Prostatepedia

Conversations With Prostate Cancer Experts


Leave a comment

Funding Clinical Trials

Dr. Jonathan Simons is the driving force behind the Prostate Cancer Foundation, one of the leading funders of prostate cancer research worldwide.

Prostatepedia spoke with him about what clinical trial participation can do for your own prostate cancer journey.

Join Prostatepedia to read more about prostate cancer clinical trials.

How did you become involved with prostate cancer advocacy and the Prostate Cancer Foundation (PCF)?

Dr. Jonathan Simons: When I joined the Johns Hopkins faculty in 1993 as a young assistant professor, perhaps six laboratories in the world had prostate oncologists trained in molecular biology. Johns Hopkins did not have even one clinical trial in advanced prostate cancer using a medicine actually designed to fight the disease.

Then I met Mike Milken. He’d been diagnosed with advanced prostate cancer and was seeking third and fourth opinions—not only about his own case, but the state of prostate cancer research in general. Mike wasn’t new to medical philanthropy; he’d been funding a broad range of research for decades before his diagnosis. But he was new to prostate cancer, so it was encouraging when he left our meeting saying there would be an infusion of research funds and a foundation to make progress against this disease. My mentor and research director at Johns Hopkins, Dr. Donald Coffey, told me, “If anyone’s going to change this field, he’s the guy. I didn’t realize that later I’d end up being PCF’s CEO and President.

You were quite young.

Dr. Simons: I was an Assistant Professor eight months on the Johns Hopkins faculty, and I had a six-year-old and a four-year-old son running around in my office with coloring books on weekends while we set up experiments in my small laboratory. Back then, I was funded by PCF from across the hallway. They were within shouting distance. I have now a 30-year-old and a 28-year-old who do not use crayons.

What year did you officially join PCF?

Dr. Simons: I was there at the beginning in 1993 and was invited to the inaugural celebration of the founding in Washington, DC. Early funding from PCF allowed me as a physician-scientist to train in my laboratory another generation of young investigators who have gone on to become chairpersons and full professors at leading cancer institutions. Today they work toward better precision treatments and cures for prostate cancer in fields ranging from molecular biology to drug development, early clinical trials and nanotechnology. In 2007, I was recruited from the Emory University Cancer Center as its Founding Director and appointed CEO and President of the Foundation. I feel an awesome responsibility and the privilege to continue to serve the field in this way.

PCF funds quite a bit of research, both in United States and abroad. Is there a theme behind the kind of research you fund? What is your overall strategy?

Dr. Simons: The overall strategy is to fund the world’s best, most innovative ideas early enough to reduce deaths from prostate cancer, reduce suffering from prostate cancer, and ultimately eliminate prostate cancer as a plague on humanity. What that means, though, is that we fund mostly laboratory-to-clinic, game-changing, early-stage research in university and cancer center laboratories. We find partners to leverage this funding with additional government or biopharma support. We also fund research to help guide those therapies into the clinic to test whether they are successful or not.

If the treatment shows promise, we try to leverage further the tens of millions of philanthropic dollars that we put in at the beginning with hundreds of millions more from Department of Defense, National Cancer Institute, Stand Up 2 Cancer, the V Foundation, and private foundations. About 80% of what we fund is precision treatment science, 10% basic biology, and perhaps 10% prostate cancer prevention including precision nutrition research.

Additionally, PCF was established with more in mind than accelerating cure for prostate cancer. From the beginning, we aspired to change the face of cancer research and to produce results that could help people suffering from a broad range of serious diseases. We never saw the process as a zero-sum game where increased funding for one disease diminished support for others. Rather, it has always been one of our key goals to increase the size of the research pie in ways that would benefit the greatest number of people.

Your organization funds the beginning idea—sparking research—and then other organizations like pharmaceutical companies or research institutes take the ball and run with it?

Dr. Simons: That’s exactly so. Spark, instigate, cultivate scientific proof-of-concept, and convene stakeholders to ensure there is a strong ecosystem to take those concepts forward for patients.

You partner with pharmaceutical companies. You partner with medical institutions and the United States government. What about other countries? Do you work with groups in other countries?

Dr. Simons: We fund research in 21 countries. We have working partnerships with five foundations. We usually lead invest, but we are delighted to co-invest in research, particularly new kinds of treatment. We should really be called the Global Prostate Cancer Foundation.

It has been difficult for researchers to get patients to enroll in clinical trials. Why do you think that is? What has been the obstacle to getting men to participate?

Dr. Simons: It is complex. I wish I knew all the answers. I think one reason is that patients feel fear about receiving a placebo and about being a guinea pig. That almost never happens in the kind of treatment research that we fund.

But I also think there is a lack of access to information about trial availability. I still think patients aren’t empowered to ask which clinical trials could help them have a better outcome and also help others. I don’t think the system is proactive. (Crate and Barrel bothers me a lot more about their products than the National Cancer Institute bothers patients about whether or not they might be eligible for a precision medicine trial.)

We’re trying to increase awareness of these newer precision medicine clinical trials that have a much higher probability that the drug will work because the target gene is expressed or mutated. Basically: your tumor is vulnerable now and we’re getting access to it, so the investigational drugs have a real chance of getting you back into remission. I think those are the major challenges.

Another issue is distance and travel time and associated costs. Clinical trial participation goes way down if it takes the patient more significant time to get to the hospital. If you are enrolled in a clinical trial, you have to go back and forth more often to see the doctor and nurses monitoring you. With a longer commute, participation rates fall. We’re therefore very interested in telemedicine, or using the internet, so patients don’t have to drive as much. That’s still experimental. Dr. Matthew Galsky, from Mount Sinai, is working on that problem.

Using telemedicine in clinical trials?

Dr. Simons: Yes. Most everything in the clinical trials world is still analog, and yet we live in this extraordinarily digital age. I’m talking to you on my phone—a piece of glass with some metal off ultra high frequency radio waves. Right before this call I was looking at an MRI scan on my iPhone. I can do that, but we still make patients drive 90 minutes to see a doctor when we could probably use a smartphone.

There are a lot of ways we could very reliably take care of patients in an outpatient fashion. We just haven’t fully digitized clinical trials, particularly for patients at a distance. There are a lot of ways to innovate around digital healthcare that would help make clinical trials easier for prostate cancer patients.

I think some men assume that a clinical trial might not be an option until their cancer has advanced. They wait until things have gotten really bad and then they look for a trial. I don’t get the impression that many people think about trials when they’re first diagnosed.

Dr. Simons: No.

But there are trials for the newly diagnosed, aren’t there?

Dr. Simons: Absolutely. And a lot of them offer the possibility of much greater longevity and survival. Your instinct should be: where is the right clinical trial? But you’re still processing, thinking, “My God, I have cancer!” We could do a much better job of educating patients.

How do most people find out about clinical trials? Just waiting for your doctor to say that she has found a trial you might want to consider? Or is the burden on the patient to find the trial?

Dr. Simons: Most of the time, if your physician isn’t a real champion, it’s just not a part of the consultation. Most clinical trial enrollment happens because you have a urological oncologist who believes in putting patients on clinical trials and is probably participating in one. We’d like patients at every stage in their journey to look for a clinical trial with the idea that it might offer a better plan of care than they would otherwise have. We could also do a better job of encouraging nurses to talk with patients about clinical trials.

How would you suggest men look for trials?

Dr. Simons: The site http://www.clinicaltrials.gov is an excellent place to look. I think www.PCF.org is an excellent place to look as well. Making a habit of asking your doctor if there are any new clinical trials for where you are is also a great idea. Create the expectation that your doctor has to pay attention to potential trials.

The site http://www.clinicaltrials.gov tends to be a little bit technical. I would think it might be difficult for the average person to sort through.

Dr. Simons: You can always just ask your nurse or doctor about it. But I agree. We put more than 82 cents on the dollar into our research mission every year. But we wish we had the resources to create an incredibly patient-friendly, readable, real-time, digital website for clinical trials. Until somebody does that, clinicaltrials.gov and pcf.org are good places to find the really important trials.

I suppose you could always come up with a list of trials and then bring it to you doctor and ask if any are appropriate for you.

Dr. Simons: Yes. For right now, that is the best thing to do. The first thousand men cured of advanced metastatic prostate cancer will all be on a clinical trial. That’s a true thing. This is how we talk to lymphoma patients. It’s just more and more possible to talk about it for prostate cancer.

Prostate cancer is undergoing a revolution that other cancers have already gone through?

Dr. Simons: We’ve cut the death rate down by 52%. That’s incredible. For the last 48%, we’re going to need clinical trials. We need patients on clinical trials to take the death rate to zero. Sometimes prostate cancer, unfortunately, escapes surgery or radiation and comes back. While we’ve significantly increased the overall survival rate, we’re not yet able to cure the majority of men. We think we can. We know we can, but we have more work to do.

What does the financial end of clinical trial participation look like? Do men have to pay a fee for the therapies?

Dr. Simons: In clinical trials, research drugs are always free. Medical care is always free. The inconvenience is what is costly. Some employers are very difficult about you missing work for a clinical trial. There is a lot of going back and forth. They call it wage and financial toxicity. One of the effects of the experimental drug is toxic to job security. (It’s hard enough when you’re a cancer patient and worried about your employer.) But the drugs, the pharmacy, the medical care, and the scans are all free.

Is there anything else you think patients might want to know about clinical trials?

Dr. Simons: The misperception is that patients will be treated like guinea pigs. But the first thousand patients cured of prostate cancer will all be on a clinical trial. Every major clinical trial is changing prostate cancer patient survival.

For example, in the SPARTAN trial for Erleada (apalutamide), the drug was so effective that within two weeks of presenting the results, it was FDA-approved. That’s a record. Data was presented showing that 800 patients were benefitting from the drug, and then it was approved.

The only drug that gained approval that quickly in all of oncology was Soltamox (tamoxifen) for breast cancer. We think this is going to happen all the time now.

The SPARTAN Trial focused on patients for whom previously there were no treatments. They saw their PSAs going up, but they were not metastatic. There was really nothing for them to do except wait until we started seeing metastases.

Now, with Erleada (apalutamide) there is a chance that they’re not going to see metastases for years. They’ve got hope. For that first group of men, all of this is possible because they found that clinical trial. Hundreds of men who participated in the SPARTAN trial are going to have a prolonged time without metastases.

Would you encourage newly diagnosed men to seek out clinical trials, even if their cancer is under control?

Dr. Simons: Yes. I encourage every patient to think about joining a clinical trial. It’s not an easy message, but there are many studies showing that you get better nursing just by being on a clinical trial. You just get more attention. You can be there for the cure.

Not a member? Join us.


Leave a comment

Dr. Fred Saad: How I Talk To My Patients About Clinical Trials

Dr. Fred Saad, MD, FRCS, is Professor and Chairman of Urology, and Director of Genitourinary Oncology at the University of Montreal Hospital Center.

Dr. Saad’s main research interests include novel therapies for advanced prostate cancer and molecular prognostic markers in prostate cancer.

Prostatepedia spoke with him about how he talks to patients about clinical trials.

Join us!

What are some of the pros and cons a prostate cancer patient might want to consider before joining a clinical trial?

Dr. Fred Saad: Depending on what state or stage of the disease you’re at, it wouldn’t be a reflex of most patients to think about a clinical trial. When you’ve reached the very latest stage of the disease and you’re told there are no other options, then I think most patients would ask if there are no other options available that are standard of care, is anything going on in research. In that situation, patients are sometimes the motor: they ask their physicians about what is available and many don’t accept an answer of nothing else.

Unfortunately, in all the other stages of the disease, it is on those who face the unanswered questions of the disease every day to explain to patients the importance of answering those questions. We can only answer those questions through clinical trials.

Some of those questions come at the very beginning. Screening for prostate cancer: Who should we screen? Who should we diagnose? What should we do once we have a diagnosis? Those questions continue through to localized disease: what is the best treatment for that patient at that time? What is the best approach once a patient fails therapy?

We have clinical trials at every single step of the prostate cancer journey. It’s up to doctors to inform patients that the reason we’re still asking ourselves questions is because we don’t have all the answers. We’re going to get those answers through clinical trials. It becomes our responsibility to tell patients that clinical trials are available, that they’re of minimal risk to the patient, but could actually help him and especially help future patients.

I explain to patients that breast cancer is way ahead of prostate because of clinical trials. There are other diseases, that we’ve almost cured because of clinical trials. We’ve got a ways to go with prostate cancer, but fortunately, we’ve made a lot of progress over the last 25 years.

Why do you think clinical trial participation isn’t as common in the prostate cancer population as it is in the breast cancer population? Do you think doctors aren’t bringing up the subject with men or there is some reluctance on the part of prostate cancer patients?

Dr. Saad: When I bring up clinical trials to my patients, over 80% agree to be a part of a clinical trial. Part of that may be our way of presenting the pros and cons of a clinical trial. But some patients may be uncomfortable or unwilling to be a part of a clinical trial even if there is one that might be appropriate for him. If presented in a proper way—honestly, transparently—the vast majority of patients accept.

Unfortunately, many patients aren’t offered clinical trials, whether their physicians aren’t involved, might not be convinced of the importance of the question, or are reluctant to refer a patient to another physician.

Also, in general, men with prostate cancer are not as proactive as women with breast cancer in pushing for research and clinical trials. This has some effect on the speed at which we make progress.

There are unfortunately a lot of roadblocks that lead us to having less than 5% of patients in clinical trials. This is really unfortunate because we’ve got a lot more questions than answers in prostate cancer. It’s critical that more patients join clinical trials.

At my clinic we don’t ask why a patient is in a clinical trial, but why isn’t a patient on a clinical trial? We have to think of clinical trials every time we see a patient with prostate cancer if we want to advance our understanding of the disease as fast as possible.

Not all clinical trials would change a patient’s treatment path, per se. For example, an active surveillance or imaging study wouldn’t necessarily change paths?

Dr. Saad: Absolutely. It’s not a question of changing the patient’s treatment path. It’s about making an active effort to put patients in clinical trials. It is more work. I hear many of my colleagues say that we already do a really good job. We don’t need to put a patient in a randomized clinical trial. That’s unfortunate because it slows down the speed with which we get answers. Given the number of men with prostate cancer, we should have answered a lot of these questions a long time ago.

There are some institutions that have a long and very strong history of putting patients on clinical trials. Those institutions are the ones that are contributing a lot to our knowledge of prostate cancer. We need more physicians and centers committed.

For individual patients, a clinical trial may or may not make a huge difference, but for the patients who come after him in that same situation it will.

Clinical trials do not always imply that more is better. Sometimes in trials we do add more treatments to have a better chance at curing that patient, but sometimes we reduce the intensity of treatment to determine if outcomes are similar but with improved quality of life.

We’re learning slowly through clinical trials what are the most appropriate approaches for different scenarios.

Not a member? Join us to read more about prostate cancer clinical trials.

 

 


Leave a comment

Dr. Fred Saad On Why He Became A Doctor

Dr. Fred Saad, MD, FRCS, is Professor and Chairman of Urology, and Director of Genitourinary Oncology at the University of Montreal Hospital Center.

Dr. Saad’s main research interests include novel therapies for advanced prostate cancer and molecular prognostic markers in prostate cancer.

Prostatepedia spoke with him about why he became a doctor.

Not a member? Join us!

Why did you become a doctor?

Dr. Fred Saad: I really never had a second choice. I was really quite young, and for some reason, I was attracted to medicine and caring for patients. It sounds ridiculous, but it started when I was eight years old. It’s a little weird for an eight year old to say that’s what he wants to do, but for some reason it was an obsession of mine. Fortunately, it worked out the way I had hoped because I never even thought about what else I could do in my life.

Like a calling?

Dr. Saad: I don’t know if it’s a calling or an attraction to the challenge of the human body and how it works, seeing if you can do something to improve people’s lives. At eight years old you really don’t know what you’re getting into. The older I got the more convinced I was that this was what I wanted to do. Fortunately, somebody accepted me into medical school. The rest is, as they say, history. Two out of my four kids have decided to become doctors, so my example wasn’t all bad I guess. One is already a doctor. One is starting medical school.

A family business.

Dr. Saad: I’m married to a doctor. So yes, I guess medicine is part of the family, part of us.

Join us to hear how Dr. Saad talks to his patients about clinical trials.


Leave a comment

Prostate Cancer Clinical Trials

Dr. Charles Myers frames our May conversations about prostate cancer clinical trials:

Over the past ten years, the management of prostate cancer has been revolutionized by the appearance of new drugs and new concepts using established drugs as well as surgery and radiation. Every one of these advances only exists because of clinical trials. This is the only path forward. This month, we discuss many of the issues patients face when they consider entering a clinical trial.

The fact that most large clinical trials include a randomization to a control arm is often a major source of patient concern, especially if the control arm uses a placebo. When the control arm involves an active treatment, that treatment will typically represent current state-of-art care that you might receive if you do not enter a clinical trial. However, the cost to you will be less because the clinical trial sponsor will commonly cover the cost of care. The financial benefit to you could easily reach thousands of dollars.

What if the trial includes a placebo arm? First, the existence of a placebo arm commonly indicates that no existing treatment has proven to be of benefit. As a patient, you should do your due diligence on this point. Second, there are strict rules in place to protect patients on the placebo arm. You should know these rules and make sure you are comfortable with them.

Patients on a trial’s placebo arm commonly do better than similar untreated patients not on a clinical trial. There is actually a large literature on why the Placebo Effect exists.

One explanation offered is that patients on the placebo typically get better standard care, and I think this is a major factor. It may also be that patients on placebo do better for psychological reasons or a mind-body effect. The latter might be particularly relevant for the treatment of nausea, pain, anxiety, or depression.

Finally, many patients enter clinical trials for altruistic reasons. By entering a well-designed clinical trial, you will help answer questions that will benefit future patients. The progress we have made over the past decade only happened because patients who came before you chose to enter clinical trials.

Not a member? Join us to read our May issue on clinical trials.

 


Leave a comment

Clinical Trials + You

In May, Prostatepedia asks doctors, advocates, and patients why men with prostate cancer should consider joining clinical trials. Chances are you’ve never thought about entering a clinical trial. You and your doctor have hammered out a prostate cancer treatment plan that takes into account your particular cancer and which side effects you’re willing to live with and which you’re not. But a clinical trial? Most men never really think about joining a trial unless their own doctor brings it up—if he or she does at all.

But there are clinical trials available to men at every stage of the prostate cancer journey from new diagnosis to active surveillance to monitoring for potential recurrence to advanced disease. Some trials offer men access to a drug or therapy that they might not otherwise be able to get. Other trials help scientists learn about prostate cancer biology or genomics. All are important and all advance our understanding of prostate cancer with the aim of eventually eradicating the disease all together.

Understanding clinical trial terminology will be important as you evaluate whether or not you’re interested in joining a particular trial. A Phase I clinical trial generally looks at drug safety and includes a smaller number of patients. A Phase II trial collects preliminary data on whether a given drug works in men with prostate cancer. A Phase III trial collects further information about drug safety and effectiveness—usually in different populations, different dosages, and in combination with other drugs. Phase III trials can lead to a drug’s FDA-approval.

Reading–and then forwarding the issue of Prostatepedia to your doctor–is a great way to start a discussion about clinical trials. Be sure to take notes and do your own research afterwards until you’re sure you understand the pros and cons of each trial you’re considering.

Support groups—online and in-person—can be wonderful resources as you evaluate your options.

The bottom line is that it’s worth investigating if there is a clinical trial available for you at this time whether or not you decide to join one in the end. You’ll learn a lot about your options moving forward and may just find one that’s a fit.

Not a member? Join us to read the issue on May 1.