Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC (NCT04506567)
Phase I/II Dose-escalation Study of Fractionated and Multiple Dose 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer
🩺 Plain-English Summary (8th-Grade Level)
The purpose of the initial (phase I) portion of this study is to find a dose level and administration schedule of the study drug, 225Ac-J591, that can be given without severe side effects. The purpose of the second (phase II) portion of the study is to determine the proportion of those with PSMA-positive tumors with \>50% PSA decline following 225Ac-J591 treatment in two regimens.
Who can join: Review the eligibility criteria below.
Location: Brooklyn Methodist Hospital - New York Presbyterian — Brooklyn, New York
Age range: 18 Years to 99 Years
🧪 Interventions in This Study
- Multiple Dose of 225Ac-J591 at 45 KBq/kg (DRUG)
- Multiple Dose of 225Ac-J591 at 55 KBq/kg (DRUG)
- Multiple Dose of 225Ac-J591 at 65 KBq/kg (DRUG)
- Fractionated Dose of 225Ac-J591 at 45 KBq/kg (DRUG)
- Fractionated Dose of 225Ac-J591 at 55 KBq/kg (DRUG)
- Fractionated Dose of 225Ac-J591 at 60 KBq/kg (DRUG)
- Fractionated Dose of 225Ac-J591 at 65 KBq/kg (DRUG)
- Fractionated Dose of 225Ac-J591 at 45 KBq/kg (Prior 177Lu-PSMA-RL) (DRUG)
- Fractionated Dose of 225Ac-J591 at 50 KBq/kg (Prior 177Lu-PSMA-RL) (DRUG)
📋 "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 (2 Sites)
- Brooklyn Methodist Hospital - New York Presbyterian — Brooklyn, New York
- Weill Cornell Medicine — New York, New York
💰 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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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.