This trial is investigating the effectiveness of pembrolizumab (Keytruda) plus enzalutamide (Xtandi) in patients with prostate cancer. The primary outcome to be measured will be the absence of cancer on the prostate after it is surgically removed. This study is being conducted in Portland, OR.
Prostatectomy or removal of the prostate is commonly used to treat prostate cancer. Hormone therapy may be given before surgery to help shrink the tumor. This treatment lowers the levels of androgens (male hormones) to stop them from helping prostate cancer cells grow. Enzalutamide is an anti-androgen, so it blocks these hormones to block tumor growth.
Pembrolizumab is an antibody-based drug that helps the immune system attack cancer cells. This study is evaluating the safety and effectiveness of pembrolizumab plus enzalutamide before prostatectomy. The main outcome to be measured will be the number of patients who have a complete pathologic response (no signs of cancer in the removed tissue) after surgery.
Who are they looking for?
This study is looking for 32 male patients with high-risk prostate cancer. Patients should have planned surgery to remove the prostate. Patients should not have any other types of cancer, nor any evidence of disease outside of the prostate. All patients must agree to use contraception from the beginning of the study through the end of surgery.
How will it work
All patients will be given pembrolizumab and enzalutamide. Treatment will last 14 to 16 weeks in total. Pembrolizumab will be given every 3 weeks and enzalutamide will be given daily. Surgery will then be done to remove some or all of the prostate. Then, the removed tissue will be examined for signs of cancer.
The main outcome to be measured will be the number of patients who do not have any signs of cancer after the surgery. The number of patients who have side effects from the study drugs at 1 month after surgery will be measured. The number of patients who have complications at 4 months after surgery will also be measured.