As I have discussed, immunological therapy will be a significant cancer treatment option in the future, but how will it actually develop and what will it look like? Provenge (sipuleucel-T), for the treatment of men with advanced prostate cancer, was the first FDA approved autologous immunologic vaccine therapy for any type of cancer. However, Provenge [...]
What is the role of diet in the treatment of prostate cancer? We hear about changing our diet as a way to slow down prostate cancer progression and we hear about diet as a preventive measure against prostate cancer. It is possible that there could be a new twist on this story, in the future, [...]
It is important to learn to use as many resources as possible as we take our trip through the treatment processes for advanced prostate cancer. Many of us limit ourselves to just our doctor and perhaps their office nurse or Physician Assistant. The reality is that there are many other individuals who can make out [...]
One question that needs more attention is why are gay men and lesbians excluded from participating in certain medical studies? A little over a year ago a letter written by three scientists from the Fox Chase Cancer Center in Philadelphia appeared in The New England Journal of Medicine. The letter cited several dozen clinical trials [...]
In one of those situations when actual clinical practice precedes the normal drug development process a recent announcement from Janssen Research & Development, LLC (Johnson & Johnson) informs that they have un-blinded their Phase 3 study, COU-AA-302, which clearly demonstrates that Zytiga (abiraterone acetate), when taken with prednisone, is effective in treating both mildly symptomatic [...]
Men who inherit a mutation in the HOXB13 gene have a 10 to 20 times increased risk of developing prostate cancer, according to the study in the January 12, 2012 issue of the New England Journal of Medicine. Finally, the first major gene mutation associated with an increased risk for prostate cancer has been identified. [...]
Will the Centers for Medicare & Medicaid Services (CMS) be able to optimize patient care with regard to both on-label and off-label drugs? CMS', at this time, has not shown itself to be either in favor or against new technology or the introduction of new uses for drugs. They still seem interested in promoting access [...]
Historically, I have been critical of the FDA, especially around the delay of the approval of Provenge. Now, it is time to take a look at the FDA and what I believe the future will be for this agency. I do first need to make it clear that I do believe that the FDA plays [...]
One of the common side effects reported from chemotherapy with Taxotere is neuropathy. In the trial used to receive FDA approval, TAX 327 which had 332 patients. In that trial the following percentage of men reported incidents of neuropathy: Neuropathy Sensory- Nerve damage causing tingling or pain, usually in feet or hands: Any Grade- 30.4% [...]
Denosumab (Xgeva), the recently approved and only therapy that prolongs bone metastasis-free survival in men with non-metastatic castrate-resistant prostate cancer (CRPC) who are at high risk for the spread of prostate cancer metastasis to bone seems to work best in men with very rapid prostate specific antigen (PSA) kinetics. The large 1,432 man, placebo controlled, [...]
