When the FDA approved Abiraterone with prednisone (Zytiga) in the pre-chemotherapy stage they approved it after an interim analysis of data was performed of the phase III clinical trial (COU-AA-302), The analysis was performed by an independent data monitoring committee that found a significant difference in radiographic progression-free survival (scans that showed no tumor progression [...]
In a poster presentation at the recent European Society of Medical Oncologists (ESMO) there was a very interesting poster presented updating a phase 3 clinical trial (CA184-043) which evaluated the overall survival (OS) with radiotherapy (RT) followed by either the immunologic drug Ipilimumab (Ipi) or with a placebo. This trial did not meet its endpoint [...]
Somehow I have been negligent and not let people know that I have written and posted a major update of my “Guide to Advanced Prostate Cancer.” As in the past, it is available as a free download from the Malecare web site. Helping me to update the book was prostate cancer survivor Craig Pynn and [...]
Provenge or Sipuleucel-T (sip-T) remains not well understood by many prostate cancer survivors as well as some treating physicians. Because Provenge does not immediately control PSA or disease progression it creates a situation where some individuals are skeptical as to its efficacy. This is true despite the clear survival advantage demonstrated in clinical trials. This [...]
The pharmaceutical company Exelixis has announced that their experimental treatment, cabozantinib has failed the Phase III clinical trial for men with metastatic castration-resistant prostate cancer (mCRPC). In the trial the experimental treatment cabozantinib was compared to the drug prednisone. In the trial known as COMET-1, Cabozantinib, a tyrosine kinase inhibitor, did not meet its primary [...]
Popular culture tells us that primary androgen deprivation therapy with leuprorelin acetate (Lupron) will not work for longer than two years! This is a significant and very problematic statement given that all of us with metastatic prostate cancer rely on delaying the move to any other treatments, especially given their cost to the quality of [...]
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 [...]
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 [...]
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 [...]
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 [...]
