits among peer trials
450 838th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00515060 · 450 participants
Psychophysical Studies of Cancer Therapy Pain
- NCT01257269 · 450 participants
Genotype and Phenotype Correlation in Hereditary Thrombotic Thrombocytopenic Purpura (Upshaw-Schulman Syndrome)
- NCT03047161 · 450 participants
Electrophysiology of Fetal Arrhythmia
- NCT03269630 · 450 participants
New Orleans Pulmonary Hypertension Biobank
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI