(DRAFT – revised November 20, 2006)
The prostate cancer community calls for a change in the drug approval paradigm to address the unmet need for effective treatments for hormone refractory prostate cancer patients for whom available treatments have not been successful.
Desired Outcome – the prostate cancer community demands the following:
Earlier access to promising treatments prior to final approval that have successfully passed safety studies (Phase I), for patients who do not qualify for clinical trials.
Increased public awareness of the plight of men with progressive advanced prostate cancer.
Statistics regarding Advanced Prostate Cancer
a American Cancer Society Facts & Figures 2005
b 5-year prevalence: SEER 2005, NODB 2005
c Oncology, Inc. Onco Track MAT June 2005
For early stage prostate cancer there are approved treatments that provide effective control for many. We encourage these men to utilize available treatments or to seek out clinical trials.
Many people believe that few men die of prostate cancer but about 30,000 do and 48,000 more are dealing with hormone refractory disease. “We are over-treating [early] prostate cancer, period. The Government knows that. The insurance companies know that. The media knows that. We are vastly under-treating advanced prostate cancer.” (Dr. Donald Coffey at the Advanced Prostate Cancer Advocacy meeting, 2/23/06).
There has been a substantial decline in the death rate for all prostate cancer due to earlier diagnosis and treatment (ACS, Cancer Facts and Figures 2005, p2). However, the death rate for advanced disease and the number of men with advanced disease remain critical concerns.
Men diagnosed with prostate cancer that is not confined to the prostate or who have recurrence following local therapy have advanced prostate cancer. Advanced Prostate Cancer progresses to to Androgen Independent (AIPC), also known as Hormone Refractory (HRPC), disease for which there is only one FDA approved treatment. These men have:
stopped responding to hormone therapy as evidenced by a rising PSA,
tissue involvement outside of the prostate, and
- used approved second-line systemic treatments which have not provided a durable remission.
These men are generally not eligible for existing clinical trials due to use of prior therapies or extent of disease progression.
Areas of Concern
There are not enough effective therapies for metastatic androgen independent prostate cancer
There are no FDA approved adjuvant therapies to halt progression for prostate cancer patients who are failing androgen deprivation before evidence of metastases.
The clinical trial process is essential to finding a cure for prostate cancer as well as to drug development. However, there will always be men who cannot participate in trials, leaving them with no or very limited therapeutic options.
- The physician community does not have access to new treatments in the pipeline because of cautions exhibited regarding regulatory approval.
Early access to novel therapies may extend the lives of many patients with Androgen Independent Prostate Cancer. By tracking outcomes in a controlled manner, we will gain insight into which treatments provide significant efficacy with tolerable morbidity.
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