🏛️ Verified NIH Record • Updated 2026-08-18

Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT (NCT05983198)

SatisfACtion: Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With mHSPC and Heavily Pre-treated PSMA-positive mCRPC, With/Without Prior 177Lu-labelled PSMA-targeted Radioligand Therapy

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Novartis Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to learn if the study drug, \[225Ac\]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Rochester — Rochester, Minnesota

Age range: 18 Years to 100 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (9 Sites)

  • Mayo Clinic Rochester — Rochester, Minnesota
  • Novartis Investigative Site — Darlinghurst, New South Wales
  • Novartis Investigative Site — Montreal, Quebec
  • Novartis Investigative Site — Dijon, Cote D Or
  • Novartis Investigative Site — Clermont-Ferrand,
  • Novartis Investigative Site — Lyon,
  • Novartis Investigative Site — Nantes,
  • Novartis Investigative Site — Saint-Herblain,
  • Novartis Investigative Site — Vandœuvre-lès-Nancy,

📞 Contact the Study Coordinator

Phone: (800) 664-4580

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.

Explore by condition: All Prostate Cancer clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗