This research study is studying a combination of hormonal therapy, chemotherapy, and
immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer. The
names of the study drugs involved in this study are:
Androgen deprivation therapy (ADT) with a drug of your physician's choice. This may
include leuprolide (Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon).
This research study is a Phase 2 clinical trial. Phase 2 clinical trials test the safety and
effectiveness of investigational drug(s) to learn whether the drug(s) work in treating a
specific disease. "Investigational" means that the drug(s) are being studied.
The U.S. Food and Drug Administration (FDA) has not approved nivolumab for hormone sensitive
prostate cancer. However, nivolumab has been approved for other uses, including for advanced
melanoma, lung cancer, head and neck cancer, kidney cancer, and bladder cancer.
The U.S. FDA has not approved docetaxel as a treatment option for hormone sensitive prostate
cancer. However, docetaxel is approved for advanced hormone resistant prostate cancer and
other cancers. There is also evidence from a high quality, phase 3 randomized clinical trial
supporting the use of docetaxel in metastatic hormone sensitive prostate cancer patients who
have a high burden of metastasis. Docetaxel is an off-label indication for hormone sensitive
The U.S. FDA has approved androgen deprivation therapy (ADT) agents, including leuprolide
(Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon), as a treatment option for
hormone sensitive prostate cancer.
The combination of ADT, also called hormonal therapy, with docetaxel chemotherapy and
nivolumab immunotherapy is considered investigational. ADT cuts off the supply of
testosterone and is the standard of care for hormone sensitive prostate cancer. The addition
of docetaxel chemotherapy has been found to prolong life for prostate cancer patients
starting hormonal therapy for the first time for metastatic disease, who also have a large
volume of cancer.
Another anti-cancer treatment modality is called immunotherapy. The immune system can kill
cells that are recognized as different or dangerous, such as infected cells and cancer cells.
Nivolumab is an antibody (a type of human protein) that work to stimulate the body's immune
system to recognize and fight cancer cells.
Hormonal therapy and chemotherapy may make cancer cells more recognizable to the immune
system, and make cancer cells more susceptible to immunotherapy. The goal of this study is to
examine the activity and safety of hormonal therapy combined with docetaxel chemotherapy and
nivolumab immunotherapy for hormone sensitive prostate cancer. The study is designed to
enrich for patients whose tumors may be more most responsive to this treatment strategy. All
patients will receive the same treatment of ADT combined with docetaxel chemotherapy and
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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