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 [...]

TAK-700 Fails to Offer A Survival Extension

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 [...]

Takeda Un-blinds & Halts the Phase 3 Study of Orteronel in Men with mCRPC That Progressed Post-Chemotherapy

A press release made yesterday brought some bad news to the advanced prostate cancer community. Takeda Pharmaceutical Company Limited (“Takeda”) announced that it has un-blinded and stopped the ELM-PC 5 Phase 3 study (C21005) of orteronel plus prednisone compared to placebo plus prednisone in patients with metastatic, castration- resistant prostate cancer (mCRPC) that had progressed [...]

Attacking Androgen Receptor Signaling In Castrate Resistant Prostate Cancer

Advanced prostate cancer eventually progresses and becomes castration resistant (CRPC) despite the fact that it is exquisitely sensitivity to androgen deprivation therapy. There has been recent evidence that prostate cancer progression at the CRPC stage is still mediated by androgen receptor signaling, so it seems that subsequent androgen receptor targeting may further contribute to disease [...]

New Approved Drugs Keep Us in the Proverbial Pickle

Over the last year or so we have seen a marked change in the treatment landscape for men with castrate resistant advanced prostate cancer. The FDA has approved sipuleucel-T (Provenge), cabazitaxel (Jevtana) and last week it also approved abiraterone (Zytiga). This changed landscape of multiple treatment options creates new problems, of course good problems. Prostate [...]

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