New Drugs for Advanced Prostate Cancer Continue to Work Their Way to Market

The count keeps growing for the benefit of patients.

ust as I had updated my new drug tally last week, another one progresses. No complaints, mind you. In fact, it’s wonderful news.

Here are the updated totals: 4 new drugs in the past two years including Jevtana (cabazitaxel), Xgeva (denosumab), Provenge and Zytiga (abiraterone). Another, enzalutimide (MDV3100) is pending approval for the FDA and currently available to patients under an expanded access program. A promising new radiotherapy, Alpharadin (radium-223 chloride) is working its way through the approvals process with a Fast-Track designation from the U.S. Food and Drug Administration (FDA).

Now today, Tokai Pharmaceuticals Inc., a biopharmaceutical company based in Cambridge, Massachusetts, said in a press release that the Food and Drug Administration has granted Fast-Track status for its lead drug candidate, a potential treatment of metastatic treatment-resistant (otherwise known as castration-resistant) prostate cancer.

As reported by Chris Reidy, of the Boston Globe, “Fast-track designation is reserved for the review of experimental drugs that treat serious or life-threatening conditions or address unmet medical needs. In general, regulators spend about 10 months reviewing a drug candidate before issuing a decision. Getting fast-track status means that Tokai could get a decision in six months on whether or not the FDA will approve the drug.”

Tokai’s drug is galeterone, or TOK-001. It aims to treat castration-resistant prostate cancer, or CRPC, an advanced, difficult-to-treat form of prostate cancer that occurs when the disease progresses despite the use of androgen deprivation therapy.

Despite recent progress in prostate cancer treatment, CRPC often becomes resistant to androgen deprivation therapy, and galeterone’s unique triple mechanism of action may offer an important therapeutic advance, said  Martin D. Williams, Tokai’s presiden t and chief executive. “We are very encouraged by the recent positive results from our ARMOR1 clinical study, and we look forward to advancing galeterone into Phase 2 development in patients with CRPC later this year.”

Of these drugs that work on the androgen receptor (AR), Zytiga, TOK-001, and Enzalutimide, they target varying and multiple mechanisms in signalling pathways for disease progression. So, not only do we have more weapons in our arsenal for advanced disease, we will also be able to study which patients and varieties of prostate cancer respond best to specific drugs or combinations of these new therapies and move closer to patient-specific treatments.

Let the numbers roll… I am up for constantly having to revise them.

With Proposed Cuts to NIH Research, 21 New Young Investigators Offer Good News

As researchers and advocates rallied in Washington today, calling for a halt to proposed medical research cuts, prostate cancer research received 21 Young Investigators committed to discovering better treatments and cures. 

 

Since budget sequestration went into effect, the news for medical research has been precarious at best. Current projected budget cuts for medical research as a result of sequestration stand at $1.6 billion. These cuts would have a devastating effect on progress against cancer and other life-threatening diseases. With the budget of the NIH holding steady over the last half-decade, the chances of research grants being funded have already fallen to roughly 1 in 6, half of the historic rate.

Advocates and researchers rallied in Washington today, calling upon legislators to preserve medical research funding at the National Institutes of Health.
Advocates and researchers rallied in Washington today, calling upon legislators to preserve medical research funding at the National Institutes of Health.

In a recent interview with USA Today, Francis Collins, director of the NIH said: “I worry desperately this means we will lose a generation of young scientists… A lot of good science just won’t be done.”

Without our young scientists, not only would scientific advances for cures dwindle, so would America’s leading position in bio-medical science. What’s more, some estimates place the potential number of jobs that would be lost in the research sector at around 20,000. I know I’ve said it before, but it needs to be repeated: funding for medical research is not a cost. It is an investment in the well-being of Americans and our healthcare system, as well as our economy.

I am pleased to report that hours before the Rally for Medical Research took place this morning in Washington, DC,
theProstate Cancer Foundation (PCF) announced $4.7 million in funding for 21 new and innovative Young IMG00043-20130408-12261-300x198Investigators(YIs) to focus on the problem of prostate cancer. PCF has funded 118 young professionals since 2007, representing a total investment of more than $25 million. Since the launch of PCF’s Young Investigator program, the contributions of young scientists funded by PCF are making measurable contributions in changing the way patients diagnosed with this disease are treated today.

One PCF Young Investigator recently told me, “We don’t know the meaning of it can’t be done… Young Investigators are the hope for the future of prostate cancer research.”

As a patient, I whole-heartedly agree. I am very hopeful of my future because of the future these young and very talented researchers are bringing to fruition.

Seeing the Unseen

Advances in PET scan imaging may soon enable clinicians to see and treat metastatic prostate cancer lesions earlier and with greater precision. 

CT-scan
Recent discoveries in PET scanning may soon enable clinicians to see and treat metastatic prostate cancer tumors earlier than ever before.

 

Ask any fellow patient who has been diagnosed with advanced metastatic disease what their biggest fear is and the answer is simple: recurrence. Of course, the quarterly or six-month PSA test–which comes with its own mix of anxiety and reassurance–remains the first step in watching for the progression of prostate cancer. But patients also wonder, is it growing? And if so, where is it growing?

To date, traditional imaging techniques such as bone scans and computed tomography (CT) have been used to detect prostate cancer tumors that have metastasized away from the gland. But they have drawbacks. They can neither detect lesions that are outside of bony areas nor discern between benign and cancerous lesions. Now all that may be changing with advances in PET (positron emitting tomography) scanning, also known a molecular imaging.

Scientists at Johns Hopkins are now attaching a positron-emitting radioactive tracer to a newly synthesized small-molecule compound that is targeted to a protein (prostate specific membrane antigen–PMSA) that is found in prostate cancer as well as in the newly-formed blood vessels of many other solid types of tumors. The result is that the radioactive tracer is able to “light up” on PET scan images of soft tissues that have been invaded by cancer cells, such as lymph nodes. With several new drugs that have come to market  for the treatment of metastatic prostate cancer, the earlier these cancerous lesions are found, the sooner treatments can be prescribed.

As a patient, I am encouraged that clinicians may soon be able to see the heretofore unseen spread of cancer and treat it earlier should mine return. So should many other patients.

According to Dr. Steven Cho, the first author on theJournal of Nuclear Medicine paper PET and PMSA (and recipient of PCF Young Investigator and Creativity Awards), “Much work remains before PET scans are routinely used to bring functional or molecular imaging into routine clinical care to improve prostate cancer treatment. However, ongoing collective work, here at Hopkins and others sites, is moving at an accelerated pace that we believe will bring this form of imaging into clinical reality for prostate cancer patients in the short-term future.”

Reassuring news, indeed.

Prostate cancer treatment options

The sheer volume of scientific data and marketing copy aside, the best allies remain information and personal preference. 

I read an article today about a new study out of NYU Langone Medical Center and Yale School of Medicine that shows that when hospitals acquire surgical robotic technology, men in that region are more likely to have prostate cancer surgery.

“The use of the surgical robot to treat prostate cancer is an instructive example of an expensive medical technology becoming rapidly adopted without clear proof of its benefit,” said Danil V. Makarov, MD, MHS, lead author and assistant professor, Department of Urology at NYU Langone Medical Center and assistant professor of Health Policy at NYU Wagner School of Public Health. “Policymakers must carefully consider what the added-value is of costly new medical devices, because, once approved, they will most certainly be used.”

I can think of other modalities and techniques about which the same can be said: proton beam therapy vs. intensity modulated radiation therapy, CT vs. MRI vs. other imaging technologies. The fact is, whenever new technologies are introduced, they come with large entry costs, sometimes widely conflicting data and an abundance of marketing messages from eager manufacturers and medical centers who hope to differentiate themselves in highly competitive markets. I remember twenty some odd years ago, smaller medical centers often shared the services of mobile CT and MRI equipment so they could also market the latest technologies and keep patients from defecting to larger, competing institutions. It’s what patients demand.  It’s what a free market encourages.

My first thought in reading the article was that it was a matter of reallocation… patients were simply electing to go to elsewhere for the new technology. But then I read: “…hospitals with surgical robots increased surgery cases an average of 29.1 per year while those without robots experienced a decline in radical prostatectomy by – 4.8 cases.” That’s still a net gainof 24.3…

Now, in this day and age where overtreatment of certain prostate cancers is a real concern, I can’t image any well-regarded institution or practice up selling patients to procedures that aren’t necessary. What I find plausible is that with a surgical option that is less invasive and offers some appealing benefits such as not needing to bank blood, shorter hospital stays and smaller incisions, more patients may be willing to entertain the thought of being more aggressive with their treatment selections. This is the area that deserves more consideration:how do you tell a patient who would prefer to have the cancer taken out, perceives an attractive option and no longer wants to consider less invasive and less aggressive options, that they can’t? At this point, they may be less willing to look at the diagnostics numbers more closely and objectively. And, until a physician can definitively tell a patient that his cancer is not a life-threatening variety, what are they to do? There is the ever prevalent threat of malpractice lawsuits.

I have always said that I was dubiously lucky enough to have clear diagnostics data (Gleason scores, percentages of involvement within the prostate, PSA doubling time, etc…) that pointed to aggressive treatment. In my casem surgery. As a result of my research, I was confident that outcomes with open or roboticsurgery are about the same and are more dependent on the surgeon’s experience (number of procedures) with a specific technique. Age can also have more of an effect on outcomes than the difference between open and robotic. Following a long consult with my surgeon and a query into the number of robotic  procedures he had performed, along with his outcome percentages for urinary continence and ED, I made my decision to have him perform the procedure robotically. Had he only done open surgery with the same stats, I might have elected for that option based on my confidence levels. Perhaps not. (I’ll admit, I am a bit of a weenie when it comes to incisions.) The most important factor was that I was comfortable with my final decision and went into surgery without reservations.

If a patient is to be comfortable with their treatment choice, aggressive or not, I believe personal preference has to play into the decision process. We are all so very different… I know one patient who chose to have open surgery with only an epidural block.  I admire the man, but I certainly couldn’t have done it!

What’s the point of all of this? No matter what the technology, there will always be a plethora of data and confusing–sometimes conflicting–opinions around it until its effectiveness and benefits play out over time, and, until the next great innovation comes along.

Keeping this reality in mind, there is no substitute for us being our own best patient advocates. To this end, our strongest allies remain information harvesting, the advice of  a trusted medical professional  and a good dose of our personal preferences guiding our final decisions.

 

Is It a Detour or Just a Winding Road?

My journey without a map yields more tests and more appointments.

As a result of today’s appointment, I am now scheduled for an echocardiogram on Tuesday and a nuclear stress test on Friday. Standard stress tests would not be able to detect if there is any base reason for my irregular EKG result.

The cardiologist, fully familiar with the side effects of Lupron, believes at this point that my palpitations and chest pains are just that–side effects that are not to be of a major concern. In this case, they would be called benign. Yet, he wants to rule out any other underlying factor.  Of course, I sat there thinking to myself… NOT A MAJOR CONCERN? You try living with the entire USC marching band AND the football team running through your chest several times a day…!  

Of course, there is reassurance to be found in his preliminary assessment. Perhaps this news alone will help control the sensations I am experiencing. It echoed what one of my most trusted associates at work had hypothesized earlier this week. If there are no underlying reasons (a plus), I might just have to live this way until I end my dance with Lupron (a BIG minus in my book). When I pressed the cardiologist for alternatives, he offered that treatment with beta blockers night help–I suppose that would be better than changing my Lupron treatment and hoping an alternate works as well at this point.

Today’s visit was able to provide some peace of mind. As I left the appointment I found myself wondering if this should be considered a frustrating detour or merely another twist on a winding road. Either way, I suppose I can’t complain. I started this journey knowing there is no road map to go with it.

Have a good weekend.

 

A Perfect Storm: PSA Screening is Imperfect But Not Failed

The morning after the final USPSTF recommendation against widespread PSA screening leaves me believing that many have missed their mark and their efforts could have been better directed.

perfect-storm

 

The debate over PSA screening began to simmer and quickly rose to a boiling point about three years ago. Opponents pointed to the problem of overtreatment (according to scholars at Johns Hopkins, overtreatment costs more than $1 billion annually in the U.S.). Proponents looked to the reduced number of prostate deaths as a mark in favor of screening. Studies from both sides of the Atlantic were both complex and provided differing data, making them easy fodder for campaign positions. In short, all the makings of a perfect storm for the debate were in place.

What was missing in the equation was general acceptance that there is a middle ground. One can find it by acknowledging that while PSA screening is imperfect, it is not a failed test. While it is not cancer-specific, it is not a failed test.

In my completely personal opinion, all parties in the debate, including the United States Preventive Services Task Force, would have been better served by launching a nationwide men’s health campaign for patients and clinicians, outlining the pros and cons of both screening and of various treatment options so patients could make informed decisionsregarding their personal healthcare. This should have been coupled with an urgent call for research funding that is making rapid progress for better, prostate cancer-specific biomarkers. Just one example, out of the University of Michigan, is a simple urine test (looking TMPRSS2:ERG gene fusion and PCA3 DNA that are expressed at high levels in 95 percent of prostate cancers) that has the potential to eliminate thousands of unnecessary biopsies and more accurately direct those who can benefit from proactive surveillance rather than aggressive treatment.

But guess what? Even with this urine test, PSA screening would still have an important preliminary role in an informed diagnostic and treatment decision process…

One fellow patient aptly captured what I believe is the feeling of many patients when he posted the following on the Men’s Prostate Cancer Support Group page of Facebook (an invitation-only private forum for men dealing with prostate cancer and treatment):  ”Enough of the nanny state. We are big boys. Give us our PSA and we can decide if we want a biopsy or further treatment knowing the risks involved. But let us decide and give us the only tool we currently have.”

Lancet Oncology, the prestigious medical journal, reports that 84 percent of women in the United States are alive at least five years after receiving a diagnosis of breast cancer. Only 70 percent of British women survive that long. Further, 92 percent of American men with prostate cancer survive for at least five years, compared to 51 percent of Britons. In Britain, PSA screening is less utilized and prostate cancer is often diagnosed in more advanced stages.

The good news that needs to be reiterated is that the Department of Health and Human Services has already stated that Medicare will continue to reimburse for PSA screening. Private insurers, some reinforced by State mandates, should also continue reimbursing for this simple blood test.

Already, many groups are rallying to reach out to their Congressional representatives, asking them to have the USPSTF recommendation reversed. How much more time and effort will that take? How much more confusion will be generated?

From the standpoint of one who believes that his advanced disease was caught in time by the PSA, I also understand and sympathize with those many men who might have been overtreated in their rush to rid themselves of what might have been a non-life-threatening variety of this disease. Thus, any further discussion on reversing the final decision of the USPSTF is futile unless it calls for a clear and concise education campaign on what the PSA is and isn’t capable of doing, the pros and cons of treatments AND and urgent call for funding new biomarkers as fast as our researchers can validate and commercialize them.

Only with better biomarkers can we put this issue to rest. Only then can we overtreat less and cure more.

Imerman Angels to the Rescue

Faced with a diagnosis of testicular cancer, one 26 year-old man initiates Imerman Angels to match newly diagnosed patients with cancer mentors.

We all know the confusion and isolation that a cancer diagnosis brings. There is so much information to absorb and so much to gather. The road ahead is covered in a shroud of fog and often, those around us, save for our caretakers, are often helpless to assist us in the way we need it most. Tomorrow I will be participating on a patient panel hosted by MOVEMBER. On it with me will be a remarkable patient who had a simple yet brilliant idea…

Jonny Imerman was diagnosed with testicular cancer at 26, during his treatment he had the support of friends and family through his journey but never met anyone his age who was a cancer survivor. He wanted to talk to someone just like him, someone who truly understood and remembered – someone who had already beaten the same type of cancer. Based on this experience Jonny founded Imerman Angels. His organization carefully matches and individually pairs a person touched by cancer (a cancer fighter or survivor) with someone who has fought and survived the same type of cancer (a Mentor Angel).

Most of us will agree that having someone who has “blazed the cancer road” ahead of us is invaluable. They have insights and suggestions that newly diagnosed patients haven’t even been able to consider. Perhaps most importantly, having a dialog with some who reminds us that we are not alone and understands exactly how we are feeling is an important assist through our journey.

Summer’s Rushing By While Some Things Stand Wonderfully Still

It’s been a whirlwind few weeks, with Home Run Challenge, Father’s Day and the 4th of July Holiday.

iced-tea
The warmth of the summer sun, a chilled glass of ice tea on the terrace and an undetectable PSA–yes, its a good summer!

I know I’ve been quiet lately–partially catching my breath after an exhilarating Home Run Challenge that has raised more than $1 million (and counting) to support much needed research to protect our fathers and sons, and placing the prostate cancer issue in front of millions of baseball fans and television viewers. I’ve also allowed myself some “me time” –letting cancer play its new secondary role in my life.

But I have to break my silence to let you know that my latest PSA result came back undetectable. While I no longer panic waiting for results, the news was every bit the same to me as a national holiday. In fact, it was my very own Independence Day, confirming at least a continued temporary, if not sustained independence from this disease.

Yes, I feel so good with Lupron behind me. My transition off treatment wasn’t an easy one. The surge of returning hormones was a reverse assault. It charged my emotions and played with my abilities almost more compared to being in the depths of treatment. Few can understand or even sympathize with what that process was like. Looking back, I believe more studies may be warranted to understand the tremendous impact coming off treatment and a storm front of surging testosterone can have on a guy. It can change a person forever. It was my own hurricane Sandy.

But that is past. And I am alive and writing this entry sitting in the warmth of the glorious summer sun.

As I take all of this in, I still have to wonder, how many men will be faced with a diagnosis today… how many will learn that their PSAs are rising… how many will begin to feel the pain in their bones, confirming their fears that their disease is indeed progressing. For them I continue to pray. For them we need to continue our assault on this disease. For them, I will continue to write whatever I can to provide some comfort and hope. It’s the least we can do.

Yes, life is unpredictable, but it’s still beautiful.  Bless you all.

Hitting ‘Em Out of the Park Against Prostate Cancer

Baseball isn’t always all about peanuts and Cracker Jacks. Sometimes it’s about saving lives.

Mets-300x214The 18th Annual Home Run Challenge (HRC) is upon us this week. The program, run by the Prostate Cancer Foundation with Major League Baseball has, in the past 17 years, done much to change how patients diagnosed with prostate cancer today are treated. In fact, with the help of $40 million raised by the HRC, six new drugs have been approved for patients in the past three years and new genetics-based tests are enabling physicians to better direct patients to the level of treatment that is optimal based on the potential aggressiveness of their disease. In short, America’s favorite pastime is raising awareness by encouraging discussions between fathers and their families leading up to Father’s Day, reducing the death rate and moving us toward a reality where we cure more and overtreat less.

By any of these measures, the program is delivering on the promise of its slogan: Keep Dad in the Game.

What’s more, it’s fun. Now through Father’s Day, baseball fans and supporters of the cause can go to the Home Run Challenge website and pledge any amount from $0.10 upward for each home run scored in all 84 MLB games played from Tuesday, June 11 through Sunday, June 16. Last year, 150 home runs were hit, raising a total of $2.2 million for research. That’s no small peanuts for a game so many Americans grew up playing.

This Father’s Day, if you are stuck deciding between yet another new tie or pair of socks to give to dad, consider telling him how much you love and care about him in a different way. Make a pledge in his honor and let him know. Then talk to him about your family history, screening and early detection and treatment. Investing in the gift of life for dad and millions of other men will take us farther than any pair of socks ever could.

Wishing you all a Happy Father’s Day filled with warm and tender memorie

There… I Said It!

It’s funny how a simple Facebook post got me to finally say “survivor” after all this time.

Torre-Dan-300x214

 

A few weeks ago, I published an entry talking about how I believed I was finally nearing a point where I would be comfortable applying the term survivor to myself. When and how a patient chooses to use the term remains a highly personal issue. I knew I was getting close, but I surprised myself this past Saturday when I posted an update to Facebook as part of my travels with PCF’s Home Run Challenge.  It included a photo of Joe Torre and me. I wrote:

The 18th Annual Home Run Challenge to Keep Dad in the Game begins. I am honored to know and have opportunities to work with Joe Torre… Baseball great…, terrific guy…, supporter of the cause… and, above all…fellow survivor.

It wasn’t until about an hour later, as I was watching the Phillies game, that I realized what I had done. I went back to that Facebook post and stared at it for a while. I felt a tremendous weight lift from my shoulders as a smile spread across my face. Survivor… I had said it and it was as natural as using my name. My cancer’s sound barrier was broken.

Yes, I still have numerous quarterly blood draws and visits to the oncologist ahead of me. And, it’s a full two years until I reach the magical five year milestone. But, for the first time ever, I actually see it and believe it will happen. It feels great!

As I look back on the past three years, I realize I’ve learned several important lessons. Life doesn’t always go as we imagine it would. But we need to go with its flow, acknowledge our blessings and balance them with the challenges we are given. I’ve learned to accept the love and support of others without restriction and to give it without expectation. And, I’ve learned to embrace life as easily as I was ready to accept death.

Life is a river and we are leaves on its currents.

I remain ever grateful to my dear MaryEllen, my sons, family and friends who helped me weather the storm. Thank you for wanting me to be alive and with you. Yes, I heeded the call to believe and you have another survivor among you.