Castate resistant metastatic prostate cancer (mRPC) withvisceral disease (tumors involving the internal organs of the body, specifically those within the chest (as the heart or lungs) or abdomen (as the liver, pancreas or intestines) is a negative prognostic factor. In many cases clinical trials of new investigational drugs rule out men with visceral disease from [...]
At the 2013 European Cancer Congress in Amsterdam Dr. Howard Scher from Sloan Kettering Hospital reported that a panel of biomarkers could identify men with metastatic, castration-resistant prostate cancer (mCRPC) who were responding well or less well to treatment with Zytiga + prednisone (abiraterone + prednisone). Dr. Scher provided data in his presentation to support [...]
Recently, the U.S. Food and Drug Administration (FDA), has begun to support the reporting and use of patient-reported outcome measures (PROMs) of symptoms as secondary end points in clinical trials for oncology treatment. These outcomes measures are likely to become increasingly important for oncology patients as they will hopefully become part of the drug label. [...]
Some bad news was reported today. Results from the Phase 3 randomized, double-blind clinical trial (Study 043) comparing Yervoy 10 mg/kg (ipilimumab) (n=399) to placebo (n=400) following radiation in men with advanced metastatic castration-resistant prostate cancer (mCRPC) who have received prior treatment with docetaxel showed no increase in overall survival. Yervoy is an immunotherapy which [...]
Researchers at Johns Hopkins has concluded that metastasis-free survival appeared to independently predictor of overall survival (OS) in men with recurrent prostate cancer who underwent androgen deprivation therapy (ADT) after developing metastases. Men with biochemically recurrent prostate cancer (PSA only) tend to survive for long periods so the FDA gold standard for clinical trial endpoint [...]
On August 13, 2013 I wrote an important post about the terrible practice beginning to rear its head called step therapy. Step therapy is the practice of insurance companies requiring less expensive drugs be prescribed prior to more expensive ones despite the comparative efficacy of the drugs and their different mechanisms of action. This practice [...]
Most of the newly approved drugs and treatments for men with advanced prostate cancer are designed and approved to be used independently of other advanced prostate cancer treatments, other than with the continuation of standard androgen deprivation therapy (ADT). The newly approved drug, Xofigo, is different. It has been designed to supplement, or actually go [...]
The exciting thing about Provenge is not only the real survival advantage that it offers with minimal side effects, but that it is a proof of concept treatment that is heralding in the potential future of many other immunotherapies. Today, we have two new possible treatments in active phase 3 trials, Prostvac and Yervoy. [...]
Enzalutamide (Xtandi) monotherapy induced striking declines in prostate-specific antigen (PSA) in a majority of patients with hormone-naive prostate cancer in a phase II trial, and this oral agent appears to have little effect on bone mineral density. If these findings are confirmed in a phase III trial, then enzalutamide may be an alternative to androgen [...]
The following post is actually a response to a listserve issue over the side effects of Xofigo. I decided to post my response here to avoid the limit of lines allowed on the listserve and because I feel that it is also of interest to my regular readers of this blog. My response is using [...]
