Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC
Public ClinicalTrials.gov record NCT04506567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/II Dose-escalation Study of Fractionated and Multiple Dose 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04506567
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Interventions
- 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
- 68Ga-PSMA-HBED-CC injection Diagnostic Test
Drug · Diagnostic Test
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 17, 2020
- Primary completion
- May 31, 2025
- Completion
- Nov 30, 2026
- Last update posted
- Aug 18, 2026
2020 – 2026
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Brooklyn Methodist Hospital - New York Presbyterian | Brooklyn | New York | 11215 | — |
| Weill Cornell Medicine | New York | New York | 10065 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04506567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04506567 live on ClinicalTrials.gov.