RECRUITING

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 80 participants will be randomized.

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 80 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

Mobile

Urology Associates of Mobile, Mobile, Alabama, United States, 36608

Denver

Rocky Mountain Cancer Centers, Denver, Colorado, United States, 80218

Jacksonville

University Of Florida, Jacksonville, Florida, United States, 32218

Athens

University Cancer and Blood Center LLC, Athens, Georgia, United States, 30607

Indianapolis

Urology Of Indiana, Indianapolis, Indiana, United States, 46254

Des Moines

Unity Point Clinic, Des Moines, Iowa, United States, 50323

Omaha

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

Syracuse

Associated Med Professionals of NY, Syracuse, New York, United States, 13210

Springfield

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

York

Wellspan York Hospital, York, Pennsylvania, United States, 17403

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 100 Years

    Sexes Eligible for Study

    MALE

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Novartis Pharmaceuticals,

    Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

    Study Record Dates

    2030-05-18