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Phase III Trial Comparing Orteronel (TAK-700) Plus Prednisone Against Placebo Plus Prednisone Fails

Reporting both negative clinical trial results is as important as reporting positive results. However, pharmaceutical companies often bury negative results. Fortunately (actually unfortunately because there were negative results) a Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in men with metastatic castration-resistant prostate cancer (mCRPC) that has progressed [...]

Controversy at ASCO GU: Conflicting Randomized Trials on Docetaxel Plus ADT for Hormone Sensitive Metastatic Prostate Cancer *

Last year after the ASCO meeting in Chicago I declared that there was one particular presentation of the CHAARTED trial that would be a game changer for the treatment of newly diagnosed men with very significant prostate cancer. The game changer was that men diagnosed with significant disease and who were still ADT naive (not [...]

Detecting Prostate Cancer Cells in Blood Can Give An Early Warning of Treatment Failure and Shorten Clinical Trials

There is more evidence that the blood test used to count the number of cells circulating in the blood and shed from prostate tumors (circulating tumor cells or CTCs) can indicate whether a treatment is working or not working. A major new study showed that the number of these circulating tumor cells in the blood [...]

A Real Role for Immunotherapy in the Treatment of Advanced Prostate Cancer

Immunotherapy has a major and expanding role in the treatment of cancer, including advanced prostate cancer. Over time there have been a number of naysayers as the immunotherapy Provenge has played the role whipping boy by critics. The common criticism leveled at Provenge can be summed up simply, “It doesn’t work.” The plain truth is [...]

Coming Back to Continue the Blog and New Data Disclosed on Enzalutamide at the Plenary Session at the 2015 European Association of Urology Congress

Before I get into the meat of today’s post about enzalutamide, I want to briefly make some personal comments about my absence from this blog. As I had mentioned I have been diagnosed with a fifth primary cancer, appendiceal cancer. It is a rare cancer, which required my having to remove my appendix, a piece [...]

Prostvac In Combination With Yervoy Yields A Survival Advantage

There is some really exciting news on the horizon around immunotherapy for advanced prostate cancer. Bavarian Nordic, the pharmaseutical company that has, along with the National Cancer Institute (NCI), been running clinical trials on Prostvac has unoffically let it been known that Prostvac when combined with another investigational immunologic therapy, Yervoy, has helped to significantly [...]

Radiologic Progression Free Survival Might Predict Treatment Response and Survival

In a recent publication it was suggested that radiographic progression-free survival (rPFS) in men with metastatic castration-resistant prostate cancer (mCRPC) was highly consistent and highly associated with overall survival. This reproducible quantitative find could have implications for the interim measurement of treatment response in future studies, according to Dr. Michael J. Morris of Memorial Sloan [...]

On the Horizon – Bipolar Androgen Therapy

A Small study suggests that alternating testosterone levels may make hormonal therapy work longer A recent very small study was published that might lend a new light on hormone therapy for advanced prostate cancer, Bipolar ADT. This study suggests that a new treatment strategy might be effective where men alternate between low and high levels [...]

US Government Begins to Crack Down on Clinical Trials Reporting

Yes, it is true, many clinical trial results are not published, especially negative results. This is even true for FDA approved drugs and treatments! Failing to publish, or actually hiding negative results and harmful side effects that occur in clinical trials is too common and jeopardizes each and everyone of us, including survivors of advanced [...]

Radiotherapy Should Be Added to Hormone Therapy in Node-Positive Prostate Cancer as the New Standard of Care

In the normal course of events node-positive prostate cancer has typically been excluded from clinical trials. This leaves our oncologists with little evidence to guide the management for those of us who have this flavor of prostate cancer. A recent anaylisis presented at the European Society for Medical Oncology (ESMO) 2014 Congress begins to shed [...]

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