Prostate Cancer Clinical Trials – A New Day for Patients

November 8, 2012

Today prostate cancer patients with advanced disease have three relative new treatments available that improve overall survival. Provenge, Zytiga and Xtandi have all been approved by the Food and Drug Administration (FDA) over the past two years. These treatments represent significant progress for patients who for years had only chemotherapy to rely upon following hormone therapy. But the good news does not stop here.
Thomas A. Farrington, at PHEN's 2012 Summit
There are an increasing number of clinical trials using these “FDA approved” treatments. Importantly, these clinical trials are not experimental and seeking to prove the effectiveness and safety for these treatments. Effectiveness and safety were determined for each as part of the FDA approval process. Instead many of these trials are studies to better understand the treatments’ level of effectiveness relative to parameters such as stages of disease, genetic factors, in combination with other treatments, etc.

In most instances men participating in these trials are able to receive treatment with these expensive drugs for no cost and no increased risk. Clinical trials using these new treatments represent a new day for prostate cancer patients, especially for those that cannot afford these treatments.

It is important for African American men, who are at a higher risk for needing treatment for advanced disease, to participate in these trials to help better understand how these treatments can impact on eliminating the prostate cancer epidemic that we now suffer. Also, in some cases these trials will remove the access barrier that some men face.

PHEN will continue to highlight and focus on important clinical trials to insure that the men most impacted by prostate cancer are knowledgeable and have the opportunity to participate in this exciting new day for patients.

Remember, knowledge is the best defense against prostate cancer.


Opportunities for Early Access to New Treatments

June 27, 2012

Rapid advances in the development of treatments for advanced prostate cancer are creating some unique opportunities for access to these treatments at no cost to patients under “Early/Expanded Access Programs.”

PHEN President, Thomas A. Farrington

These opportunities become available when phase 3 clinical trial results are proven effective and the trials are halted. However, there is still a Food and Drug Administration (FDA) process that companies must complete before these proven treatments can be “marketed” to the public. This process takes many months before it is completed.

I serve as a member of a committee called “The Early/Expanded Access Program for Prostate Cancer Patients.” This committee advocates for early access to those treatments that have completed the phase 3 clinical trial and awaits final FDA approval. This is information about the committee and its purpose.

We are pleased and excited that Astellas/Medivation has made MDV3100 (Enzalutamide), and Bayer has made Radium-223 Chloride (Alpharadin) available under the early access program. Both these treatments are for “advanced prostate cancer patients.” Information about each is included in the June Treatments and Clinical Trials e-newsletter.

These early access program opportunities are especially appealing to those patients that have urgent needs, and also for patients who may have difficulties in affording these treatments once they receive final FDA approval. I urge advanced prostate cancer patients to review the information on each of the treatments to determine if there could be a personal benefit.


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