Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC (NCT06855277)
A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Urology Centers Of Alabama Pc — Homewood, Alabama
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (95 Sites)
Showing the first 25 of 95 sites.
- Urology Centers Of Alabama Pc — Homewood, Alabama
- Stanford University Medical Center — Palo Alto, California
- Sansum Clinic — Santa Barbara, California
- Rocky Mountain Cancer Centers — Denver, Colorado
- Florida Cancer Specialists — Fort Myers, Florida
- Baptist Health South — Miami, Florida
- AdventHealth — Orlando, Florida
- University Cancer and Blood Center LLC — Athens, Georgia
- Northwestern University — Chicago, Illinois
- University of Illinois Cancer Center at Chicago — Chicago, Illinois
- Univ Of Iowa Hospitals And Clinics — Iowa City, Iowa
- University of Kansas Hospital — Kansas City, Kansas
- East Jefferson Hospital — Metairie, Louisiana
- Beth Israel Deaconess Med Center — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- Karmanos Cancer Institute — Detroit, Michigan
- Wash U School of Medicine — St Louis, Missouri
- Nebraska Cancer Specialists — Omaha, Nebraska
- Astera Cancer Center — East Brunswick, New Jersey
- New Jersey Urology LLC — Voorhees Township, New Jersey
- New Mexico Oncology Hematology — Albuquerque, New Mexico
- Bassett Medical Center — Cooperstown, New York
- Weill Cornell Medicine NY-Presb — New York, New York
- University of Rochester Medical Ctr — Rochester, New York
- Associated Med Professionals of NY — Syracuse, New York
📞 Contact the Study Coordinator
Phone: (888) 669-6682
Email: novartis.email@novartis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described — Homewood, Alabama
- Stereotactic Ablative Radiation Therapy for Prostate Cancer — Charleston, South Carolina
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.