A Phase II Study of Degarelix plus Ipilimumab with Radical Prostatectomy in Men Newly Diagnosed with Metastatic Prostate Cancer

Protocol
13-134
Full Title
A Phase 2 Study Combining Ipilimumab and Degarelix with Radical Prostatectomy in Men with Newly Diagnosed Metastatic Castration Sensitive Prostate Cancer
Phase
II
Purpose

Degarelix is a drug approved for the treatment of advanced prostate cancer. It lowers the levels of cancer-fueling testosterone in the body.

Ipilimumab is a drug used to treat advanced melanoma, but its use in prostate cancer is considered investigational. It is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that one way cancers can escape the immune system could be through this shut-down mechanism. An antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune reaction to continue. This immune reaction may help the body to destroy cancer cells.

In this study, researchers are evaluating the safety and effectiveness of giving both degarelix and ipilimumab before and after prostate removal surgery (prostatectomy) in men newly diagnosed with metastatic prostate cancer who have not yet received any other treatments. The use of surgery to remove the prostate in men with advanced disease is also considered investigational.

Investigator
Autio, Karen, MD
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic hormone-sensitive prostate cancer that is newly diagnosed and has not yet been treated with surgery, chemotherapy, radiation therapy, or immunotherapy.
  • Only a very short course of prior hormone therapy is allowed.
  • This study is open to men age 18 and older.

For more information about this study and to inquire about eligibility, please contact the office of Dr. Karen Autio at 646-422-4632.

Disease(s)
Prostate Cancer
Locations
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