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NCT04506567 · ClinicalTrials.gov registry record · Phase 1
Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC
A Phase 1 study of Prostate Cancer, sponsored by Weill Medical College of Cornell University.
- Active
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT04506567: Active Phase 1 study of Prostate Cancer, sponsored by Weill Medical College of Cornell University.
NCT04506567 is a Phase 1 study of Prostate Cancer that is active but no longer recruiting, run by Weill Medical College of Cornell University. The registered enrollment target is 60 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04506567, a Phase 1 study of Prostate Cancer, is active but no longer recruiting, sponsored by Weill Medical College of Cornell University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Conditions Studied
Interventions
- DRUG Fractionated dose of 225Ac-J591
- DIAGNOSTIC_TEST 68Ga-PSMA-HBED-CC injection
- DRUG Multiple single doses of 225Ac-J591
Study Locations (2)
New York
- Brooklyn Methodist Hospital - New York Presbyterian - Brooklyn
- Weill Cornell Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-08-18 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What the registry record for NCT04506567 still lists
NCT04506567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Fractionated dose of 225Ac-J591 is the first listed.
NCT04506567 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04506567 about?
NCT04506567 is a clinical study titled "Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC". 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-pos...
What is the current status of trial NCT04506567?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2020-08-18. Estimated completion is 2026-06.
What conditions does trial NCT04506567 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT04506567?
The interventions under investigation include: Fractionated dose of 225Ac-J591 (DRUG), 68Ga-PSMA-HBED-CC injection (DIAGNOSTIC_TEST), Multiple single doses of 225Ac-J591 (DRUG).
Who is sponsoring clinical trial NCT04506567?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04506567 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04506567's enrollment target sits among peer trials
60 421st of 735 higher than 293 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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