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Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617

NCT07054346 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-04-01

No results posted yet for this study

Summary

There is evidence that Actinium-225 Prostate-Specific Membrane Antigen (225Ac-PSMA) has a potentially higher level of efficacy than 177 Lutetium Prostate-Specific Membrane Antigen (177Lu-PSMA) as a radioligand therapy. This single center, pilot study will compare differences in the mechanisms of actinium-225 and lutetium-177 radioligand therapies (RLT) in participants with high or very high risk localized or locoregional prostate cancer planning on undergoing a prostatectomy.

Conditions

  • Prostate Cancer
  • Prostate Cancer (Diagnosis)
  • High-risk Prostate Cancer
  • Localized Prostate Carcinoma
  • Very High Risk Prostate Carcinoma

Interventions

DRUG

177 Lutetium Prostate-Specific Membrane Antigen 617

Given intravenously (IV) or intra-arterially (IA)

DRUG

Actinium-225 Prostate-Specific Membrane Antigen 617

Given IV or IA

PROCEDURE

Non-investigational, Prostatectomy

Undergo non-investigational surgical procedure to remove prostate.

PROCEDURE

Prostate Tissue Collection

Whole prostate tissue will be collected for correlative research at time of prostatectomy.

PROCEDURE

Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)

Imaging procedure

PROCEDURE

Blood Sample Collection

Blood samples will be obtained for research purposes

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Thomas Hope

    lead OTHER

Principal Investigators

  • Thomas A Hope, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-08
Primary Completion
2027-04-30
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT07054346 on ClinicalTrials.gov