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).
Who Can Participate?
Eligibility
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
Age Range
0-64
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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)
- Have blood draws
- Have physical exams
- Get the study drug by IV during 2 study visits that are 14 days apart
- Have CT scans
- Have blood draws
- Answer questionnaires
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 2, Open-label Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants with PSMA PET-Positive Castration-Resistant Prostate Cancer
Principal Investigator
Daniel
George
Protocol Number
PRO00116010
NCT ID
NCT06549465
Phase
II
Enrollment Status
Pending Open to Enrollment