An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
NCT05939414 · PSMA-DC Phase 3Recruiting
- Lead sponsor
- Novartis Pharmaceuticals (Industry)
- Enrollment
- 450 (estimated)
- Start date
- 12 Mar 2024
- Primary completion
- 25 Apr 2028 (estimated)
- Study completion
- 3 Oct 2031
- Last update posted
- 21 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 2
Interventions
- AAA617 Drug
- piflufolastat (18F) Drug
- gallium (68Ga) gozetotide (25μg) Drug
Conditions and primary outcome
- Oligometastatic Prostate Cancer (OMPC)
Primary outcome
Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS) (From date of randomization until first evidence of radiographically detectable bone or soft tissue distant metastasis or death due to any cause, whichever occurs first, assessed up to approximately 30 months)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT05939414.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT05939414 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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