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Neoadjuvant [177Lu]Lu-PSMA I&T in Oligometastatic Prostate Cancer
NCT06259123Phase 2
Key facts
- Status
- Recruiting
- Start
- Feb 2024
- Primary completion
- Jan 2027
- Countries
- 1
- Sponsor
- Medical University of Vienna
- Modality
- Small Molecules
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, open-label, single-arm trial of lutetium Lu 177 PSMA I&T in prostate cancer (PCa), sponsored by Medical University of Vienna. Primary endpoint: Incidence of treatment-emergent adverse events at 12 months. Started Feb 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Oligometastatic PCa Arm
Patients receive neoadjuvant [177Lu]Lu-PSMA I&T followed by radical prostatectomy
03
Who it enrols
Patients with oligometastatic prostate cancer (M1a/b <=5 osseous, M1c <=3 lung) diagnosed by PSMA PET, planned for radical prostatectomy, with adequate organ function and no prior ADT.
04
Endpoints
Primary
Incidence of treatment-emergent adverse events
Secondary
PSA response to neoadjuvant PSMA-RLT and radical prostatectomy
Imaging response and stability to neoadjuvant PSMA-RLT and radical prostatectomy
Any therapy- and androgen deprivation therapy-free survival after radical prostatectomy
Estimate time to castration-resistant prostate cancer
Evaluate pathologic response at radical prostatectomy
Quantification of circulating free tumor DNA
Assess quality of life under the systemic PSMA-RLT
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