Advanced Prostate Cancer--Trials Don't Live Up to Expectations

 Dr. Tom Beer and Dr. Joshi Alumkal, of Oregon Health and Science University,  published an editorial in the July 12, 2016 issue of the Journal of Clinical Oncology questioning the value and accuracy of recent Clinical Trials using Docetaxel (a chemotherapy drug) to control symptoms and prolong life in metastatic castration-resistant prostate cancer (mCRPC) patients. Here are some of the topics they covered.

Since 2004 numerous Phase III clinical trials have used Docetaxel as one part of clinical trials looking for survival advantage in men with advanced prostate cancer. More than half of the trials failed to produce positive results and others produced very weak results. The authors explore how and why this has happened.

Some trials produce 'statistical' success (e.g. significance)  but not much 'clinical' benefit (e.g. a survival benefit of only a month or two). With such a high rate of Phase III failures, it makes sense to change the design of these clinical trials. The authors suggest:

1    Include the patient in the planning process. What do these men want and expect? What would be a positive outcome for them? What would make them want to volunteer for a clinical trial?

2    Identify and focus on patients most likely to benefit from a particular drug or treatment. Then design small studies including only those patients.

3    Determine what success is--improvement in survival, better quality of life, lower risk of toxicity, etc.

There have been too many failures in mCRPC phase III clinical trials to justify continuing the same procedures again and again. Trials are costly, patients are exposed to potentially toxic agents with little benefit, and marginally effective drugs may be moved toward approval. Studies should focus on providing the greatest likelihood of significantly improving the lives of patients.



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To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

ASCO 2015 Prostate Cancer Updates from a Roundtable of Experts

What's new and encouraging in prostate cancer treatment and research? This panel of experts, Dr. Bruce Montgomery,Moderator, Dr. Emanuel Antonarakis, Dr. Tomasz Beer, and Mr. Tom Kirk who is President and CEO of Us Too International, explain advances in research and treatment in 2015.
Prostate cancer patients and cancer patients in general will find some hopeful news in this discussion.






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To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

OHSU led Prostate Cancer Clinical Trial results in FDA approval

This is a reprint of an article from the  Portland Oregonian, written by Nick Budnick

A prostate cancer drug spearheaded by Oregon researchers has received federal approval based on studies showing it prolongs life without chemotherapy.

Enzalutimide was approved for prostate cancer under the name Xtandi^® two years ago, but was authorized only for patients who were already on chemotherapy.

Now, the Food and Drug Administration has approved the drug for a new group of patients based on trials overseen by Knight Cancer Institute at Oregon Health & Science University.

The drug slows the disease, it doesn't cure it. However, the pill's expanded approval is significant for prostate cancer sufferers, many of whom never enter chemotherapy. Some don't care to undergo chemo's debilitating side effects, and some older patients are too vulnerable to even try.

The study found that the average treatment time on the daily pill – meaning until chemotherapy was deemed medically appropriate -- was 16 months, said Tomasz Beer, the institute's deputy director who oversaw the trials. Subsequent data suggests the period may be as long as 19 months.

In contrast, the average time before chemotherapy was required for people on the placebo pill was about four months.

"It's buying you close to a year and a half where your cancer is controlled by a pill," Beer said.

The drug also lowered the likelihood of death by 30 percent at any one time, according to trial results. The study was conducted on more than 1,700 patients in numerous countries including the United States, Canada, Europe, Australia, Russia, and Japan.

Treatment costs are about $7,500 a month.

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To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Enzalutamide shown to extend survival in prostate cancer

A video summary of my presentation at GU Cancers Symposium in San Francisco in the last days of January 2014.



 From http://ecancer.org.  To go the ecancer site, click here

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

The West Coast Prostate Cancer Dream Team

Research Dream Team Studies Prostate Cancer Treatment Resistance from Patient Power® on Vimeo.


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Can the immune system remember?

The study we discuss here is not "ready for prime time" but it does report some exciting findings that suggest that immunologic therapy for cancer can produce long term immune memory



To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Larry and Tom interviewed: prostate cancer, clinical trials, and our book

We were interviewed by the blog JoinClinicalTrials.com a while back.  Here we share the interview with you:

1. How did the two of you become colleagues/friends and what was the inspiration behind your blog? 

We met in the prostate cancer clinic as patient and physician and forged a friendship over the years.  The blog, along with the book was inspired by a strong desire to share knowledge about clinical trials with people who are living with cancer and who are called upon to make decisions about their cancer care. 

 2.  You are co-authors of the book Cancer Clinical Trials. Please tell us about it and what prompted you to write a book about clinical trials?

For 15 years now I have been deeply involved in clinical trials.  I have talked to thousands of cancer patients about hundreds of clinical trials.  Despite the fact that we spend a lot of time with each potential participant, I frequently had the nagging feeling that in the course of a clinic visit, or even several, we could never quite do a good enough job sharing all the knowledge I wanted to share with my patients.  The book was the only way to get this done.

 3. Dr. Beer, could you please address some of the common misconceptions and fears that people have in regards to clinical trials?

Well, there are many, and we cite examples throughout the book of misconceptions we have run across.  I think the first thing people worry about is that they will get a placebo and not a real drug.  We talk a lot about the way placebos are used in research in the book.  I think that is the area where there are the most misconceptions. 

There are many other areas.  For example, many people think that clinical trials are only appropriate when all other options have been exhausted.  That is not true at all.  Clinical trials are seeking to improve care across the entire spectrum of the disease and may be worthy of consideration at various points in the battle with cancer.

 4.  (Dr. Beer) Many people think that clinical trials are an option only after they have tried every other treatment for their cancer; however, is that really the case? Is it possible for patients to participate in trials in different stages of their disease?

No question about it.  Clinical trials seek to improve care in all situations including front line care.  The trials may be different in patients that have good standard treatment options.  For example, the standard treatment may be included for all patients and the new drug is added to it. 

But without clinical trials that test even the most fundamental cancer treatments, we would not have made the advances we have.  For example, breast cancer is often treated with surgery that removes only the cancerous lump and spares the breast.  Clinical trials that proved this was a sound approach are responsible for women being able to keep their bodies intact through cancer treatment.

More of our interview in the next post.

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2013 Tom Beer and Larry Axmaker

Hormonal Therapy for Prostate Cancer - Education Video

In an occasional departure from our focus on clinical trials, we thought we would share our latest patient education videos for prostate cancer patients.  Here Dr. Beer discusses hormonal therapy for prostate cancer - very much the way it would be discussed in a clinic visit. 


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Chemotherapy for Prostate Cancer - Education Video

In an occasional departure from our focus on clinical trials, we thought we would share our latest patient education videos for prostate cancer patients.  Here Dr. Beer discusses chemotherapy for prostate cancer - very much the way it would be discussed in a clinic visit. 


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Immunotherapy for prostate cancer - patient education video

In a bit of a temporary departure from our focus on clinical trials, we thought we would share our latest patient education videos for prostate cancer patients.  Here Dr. Beer discusses immunotherapy for prostate cancer - very much the way it would be discussed in a clinic visit.  In the coming weeks, we will share our videos on chemotherapy and hormonal therapy for prostate cancer patients.

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

A prostate cancer Dream Team—new hope for men with advanced prostate cancer

 StandUp To Cancer (SU2C) and the Prostate Cancer Foundation have combined resources to fund a Dream Team of Oncologists/Scientists to study personalized treatment for advanced prostate cancer. The three-year project will receive up to 10 million dollars from the sponsoring organizations.

Six doctor/scientists were chosen to work together to identify resistance pathways in advanced prostate cancer and find better treatments. Four campuses of the University of California (San Francisco, Los Angeles, Santa Cruz, and Davis), the University of British Columbia, and the Oregon Health and Science University are involved. This is exciting to me (Larry) as I enter my 10th year with with prostate cancer.

Dr. Tomasz Beer, Deputy Director of the Knight Cancer Institute at OHSU and my oncologist, co-author, and friend, is one of six top scientists picked for the project. Dr. Eric J Small and Dr. Owen N. Witte have been chosen to co-lead the team. The full title of the project is: Targeting Adaptive Pathways in Metastatic Treatment Resistant Prostate Cancer (quite a mouthful). It will concentrate on men who have no reliable treatment options. Current standard treatments to lower testosterone levels often don’t work or stop working in men with advanced prostate cancer.

In the U.S. a man is diagnosed with prostate cancer every 2 minutes and someone dies from prostate cancer every 18 minutes.

According to the Knight Cancer Institute:

Treatment of patients diagnosed with hormone-dependent prostate cancer includes chemical or surgical castration, using drugs or surgery to reduce androgen hormones such as testosterone and dihydrotestosterone. However, as with most hormone-dependent tumors, prostate cancer becomes resistant to this therapy. These resistant tumors are referred to as treatment-resistant prostate cancer or TRPC.

This new Stand Up To Cancer Dream Team will explore the idea that resistance is a result of the prostate cancer cells using common cellular responses, called adaptive pathways, to escape current therapies. The team believes that by identifying these pathways and inhibiting them, they will be able to overcome treatment resistance and profoundly improve survival and quality of life for these patients.

To test their idea, Small, Witte, Beer and their colleagues will systematically subject patient biopsies (fixed, frozen and fresh tissue) and blood samples to a comprehensive molecular assessment and pathway-based analysis to determine the activity level of known and novel pathways. Once the pathways activated in TRPC tumors are identified, the Dream Team will devise co-targeting approaches in the laboratory. After validation they will test novel therapeutic combinations that co-target adaptive pathways associated with resistance. By combining established therapies with new treatments that co-target adaptive pathways, the Dream Team hopes to dramatically improve outcomes for men with advanced prostate cancer.

The long-term goal of the project is to improve outcomes for men with advanced prostate cancer (including me and possibly you). This would include increased length of life, reduced side effects, and a better quality of life. Clinical trials are scheduled to begin in 2013.

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

KOIN TV visits about a new drug for prostate cancer

As part of their Stand Up to Cancer programming, KOIN-TV visited with us a bit ago.  This in an inspiring piece with one of our cancer patients.  We are so glad to see stories like this become a reality.


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Enzalutamide approved - clinical trials deliver

Enzalutamide (formerly MDV-3100) is a drug for advanced prostate cancer that we have mentioned a number of times.  Today, it is no longer experimental.  It is approved and very soon patients with advanced prostate cancer will have another option for treatment.  This is what clinical trials are all about.

The following is a message from the FDA's Office of Hematology and Oncology Products Director, Dr. Richard Pazdur.

On August 31, 2012, the U. S. Food and Drug Administration approved enzalutamide (XTANDI® Capsules, Medivation, Inc. and Astellas Pharma US, Inc.), for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. 

The approval was based on a single randomized, placebo-controlled, multicenter trial enrolling 1199 patients with metastatic castration-resistant prostate cancer who had received prior docetaxel.  Patients were randomly allocated to receive enzalutamide 160 mg orally once daily (N = 800) or placebo (N = 399).  Study treatment continued until disease progression, initiation of new systemic antineoplastic treatment, unacceptable toxicity, or withdrawal.  Patients were required to continue androgen deprivation therapy and were allowed, but not required, to continue or initiate glucocorticoids during the study period.  Forty-eight percent (48%) of patients on enzalutamide and 46% on placebo received glucocorticoids. 

The primary efficacy endpoint was overall survival (OS).  At the pre-specified interim analysis after 520 events, a statistically significant improvement in OS [HR 0.63 (95% CI: 0.53, 0.75), p < 0.0001, log rank test] was observed.  The median OS was 18.4 and 13.6 months in the enzalutamide and placebo arms, respectively.

The most common (>=5%) grade 1-4 adverse reactions included asthenia or fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension.  Grade 3-4 adverse reactions were reported in 47% of patients treated with enzalutamide and in 53% of those on placebo.

Seizures occurred in 0.9% of patients on enzalutamide.  No patients on the placebo arm experienced seizures.  In the clinical trial, patients experiencing a seizure were permanently discontinued from therapy.  All seizures resolved.  Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizures were excluded from the clinical trial.  The safety of enzalutamide in patients with predisposing factors for seizures is unknown. 

The recommended dose and schedule for enzalutamide is 160 mg orally once daily.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203415lbl.pdf


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Video: abiraterone and enzalutamide for advanced prostate cancer: results from ASCO 2012 discussed

A video summary of the most important data regarding abiraterone (Zytiga ®) and enzalutamide (MDV-3100) - two of the most important new drugs in prostate cancer.  Recorded at ASCO 2012.

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Dr. Beer's radio interview: clinical trials and advances in prostate cancer

UPDATE:  the interview is now available online as a podcast.  Click here.

Dr. Luke Nordquist, who has quite a following in the heartland of the country, will be interviewing Dr. Beer this weekend.  The show will air Sunday August 5^th at 9:30-10 AM CST (7:30 AM PST) on 1110AM KFAB (www.kfab.com).

It can also be heard over the internet on www.iheartradio.com (Omaha, 1110AM KFAB), so you can catch it online even if you are out of the listening area.

We will be talking about cancer clinical trials:  what they are, how they work, and how one might learn more about experimental therapy.  It will be a fun show and all about helping people living with cancer make informed decisions about their cancer care. Tune in if you get a chance or check it out online.

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker

Podcast: Drs. Armstrong and Beer discuss new prostate cancer treatments

Podcast of Dr. Andrew Armstrong and Dr. Tom Beer speaking about new treatments for the most advanced form of prostate cancer.  Listen by clicking on the MP3 icon to the left.  You can also read the text of the interview and listen to the podcast at the Cancer Network website.

To put a smile on your face see Larry's latest cartoon


(c) 2012 Tom Beer and Larry Axmaker

ASCO 2012 Update on advanced prostate cancer treatment

ASCO is the world's largest oncology meeting.  Important new data about abiraterone and MDV-3100 were presented at the meeting.  Both of these drugs have been shown to have a significant benefit for patients with metastatic prostate cancer that is resistant to standard hormonal therapy.


I had the privilege of reviewing the latest developments in treatment of advanced prostate cancer.  The slides for my talk are available here.  It's a large file, so be sure you have a broad band connection to download.  The slides are fairly technical at times, but do include "current status" summary slides that provide a succinct summary of the status of each of the new agents discussed.


To put a smile on your face see Larry's latest cartoon.

To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker

Video: Latest Developments in Advanced Prostate Cancer Treatment with Dr. Beer

A comprehensive discussion on all the principal current treatments and the most promising emerging drugs for advanced prostate cancer.  In this talk, we discuss hormonal agents including abiraterone and MDV-3100, chemotherapy drugs including docetaxel and cabazitaxel, immunologic therapy with sipuleucel-T, biologic therapy with XL-184, and bone targeted therapy with alpharadin.  We then put it altogether to offer a vision for the treatment paradigm of the near future.


For those of you that watched the previously posted talk, this one is a bit more inclusive and comprehensive.  It is a different program that was put together with the team at Medscape.

To see the entire program and slides, you will need to go the Medscape website.  You will likely need to sign up to be a member of Medscape to get full access to these materials.  There is no cost to doing this.


To learn more about clinical trials, take a look at our book.
To put a smile on your face see Larry's latest cartoon.


(c) 2012 Tom Beer and Larry Axmaker

Dr. Beer speaks about experimental drugs for prostate cancer

The full original program can be found at the Research to Practice website.

Guest Post: Clinical Trials Are a Perplexing Issue for Many Patients

We asked a number of thoughtful people to read a pre-publication copy of our book and give us some feedback.  We are incredibly fortunate to have the counsel of Dan Zenka.  After looking at the book, Dan posted the following on his blog and allowed us to re-publish his thoughts here to share them with you.

Dan Zenka is senior vice president of the Prostate Cancer Foundation, the world’s leading private supporter of research for a cure. Two years after joining PCF, Dan was diagnosed with his own case of prostate cancer. Following a radical prostatectomy, it was determined that he had metastatic disease. He has undergone seven weeks of radiation therapy and is currently on two to three years of hormone deprivation therapy. Just days after his diagnosis, Dan started his own cancer blog, www.mynewyorkminute.org where he discusses a range of issues related to navigating prostate cancer and is read by a growing audience of men and their caretakers around the world.  What follows are Dan's words:

Despite the prospect of receiving one of the latest new drugs that might extend survivorship, a lack of understanding and access, among other issues, leave many saying “I’ll pass.”

Clinical trials are a crucial component of a drug’s development and ultimate approval by regulatory agencies. On the upside is the chance that a participant will benefit from the therapeutic effect of a new compound that can add months if not years to their life. On the downside, a patient might delay more immediate, already-approved treatments only to find out that they were in the placebo arm of the study and are left to resume their original plan. And then there is the real bonus–finding yourself in a Phase III trial in which the drug meets the study’s pre-specified interim efficacy stopping criteria, demonstrating a clinically meaningful and statistically significant improvement in overall survival compared to the placebo. In that case, something called the Independent Data Monitoring Committee (IDMC) recommends that the