A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
Running, not enrolling · Phase 2
Conditions studied: Prostatic Neoplasm
In brief
The purpose of this study is to evaluate the efficacy and safety of AAA617 alone (Lutetium \[177Lu\] vipivotide tetraxetan) and in combination with an Androgen Receptor Pathway Inhibitors (ARPI) in participants with PSMA-positive, castration-resistant prostate cancer and no evidence of metastasis in conventional imaging (CI) (i.e., CT/MRI and bone scans).
Key facts
- Study ID
- NCT05849298
- Run by
- Novartis Pharmaceuticals
- People needed
- 49
- Starts
- 2024-01-03
- Expected to finish
- 2026-12-23
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Naples, Italy
- Novartis Investigative Site — Kielce, Poland
- Novartis Investigative Site — Singapore, Singapore
- Novartis Investigative Site — Seoul, South Korea
- Novartis Investigative Site — Seoul, South Korea
- Rocky Mountain Cancer Centers — Denver, Colorado, United States
- University Cancer and Blood Center LLC — Athens, Georgia, United States
- Urology Of Indiana — Indianapolis, Indiana, United States
- Unity Point Clinic — Des Moines, Iowa, United States
- Urology Cancer Center PC — Omaha, Nebraska, United States
- Associated Med Professionals of NY — Syracuse, New York, United States
- Oregon Urology Institute — Springfield, Oregon, United States
- Wellspan York Hospital — York, Pennsylvania, United States
- Univ of Texas Southwest Med Center — Dallas, Texas, United States
- Rio Grande Urology — El Paso, Texas, United States
- Houston Methodist Hospital — Houston, Texas, United States
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Montreal, Quebec, Canada
- Novartis Investigative Site — Montreal, Quebec, Canada
- Novartis Investigative Site — Olomouc, Czechia
- Novartis Investigative Site — Angers, France
- Novartis Investigative Site — Brest, France
- Novartis Investigative Site — Strasbourg, France
Full record on ClinicalTrials.gov
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