Treating Metastatic Prostate Cancer with a New PARP Inhibitor AZD5305 in Combination With Hormone Therapy (PETRANHA)

About the Study

The current standard treatment for metastatic prostate cancer is the use of hormone therapy. This study will look at the effectiveness of a new PARP inhibitor drug called AZD5305 in combination with different hormone therapies to treat metastatic prostate cancer, compared to the current standard treatment. The goal of the study is to determine if the addition of the study drug AZD5305 is safe and effective at stopping the growth of metastatic prostate cancer.

What the Study Involves

There are two phases to the study, a dose escalation phase and an expansion phase. For each phase, people enrolled in the study will be assigned to one of several different groups. Participants in all groups will receive AZD5305 orally and one of the following oral hormone therapies:

• Enzalutamide (Xtandi)
• Abiraterone Acetate (Zytiga)
• Darolutamide (Nubeqa)
• Apalutamide (Erleada)

People enrolled will be monitored for tumor growth and other outcomes. They will continue with both medications daily until disease worsens or they withdraw from the study.

People, 18 years or older, who meet the following:

• diagnosis of metastatic prostate cancer 
  • Phase 1: people with castration-sensitive or castration-resistant prostate cancer will be eligible.
  • Phase 2: only people with castration-resistant prostate cancer will be eligible.
• must be eligible for hormone therapy medication.
• have a life expectancy of more than 16 weeks.
• must be at least 4 weeks out from surgery or radiation.

People will not be eligible to participate if:

• they have previously received treatment with:
  • a PARP inhibitor.
  • any of the following hormonal therapies: Xtandi (Enzalutamide), Zytiga (abiraterone acetate), Nubeqa (darolutamide) or Erleada (apalutamide). 
  • lutetium prostate-specific membrane antigen (Lu-PSMA)
  • platinum chemotherapy