Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

NCT05939414 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 450 participants
Start Date 2024-03-12
Est. Completion 2031-10-03
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05939414 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05939414?

The interventions under investigation include: AAA617 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05939414?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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