CONVERGE-01 (Prostate Cancer) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called Actinium-225 rosopatamab tetraxetan (the study drug) is a safe and effective option for patients with castration-resistant prostate cancer (CRPC).
Metastatic Castration-Resistant Prostate Cancer (CRPC)
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with advanced or metastatic CRPC
- Have been previously treated with at least one androgen receptor signaling inhibitor and either Lu-177-PSMA-617 or Lu-177-PSMA-I&T
For more information about who can join this study, please contact the study team at julia.hurrelbrink@duke.edu.
What is Involved?
The study is divided into three periods: a screening period, the study dosing period, and a follow-up period.
If you choose to join the study, during the screening period you will:
- Have a biopsy
- Have a CT scan
- Have a bone scan
- Have an electrocardiogram (EKG)
- Realizar extracciones de sangre
- Someterse a exámenes físicos
If we find that you are eligible to join during the screening period, you will proceed to the dosing period. During this period of the study, you will get a random assignment (fair, equal chance) to a certain dose level of the study drug. If you participate in Part 2 of the study, there are 2 different dose levels to which you might be assigned. If you participate in Part 3 of the study, there are 3 different dose levels to which you might be assigned. Whether you are in Part 2 or Part 3 of the study will depend on when you join.
During the dosing period, you will:
- Get the study drug by IV during 2 study visits that are 14 days apart
- Have CT scans
- Realizar extracciones de sangre
- Responder encuestas
After you get your last dose of the study drug, you will begin the follow-up period. We will schedule you to come in for return visits for up to 2 years so we can keep tabs on your health and progress.
Study Details
