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Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer

NCT06388369 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-03-13

No results posted yet for this study

Summary

A randomized, open-label Phase I/II study of neoadjuvant treatment with \[177Lu\]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy.

Conditions

  • Very High Risk Prostate Carcinoma

Interventions

RADIATION

[177Lu]Lu-PSMA-617

2 cycles of 7,4 GBq \[177Lu\]Lu-PSMA-617 at 6 weeks intervals

DRUG

Ipilimumab

4 cycles of Ipilimumab 3mg/kg at 3 weeks intervals

Sponsors & Collaborators

  • Advanced Accelerator Applications

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • University Hospital, Essen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2026-03-09
Completion
2026-03-09

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT06388369 on ClinicalTrials.gov