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PSA Decline is a Potential Biomarker for Identifying Early Resistance to Zytiga and Xtandi In Men Who are Post Chemotherapy*

Abiraterone Acetate (Zytiga) and enzalutamide (Xtandi) are the newest generation hormonal agents.  They both have demonstrated a survival advantage in men with castrate resistant prostate cancer (CRPC) who have already been treated with docetaxel (chemotherapy). Unfortunately all men who are responsive to both of these drugs eventually become resistant.   Some men are subject to early [...]

Impact of Prior Abiraterone Acetate (Zytiga) on Subsequent Activity of Docetaxel (Chemotherapy) in Men with Metastatic Castration-Resistant Prostate Cancer

The explosion of new therapies for men with metastatic castration resistant prostate cancer (mCRPC) raises serious questions about the optimal sequencing of these new treatments as well as whether cross-resistance occurs between these drugs. It was recently reported that chemotherapy with docetaxel (D) is not effective in in men who did not have a ? [...]

Zytiga in Québec, Radium-223 in England & Lets Change Our Antiquated Approval Nonsense

Men with metastatic castration-resistant prostate cancer (mCRPC) in Québec, Canada now have access to Zytiga (abiraterone acetate) prior to having chemotherapy. Effective February 3, 2014, the province has added ZYTIGA to the public drug formulary for the treatment of mCRPC in men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT). [...]

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 [...]

PLATO – A New Phase 4 Clinical Trial Extending the Use of Xtandi & Combining It with Zytiga

The makers of Enzalutamide (Xtandi), Astellas Pharma US, Inc and Medivation, Inc have begun a Phase 4 clinical trial known as PLATO. The study is designed to evaluate the efficacy and safety of continued treatment with enzalutamide (Xtandi) plus abiraterone acetate (Zytiga) and prednisone as compared to treatment with Zytiga and prednisone alone in men [...]

Is Zytiga with Prednisone Effective in Men with Metastatic Prostate Cancer Who Have Visceral Disease?

Castate resistant metastatic prostate cancer (mRPC) withvisceral disease (tumors involving the internal organs of the body, specifically those within the chest (as the heart or lungs) or abdomen (as the liver, pancreas or intestines) is a negative prognostic factor. In many cases clinical trials of new investigational drugs rule out men with visceral disease from [...]

Is Zytiga Working and When to Move on to Another Treatment? Knowing by Counting Your CTCs

At the 2013 European Cancer Congress in Amsterdam Dr. Howard Scher from Sloan Kettering Hospital reported that a panel of biomarkers could identify men with metastatic, castration-resistant prostate cancer (mCRPC) who were responding well or less well to treatment with Zytiga + prednisone (abiraterone + prednisone). Dr. Scher provided data in his presentation to support [...]

The Differences in Ketoconazole & Abiraterone (Zytiga)

Zytiga  (abiraterone acetate) and Ketoconazole (keto) are both widely used in prostate cancer therapy to treat men with advanced prostate cancer.   They both have a common mechanism of action, they both work by inhibiting the enzyme CYP17 that is responsible for androgen biosynthesis (creation).  Inhibiting CYP17 lowers testosterone levels, which results in prostate cancer tumor regression. Because [...]

From the 2013 Genitourinary Cancers Symposium – An Update of the Abiraterone Acetate (Zytiga) with Prednisone Clinical Trial

At the recent 2013 2013 Genitourinary Cancers Symposium there was an abstract presented that updated data from the COU-AA-302 clinical trial of Abiraterone Acetate (Zytiga) with prednisone. The updated data confirms that Zytiga with prednisone improves overall survival (OS) in men with metastatic castrate resistant prostate cancer (mCRPC) post-docetaxel therapy (chemotherapy)(Lancet Oncol 2012;13:983-92). The trial [...]

Some Good Morning News, Zytiga Approved by the FDA for Earlier Use

Some mornings we just wake up to great news and today is one of those mornings. The Food and Drug Administration (FDA) has just announced that they have approved Zytiga (abiraterone acetate) for use prior to chemotherapy. - This FDA announcement is an expansion of their prior approved (April 2011) for the use of Zytiga [...]

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