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Conversations With Prostate Cancer Experts


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Leading a support group

Mr. Rupen Sheth leads the Silicon Valley Prostate Cancer Education and Support Group  in Mountain View, CA.

Prostatepedia spoke with him about his prostate cancer journey and his experiences in running a local support group for fellow patients.

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How did you find out that you had prostate cancer? What treatment path did you take?

Mr. Rupen Sheth: After about age 50, I missed my annual physicals for a couple of years. I first had my PSA checked at age 52, and that was the first time my PSA reading was taken, which was detected at 24. That was the first alert, so my situation was fairly sudden.

I had no idea what PSA meant. I saw that it had exceeded the normal amount, but I didn’t know anything about the prostate or its function. I just thought it was a reading that’s beyond the threshold, just like blood pressure and cholesterol. I thought there were ways to remedy it.

At first, the urologist gave me some medications to see if I had an enlarged prostate. But when we retested, the readings were about the same. He referred me to a local urologist who did a digital rectal exam (DRE), which came back normal. He suggested doing a biopsy at that time.

Just like any newbie, I proceeded with what he recommended. He did a random 12-core biopsy. It was only later that I learned about scans and doing an MRI-guided biopsy, which would have been better. Five out of twelve cores were positive, with one at Gleason 4+5.

It was only then that I started researching and tried to get an understanding of what all this meant. I had CT and bone scans, which came back negative. After some initial research, I realized that I needed to work with some better doctors, oncologists, and institutions than the ones the urologist referred me to. My experience with that urologist was not positive. I sought out folks at Stanford University in Palo Alto and had discussions with a number of people there.

I was almost on a path for getting surgery, but I learned more about long-term outcomes of other treatment options versus surgery and decided to change my course of care.

Instead of getting surgery, I opted for a tri-modal treatment at Stanford, which included two sessions of high dose-rate (HDR) brachytherapy, with five weeks of intensity-modulated radiation therapy (IMRT), followed by androgen deprivation therapy (ADT), which I stayed on for about 18 months. After discussions with my oncologist, we stopped my Lupron (leuprolide) after 18 months. I’m at a point now when we’re monitoring it on a periodic basis.

How has the prostate cancer journey changed you?

Mr. Sheth: There have been a lot of positives from this, despite the initial shock that you typically go through. We have access to a lot of information, which is both good and bad. It can be overwhelming. There is a lot of garbage out there too. You have to be able to filter through that. That requires you to have people who can coach or guide you.

I lean on support groups a lot because there are a lot of people who have been through this journey and have made mistakes. I learn a lot from the missteps that others have taken.

Ultimately, you’ve got to be able to take all of this information and come up with your own road map. I’ve come to realize that you’ve got to take action and control what needs to be done. Others can serve as a guide, but this is about you. That realization has been a positive.

This whole experience has made me a better person in many ways. I’m more conscious of diet and exercise than before. I’m more tolerant and sympathetic. It’s given me a chance to pause and reflect, to determine what is truly important. Those are all good things. Despite 18 months of roller-coaster times, it’s been a good experience.

How did you first become involved with the support group?

Mr. Sheth: As I was trying to determine my treatment options, I looked to speaking to others who had been through this journey. I got some referrals for local support groups. But interestingly enough, it was quite difficult to find out which local prostate cancer support groups were operating. The information online was not current, so it took me a few weeks to get in touch with the individuals who ran the local support groups.

I attended a couple of these. When I attended, I presented the treatment course I thought I would take based on everything that I had researched. It was reassuring to get some validation that the plan that I had chosen seemed to be the right one.

I continued to attend the meeting because I was learning a lot. I found out that the more you know, the more you know you don’t know. I was committed to prostate cancer, so I wanted to know as much as I could about it. There was a wealth of knowledge among the folks who had been through it. I was just observing and learning. It was also an opportunity for me to know enough so that, if by chance there is recurrence, I’ll be better prepared. As I attended, I got more actively involved.

And now you lead the group?

Mr. Sheth: Right. I felt that the group had given me so much and now I had an opportunity to give back.

Our support group has a ton of books and DVDs. A gentleman, Dean Andrus had been our librarian for over a decade. He used to carry all of the material to all of the meetings to facilitate people who wanted to check stuff out.

I started off by taking ownership of the library from him and looked for ways to improve and optimize it. I worked with the El Camino Hospital. They have two library facilities, so we got all of our materials checked in there and set up online so that people can search the catalog, request materials, and check them out.

At first when the previous group leader had retired, the steering committee talked me into leading the group. And again, because of all the support I had gotten from a lot of great members, I felt it was one of the ways for me to do my little community service.

How do you develop programming for and organize the group? Do you have guest speakers? A newsletter?

Mr. Sheth: Our group meets monthly. We also run an advanced prostate cancer group, led by Walter D’Ardenne that meets just prior to ours. A lot of the members from the advanced group participate in my group as well. They serve as a sort of advisory panel because they have a lot of experience and knowledge.

I am a part of the steering committee. We meet more often per month. We talk about how things are going and discuss ideas, topics, and speakers. There’s a good mix of people who are new to this and others who have a number of years’ experience. So, we try to get a mix of relevant topics and some of the new, emerging topics as well. Because there’s a lot of research being done, we try to get others who are doing clinical trials in this space to stay current.

We attend conferences and relevant cancer symposiums. We bring back information on what we learned and discuss it in our meetings. We try to promote and propagate that information through our newsletters and our website.

I took it upon myself to build the website, get the whole layout structure in place, administer it, and host it for the three local support groups.

You’re doing quite a lot.

Mr. Sheth: Yes, but because there are already so many websites, I didn’t want to create yet another one. For us, it was mostly about promoting the resource gems, the topics that are important, useful nuggets, and other things that we discuss in our meetings. Mostly, it’s a collection of references to other sites. We’re not creating new content. We’re merely cataloging and curating other relevant sources.

How many people do you have in these three groups? How many people do you have in your email list?

Mr. Sheth: My email distribution list is about 350. Because I always look for ways to reduce the amount of work that I have to do, especially repetitive work, I didn’t want to manage our list manually. There are a lot of good, free services available, so I chose MailChimp for the newsletter. It allows folks to opt in and out on their own, which keeps it easy. Generally, about 40 members come to each meeting.

Do you get the same 40 people each time, or do you have a core group that comes every time and then newbies?

Mr. Sheth: There are about ten people who are always there. They’re part of the steering committee. There could be a few more who are regulars. And then another 10 to 15 who frequent our meetings but who are not regulars. They try to come to as many meetings as possible. There are about two to five new members. If we have a speaker or a topic of great interest, then there could be more people who attend.

What is it about helping other men with prostate cancer that you find rewarding?

Mr. Sheth: I’ve found that this particular area is more confusing for folks. A lot of the responsibility has been given to the patient because there is no clear choice. I’ve seen folks make decisions prematurely. Everything that I’ve learned from others provides a way for me to guide folks, to help them get out of their fear that leads them to not make those hasty decisions. I try to get them to understand that they’re not alone and that this is a slowly progressing disease. You have time. You can research, gather the information, and make the right decision.

For me, providing that type of coaching, mentoring, and guidance to others is very fulfilling because a few people did that for me, and it helped a great deal. I’ve seen people who didn’t have that, and I want to make sure that we’re doing all we can to make that available to everybody who needs it.

Do you have any advice for men who want to run their own support group or who are running a support group?

Mr. Sheth: See if other existing national groups or organizations have the framework, resources, and guidance that you could take advantage of so that you don’t need to figure everything out on your own. Organizations like the California Prostate Cancer Coalition (CPCC), Us TOO, and the American Cancer Society have affiliations or chapters that you could create. See if you can associate with one of those national organizations because it will help guide you through that process.

Then get other volunteers. Don’t try to do everything yourself. There are plenty of people, and you can delegate and rely on others so that you can do this as a team.

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Mr. Tony Crispino: Patient + Research Advocacy

Mr. Tony Crispino found out that he had prostate cancer at age 44. In the years since his treatment, he has become an outspoken prostate cancer advocate. Today, he runs a support group for other patients in Las Vegas, Nevada and is a Patient Advocate at Southwest Oncology Group (SWOG) where he works with leaders in prostate cancer research on cutting-edge clinical trials.

He spoke with Prostatepedia about his own journey as well as ways in which you can get involved in advocacy.

How did you find out that you had prostate cancer?

Mr. Crispino: Like most, I was asymptomatic. I was 44 years old and had no reason to believe that I had cancer. I wasn’t even aware that I had a PSA test taken, and I was unaware of what PSA was. It was by chance that I’d had a diagnostic PSA, which was at 20, and then I found out that I had stage IIIB disease.

Which treatment path did you take?

Mr. Crispino: Being diagnosed in 2006, I had fewer options than patients have today. We didn’t have Zytiga (abiraterone), Xtandi (enzalutamide), or Erleada (apalutamide) then. The path I chose was not considered standard-of-care yet, but eventually, it became that for guys with locally advanced disease. I read papers from Harvard, Stanford, UCSF, UCLA, and more, and I decided that a multimodal approach was reasonable. So radiotherapy, hormonal therapy, and participation in research trials were all reasonable. Today, I would likely be offered Zytiga (abiraterone) [per STAMPEDE], six cycles of Taxotere (docetaxel) [per CHAARTED], or both. But I am fortunate to have a good outcome with what I chose. I have not been treated since 2010, and I have a durable remission.

Has the prostate cancer journey changed you in any way?

Mr. Crispino: A cancer diagnosis is a life changing experience for most. Nearly all who are diagnosed and their families have a new reality. My well-known mantra to others diagnosed is to stay positive. I followed that rule, and once I came to understand my condition, it was time to take that lemon and make lemonade. My negatives are obvious, but my positives outweigh them. I have done well with advanced disease and that helps as there are many who are not as fortunate, and it becomes more difficult for them to stay positive.

I got involved as an advocate, which has been one of the blessings in my life. I have been actively involved in support, mentoring, research, serving on guidelines panels, and lobbying, and I have authored many physician-facing documents. I would have never had those opportunities without that diagnosis, and I would never have dreamed of being a part of them.

How did you first become involved with prostate cancer patient advocacy?

Mr. Crispino: Almost immediately, I was an online surfer like never before trying to regain control of my life. It was through this method that I became educated, a support group leader, and determined to be a part of cancer treatment as more than a patient. But first I had to experience the support I received from all those who paved the way ahead of me.

What do you do with Us TOO and SWOG?

Mr. Crispino: Us TOO is education and support. I am well equipped to help in these areas, and I have run the Las Vegas chapter for over 10 years.

SWOG is a fantastic experience. There are only four such networks in the National Cancer Institute (NCI) group called the National Clinical Trials Network (NCTN). Being included in clinical trial design and evaluation is a very unique experience that very few patient representatives in this area of research get to participate in. SWOG has led me to my membership in societies like ASCO, participation in guidelines panels for ASCO, AUA, SUO, ASTRO, and being elected to the Prostate Task Force for the NCI.

Why do you continue reaching out to other men with prostate cancer?

Mr. Crispino: I have a great deal of experience across the board. It is not only helpful to the diagnosed patient but rewarding to be able to help others. Reaching out to the patient community allows me to help the physician community and vice versa. It is very fulfilling.

Do you have any advice for other men with prostate cancer?

Mr. Crispino: Get educated. I tell all those I mentor that educated decisions are always better than emotional decisions or passing the decision on to your oncologist. Shared decision making requires that you have some knowledge before a decision.

Beware of bias, as there is plenty of it in the patient and physician communities. Beware of conflicts of interest, as there is plenty of it in the physician community. Even with good intentions, biases and conflicts of interests are common.

Do you have any advice for men with prostate cancer who’d like to get involved with advocacy but aren’t sure how to go about it?

Mr. Crispino: Just do it! Many of the positions I hold are elected and have term limits. This means that someone has to grab the baton and move the effort forward when I move on. Being a part of effective advocacy requires many things.

Become educated through peer groups and reading, and by that I mean, listen to all experiences and take notes.

Lose or limit your biases. This is easier said than done. We all think that our decisions are the best and can apply to everyone in the same way. Strong bias might help in the physician and patient communities, but it’s not a good trait in research and guidelines panels. It can be harmful in support and education communities.

Define the area in which you think you can be the best advocate. Being an advocate is a broad role. You can lobby and participate in the political side, which I did but I found it wasn’t my niche. You can be a research advocate, a support advocate, a patient-physician liaison, or even an online poster.

Partake in physician-patient group meetings. Whether it’s attending an ASCO, AUA, ASTRO, or coalition meeting, be there. You will see what it’s about and whether it’s for you. This is not always easy as these types of group meetings can require travel. If you cannot do that, you can still be an effective support advocate in various ways. For example, you could advocate online or by attending support groups meetings.

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How You Can Participate in Genomic Research

Dr. Eliezer Van Allen, Assistant Professor of Medicine at Harvard Medical School, a clinician at Dana-Farber/Partners Cancer Care, and an Associate Member at the Broad Institute of MIT and Harvard, focuses on computational cancer genomics, using new technology in precision medicine, and resistance to targeted prostate cancer therapies.

Prostatepedia spoke with him about how even those of you in remote areas can participate in nationwide genomic research study for men with advanced or metastatic prostate cancer.

What is it about medicine and caring for patients that keeps you interested and engaged?

Dr. Eliezer Van Allen: There are two answers to that question. One, the scientific answer, is that it’s been so remarkable to see how quickly advances that we’ve learned from studying patients with cancer have immediately translated into the clinic and have impacted my patients’ lives. It’s impacted people I don’t know, and that cycle of innovation is becoming quicker. It’s so exciting. It’s a privilege to be part of that from a professional level.

The other answer is more of a humanistic thing. I went into medicine because of my experiences at Camp Kesem, which is a camp for kids whose parents had cancer. It was a life-changing experience to be involved with that and to help drive it from the beginning. Whether or not any individual therapy works for any of my advanced cancer patients, there’s a human element to this job that’s very profound. That is also a privilege, to be involved with that day-to-day, no matter what.

Camp Kesem is still around, right?

Dr. Van Allen: Yes, it’s growing amazingly. There are over 100 camps now around the country, and thousands of families are involved. It’s wonderful.

Have you had any patients who changed either how you view the art of medicine or your own role?

Dr. Van Allen: Absolutely. At some level, every single patient both challenges and reinforces aspects of what it means to be a doctor and deliver care. Each in their own way has changed the way I think about things. There are obviously some stories that stand out and some experiences.

Some of the patients who’ve had the most catastrophic outcomes and succumbed to the disease in rapid form have taught me the most about what it means to live your life to the fullest, whatever that means to you. I have a lot of respect for them.

It’s a special thing to care for people at the particular moment, when they face big life questions.

Dr. Van Allen: About eight or nine years ago, I wrote a piece for the Journal of Clinical Oncology’s Art of Oncology series. It was about this one patient I had as a first-year fellow who had this positive thinking attitude in the wake of the most potentially catastrophic scenarios up until he passed away. It was such a surreal thing. In that case, it was rare, but I think it teaches you a lot about what it means to be human and how hard this disease is.

What is the goal of the Metastatic Prostate Cancer Project?

Dr. Van Allen: The Metastatic Prostate Cancer Project is a patient-driven research project whereby, rather than expecting the patients to come to us to join and participate in advanced research, we bring the project to their doorstep, and we engage with patients in new ways. We give patients an opportunity to share information about themselves and share their tumor specimens for us to do genetic testing. The goal is building the largest genomic registry of prostate cancer that we can learn from, and in so doing, accelerate that discovery to translation cycle even more.

Can you give us some updates on how the project has been going since you launched?

Dr. Van Allen: We launched this project in January 2018 in a patient population that is known not to talk about their disease in any venue, under any circumstances, to anyone. There’s no social media presence for this disease space, or at least on the surface, and frankly, we would’ve been thrilled had ten people signed up. Our sister project, the Metastatic Breast Cancer Project, has a loud and overt presence of women taking selfies with their saliva kits, so we weren’t sure how this was going to work.

We’re a little past a year from launch and over 700 men have engaged in research, given us consent to access their samples, filled out the patient-reported survey, and joined this Count Me In movement. It’s remarkable, but not only have these 700 men signed up, we’re already at the other end of the cycle of this project now, and we’ve generated complete data sets for the initial wave of these men. By complete data set, I mean genetic, clinical, and patient-reported data, and we’ve put that data out to the entire community in the research setting to learn from.

This proves the principle that we mean what we say when we’re generating data for the community. We’re not trying to build a silo here. This is patient-demanded, and therefore patient-driven, from day one. From every aspect across the board, it’s been remarkable and exciting to see how we’ve done so far.

We are 150% absolutely still looking for patients. We’ll always be looking for patients. Anyone who’s interested should feel comfortable to go to MPCProject.org and click Count Me In.

What kinds of patients should join? Anyone with prostate cancer?

Dr. Van Allen: This project is for advanced or metastatic prostate cancer, which means prostate cancer that’s left the gland. That could be folks with local, regional prostate cancer involved in the lymph nodes, folks with biochemical recurrence only (only PSA detected in the blood), and all the way to patients with heavily pretreated, advanced disease that’s spread to bone, liver, or wherever. Anyone in that spectrum is considered advanced or metastatic from our perspective.

The project is basically unending, right?

Dr. Van Allen: That’s the goal, releasing it as fast as we can.

Do you just release the data, or are you also forming collaborations with other institutions or projects?

Dr. Van Allen: We’ll release the data. We’re obviously going to try to learn from it ourselves and use it to come up with perhaps new drug targets, biomarkers, and whatnot, but also we would like to connect with other efforts that are spiritually aligned in any way that’s feasible.

One of the best outcomes would be that some researcher who is in no way affiliated with our project finds our data useful and uses it for their research to inform what they do. We’re already starting to see that happen with our sister projects where there are scientists and labs that we are not affiliated with who are using the data to inform how they think about their research and their projects. All of those outcomes are on the table, and we’re excited to pursue all of them.

Is there anything else you want patients to know about how the project is doing, about further studies you’re doing, or other studies you think people may find interesting?

Dr. Van Allen: This is a patient-driven project. Some of the patients who’ve given us feedback on their experiences so far have also prompted questions that we can ask that we, in our little academic bubble, probably would’ve never thought of. That’s how we’re starting to dive into things that are driven by patient experiences or that we’re observing in the patients who have signed up, down to questions that might seem curious but are illuminating, ones that we hadn’t intended initially.

For example, in the first patient data release, when asked if they had surgery for their prostate, almost half the patients marked: “unknown.” We can compare that to their medical record and sort that out, but it provides a window into something that wasn’t the initial intent of the project. That feedback opened up a lot of interesting questions and opportunities for research that we hadn’t necessarily anticipated up to that point.

Men didn’t know if they’d had prostate cancer surgery or not?

Dr. Van Allen: It may have been the way we asked the question. It may have been that patients were interpreting what they were supposed to answer. We don’t know. The point is that this is not something we initially set out to do, but it is an early example of how patients can guide where the research needs to go.

I just presented this project at the American Urologic Association meeting, and a gentleman came up to me afterwards. He’s had metastatic prostate cancer for four years and a complete response to cancer immunotherapy, and he wanted to know if he was eligible for this project. Not only is he eligible, but he’s an extraordinary case. We want to understand why. This patient is not within 500 miles of an academic medical center, and he would otherwise never be approachable or available to engage in research. We exchanged information, and he’s going to sign up.

Patients may not realize: they have the power to drive this field forward in this unique way. It’s not something that medicine is used to doing. We want to get the message out that this is all starting with patients and their ability to contribute. That will determine how far this goes.

It’s easy for them to participate: go to the website, fill out the forms, and give a blood sample?

Dr. Van Allen: Yes. You don’t even have to do the blood sample if you don’t want to. It’s exactly what you described. Go to the website, click a few buttons. There’s a very simple online consent form. We’ll send you a saliva kit and a blood biopsy kit and take it from there.

Can you still participate even if you’re in a remote area?

Dr. Van Allen: Yes, anywhere in the United States and Canada. For the blood biopsy, we send you a kit, and you bring it to your next lab draw, PSA test, or whatever, and there are instructions in the kit for the phlebotomist. In some cases, phlebotomists have not been willing or able to participate, so we can provide vouchers to patients to do it at a Quest Diagnostics lab or somewhere convenient to them. The intent here is that the patient bears no financial burden in participating.

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Helping Other Patients

In June, Prostatepedia is talking about ways in which you as a patient can benefit from and in turn contribute to the prostate cancer community.

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What do we mean by that? Chances are, when you were first told that you had prostate cancer, you were afraid. Once that fear passed—if it did—you realized you had some decisions to make. There are a lot of controversies in how the medical profession treats prostate cancer; the path is not always clear. Shared decision-making means that you, as a patient, have to participate and form your own opinion: you can no longer just leave everything up to the discretion of your doctor. This is a good thing, but it does require more effort on your part. Most of you turned to friends and family or began searching online for more information. Some of you joined support groups where you learned from other men with the disease.

The things you learned as you moved through that process are valuable —whether your cancer is under control or not. Your experience will help other men in countless ways.

How can you share that experience with others?

You can join a support group. You can even start a support group if you live in a community without an active group. (Read carefully the conversations with Silicon Valley support group leader Rupen Sheth and Us TOO’s Director of Support Group Services Terri Likowski about how to go about this.) You can even join an online support group if making it out to a monthly in-person meeting isn’t possible.

But what if that type of interaction really doesn’t fit with your personality or lifestyle? You can potentially get involved with clinical research advocacy. We published a conversation with the chair of the Southwest Oncology Group’s patient advocate committee last month, and this month, we feature a conversation with their Patient Advocate Tony Crispino, who works with leaders in prostate cancer research on cutting edge clinical trials.

Or, your cancer itself can contribute to our global prostate cancer community. How? If you’ve got metastatic prostate cancer, your blood or saliva can help researchers build a genomic registry of prostate cancer so that they can learn as much as they can about prostate cancer. Read Dr. Eli Van Allen’s conversation to find out about how to join and what types of strides his Metastatic Prostate Cancer Project has been making in the past year and a half.

The point is that some greater good can come from your prostate cancer journey. You can contribute to our efforts to eradicate this disease: whether it’s in the form of sharing your story with a friend over a cup of coffee or helping researchers decode the information carried within your blood.

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Global Access To Xtandi

Ms. Merith Basey is the Executive Director of Universities Allied For Essential Medicines (UAEM) North America, a global network of university students who believe that their universities have an opportunity and a responsibility to improve access to publicly funded medicine developed on their campuses.

Prostatepedia spoke to her about UAEM’s Xtandi (enzalutamide) campaign and how prostate cancer patients can help.

Can you tell us about UAEM’s Xtandi (enzalutamide) campaign?

Ms. Basey: We launched this campaign at the University of California in Los Angeles (UCLA) to urge the university to drop its pursuit of a patent claim in India for the drug Xtandi, which people may know by its generic name, enzalutamide. The drug was developed at UCLA with the support of public grants or funds from the National Institutes of Health (NIH) and the Department of Defense (DoD). Xtandi (enzalutamide) is currently sold in the United States at an eye-watering $130,000 per patient per year and around $30,000 in Canada while at the same time we know it is estimated to cost just a few dollars to produce. Obviously, these prices are out of reach for most.

In India, prostate cancer is among the top ten most commonly diagnosed forms of cancer. And yet UCLA filed a patent claim with the High Court of Delhi on behalf of two massive pharmaceutical giants, Pfizer and Astellas that acquired the rights for the medicine from the university. Our concern is that, if this patent is granted, it will further obstruct the introduction of a more affordable, lower priced generic drug onto the Indian market and it will set a very dangerous precedent for the role of universities in determining patient access. We know the potentially devastating impact that this could have for people living with cancer in India and other countries that import their generics from India as well. In our view, the impact of this case goes far beyond this one drug, one community, one country. This is about standing up for health equity and justice and putting people’s lives over profits.

To give you some further background to this story, while UCLA still currently holds three patents on Xtandi. they initially licensed the drug to Medivation, a biotech based in San Francisco. In 2016, Medivation was acquired by Pfizer and they ended up in an agreement with Astellas, a large Japanese pharmaceutical corporation. In the same year, UCLA then sold its royalty interests on the patents for the drug to Royalty Pharma for a massive $1.14 billion dollars. The Xtandi site application in India was initially rejected by the Indian Patent Office on the grounds that it wasn’t patentable. This was when UCLA filed the patent appeal suit with the High Court of Delhi. At UAEM, we believe universities must be part of the solution not part of the problem to the global challenge of high drug prices. They need to live up to their social missions rather than protecting corporate interests. We know the impact it will have on people who need access to this drug as well as others in many countries around the world.

In response, we’ve been organizing students, and they have been leading a campaign at their university to urge the UC President, Janet Napolitano, to drop the patent claim. Students have spoken up at multiple Board of Regents meetings in San Diego, Los Angeles, and San Francisco. They’ve met with some of the deans, and collected over 3,500 signatures that were delivered to Janet Napolitano. At the most recent campus rally the university even appeared to silence the student voices reducing the opportunities to speak and even putting up barriers outside the building. Disappointingly,

The UC offices have acknowledged that they know the campaign is happening but the overall silence from Janet Napolitano and the Regents has been deafening. The university is publicly funded, and the drug was developed with public research dollars, they should not be fighting a court battle on behalf of private pharmaceutical corporations. This is not the role of the university. We believe that they’re on the forefront to provide access to medication for people regardless of income which is not what they’re doing.

How can someone reading this participate? What can we do?

Ms. Basey: There are several ways to help.

1) If you can, any financial donation to UAEM makes a difference. We’re grassroots, a small and lean organization so any donation goes a long way for our campaigning . Learn more here.

2) We’d love to hear from you at: info@uaem.org You can follow us on most social media!

3) Email President Janet Napolitano–she is the woman with the power within the University of California system to drop the claim–at janet@ucop.edu. Tell her why this drug is so important and why the UC should drop the patent claim and make efforts to ensure publicly funded drugs developed on university campuses should be made affordable and accessible to the public who paid for the research in the first place.

4) We’d also like to hear from people who are affected by prostate cancer who might be interested in writing or being part of the campaign. We’d particularly like to hear from people in California as we’re scaling up our efforts there as well as in India.. Your voices matter. Email us at info@uaem.org

We want to make sure that winning this fight sends a message not only to universities about the importance of living up to their social missions but also to pharmaceutical corporations. They’re making billions of dollars off this drug at the expense of patient lives, and we can urge them to do better.

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NRG Oncology’s Clinical Trials

Dr. Mark Hurwitz, a widely recognized leader in the fields of thermal medicine and genitourinary oncology, is the Vice-Chair for Quality, Safety and Performance Excellence and Director of Thermal Oncology for the Department of Radiation Oncology at The Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia, Pennsylvania.

Dr. Hurwitz talked to Prostatepedia about NRG Oncology and a trial he’s running with them that looks at anti-androgen therapy and radiation therapy with or without Taxotere (docetaxel) in treating patients with prostate cancer that has been removed by surgery.

Why did you become a doctor?

Dr. Hurwitz: Medicine is an extraordinarily rewarding career in regards to being able to help people at important and often critical junctures in their lives. It’s extremely humbling to see strangers walk into my office and put their trust in me to help them through a difficult time in their lives.

It’s an enormous responsibility.

Dr. Hurwitz: It is, but one that comes with many years of training and preparation for a physician to get to the point when we enter practice.

What is NRG Oncology? What has been your involvement with the group?

Dr. Hurwitz: Several years ago, the National Cancer Institute (NCI) mandated the merging of cooperative cancer research groups into fewer but larger groups. One of these groups NRG Oncology, was the result of the merging of the Radiation Therapy Oncology Group (RTOG) with the Gynecologic Oncology Group and the National Surgical Adjuvant Breast and Bowel Project (NSABBP). This dynamic new large cooperative research group is primarily supported by the NCI. It’s been exciting and rewarding to be a part of this new larger group putting all our resources together to bring trials to patients.

I’ve been involved with NRG Oncology since its inception. Predating that, I was involved with both RTOG, as well as the Cancer and Leukemia Group B (CALGB) during my years at Harvard Medical School.

What kinds of trials does NRG oncology run?

Dr. Hurwitz: The focus of cooperative groups, including NRG Oncology, is on conduction of clinical trials to answer important questions that are best addressed by getting multiple centers involved. These tend to be Phase II or Phase III trials involving hundreds, and sometimes thousands of patients, to answer a critical question that experts in a given field see as being one of the most impactful issues to address for a given set of patients.

NRG is also involved in translational science as well. Almost all of our clinical trials have an incorporated translational aspect to them to answer leading-edge questions in regards to some of the pertinent science behind advancing treatment for our patients.

Are the participating institutions limited to within the US?

Dr. Hurwitz: There are international participants. The group does have a North American focus. Therefore, the United States, as well as many Canadian institutions, are very active in NRG, but NRG has branched out to include international institutions outside of North America as well.

Is it difficult to enroll patients in trials?

Dr. Hurwitz: We all in academic medicine seek to engage more patients with involvement in clinical trials. Only a small percentage of patients nationally participate in clinical trials, so there’s a real opportunity to match patients and their needs with the clinical trials that will help advance the field, as well as their own personal care.

Some of the challenges include having appropriate trials available for patients seen within a practice, as well as the time commitment both in terms of the extra time that the physician needs to take to explain trials as well as the resources needed to support the conduction of clinical trials at a given site.

There is also the issue of awareness both on the patient and provider sides as to opportunities for clinical trial participation.

Why should patients consider joining the clinical trial?

Dr. Hurwitz: There are several reasons for patients to consider trials. A trial often provides patients access to leading-edge therapeutic strategies that may not be available off clinical trials.

It also will help provide additional information that will benefit future patients, although our focus is always on the patient who is sitting in front of us.

Also, interestingly enough, there are multiple studies that have looked at the impact of clinical trial participation on patient outcomes, with very consistent findings that patients on clinical trials tend to have better outcomes including survival outcomes than patients not on clinical trials. This is likely due to a number of factors, including the rigorous monitoring of patients on clinical trials as well the follow up after treatment that is done. These patients are followed very closely. There are state-of-the-art treatment guidelines that must be followed on clinical trials to help reduce undesirable variability in patient care. These aspects of clinical trials help to improve outcomes regardless of the particulars of any clinical trial.

Are there certain stages along the cancer journey when a patient should consider a trial?

Dr. Hurwitz: There are clinical trials that are suitable for patients across the whole spectrum of disease severity. In the case of prostate cancer, there are trials for patients with very favorable risk disease for which active surveillance is an option to trials for patients who are on second or third line interventions for metastatic prostate cancer. And everything in between. It’s not a matter of whether a patient has a certain stage of disease. There are questions to be answered at each stage of a given disease for which clinical trials may provide benefit.

Are there any considerations patients should keep in mind as they evaluate trials?

Dr. Hurwitz: People have to gauge the particulars of a trial much like the particulars of any proposed treatment for malignancy in regards to what makes them most or least comfortable with the options before them.

Let’s say a patient participates in an NRG trial. Are they informed of the results once the trial is completed?

Dr. Hurwitz: There have been increased efforts in recent years to disseminate outcomes of trials to patients. It’s a particular challenge in some diseases like prostate cancer where the results may come a decade or more after trial participation.

That’s true.

Dr. Hurwitz: There is an effort regardless of the outcome of the trial to make not just practitioners but patients aware of the results.

Are there interesting NRG prostate cancer clinical trials that you’d like to highlight?

Dr. Hurwitz: I’m happy to highlight NRG-GU002, for which I am privileged to serve as the principle investigator. This trial builds on a prior Phase II single-arm RTOG trial, RTOG-0621, which I led that revealed very promising outcomes with the addition of Taxotere (docetaxel) and hormonal therapy to radiation for patients with adverse risk factors post-prostatectomy. NRG-GU002 builds upon the single-arm Phase II trial as a randomized Phase II into Phase III trial exploring the use of radiation and hormonal therapy with or without Taxotere (docetaxel) in men who fail to achieve a PSA nadir of less than 0.2 nanograms per milliliter after prostatectomy. This is a particularly high-risk group of patients in regards to risk of subsequent treatment failure. We have been very encouraged by the efficacy of Taxotere (docetaxel) in treating prostate cancer. Taxotere (docetaxel) has been shown initially in metastatic prostate cancer and subsequently in locally advanced disease to have a survival advantage—as opposed to using radiation or hormonal therapy alone in the primary treatment setting. Therefore, there is a lot of interest in exploring its utility in the post-prostatectomy setting for high-risk patients.

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Reporting Clinical Trial Results

Ms. Merith Basey is the Executive Director of Universities Allied For Essential Medicines (UAEM) North America, a global network of university students who believe that their universities have an opportunity and a responsibility to improve access to publicly funded medicine developed on their campuses.

Prostatepedia spoke to her about UAEM’s transparency campaign to get universities to report the results of the clinical trials they run and how prostate cancer patients can help.

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How did you get involved with health advocacy?

Ms. Merith Basey: A little bit by accident. My interest in public health and health advocacy stemmed from my undergraduate degree in modern languages and my interest in Latin America.

In 2004, I volunteered with an organization in Ecuador called AYUDA in conjunction with a local diabetes foundation that worked with children with Type 1 diabetes and their families. We worked together to provide diabetes education to children with Type 1 and their families so that they could learn how to better manage their condition and increase access to resources.

It changed my life. I ended up working for that organization for a number of years in a number of different settings. However, during that time, I began to see that, in some of the countries in which we worked, access to insulin was an ongoing challenge, and for many families, the price of insulin was simply too high. The lack of action at that time spurred me and a small group of advocates to launch the 100 Campaign for access to insulin back in 2012. Today, one in two people who need access to insulin still don’t have regular access, a challenge that is increasingly apparent in the United States and in many countries around the world. It was through this lens that I ended up in health advocacy.

What is Universities Allied for Essential Medicine?

Ms. Basey: Universities Allied for Essential Medicine (UAEM) was founded in 2001 at the height of the HIV/AIDS epidemic. A drug called d4T, or stavudine, had been developed at Yale University with public funds and was being used as part of a cocktail of drugs, at least in the United States, to treat people living with HIV.

At the time, Doctors Without Borders/Medecins sans Frontiers (MSF) was looking to treat people living with HIV in South Africa where the burden of disease was highest. They realized that the price of this one drug was too high for them to be able to treat the millions who were in need of access to treatment. However, a young student and activist who started Yale law school that year decided to take action. She organized, with other students in conjunction with MSF and Civil Society, with the goal of lobbying her university and the company Bristol-Myers Squibb (who had purchased the rights to the drug) to change the license between them to allow for the legal generic importation of this drug into South Africa. The campaign was a success; it led to a 90 percent reduction in the price of that drug in that region, allowing MSF to treat people living with HIV for the first time.

That’s the founding story of UAEM and is at the heart of our work, primarily based on university campuses in the United States and today in over 20 countries around the globe. A simplified vision of our work is that we believe no one should be poor because they’re sick or sick because they’re poor.

We understand the role that universities have in the drug development pipeline and believe that they should be critical partners and leaders in ensuring access to affordable medicine, especially when it is developed with taxpayer funds. Also, in particular, we work to urge universities to increase their research into neglected diseases since most research in the current system tends to go into drugs or treatments for wealthier and historically whiter populations. A lot of other drugs for diseases that predominantly impact the poor are left behind until there’s an urgent demand like there was for Zika and Ebola. It is estimated that 90 percent of the research dollars go to just 10 percent of the global burden of disease.

Do you focus on universities because that is where some of this initial research is done or because you’re trying to activate younger students on campus?

Ms. Basey: I think it’s both in part. Initially, it was inspired by that success story at Yale, but it was also about understanding where students have power. Students are key stakeholders in university systems, and while they are actively enrolled, they have unique power and access to faculty and other decision-makers. They have the right to be able to meet with the administration, ask them about their policies, and urge them to address historic inequities or errors.

Secondly, universities are the key drivers of much of our most innovative biomedical research. In the United States, for example, every year $37 billion of taxpayer money goes in the form of grants from the National Institutes of Health (NIH) to universities across every state and in a number of countries around the world to do biomedical research and clinical trials.

Given this massive public investment into researching and developing new compounds and medical innovations, it is also an opportunity to influence the way that those drugs are patented and eventually licensed into the hands of pharmaceutical corporations down the line. We also believe that the public should have a return on that investment and that the product of that investment should be accessible and affordable to the people who paid for them in the first place: the public.

Yes, the National Cancer Institute (NCI) and the National Institute of Health (NIH) fund quite a number of clinical trials. Most of the people reading this are familiar with trials as potential participants. But what happens when a trial is completed?

Ms. Basey: It depends on who is leading the trial. In the United States, for example, when a university is responsible for leading a clinical trial and it is completed, the results should be reported onto a public database within a period of 12 months. (There are of course exceptions based on a number of different criteria). A significant portion of NIH funding is invested into clinical trials. It’s estimated that in 2017, at least about 38 percent of that $37 billion figure that goes to universities actually goes directly into funding for university-driven clinical trials, clinical research, and other activities related to clinical trials.

On average, however, it has been estimated that only about 50 percent of clinical trials are registered and reported. This obviously has impact. I can’t speak for the specific motivations that certain individuals might have for entering a trial, but in general, people participate to help find out more about the effects of specific treatments on a particular disease whether that be in the hope of helping improve their own health or the health of others. Knowing that, it’s unethical that this data goes unpublished.

Why is this data not reported?

Ms. Basey: A couple of things are happening. Obviously, that 50 percent is a global figure so it is a global problem. In the United States, however, even though the FDA Amendments Act makes it required by law for certain trials to be posted, according to UAEM’s recent report (www.altreroute.com/ clinialtrials) 31 percent of trials that are due are still missing results on the public registry with performance varying strongly between the top 40 institutions reviewed. Why are they not reporting? In some cases, they don’t report because they haven’t been required to, because it takes time, and because often the results are not favorable to the people funding the trials. Trials with negative results are two times as likely to go unreported as trials with more positive results. Publications typically like to report favorable outcomes rather than negative outcomes. If you are a private pharmaceutical corporation funding a trial for a drug you intend to produce and the initial results are not in your favor (due to limited effects on health outcomes or number of adverse effects) or if there isn’t a legal obligation to report, you may choose not to publish data. Obviously, this is entirely unethical but the evidence suggests it happens.

Best practices are set out to say that all clinical trials should be posted because, without all the data it’s going to skew data in a manner that is ultimately harmful. It’s going to skew the results. It’s going to skew the information that doctors are going to have in terms of deciding which drug is safer than another. The system is flawed in that sense. Failing to publish trial results means the decisions-makers with regards to medical treatments won’t have full information about the benefits or risks of treatments.

Just to clarify for patients, how are the results of clinical trials usually reported?

Ms. Basey: In the United States, a trial would first have to register on clinicaltrials.gov when the trial starts. (Although not all studies are required to be registered, e.g. observational studies or trials that do not study a drug, biologic, or device). Clinicaltrials.gov is a United States government database that has all that information for both federally and privately funded trials conducted under investigational new drug applications to test effectiveness of experimental drugs for serious or life-threatening diseases or conditions. Because of this FDAAA Final Rule, specific trials that involve patients will need to register or report their data within 12 months on that same database. At UAEM, in conjunction with TranspariMED, we just looked at the top 40 United States universities driving a lot of this biomedical innovation via clinical trials. Even though the law required that they register and report data within 12 months, about a third of these university-driven trials were unreported.

Essentially, they’re breaking the law. For every day that they hadn’t reported, the FDA could fine them $10,000. There’s quite a large incentive (beyond the ethical one) for them to report, but the FDA so far hasn’t collected any fees. We need to be making sure that all data and all trials are ultimately registered and reported so that there is full transparency and full information for everybody in terms of open data. It really comes down to making sure that data isn’t hidden.

So you’re running an awareness campaign?

Ms. Basey: For us, it’s very clear that, as receivers of public funds and given their social missions, universities should be leading the way in terms of registering and reporting of their own clinical trials. The campaign that we’re running is not only to urge universities to register and report but to go a step further. The World Health Organization (WHO) developed a joint statement on public disclosure of results from clinical trials. This was first signed in May 2017 by 21 key funders of clinical trials around the world including the Wellcome Trust, the Gates Foundation, MSF, the Indian Council of Medical Research and the Drugs for Neglected Diseases Initiative, just to name a few. They agreed, that if they fund clinical trials they will require investigators to register and publicly report the results in a timely manner. We go little bit further because we are also asking those universities or institutions to come up with a policy to hold themselves and others accountable. We have students in over 50 universities in North America and in 20 different countries around the world organizing on their campuses to urge their universities to make sure that they’re registering and reporting their own clinical trials and thinking about signing this WHO joint statement on clinical trial transparency.

Is there anything that my readers can do to help?

Ms. Basey: If you’ve had the privilege of going to a university, call or email your alma mater to ask them about their policy or their performance if they are listed in our report. Let them know that this is something you support and you’d like them to take action. We know that universities respond to pressure from their alumni. You could also financially support UAEM’s grassroots campaign directly via http://www.UAEM.org

At UAEM we will continue to urge universities to step up to their commitments. They are, ultimately, morally bound to be transparent with their research outcomes since most of these trials are publically funded. We’re really proud to see that the universities that are 100 percent reporting are actually beginning to mobilize and think about moving forward with signing onto the WHO statement. But we still have a long way to go. Every pressure and encouragement is recommended.

Clinical trial transparency helps accelerate medical progress for new treatments and improve our understanding of treatment efficiency and safety, ultimately contributing to improved access to medicines and better health outcomes for us all.

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