Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
177Lu-PSMA-617 + EBRT + Short-Term ADT vs EBRT + Long-Term ADT in High-Risk Localized Prostate Cancer
NCT07550517Phase 2
Key facts
- Status
- Recruiting
- Start
- Aug 2026
- Primary completion
- Aug 2032
- Countries
- 1
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center
- Modality
- Small Molecules, Peptide-Drug Conjugates
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, randomised, open-label trial of lutetium lu 177 vipivotide tetraxetan in prostate cancer (PCa) (2 arms), sponsored by Sidney Kimmel Comprehensive Cancer Center. Primary endpoint: Rate of testosterone recovery up to 3 years. Started Aug 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Arm A (EBRT + 6 mo ADT + 177Lu-PSMA-617)
Participants will receive EBRT + 6 mo ADT + 177Lu-PSMA-617
Arm B (EBRT + 24 mo ADT)
Participants will receive EBRT + 24 mo ADT
03
Who it enrols
Men >= 18 years with high-risk localized prostate cancer (cT3a, Grade Group 4/5, or PSA > 20 ng/mL), PSMA-PET SUVmax > 10, ECOG <= 2, adequate organ function, and no prior definitive treatment for prostate cancer.
04
Endpoints
Primary
Rate of testosterone recovery
Secondary
Biochemical disease-free survival
Time-to-Next-Intervention
ADT-free survival
Metastasis-free survival
Overall Survival
Toxicity as assessed by adverse events
Quality of Life as assessed by Expanded Prostate Index Composite
Quality of Life as assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Beyond the preview
Go deeper on NCT07550517.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT07550517.