An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
Recruiting now · Phase 3
Conditions studied: Oligometastatic Prostate Cancer (OMPC)
In brief
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).
Key facts
- Study ID
- NCT05939414
- Run by
- Novartis Pharmaceuticals
- People needed
- 450
- Starts
- 2024-03-12
- Expected to finish
- 2031-10-03
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Highlands Oncology Group — Fayetteville, Arkansas, United States (enrolling)
- Wash U School of Medicine — St Louis, Missouri, United States (enrolling)
- Stanford University — Palo Alto, California, United States (enrolling)
- VA Greater LA Healthcare System — Los Angeles, California, United States (enrolling)
- VA Palo Alto Health Care System — Palo Alto, California, United States (enrolling)
- Cancer Specialists of North Florida — Jacksonville, Florida, United States (enrolling)
- Woodlands Medical Specialists — Pensacola, Florida, United States (enrolling)
- Piedmont Healthcare — Atlanta, Georgia, United States (enrolling)
- UCSF — San Francisco, California, United States (enrolling)
- The Cancer Institute of Alexian Brothers — Elk Grove, Illinois, United States (enrolling)
- Rocky Mountain Cancer Centers — Denver, Colorado, United States (enrolling)
- University of Kansas Hospital — Kansas City, Kansas, United States (enrolling)
- Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States (enrolling)
- East Jefferson Hospital — Metairie, Louisiana, United States (enrolling)
- University of Maryland Medical Ctr — Baltimore, Maryland, United States (enrolling)
- Johns Hopkins Kimmel Com Cancer Ctr — Baltimore, Maryland, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States (enrolling)
- BAMF Health — Grand Rapids, Michigan, United States (enrolling)
- University of Chicago — Chicago, Illinois, United States (enrolling)
- William Beaumont Hospital — Royal Oak, Michigan, United States (enrolling)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
- St Louis University — St Louis, Missouri, United States (enrolling)
- Unity Point Clinic — Des Moines, Iowa, United States (enrolling)
- The Urology Center PC DBA UroHealth Partners — Omaha, Nebraska, United States (enrolling)
Full record on ClinicalTrials.gov
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