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 80 participants will be randomized.
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 80 participants will be randomized.
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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Urology Associates of Mobile, Mobile, Alabama, United States, 36608
Rocky Mountain Cancer Centers, Denver, Colorado, United States, 80218
University Of Florida, Jacksonville, Florida, United States, 32218
University Cancer and Blood Center LLC, Athens, Georgia, United States, 30607
Urology Of Indiana, Indianapolis, Indiana, United States, 46254
Unity Point Clinic, Des Moines, Iowa, United States, 50323
Urology Cancer Center PC, Omaha, Nebraska, United States, 68130
Associated Med Professionals of NY, Syracuse, New York, United States, 13210
Oregon Urology Institute, Springfield, Oregon, United States, 97477
Wellspan York Hospital, York, Pennsylvania, United States, 17403
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to 100 Years
MALE
No
Novartis Pharmaceuticals,
Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals
2030-05-18