Full Title
A Randomized Open-label Phase 2 Study of TALazoparib with or without ENzaluTamide in Patients with Metastatic Castration-Resistant Prostate Cancer and HRR Mutations After Progression on Abiraterone Acetate (TALENT)Purpose
Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the best treatments for prostate cancers that have metastasized (spread). The benefits of hormone treatments often do not last, however. Over time, many prostate cancers keep growing even with hormonal therapies. These are called castration-resistant prostate cancers (CRPC).
Researchers are assessing talazoparib, alone or with enzalutamide, to treat metastatic CRPC with an HRR (homologous recombination repair) mutation. Having an HRR mutation means that your cells have a change (mutation) that affects how they repair DNA damage. An HRR mutation can cause cancer cell growth. Some commonly known HRR mutations include changes in the BRCA and ATM genes.
PARP is a protein that works in your cells to help repair damaged DNA. Talazoparib stops PARP in cancer cells from repairing damage to themselves and their DNA. This action can lead to the death of the cancer cells. Enzalutamide works by blocking the effects of androgen, which helps stop cancer growth and spread. Both drugs are taken orally (by mouth).
If you take part in this study, you will be randomly assigned to get one of these treatments:
- Talazoparib plus enzalutamide, along with standard androgen deprivation therapy (ADT).
- Talazoparib alone, plus standard ADT.
Who Can Join
To join this study, there are a few conditions. You must:
- Have CRPC which keeps growing after treatment and has an HRR mutation.
- Have recovered from the serious side effects of previous therapies before getting the study treatment.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information about this study or to see if you can join, please call Dr. Karen Autio’s office at 646-422-4632.