Looking Forward Towards the Future – Zytiga or Xtandi First After Provenge

What will happen when enzalutamide (Xtandi) is approved for use in advanced prostate cancer in the disease stage prior to chemotherapy (that is if it is approved)?  Already occupying this space and already approved by the FDA is both Provenge and abiraterone (Zytiga).  Where will Xtandi fit in? Until we have a lot more data, [...]

Limiting Lower Urinary Tract Symptoms in Men with Prostate Cancer

Prostate cancer is commonly associated with lower urinary tract symptoms (LUTS). The use of GnRH agonists or antagonists (first line ADT) is widely used as the primary treatment for advanced prostate cancer (pc) and/or to reduce prostate volume (TPV). It is thought that the ADT contributes to the development of LUTS. Researchers pooled multiple other [...]

Results of the Earl Access Trial of Enzalutamide Leading to the FDA Approval

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 [...]

Drunk by Chemotherapy!

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 [...]

An Analysis of the Clinical Benefit of Chemotherapy & Xtandi Post Zytiga in Men with Metastatic Castration Resistant Prostate Cancer

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 [...]

Nadir PSA Levels and Time to Achieving Nadir Are Significant Prognostic Factors

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 [...]

What you Need to Know About Denosumab (Xgeva)

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 [...]

Finding BioMarkers to Drug Sensitivity, The Next Step – ASCO Annual Meeting at ASCO GU

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 [...]

TAK-700 Fails to Offer A Survival Extension

Much of my reporting about ASCO 2014 has included only positive studies, but there is always a share of studies and trials that do not prove to be of a direct positive  value to men with Advanced Prostate Cancer.  Today’s report includes one of these negative reports.  Remember, a negative report is as valuable as [...]

ASCO 2014 – Exercise Cuts Cytokines in Prostate Cancer

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 [...]

Go to Top