This trial is evaluating the effectiveness and safety of combining nivolumab (Opdivo) with docetaxel (Taxotere) and prednisone (Deltasone) in men with metastatic castration-resistant prostate cancer (mCRPC). The main outcomes to be evaluated will be survival without cancer worsening and overall survival.
CRPC is a difficult to treat form of prostate cancer (PC). It no longer responds to hormonal therapy. In mCRPC, the cancer has spread away from the prostate gland. Immunotherapies such as nivolumab may improve the response of the immune system to find and kill cancer cells. Docetaxel is the mainstay chemotherapy in patients with CRPC. It is commonly used in combination with the corticosteroid drug, prednisone.
This trial is evaluating the effectiveness of the combination between nivolumab and docetaxel plus prednisone in patients with mCRPC. The main outcomes to be evaluated will be survival without cancer worsening and overall survival.
Who are they looking for?
This trial is recruiting 984 men with mCRPC. Participants must have evidence of metastatic disease, must be on hormonal therapy, or have undergone removal of the testicles and had cancer worsening. Participants must agree to use specific birth control during the study.
Men who have had another cancer within 3 years of this study or an autoimmune disease or conditions requiring corticosteroids will not be able to participate. Men who had previously received other immunotherapies such as nivolumab or who have had chemotherapy for mCRPC will also be excluded.
How will it work
There will be 2 groups in this trial. Participants will receive either nivolumab or a placebo combined with docetaxel and prednisone.
The main outcomes to be measured will be the worsening of the cancer measured on images and overall survival. Other outcomes evaluated will be the overall response to treatment, duration of response, and occurrence of side effects. Participants will be followed up for up to 3 years.