Clinical trial to examine effectiveness of combined vaccine and hormone treatment for prostate cancer

Investigators at The Cancer Institute of New Jersey (CINJ) have partnered with the National Cancer Institute (NCI) and launched a clinical trial examining the effectiveness of a combined vaccine and hormone treatment for prostate cancer that is resistant to hormone therapy and not visible on imaging tests such as a CT scan and a bone scan. Researchers will compare these effects to those in patients who are receiving hormone therapy alone. CINJ is a Center of Excellence of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School.

According to the NCI, one in six men will be diagnosed with prostate cancer in his lifetime. Numerous studies have shown that while the majority of prostate cancer patients are diagnosed with disease that has not spread beyond the prostate, between 30 and 40 percent of those patients will have disease progression within ten years after having received initial treatment as shown by a rise in prostate specific antigen (PSA) level. Patients in this instance who have a rising PSA level without evidence of disease spread on imaging tests are commonly treated with hormone therapy. Even with hormonal therapy, PSA levels can still rise.

Investigators at CINJ and the NCI will explore using the body's own T-cells as a means to directly target prostate cancer. T-cells are a type of white blood cell that plays a key role in the body's natural defenses in fighting off disease. At focus in this trial is an experimental vaccine called PROSTVAC VF. PROSTVAC VF is a virus that has been modified to produce a PSA protein whose presence helps focus the body's immune response against the prostate tumor. Other human genetic material in the PROSTVAC VF vaccine produces three proteins that help increase the T-cell's ability to destroy its target.

All patients accepted for this study will receive flutamide, which is a standard hormone therapy for prostate cancer. Patients will randomly be assigned to receive the vaccine or no vaccine. Those patients not originally assigned to receive the vaccine will be given it at a later date if PSA levels are rising.

Mark Stein, MD, medical oncologist at CINJ and assistant professor of medicine at UMDNJ-Robert Wood Johnson Medical School, is the lead CINJ researcher on the new study. "With growing use of immune therapy to treat advanced forms of prostate cancer, there is great interest in exploring the impact that this type of treatment could have on the disease at a pre-metastatic stage," he said.

Adults who are diagnosed with prostate cancer that is unresponsive to hormone therapy and not visible on imaging tests such as a CT scan and a bone scan, and have a rising PSA level, are eligible to take part in the trial, although other criteria must be met. Prior to being accepted into the study, participants would be required to undergo a number of tests including blood work and a physical exam. Participants would undergo PSA testing as well as other laboratory assessments on a regular basis throughout the duration of the study.

For more information on how to take part, individuals should call CINJ's Office of Human Research Services at 732-235-8675 or e-mail [email protected]

The trial is sponsored by the NCI's Cancer Therapy Evaluation Program.

Clinical trials, often called cancer research studies, test new treatments and new ways of using existing treatments for cancer. At CINJ, researchers use these studies to answer questions about how a treatment affects the human body and to make sure it is safe and effective. There are several types of clinical trials that are currently underway at CINJ, including those that diagnose, treat, prevent, and manage symptoms of cancer. Many treatments used today, whether they are drugs or vaccines; ways to do surgery or give radiation therapy; or combinations of treatments, are the results of past clinical trials.

As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, CINJ offers patients access to treatment options not available at other institutions within the state. CINJ currently enrolls more than 3,000 patients in clinical trials annually, including approximately 17 percent of all new adult cancer patients and approximately 70 percent of all pediatric cancer patients. Enrollment in these studies nationwide is fewer than five percent of all adult cancer patients.


The Cancer Institute of New Jersey


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