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

Sponsor
University Hospital, Essen
Study ID
NCT06388369
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Very High Risk Prostate Carcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [177Lu]Lu-PSMA-617 — RADIATION
    2 cycles of 7,4 GBq \[177Lu\]Lu-PSMA-617 at 6 weeks intervals
  • Ipilimumab — DRUG
    4 cycles of Ipilimumab 3mg/kg at 3 weeks intervals

Study Details

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.

Key Dates

Start date
Aug 25, 2025
Status verified
Mar 2026
Primary completion
Mar 9, 2026
Completion
Mar 9, 2026

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Combination Therapy
    4 cycles of Ipilimumab 3mg/kg + 2 cycles of 7,4 GBq \[177Lu\]Lu-PSMA-617
  • Active Comparator: Neoadjuvant Mono Therapy
    2 cycles of 7,4 GBq \[177Lu\]Lu-PSMA-617

Primary Outcome Measure

Feasibility to perform prostatectomy on time [ Time Frame: During the intervention/procedure ]

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