Men's Health

New Prostate Cancer Vaccine Shows Promise

There are many health concerns today when it comes to illnesses, but one of the number one health concerns for a man to consider is prostate cancer. There are already treatments available for this type of cancer, but now there is a new one to consider. Provenge, which an experimental treatment vaccine for advanced prostate cancer, has met researchers’ goal in a key trial that is needed to get FDA approval. This news was recently announced by Dendreon, which is the company that makes the vaccine Provenge.

Mitchell Gold, M.D. and the president and chief executive of Dendreon, said that they believe that this vaccine is truly a breakthrough for the prostate cancer community a testament to the promise of the field for cancer immunotherapies. Provenge is a biologic drug that is given by infusion to spur the immune system to help fight against advanced prostate cancer that does not respond to anti-androgen treatment.

In 2007, an FDA advisory panel recommended that the FDA approve the new vaccine Provenge. However, the FDA requested that more information be collected to see whether Provenge prolongs survival. This request led to a new study of approximately 512 men that has advanced prostate cancer. These men had metastatic, androgen-independent prostate cancer, which means their cancer had spread and it was not responding to the anti-androgen treatment.

In this study, the overall survival was significantly better for the men that were taking Provenge than those that were taking a placebo. The results of this study were “unambiguous” and “very consistent” with previous trials for Provenge, says Gold. Dendreon plans to submit the results of this study to the FDA in the fourth quarter of 2009, and after that the FDA will have approximately six months to review all of the material.

Gold stated that this new data can support the use of Provenge being used as a frontline treatment in men that have metastatic, androgen-independent prostate cancer. He also noted that no new side effects from the vaccine stood out in the recent study. In the previous trials conducted, the most common side effects in the men taking Provenge were headache, chills, shortness of breath, fever, tremor, fatigue, and vomiting, mainly at a low level and for one to two days following the infusion of the vaccine.

Gold said that most of the men would first have surgery or some other form of local therapy, then the anti-androgen therapy if their cancer recurred, and if their PSA levels rose after these steps, then the Provenge vaccine would come into play as potential treatment option for them if these others didn’t work. In the men that had prostate cancer, PSA or prostate-specific androgen levels are used to help gauge the success of the treatment for the cancer.

However, at this time Dendreon is not releasing any further details of this study until April 28th, when the findings of the study will be presented at the American Urological Association’s annual meeting held in Chicago. The technology that is used to make the Provenge vaccine may also prove to be useful against other forms of cancer as well, Gold says.

The American Cancer Society has also released a statement about the Provenge news. The statement was made by Otis W. Brawley, MD, and the chief medical officer at the American Cancer Society. Brawley stated that Dendreon’s announcement about the new study for vaccine Provenge has shown reason for optimism for a vaccine that has generated controversy for the past several years. “We have to respect the scientific process, an important part of which is a full disclosure and careful review and discussion of the data, which the company says will not be released until an upcoming medical meeting. One of the most important question’s we’ll be looking at will be the magnitude of the survival advantage; how much longer the men taking the vaccine lived compared to those on standard therapy. As with any new therapy, it will take a detailed analysis to fully understand the impact of this potential new treatment for patients with advanced prostate cancer. We look forward to the presentation of the study at the upcoming meeting.”