Just One Year On Androgen Deprivation (ADT) Creates Significant Lipid and Glucose Metabolism Problems

It is a widely understood that androgen deprivation therapy (ADT)  causes adverse side effects and events.  Some researchers believe that the ADT-induced alterations in lipid and glucose metabolism may be race-dependent. To evaluate this concern the researchers recruited Japanese men with newly diagnosed prostate cancer who also underwent at least one year of ADT.  They [...]

Developing a New Prognostic Model for in Men with First Line Chemotherapy

Current Prognostic models for overall survival (OS) for men with metastatic castration-resistant prostate cancer (mCRPC) have become dated. They don’t  adequately reflect the many new drugs used in clinical practice. To develop a relevant model data from a phase III trial of 1,050 men with mCRPC were used (Cancer and Leukemia Group B CALGB-90401 [Alliance]) was evaluated. [...]

The Ipilimumab (Yervoy) Results – A Failure that Should Not Have Been A Failure

Last October at the European Cancer Congress 2013 there was a release of data from a phase 3 study of Ipilimumab (CA 184-043) that showed that it might be effective in treating castration-resistant prostate cancer in men who have a low burden of disease; however it failed to show at the required 95% confidence level [...]

Tri-weekly Docetaxel Versus Bi-weekly Docetaxel as a Treatment for Advanced Castration Resistant Prostate Cancer: Quality of Life Analysis

Administering chemotherapy using docetaxel (taxotere or T) on a bi-weekly basis with prednisone improved progression free survival and overall survival when compared with the standard tri-weekly schedule for men with advanced castration resistant prostate cancer (CRPC) (Lancet Oncol. 2013;14:117-124). However, quality of life (QoL) differences have not been evaluated. In a trial to evaluate the [...]

Application for the FDA Approval of Xtandi in the Pre-Chemo State Has Finally been Submitted

The good news is that finally Astellas and Medivation have  submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of XTANDI (enzalutamide) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. As of today XTANDI is currently only approved for [...]

Can Zytiga Be Used In Men Previously Treated With Ketoconazole: A Prospective Phase II Study

Some men with advanced prostate cancer have been given the antifungal treatment Ketoconazole (Keto) as a second line hormone treatment. Like Keto, this newer hormone treatment that is now available, Abiraterone acetate (AA) (Zytiga) works by inhibiting CYP17, the rate-limiting enzyme in androgen biosynthesis. The question being asked, if Keto has failed ,given its similar [...]

Denosumab for the Prevention of Skeletal Events in Men with Castration-Resistant Advanced Prostate Cancer

From: the 2014 ASCO GU Meeting Abstract No: 35 Researchers have found in a randomized controlled trial of men with metastatic castration-resistant prostate cancer (mCRPC) the use of the treatment denosumab was superior to the more commonly used zoledronic acid (ZA) for reducing skeletal-related events (SRE). SREs are defined as a pathological fracture, surgery or [...]

An Early Peek At the Phase III PREVAIL Trial of Enzalutamide (Xtandi) Results – Good For Prostate Cancer

An important update from the phase III PREVAIL study (Xtandi in the pre-chemotherapy stage) was released thsi evening (actually yesterday evening) in advance of a formal presentation this Thursday at ASCO GU. The news is good, no the news is great. Last November the trial of Xtandi in men with metastatic castrate resistant prostate cancer [...]

Is The FDA Changing Their Criteria for Drug Approval? Maybe A Little

Is the FDA softening their stance on approving drugs using progression radiographic progression-free survival (rPFS) (how long it takes for the disease to progress based on scans) as opposed to only survival? The answer is maybe, under certain circumstances. An article in Clinical Cancer Research looked into the US Food and Drug Administration’s thinking about [...]

On The Horizon – Galetrone (TOK-001) for Men with Advanced Prostate Cancer

It is probably still years off, but it is worth watching. Galetrone (TOK-001) has just completed phase II trials with the results scheduled to be released at ASCO-GU at the end of the month. I will be attending this conference and will be present for their presentation and report it to you from the conference. [...]

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