PSMAfore: Lu-PSMA for men with castrate-resistant prostate cancer

What is the Purpose of this Study?

If you choose to join this study you will:
- Be randomly assigned to receive either the study drug 177Lu-PSMA-617 or a hormone therapy that is already approved
-- 177Lu-PSMA-617 is a radiation-based medicine that you will receive once every 6 weeks for a total of 36 weeks
-- The hormone therapy is a pill that you will take every day
- Have blood tests
- Complete questionnaires
- Have imaging tests, including a 68Ga-PSMA-11 imaging scan
What is the Condition Being Studied?
Metastatic Castrate-Resistant Prostate Cancer

Who Can Participate in this Study?

Adults with advanced or metastatic castrate-resistant prostate cancer who:

- Have already received either abiraterone or enzalutamide

- Have not received a taxane-based chemotherapy

- Have a tumor that expresses the marker PSMA

For more information about who can join this study, contact the study team at julia.hurrelbrink@duke.edu.

Age Group
Adults
Participating Institutions

What is Involved?

We are doing this study to learn if the study drug called 177Lu-PSMA-617 is safe and effective compared to changing a hormone therapy in men with metastatic castrate-resistant prostate cancer.

If you are initially assigned to receive the hormone therapy, you may be able to "crossover" to the 177Lu-PSMA-617 arm if your cancer continues to grow while you are on hormone therapy.

Study Details

Full Title
A phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of androgen receptor-directed therapy in the Treatment of Taxane Naïve Men with Progressive Metastatic Castrate Resistant Prostate Cancer (CAAA617B12302)
Principal Investigator
Daniel George
Eleanor Easley Distinguished Professor in the School of Medicine

Protocol Number
IRB:
PRO00108277

NCT:
NCT04689828
ClinicalTrials.gov
View on ClinicalTrials.gov