Malecare was actively involved, along with its partners, in setting up the early access trial for enzalutamide (Xtandi). The trial was conducted after the final Phase 3 AFFIRM trial that was eventually used to obtain FDA approval had been stopped, but before the FDA and received the final submission of the data. Given the significant [...]
Want your insurance company to pay for next drunk? According to the FDA they in fact might be willing! All kidding aside, the FDA has issued a drug safety communication regarding the risk of intoxication with some of the intravenous generic prostate cancer chemotherapy (docetaxel) formulations containing ethanol. The drugs are marketed as generic docetaxel [...]
The FDA approved Abiraterone acetate (Zytiga) plus prednisone because it demonstrated a survival benefit for men with metastatic castrate resistant prostate cancer (mCRPC) in the pre-chemotherapy setting. Given the newness of the approval of Zytiga in this disease stage there is a lack of data on how Zytiga affects the efficacy of enzalutamide (Xtandi) or [...]
Hormone therapy or Primary androgen deprivation therapy (PADT) is the usual first “go to” therapy for men when they are diagnosed with metastatic prostate cancer whether it is a primary diagnosis or the result of a recurrence. The natural progression of the disease is to become unresponsive to the treatment (castrate resistant) leading to a [...]
Xgeva is used in men with advanced and metastatic prostate cancer with bone metastases for the prevention of developing additional skeletal-related events (not to be confused with bone mineral density). In a phase 3 trial, the 147 Study, evaluating denosumab (Xgeva) versus placebo 1,432 men with castrate-resistant prostate cancer demonstrated that Xgeva improved median bone [...]
Now that we have new treatments available to fight advanced, metastatic prostate cancer we need ways to decide on the best treatments given that many of the treatments occupy the same disease space. This is especially important with the soaring costs of many treatments as well as the need to not waste time by giving [...]
Research released at the ASCO meeting in Chicago confirms that regular exercise is a must for men with advanced prostate cancer. It was found that a regular and structured physical exercise program reduces cytokine production which is related to depression and to the inflammatory processes. According to the researchers these factors may impact prostate cancer [...]
Current practice has been to immediately begin hormone therapy (ADT) as soon as a man has a bio-chemical (PSA only) relapse. A recent presentation at ASCO 2014 has shown that immediate ADT actually offers little or no survival benefit over deferred ADT to advanced prostate cancer survivors who experience a PSA only relapse after radical [...]
I was asked if there was one item that was a real game changer at the American Society of Clinical Oncologists (ASCO) meeting for men with advanced prostate cancer. The answer is yes, at this meeting it was formally shown by a study that starting chemotherapy (docetaxel) along with androgen deprivation therapy (ADT) in some [...]
ASCO has become a little more interesting for prostate cancer. Today's item is about a mega-analysis that confirms that the site of metastatic tumors will powerfully predict overall survival (OS) among men with metastatic castration resistant prostate cancer (mCRPC). Older and smaller studies had previously suggested that the metastatic site is prognostic for OS. This [...]
