A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

Description

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.

Conditions

Prostatic Neoplasm

Study Overview

Study Details

Study overview

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.

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

A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

Condition
Prostatic Neoplasm
Intervention / Treatment

-

Contacts and Locations

Omaha

Urology Cancer Center PC, Omaha, Nebraska, United States, 68130

Springfield

Oregon Urology Institute Research, Springfield, Oregon, United States, 97477

Myrtle Beach

Carolina Urologic Research Center, LLC, Myrtle Beach, South Carolina, United States, 29572

Dallas

Urology Clinic of North Texas, Dallas, Texas, United States, 75231

Dallas

Univ of Texas Southwest Med Center Cardiovasc And Thoracic Surg, Dallas, Texas, United States, 75390-9034

Houston

Houston Methodist Hospital Research, Houston, Texas, United States, 77030

Participation Criteria

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.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    MALE

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Novartis Pharmaceuticals,

    Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

    Study Record Dates

    2028-12-22