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

One new type of medication may treat many cancers

Wouldn't it be great if there were medications that would treat many types of cancer? Well, they might be on the horizon.

For the first time ever, three different pharmaceutical companies; Merck, Roche, and Sanofi, are testing drugs that, hopefully, will restore a mechanism that normally makes badly damaged cells self-destruct. This is the norm in our bodies. Remember that cancer cells are dangerous because they do not self-destruct.

A protein molecule known as p53 normally allows damaged cells in the body to self-destruct but, in about half of all cancers, it is disabled when another protein molecule found in cancer cells, MDM2, attaches to it. This stops cancer cell death and allows the cancer to keep growing. Researchers have long hoped to find a way to restart p53.

Recent research has found ways to break the two proteins apart, allowing the p53 gene to once again trigger the death of damaged (cancerous) cells. Testing with mice has been quite successful.

It doesn't seem to matter whether the cancer is identified as breast, colon, lung, prostate, cervical, or one of many other cancers. The process is the same. Current trials are in very early stages, testing safety and finding a dose that is effective in humans. Small numbers of people with a variety of cancers will be carefully monitored while the treatment is tested in clinical trials.

Don’t expect an FDA approved drug very soon, but the implications are positive. If one medication can treat up to half of all cancers it would have a major effect on costs, treatments, and results. Stay tuned.

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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

Myths and truths about cancer clinical trials

Myth #1—Cures already exist for many cancers but drug companies are keeping them under wraps in order to make even higher profits when they are released or to profit from current less effective drugs.

Truth #1—You gotta be kidding! The world drug market is large and very competitive and no pharmaceutical company is going to give up a chance to market a great product. Holding back could give other companies a chance to develop and market a similar drug.

Myth #2—Many experimental cancer drugs in the U.S. have already been tested and approved in other countries.

Truth #2—Sometimes drugs ARE available first in other countries. But the U.S. is by far the world leader in cancer research and new drugs are more often than not available to Americans first.

Myth #3—If I join a clinical trial, whether it is successful or not, I’ll be disqualified from ever participating in a trial again.

Truth #3—Nope. Many people with cancer participate in two, three, or more trials in their lifetime. This author (LWA) has participated in three clinical trials and is considering a fourth. Your previous history, including clinical trials, could be considered when you apply for a new clinical trial. Do your homework and make sure joining a trial is in your best interests.

Misconception #4—In almost all cases, drug testing can be done in test-tubes, with animals, and by computer simulations. Testing on humans is seldom necessary.

Answer #4—Don’t we all wish! It would certainly be faster and cheaper if people were not needed in the drug approval process. But, in fact, testing on humans is currently the only way to determine proper dosages, the effects of side effects, and whether or not the drug actually cures or manages cancer.

Myth #5—Drug companies pay hospitals and doctors a lot of money to ensure they get the best possible results from clinical trials. The better the results, the higher the payments.

Truth #5—The pharmaceutical companies often pay for some or most of the costs of a clinical trial. These payments are never linked to the results of the trial.  And, at the end of the day, academic centers do not make a profit on clinical research.  There are several layers of safeguards to make sure trials are conducted scientifically and accurately.

Myth #6—Most clinical trials only accept participants who have the least serious and dangerous types of the cancer being tested in the trial in order to improve the chances of getting good results.

Truth #6—Cancer treatment drugs are developed for all levels and stages of cancer. Some trials, however, may exclude patients with serious heart, lung, kidney, or liver diseases to protect them from unknown side effects. After a drug is proven successful and safe, these high-risk people may be included in further studies.

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

Our man in Russia....a glimpse at the international nature of clinical research

A few years ago, we had the opportunity to host a 27-year old Russian oncologist in Oregon. This was a part of an international exchange sponsored by our professional society, ASCO.  Young oncologists from around the world were hosted by American institutions for a week to get some experience with research conducted in the US.  Who would have thought that our guy, Ilya Tsimafeyeu would become the CEO of RUSSCO, the Russian counterpart to ASCO, the American Society of Clinical Oncology.  

It was fun to see a recently interview with Ilya, or shall I say, the CEO.  Take a look at it here if you would like a glimpse of how things are going in Russia.

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

Gold Nanoparticle Therapy to be used in first clinical trial

Like most of us, you have probably never heard of gold nanoparticle therapy. That’s not surprising. It's a new treatment that will be used for the first time in a cancer clinical to treat lung cancer. The process was invented by biomedical engineers, Naomi Halas and Jennifer West, at Rice University in Houston, Texas. The trial will be conducted by Cancer Treatment Centers of America.

When these nanoparticles were first tested in mice, the result was tumor remission in 100 percent of the experimental subjects.

The nanoparticles consist of microscopic balls of silica (glass) encased in a thin shell of gold. These nanoparticles are injected into the blood stream and absorbed by tumors—not healthy tissue.

After 12 to 24 hours, when the particles have been absorbed by the tumor, an infrared laser is used to heat the particles and destroy the tumor cell. Tumors are damaged or destroyed with minimal effect on healthy tissues.

The trial, approved by the FDA, will be conducted by Mark Lund, MD, Director of Interventional Pulmonology, Bronchoscopy & ICU at Eastern Regional Medical Center. Additional trials are planned for metastatic head and neck tumors and prostate cancer.

Successful results from these trials could provide new and minimally invasive treatment for some common cancers.

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

Do people know about clinical trials? Some surprises

We often say that fewer than 5% of adults with cancer participate in clinical trials during the course of their cancer therapy.  What does the bigger picture look like?  A recent publication describes the results of a 2011 survey.  A nice summary of the key findings can be found in this article.  11% of adults reported ever participating in medical research - surprisingly higher than the percentage of cancer patients.  A full 64% were aware of research opportunities.  

Participation and awareness both were more likely among folks with higher incomes, more education, among older people, people suffering from chronic conditions, and people who live close to large clinical research centers.

Although one would think that the internet would be the number one source of information about medical research (and our blog readers might think so too), participants in the survey cited television as the most common source at 53%!  46% cited radio, 44% newspaper ads, 22% the internet, and 21% learned about a research opportunity from a pamphlet in their doctor's office.  

All in all, it looks like folks living with cancer participate in medical research less than the general adult population - a surprise.  And the internet appears not to be the number 1 (or even 2 or 3) source of information about medical research for US adults - a bigger surprise.  This may change as the internet gains prominence, but we should not assume that "old media" no longer matter in spreading the word about medical research opportunities.  

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

What process does the FDA follow when determining whether to approve a drug?

FDA approval doesn’t actually take as long as most people think.  In a recent blog post, http://www.cancer-clinical-trials.com/2012/07/waiting-for-new-drug-to-be-approved.html we discussed the fact that FDA approval, at an average of 322 days, is actually a little faster than approval in Europe and Canada.  That’s not to say it’s quick, but it does not take years.  What takes a long time are all the studies necessary to collect the information the FDA requires to consider an application.  The FDA uses the “safe and effective” standard.  Effective means that cancer patients benefit in a meaningful way.  This often involves living longer, being cured of cancer, or experiencing quality of life improvements.  The FDA reviews all of the clinical trial data in detail to determine if these standards have been met.  This review takes several months.  While we all want cancer drugs to come to market as quickly as possible, it is also worth remembering that the FDA is held accountable when a drug is approved that later proves unsafe.  It’s a balancing act between moving quickly and dotting the i’s and crossing the t’s.

For more questions and answers about clinical trials, visit the Talk about Health website.
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

What are the next steps after being accepted into a clinical trial?

Acceptance into a clinical trial begins with the consent process.  Risks and potential benefits, as well as other options are explained by your physician or research nurse and also presented to you in writing in the Consent Form – typically a lengthy document.  Once you have been fully informed and have consented to the treatment, the next step is to complete the pre-treatment evaluation.  This includes a visit with your doctor or nurse, blood tests, scans to determine the extent and location of your cancer, and potentially other tests mandated by the study.  At this stage, it is still possible to be “uninvited” from the study.  This happens if a test result shows that you don’t meet all the criteria to safely participate.  Once the pre-treatment evaluation is complete, the study treatment begins. 

For more questions and answers about clinical trials, visit the Talk about Health website.
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

How is being in a clinical trial different from getting regular treatment?

In many ways, being in a clinical trial is similar to receiving standard treatment.  There are regular visits, blood tests, scans, and a cancer drug – or several – are given on a set schedule.  Side effects are monitored and adjustments are made to minimize them.  There are some differences.  As much as cancer treatment programs tend to be fairly rigid and structured, clinical trials are even more so.  Everything that happens follows a precise recipe.  There may be additional tests or surveys to fill out that would not be a part of standard care.  Some of these may include much more extensive monitoring – for example serial blood draws to measure drug levels in detail during a 24 or 48 hour period.  It is also likely that less is known about the drug or drug regimen that is being tested than standard care.  Outcomes in cancer treatment are never certain, but participating in a clinical trial involves a greater degree of the unknown.  

For more questions and answers about clinical trials, visit the Talk about Health website.
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

How many patients typically participate in each phase of the clinical trial?

Clinical trials are often described as phase I, II, III, and sometimes phase IV.  The number of participants varies greatly depending on the phase of investigation, but also depending on the cancer type, situation, and expected outcome.  Phase I trials are principally charged with determining the safe and optimal dose of a new drug or drug combination.  Such trials may involve 20 to 40 patients.  Phase II trials are where the potential of a drug to be effective is first evaluated.  Typical phase II studies range in size from 50 to 250 participants.  The higher end of that range is more common in randomized phase II studies where 2 or more doses or drug combinations are being examined side by side.  Phase III trials are the ultimate test of a new treatment.  Participants are randomly assigned to the new treatment or the current standard.  These trials involve hundreds and sometimes thousands of participants.  The number of participants needed is determined by the question being asked, the expected magnitude of the difference between the two treatments, and the percentage of patients who are expected to experience the outcome being measured.  For example, trials that seek to reduce the risk of cancer recurrence are often very large in part because many of the participants (thankfully) don’t suffer a recurrence at all.  A large number of participants are therefore needed to make sure that enough of them have a recurrence so that a difference can be detected.

For more questions and answers about clinical trials, visit the Talk about Health website.
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

How does the FDA know about new side effects for a drug that has already been approved?

The FDA has surveillance programs in place to monitor the safety of drugs after approval.  These programs primarily rely on physicians reporting to the FDA the side effects they see.  While not all physicians routinely make such reports, enough do that unexpected side effects usually come to light.  For some drugs that are approved with some questions about safety, special requirements can be put into place.  These might include so called phase IV studies to gather more safety data or special prescribing programs for high-risk drugs.

For more questions and answers about clinical trials, visit the Talk about Health website.
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

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

In the US, who decides what cancer research is funded and how much funding each project receives?

There is no single authority that allocates cancer research funding.  Each funder has a process.  The largest source of funding for research is the National Institutes of Health which uses a peer-review process.  Panels of researchers review and rank research proposals.  This is probably the best process we have.  It is independent and invites the best thinkers to drive it.  Sometimes this process does, however, end up emphasizing funding for ideas that fit well with today’s thinking.  Unconventional ideas may not always be appreciated by peer scientists.  The pharmaceutical industry is the other large source of funding.  It allocates funding largely based on it’s view of market opportunities for new drugs, although industry also provides funding for independent research.  Many private foundations, and government agencies other than the National Cancer Institute are also important.  They generally follow the peer-review process or some variation on it.

For more questions and answers about clinical trials, visit the Talk about Health website.
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