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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
Sponsor: Novartis Pharmaceuticals
Summary
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
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
Key Details
Gender
MALE
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
443
Start Date
2025-02-27
Completion Date
2033-07-19
Last Updated
2026-05-27
Healthy Volunteers
No
Conditions
Interventions
Investigators choice of SoC
The control treatment in Phase III is investigator's choice of SoC
AAA817
The investigational treatment is AAA817
AAA817
The investigational treatment is AAA817
AAA817
Investigational treatment is the Dose B of AAA817
Locations (81)
VA Greater LA Healthcare System
Los Angeles, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Sansum Clinic
Santa Barbara, California, United States
Saint Johns Cancer Institute
Santa Monica, California, United States
Hartford Hospital
Hartford, Connecticut, United States
AdventHealth
Orlando, Florida, United States
University Cancer and Blood Center LLC
Athens, Georgia, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Hospital
Kansas City, Kansas, United States
East Jefferson Hospital
Metairie, Louisiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
WA Uni School Of Med
St Louis, Missouri, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
New Jersey Urology LLC
Voorhees Township, New Jersey, United States
Associated Med Professionals of NY
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Central Ohio Urology Group
Gahanna, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Texas Oncology
Dallas, Texas, United States
Urology San Antonio
San Antonio, Texas, United States
Utah Intermountain Medical Center
Murray, Utah, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States
Novartis Investigative Site
Darlinghurst, New South Wales, Australia
Novartis Investigative Site
Herston, Queensland, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Fuzhou, Fujian, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Shenyang, Liaoning, China
Novartis Investigative Site
Xian, Shanxi, China
Novartis Investigative Site
Xian, Shanxi, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Guangzhou, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Beersheba, Israel
Novartis Investigative Site
Haifa, Israel
Novartis Investigative Site
Jerusalem, Israel
Novartis Investigative Site
Petah Tikva, Israel
Novartis Investigative Site
Ramat Gan, Israel
Novartis Investigative Site
Tel Aviv, Israel
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Chiba, Japan
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Fukushima, Japan
Novartis Investigative Site
Ishikawa, Japan
Novartis Investigative Site
Kyoto, Japan
Novartis Investigative Site
Petaling Jaya, Selangor, Malaysia
Novartis Investigative Site
Petaling Jaya, Selangor, Malaysia
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Basel, Switzerland
Novartis Investigative Site
Bellinzona, Switzerland
Novartis Investigative Site
Bern, Switzerland
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taoyuan, Taiwan