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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 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.

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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.

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

FieldValue
Enrollment Target 60 participants
Start Date 2020-08-18
Est. Completion 2026-06
Phase Phase 1

What the Registry Record Tells You About NCT04506567

The ClinicalTrials.gov registry entry for NCT04506567 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.