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
- 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
Protocol Number
IRB:
PRO00108277
NCT:
NCT04689828
ClinicalTrials.gov
View on ClinicalTrials.gov