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 [...]

A Caution About Yesterday’s Post About Combining Treatments with Chemotherapy

My post to this blog that was written yesterday indicated that for certain men the early use of chemotherapy (docetaxil) could provide significant life extending benefits, especially for men with very advanced prostate cancer. For the purpose of clarification, in this case early use means in men who are still hormone responsive. Given that chemotherapy [...]

Early Chemotherapy for Men Who Are Still Hormone Responsive – For Some It Might Offer Extra Survival

When I was first diagnosed with metastatic prostate cancer one of the first questions that I asked my doctor was whether it made sense for me to start chemotherapy immediately. I very clearly remember him telling me that there was absolutely no evidence that starting chemotherapy at this early stage would do anything to extend [...]

A First Victory in Our Fight Against Fail First Therapy – Thanking Health Partners in Minnesota for Their Concern for Men with Advanced Prostate Cancer

Fail First Therapy or Step Therapy has been a topic I have written about in prior posts. It is my considered opinion that as it works its way into the treatment protocols for advanced prostate cancer it will have nothing but a very negative result for our health and longevity. What is Fail First Therapy [...]

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 [...]

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