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Recruiting Phase 2Phase 3 Interventional

Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

ClinicalTrials.gov ID: NCT06780670

Public ClinicalTrials.gov record NCT06780670. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 27, 2026, 3:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

PSMAcTION: A Phase II/III, Open-label, International, Multicenter, Randomized Study of AAA817 Versus Standard of Care in the Treatment of Adult Participants With PSMA Positive Metastatic Castration-resistant Prostate Cancer Who Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment

Study identification

NCT ID
NCT06780670
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
443 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 27, 2025 (Actual)
Primary completion
Jun 27, 2028 (Estimated)
Completion
Jul 19, 2033 (Estimated)
Last update posted
Sep 22, 2026

2025 – 2033

United States locations

U.S. sites
35
U.S. states
24
U.S. cities
33
Facility City State ZIP Site status
Honor Health Research Institute Scottsdale Arizona 85258 Recruiting
VA Greater LA Healthcare System Los Angeles California 90073 Recruiting
VA Palo Alto Health Care System Palo Alto California 94304-1207 Recruiting
Stanford University Medical Center Palo Alto California 94304 Recruiting
Sansum Clinic Santa Barbara California 93105 Recruiting
Saint Johns Cancer Institute Santa Monica California 90404 Recruiting
Rocky Mountain Cancer Centers Denver Colorado 80218 Recruiting
Hartford Hospital Hartford Connecticut 06102 Recruiting
Baptist Health South Miami Florida 33173 Recruiting
AdventHealth Orlando Florida 32804 Recruiting
University Cancer and Blood Center LLC Athens Georgia 30607 Recruiting
Emory University Atlanta Georgia 30322 Recruiting
University of Chicago Chicago Illinois 60637 Recruiting
Indiana University Indianapolis Indiana 46202 Recruiting
University of Kansas Hospital Kansas City Kansas 66160 Recruiting
East Jefferson Hospital Metairie Louisiana 70006 Recruiting
Dana Farber Cancer Institute Boston Massachusetts 02115 Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 Recruiting
WA Uni School Of Med St Louis Missouri 63110 Recruiting
Nebraska Cancer Specialists Omaha Nebraska 68154 Recruiting
New Jersey Urology LLC Voorhees Township New Jersey 08043 Recruiting
Mount Sinai Hosp Med School New York New York 10029 Recruiting
Associated Med Professionals of NY Syracuse New York 13210 Recruiting
Montefiore Medical Center The Bronx New York 10467 Recruiting
Central Ohio Urology Group Gahanna Ohio 43230 Recruiting
Oregon Urology Institute Springfield Oregon 97477 Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 Recruiting
Carolina Urologic Research Center Myrtle Beach South Carolina 29572 Recruiting
Texas Oncology Dallas Texas 75251 Recruiting
Urology San Antonio San Antonio Texas 78229 Recruiting
Utah Intermountain Medical Center Murray Utah 84107 Recruiting
Virginia Cancer Specialists Fairfax Virginia 22031 Recruiting
Onco Hemato Asso of SW Virginia Roanoke Virginia 24014 Recruiting
Fred Hutchinson Cancer Research Center Seattle Washington 98109-1024 Recruiting
Medical College Of Wisconsin Milwaukee Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 58 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06780670, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 22, 2026 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06780670 live on ClinicalTrials.gov.

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