Spots Global Cancer Trial Database for A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
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Trial Identification
Brief Title: A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
Official Title: An International Prospective Open-label, Multi-center, Randomized, Non-comparative Phase II Study of Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) Alone and Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) in Combination With Androgen Receptor Pathway Inhibitors in Patients With PSMA PET Scan Positive Castration-Resistant Prostate Cancer
Study ID: NCT05849298
Conditions
Study Description
Brief Summary: 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). Approximately 120 participants will be randomized.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Urology Cancer Center PC, Omaha, Nebraska, United States
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Olomouc, CZE, Czechia
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Krakow, , Poland
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Granada, Andalucia, Spain
Novartis Investigative Site, Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Vigo, Galicia, Spain
Novartis Investigative Site, Madrid, , Spain
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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