Are you considering participation in a clinical trial as a treatment option for advanced prostate cancer?Tuesday, September 21st, 2010
If so, here is information on a currently-enrolling research study designed to evaluate an investigational immunotherapy (ipilimumab) for advanced prostate cancer.
Why is it important to continue research for new treatment options for Advanced Prostate Cancer?
The American Cancer Society estimates that 32,050 men will die of advanced prostate cancer in 2010. Prostate cancer is the second leading cause of cancer death in American men, behind only lung cancer, and accounts for about 11% of cancer-related deaths in men. Men of African or African-American descent are twice as likely to be diagnosed with prostate cancer as men of European descent, and are often diagnosed with advanced prostate cancer. These statistics indicate that we must continue to look for alternative treatment options for patients with advanced prostate cancer.
Clinical trials in advanced prostate cancer are an important means of discovering new treatment options. In 2004, the results of two Phase 3 studies (TAX327 and SWOG S9916) established docetaxel as a new standard for first-line therapy in patients with hormone refractory prostate cancer (HRPC). Docetaxel remained the only approved treatment option in HRPC until June of this year when cabazitaxel was approved for patients that had failed docetaxel. Once again this approval was based on Phase 3 clinical trial data (TROPIC). Both docetaxel and cabazitaxel were approved based on ~ 3 month increased overall survival in their respective patient populations. Although the approval of any drug that increases survival is welcome, clearly there is an ongoing need for clinical trials investigating new drug options using innovative mechanisms of action to fight the battle against advanced prostate cancer.
What is the investigational drug Ipilimumab and how does it work?
Ipilimumab is a member of a class of agents referred to as immunotherapeutics or immunotherapy agents. These agents are designed to use a patient’s own immune system to fight disease. One theory as to how cancer cells continue to grow is that they somehow hide themselves from immune cells or that the patient’s immune response is not robust enough to kill all the cancer cells. The goal of immunotherapy agents is to either boost the immune response or somehow make cancer cells more visible to the immune system so that they can be better targeted and killed.
Ipilimumab is a fully human monoclonal antibody, which means that it binds to a specific target (antigen) within the body. Specifically, ipilimumab binds to a molecule found on T-cells that is called Cytotoxic T Lymphocyte Antigen 4 (CTLA-4). CTLA-4’s normal role is to act as part of a breaking mechanism that keeps our immune system from over responding. When a foreign antigen is presented to a T-cell, a response is generated so that the body’s immune system attacks and destroys the foreign cells. In order to keep the immune system from generating too much of a response, which could lead to immune cells attacking non-foreign or “self” cells, CTLA-4 works in conjunction with other molecules to put a “brake” on the immune response. By binding to CTLA-4, ipilimumab removes this “brake”, potentially leading to a more robust immune response. The clinical trial described below, sponsored by Bristol-Myers Squibb (BMS CA184043), is designed to determine if bone-directed radiotherapy combined with ipilimumab treatment leads to an increase in survival benefit for patients with metastatic prostate cancer that have received prior docetaxel.
How do I get more information on this Research Study?
About 800 patients throughout the world, approximately 300 in the United States, are expected to participate in this study. Participants may be in the study for 1 year or more, depending on how they respond to the study therapy. The study is currently enrolling in the US and globally, with enrollment expected to continue until July 2011.
Participants in this study may receive, at no cost, study-related: medical care, study medication, laboratory work and evaluations.
Medical insurance is not necessary to participate in this study, and study-related travel/parking may be reimbursed.
To participate, you must:
have a diagnosis of prostate cancer that has metastasized to the bone
have previously undergone at least 1 chemotherapy regimen containing docetaxel (Taxotere)
A study physician will discuss complete study criteria with you
For more information about this study including the location of study centers across the country, visit www.clinicaltrialspotlight.com or clinicaltrials.gov and search under NCT00861614, then speak with your physician to discuss if participating in this study might be of benefit to you.