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.
Prostatic Neoplasm
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.
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 Cancer Center PC, Omaha, Nebraska, United States, 68130
Oregon Urology Institute Research, Springfield, Oregon, United States, 97477
Carolina Urologic Research Center, LLC, Myrtle Beach, South Carolina, United States, 29572
Urology Clinic of North Texas, Dallas, Texas, United States, 75231
Univ of Texas Southwest Med Center Cardiovasc And Thoracic Surg, Dallas, Texas, United States, 75390-9034
Houston Methodist Hospital Research, Houston, Texas, United States, 77030
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
MALE
No
Novartis Pharmaceuticals,
Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals
2028-12-22