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Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer

NCT04597411 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2026-04-30

No results posted yet for this study

Summary

This is a Phase 1, open-label, international, dose escalation study to evaluate the safety of \[225Ac\]Ac-PSMA-617 (225Ac-PSMA-617) in men with PSMA-positive prostate cancer who have and have not had prior exposure to \[177Lu\]Lu-PSMA-617 (177Lu-PSMA-617) or \[177Lu\]Lu-PSMA I\&T (177Lu-PSMA I\&T).

Conditions

  • Prostatic Neoplasms, Castration-Resistant

Interventions

RADIATION

225^Ac-PSMA-617

administered intravenously under the dose escalation schedule

RADIATION

68^Ga-PSMA-11

administered intravenously at a dose of 111 - 185 MBq (3 - 5 mCi)

Sponsors & Collaborators

  • Endocyte

    lead INDUSTRY

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • Australia
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597411 on ClinicalTrials.gov