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NCT06855277 · ClinicalTrials.gov registry record · Phase 3

Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC

A Phase 3 study of Prostate Cancer, sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 3
Development phase
940
Enrollment target
20
Study locations

NCT06855277 is a Phase 3 study of Prostate Cancer that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 940 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT06855277, a Phase 3 study of Prostate Cancer, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 3
Development phase
940 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether \[225Ac\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \[177Lu\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.

Conditions Studied

Prostate Cancer

Interventions

  • DRUG Standard of Care
  • DRUG AAA817
  • DRUG ARPI

Study Locations (20)

New York

  • Bassett Medical Center - Cooperstown
  • Weill Cornell Medicine NY-Presb - New York
  • University of Rochester Medical Ctr - Rochester
  • Associated Med Professionals of NY - Syracuse

Florida

  • Miami Cancer Institute at Bapt - Miami
  • AdventHealth - Orlando

São Paulo

  • Novartis Investigative Site - São Paulo
  • Novartis Investigative Site - São Paulo

California

  • Sansum Clinic - Santa Barbara

Colorado

  • Rocky Mountain Cancer Centers - Denver

Iowa

  • Univ Of Iowa Hospitals And Clinics - Iowa City

Kansas

  • University of Kansas Hospital - Kansas City

Missouri

  • Wash U School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 940 participants
Start Date 2025-07-01
Est. Completion 2032-11-04
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT06855277

The ClinicalTrials.gov registry entry for NCT06855277 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 940 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 (55% 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 3 interventions - of which Standard of Care is the first listed.

NCT06855277 reports 20 study locations spanning 15 distinct geographic areas - top geographies include New York, Florida, São Paulo.

Frequently Asked Questions

What is clinical trial NCT06855277 about?

NCT06855277 is a clinical study titled "Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC". The purpose of this study is to determine whether \[225Ac\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of stan...

What is the current status of trial NCT06855277?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 940 participants. The study started on 2025-07-01. Estimated completion is 2032-11-04.

What conditions does trial NCT06855277 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT06855277?

The interventions under investigation include: Standard of Care (DRUG), AAA817 (DRUG), ARPI (DRUG).

Who is sponsoring clinical trial NCT06855277?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06855277 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Iowa, Kansas. 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

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.