This trial is examining the effectiveness of cabozantinib (Cabometyx) combined with atezolizumab (Tecentriq) for metastatic castration-resistant prostate cancer (mCRPC; cancer that is no longer responding to hormone therapy). The main outcomes to be measured are progression-free survival (PFS) and overall survival (OS) of patients. This trial is being conducted in California and Tennessee, United States.
Prostate cancer is one of the most common forms of cancer in men. mCRPC is cancer that is resistant to hormonal therapy and has spread. Cabozantinib is a tyrosine kinase inhibitor (enzymes that are responsible for cellular processes in the body). It is being investigated for its effectiveness in preventing further spread and increasing the survival of patients with mCRPC in combination with atezolizumab.
The main outcomes in this trial are PFS and OS of patients following treatment.
Who are they looking for?
This study is looking to recruit 580 patients. Patients must have confirmed adenocarcinoma of the prostate that has spread outside the prostate gland. Patients should have received prior treatment with one and only one hormonal therapy such as abiraterone (Zytiga), apalutamide (Erleanda), darolutamide (Nubeqa), or enzalutamide (Xtandi). Patients must have surgical or medical castration, meaning testosterone levels below 50 ng/dL (1.73 nmol/L).
Patients will be excluded from this trial if they have received prior non-hormonal therapy including radiation therapy within 4 weeks. Brain metastases, spinal cord compression, and blood-thinning medication are also exclusion criteria. Any uncontrolled infections, major surgery or live vaccine within 4 weeks or another cancer will also exclude patients from the trial.
How will it work
The trial will have two study arms. The first arm will receive cabozantinib 40mg oral once daily and atezolizumab 1200mg every 3 weeks. The second arm will receive either abiraterone 1000mg oral once a day plus prednisone (Deltasone; a corticosteroid) 5mg orally, twice a day, or enzalutamide 160mg orally once daily.
The main outcomes evaluated will be PFS, OS and response rate. Patients will be followed over a time-frame of 37 months.