Based on the assumption that Enzalutamide (Xtandi) is approved for use in men with castrate resistant metastatic prostate cancer (advanced prostate cancer or mCRPC) who have not had prior chemotherapy, pretty much a foregone conclusion based on the extraordinary phase III Prevail Trial results, including a statistically significant survival advantage of 2.2 months with a [...]
Is the FDA softening their stance on approving drugs using progression radiographic progression-free survival (rPFS) (how long it takes for the disease to progress based on scans) as opposed to only survival? The answer is maybe, under certain circumstances. An article in Clinical Cancer Research looked into the US Food and Drug Administration’s thinking about [...]
You have cancer and now you need to add a new battle, with your insurance company because they have denied your request to cover a certain drug or a treatment. Going to your health insurer is always frustrating and time-consuming. They don't care if what you need will extend your life or make living better, [...]
It is probably still years off, but it is worth watching. Galetrone (TOK-001) has just completed phase II trials with the results scheduled to be released at ASCO-GU at the end of the month. I will be attending this conference and will be present for their presentation and report it to you from the conference. [...]
One of the common and constant complaints I hear at prostate cancer support groups is about the need to wake during the night and use the bathroom to urinate (nocturia). There is a relationship between our ageing and the need to urinate at night, but it does seem to be made even more acute if [...]
The dirty little secret that is kept from most of us when we receive primary treatment for prostate cancer is that there is a recurrence rate approaching 33%. This amazingly high rate is consistent no matter what primary treatment is elected. Radiation, surgery, HIFU the rates are the same, about 1/3 of us will experience [...]
The PSA controversy continues to plague men’s health. The United States Preventive Task Force’s recommendation against using the PSA blood test as a screening tool for prostate cancer (PCa) will bring additional harms to men. Since the beginning of PSA testing the mortality rate from prostate cancer has declined significantly, but there has been no [...]
My blog post last Friday was among the top twenty most important ones I have written. I want to be sure that if you have taken Provenge commercially, meaning not during a clinical trial, you need to know that you might have been under-dosed and might need to be retreated. Dendreon, the company that manufactures [...]
It was announced that some dosages Provenge (sipuleucel-T) did not meet the potency release specification for CD54 upregulation, an error that might affect the ability of Provenge to kick-start the immune system. This quality control error affected less than 0.3% of Provenge’s commercial doses released since its commercial launch. Dendreon has agreed with the Food [...]
One thing I have noticed at some of the support groups I run is that there seems to be a very uneven distribution of when men start taking Zoledronic Acid (ZA). Hormone therapy (ADT) has many negative side effects and the loss of bone mineral density (thinning of the bones) that ZA (and similar drugs) [...]
