Europe Awaits Xtandi – A Positive CHMP Opinion on the Clearance of Enzalutamide In the Pre-Chemotherapy Stage of Prostate Cancer

Some good news for my European brothers, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adapted a positive opinion in support of the label expansion of enzalutamide (XTANDI) to include the treatment of men with metastatic castrate resistant prostate cancer (MCRPC) who are asymptomatic or mildly symptomatic after the failure [...]

Updated Overall Survival (OS) Data from a Phase 3 Trial of Ipilimumab (Ipi) vs. Placebo in Men Post Chemotherapy

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 [...]

Bayer Issues a Formal Statement About the Halting of the Production of Xofigo (Radium Ra 223 Dichloride)

Its day 20 since Xofigo production stopped. How are you? Please email Joel at joel@malecare.org about how the Xofigo shutdown has affected your life. Bayer has issued a public statement about the shortage of Xofigo (radium Ra 223 dichloride). After reviewing their statement I find that there is no new information that we haven’t already [...]

Lack of PSA Decline as an Independent Predictor of Biochemical Failure Post Salvage Radiation Therapy

It would be of great advantage to us if we were able to improve the early detection of responders to salvage external beam radiotherapy (RT) after failed radical prostatectomy (RP). Early detection would allow us to make earlier treatment decisions which should provide for better results. In an attempt to better improve our understanding of [...]

An Increase in the Risk of Second Primary Cancers in Men with Prostate Cancer: A Population-Based Cohort Study

The good news for us is that the survival of men diagnosed with prostate cancer has improved over time. The current 10-year relative survival rate is 99.7%! However, the long survival of men who have prostate cancer raises questions about their risk of a second primary cancer and the need for continued surveillance. A very [...]

Xofigo Patients Face Uncertainty About Their Health

Men currently being treated with Xofigo should ask their doctors, today, “What should I do in light of the current shortage of Xofigo?” In our October 8, 2014 bog post, we cited data from the ALSYMPCA clinical trial for Xofigo, which was given to Malecare during an interview with Joseph Germino, MD, PhD, Vice President [...]

By |2014-10-10T11:57:24-04:00October 10th, 2014|Advanced Prostate Cancer, Uncategorized|0 Comments

Xofigo distribution temporarily suspended because of a recently discovered manufacturing problem

The world wide supply of Xofigo (radium Ra-223 dichloride) available for patients will run out on October 10, 2014. Xofigo is the newly FDA approved treatment for men with castrate resistant metastatic prostate cancer (CRPC) with bone metastases without any known visceral metastases. Individual batches of drugs are inspected prior to release to patients. Bayer’s [...]

A Review of the Literature on the Treatment of Oligometastasis in Prostate Cancer

Oligometastasis can be described as a state of limited metastatic disease following failed primary treatment or even prostate cancer as it is first diagnosed. Many doctors believe that it is amenable to aggressive local therapy to achieve long-term survival. In a review designed to explore the role of ablative radiotherapy and surgical management of oligo-metastatic [...]

Multiple vs. One External Beam Radiation Dose for Palliation of Bone Pain in Men with Prostate Cancer

A man in the advanced prostate cancer online support group has asked, “Why the radiation (external beam to relieve bone pain from prostate cancer and to protect the bones from fractures) is given in so many "mini" doses rather than one or two larger doses. The answer is it doesn't necessarily have to be delivered [...]

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