Now that Radium-223 Dichloride (Xofigo) has been approved by the FDA for use in men with castrate resistant prostate cancer with bone metastases we will begin to see the actual treatments happening. The next question in the process that will arise is whether or not it is safe and effective to re-treat an individual with [...]
The makers of Enzalutamide (Xtandi), Astellas Pharma US, Inc and Medivation, Inc have begun a Phase 4 clinical trial known as PLATO. The study is designed to evaluate the efficacy and safety of continued treatment with enzalutamide (Xtandi) plus abiraterone acetate (Zytiga) and prednisone as compared to treatment with Zytiga and prednisone alone in men [...]
If you are interested in participating in a clinical trial but just can not figure out how to navigate the government's clinical trial web page (www.clinicaltrials.gov) you could call 1-800-4-CANCER for assistance. This number will put you in touch with the National Cancer Institute's (NCI) Center for Cancer Research. The operators who answer the phone [...]
We are in the fortunate position because the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) continues to evolve as new agents with the ability to extend survival gain FDA approval. The most recently FDA approved treatment, the alpha emitting radiopharmaceutical radium-223 (Xofigo) was approved for men with bone metastatic prostate cancer. Most other [...]
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 [...]
