Tag Archive for: enzalutamide

Emerging Promising Advanced Prostate Cancer Treatments

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Emerging Promising Advanced Prostate Cancer Treatments from Patient Empowerment Network on Vimeo.

What emerging advanced prostate cancer treatments are showing promise? Expert Dr. Yaw Nyame with the University of Washington shares his perspective about the treatment landscape, updates on clinical trials showing promise, and how to help ensure optimal patient care.

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Transcript:

Lisa Hatfield:

Can you speak to the current treatment landscape and any new research coming out about advanced prostate cancer treatment that you are excited about? And how do you work with your patients to make treatment decisions, particularly those in underrepresented communities?

Dr. Yaw Nyame:

So, two very different questions. The first thing I’ll say is the landscape is changing, and there are a lot of exciting things. There are some trials that are showing that the combination of systemic therapies like the hormone blockade, whether it be hormone blockade at a large level, at the cell level with some of those novel agents like abiraterone (Zytiga) and enzalutamide (Xtandi) or even chemotherapy, how we combine those are all very exciting. But we also know that local control of the prostate, so either using radiation to the prostate, which was shown to be beneficial in a clinical trial from the UK called STAMPEDE, we have an ongoing clinical trial called SWOG 1802, which is looking at whether surgery locally to the prostate can add additional benefit to men with advanced prostate cancer.

So I think it’s exciting to understand how we can improve survival. It used to be around three-year survival for prostate cancer when you were diagnosed with advanced forms. We’ve moved that to beyond five years because of how many incredible new advances we have and these combinations of local therapy and systemic therapy. We also have new drugs coming into the landscape like lutetium Lu 177 vipivotide tetraxetan (Pluvicto), which is a PSMA tagged radioligand which has, you know, shown some really great results in the castration-resistant or hormone resistant space that’s being tested now earlier in the hormone sensitive space and high risk localized space.

So there are a lot of really fantastic and exciting new advances. I’m skipping over other types of medications that are really in the precision oncology space, like the PARP inhibitors which are shown to be beneficial in people who have, you know, certain genetic, you know mutations and DNA recombination.

So I think we continue to see evolution in this space where, you know, we used to sort of see this cancer as a one size fits all. And you know, we sort of try to sometimes hit a square peg into a round hole, and now we’re able to really say, okay, your cancer has these features and this combination of things is what’s going to work best. But the problem with that is the more nuanced and the more personalized our care gets, the more opportunity there is for people who are on the margins to be lost.

And so, you know, our historically, you know, marginalized and minoritized populations are sometimes going to be the ones at highest risk for not getting the latest and greatest. One of the things that I’m really interested in supporting and seeing supported in cancer centers and in clinical sites across the country is patient navigation.

Providing services that help people get connected to all the different types of doctors, all the different types of institutions that might offer them the treatments and the workups that they need to make sure that they get access to the best care that’s available. And that’s not only supporting the patient oftentimes, but that’s supporting their caregivers, their families, and making sure that what is a really complex process. It’s not just going in for one doctor’s visit oftentimes, right?

Seeing a lot of different specialists, getting a lot of different tests. But that process is supported for people that have especially among people that have significant social needs and may not be able to navigate that on their own. My activation tip in this space is to absolutely do your homework and find resources to help you navigate this very confusing and very busy landscape when you have your diagnosis.

A lot of cancer centers have patient navigators, okay? And if they don’t, they should. So that is one resource that you should not be afraid to ask for and utilize is someone from the doctor’s office. That’s just going to take the time to make sure if you need to be connected to an insurance, you know agency like Medicare or Medicaid, that you’re connected, that if there are certain appointments you need to make, that they help you schedule and if you need transportation support, that they help connect you to that. And so finding those resources, whether it’s through your community and peer network or through the cancer center, is really important to make sure that you can get as comprehensive of care as you can.

Sherea Cary:

My activation tip for care partners when addressing things like treatment and new research is for the care partner to be as informed as possible about other health issues that the patient may have, and to be transparent with the oncologist about what other things are going on in the patient’s life to make sure that they fit some of the new research that’s coming out or be able to, or the patient and the care partner are able to overcome those barriers that may separate them in some of the treatment decisions. 

Lisa Hatfield:

Right, thank you both Dr. Nyame and Sherea, who is a care partner. Thank you for that. Those activation tips. 

[ACT]IVATED Prostate Cancer Post-Program Survey

What Can Signal Hormone-Sensitive Advanced Prostate Cancer?

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What Can Signal Hormone-Sensitive Advanced Prostate Cancer? from Patient Empowerment Network on Vimeo.

Advanced prostate cancer patients may experience common symptoms, but what are they? Expert Dr. Yaw Nyame with the University of Washington explains the range of symptoms that metastatic patients may experience and common treatments for advanced prostate cancer.

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Transcript:

Lisa Hatfield:

What is advanced hormone-sensitive prostate cancer, and are there specific symptoms or warning signs to be aware of?

Dr. Yaw Nyame:

When we have prostate cancer that has spread beyond the prostate. We define that as advanced or sometimes we call it metastatic prostate cancer. And early on in that process, we can control and often kill many of those prostate cancer cells by taking away testosterone. Testosterone ends up being like the fuel that allows these cancers to grow. And so when we say a prostate cancer is hormone-sensitive, what we mean is it’s sensitive to testosterone, and by shutting off testosterone, we can effectively manage and or kill those prostate cancer cells.

Over time, when we shut off that testosterone, prostate cancers will learn how to produce internally their own testosterone or develop resistance or find ways to still survive in the absence of testosterone, and when that happens, we call that pheromone-resistant or sometimes you will hear the term castrate-resistant prostate cancer.

Advanced prostate cancers are going to be in a category of cancers where people may have symptoms, those symptoms aren’t always specific, they can range from difficulty urinating, having blood in the urine, having fractures of bones that have been invaded with cancer, weight loss, loss of appetite, and so that is sort of a broad spectrum of symptoms that someone could potentially experience with an advanced prostate cancer, but not all folks are going to have those particular symptoms, because oftentimes when you have severe prostate cancer-related symptoms, those are in pretty advanced stages, meaning you have a pretty high amount of cancer that is outside of the prostate.

My activation tip, when it comes to hormone-sensitive prostate cancer that is advanced, is to be informed about the latest therapies that we offer in this space, because it is constantly changing 15 years ago. The mainstay of treatment was just hormone blockade, and we put people on medications that took their testosterone away or offered them surgeries to take away testosterone from the testicles. We then added on these novel testosterone or androgen-blocking medications like abiraterone (Zytiga) or enzalutamide (Xtandi), which people will hear about when they look up the space of what their diagnosis, then we added on chemotherapy in the form of docetaxel (Taxotere), and now we’re doing combinations where we add the hormone blockade and medicine like abiraterone and chemotherapy, what we call triplet therapy as now first-line therapy.

And so this space is changing so much that when you have this diagnosis, you need to take a pause and do your homework so that you are prepared to have a conversation with your medical oncologist about whether you need doublet therapy, one of the two medications or triplet therapy, or if you even need to consider the addition of something like radiation to the prostate. All of these are standard of care, and it’s no longer just a one medication pipeline for treatment is really an individualized and complex therapy.

[ACT]IVATED Prostate Cancer Post-Program Survey

Establishing Treatment Goals: What Are Options for Advanced Prostate Cancer Therapy?

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Establishing Treatment Goals: What Are Options for Advanced Prostate Cancer Therapy? from Patient Empowerment Network on Vimeo.

Prostate cancer treatment goals can vary by patient – thus why it’s essential to have different treatment options. Expert Dr. Xin Gao explains the importance of establishing treatment goals and shares an overview of available options. 

Dr. Xin Gao is a Medical Oncologist at Massachusetts General Hospital. Learn more about this expert Dr. Gao.

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Transcript:

Katherine:

Dr. Gao, now that we know what goes into understanding a patient’s disease, I’d like to talk about treatment, starting with treatment goals. How do goals vary by patient, if they vary at all? 

Dr. Gao:

Sure, yeah. I do think they vary, and I think it is important to be clear about what the realistic goals of treatment might be so that the patient can make an informed decision on how the prostate cancer should be treated or managed. 

Some prostate cancers are highly curable, although there isn’t anything that’s 100 percent, right? And others are curable, but we acknowledge that there may still be a significant risk of relapse despite treatment. And maybe that rough percentage, the probability of cure and sort of the potential downsides or side effects of treatment, that’s something that the patient has to weigh in terms of whether they want to proceed with that treatment or not.   

And then, there are cancers, especially with advanced prostate cancers, that are unfortunately not curable, but yet treatments have the ability to significantly prolong somebody’s life, to slow the cancer progression down or even to shrink it, and to improve cancer-associated symptoms and other sources of distress that we talked about earlier.  

And so, with each patient, I think it is important to talk about these treatment goals because it may not be readily clear, is this a curable cancer or not? And it might not be clear how much benefit they might expect with treatment or are we talking about a marginal benefit? And then that way, you know, they can think about it, talk about it with their family, and kind of factor into their overall benefit risk calculation about whether to do something or not. 

Katherine:

Would you provide an overview of current treatment options for advanced disease? 

Dr. Gao:

Sure. So, it’s a big, very open-ended question, I think.  

So, I think you can divide it up into sort of the major treatment modalities, so things like radiation or radiation types of therapies, chemotherapy, hormonal therapies which are the mainstay of prostate cancer treatments, targeted therapies, and immunotherapies.  

Starting with hormonal therapies which are the backbone of prostate cancer treatments, for advanced prostate cancer, androgen deprivation therapy or ADT is often given indefinitely as the typical standard of care treatment and there are various forms of ADT, most commonly in the form of long-lasting injectable medications – leuprolide (Eligard/Lupron Depot), goserelin (Zoladex), sometimes degarelix (Firmagaon)  is used. And then more recently, there was an FDA approval a couple years ago of an oral pill called relugolix (Orgovyx), which is also a form of ADT or androgen deprivation therapy.  

These medications block the body’s ability to make testosterone which is important for prostate cancer survival and spread. In addition, abiraterone is an oral medication that is also considered a hormonal therapy. It blocks the production on androgens or male sex hormones outside of the testes. That includes the adrenal glands and some other tissues such as prostate cancer itself. And abiraterone (Zytiga) is commonly used in advanced prostate cancer management, in addition to androgen deprivation therapy whereas ADT blocks the testes from making testosterone and androgens, abiraterone blocks the production of androgens outside of the testes.  

And then finally, oral anti-androgen medications that block the prostate cancers from being able to detect androgens or male hormones and to block the androgen receptors on prostate cancers from sending cellular signals for growth and survival are also very commonly used.  

There are older anti-androgen medications like bicalutamide (Casodex), flutamide (Eulexin), lutamide, and there are newer ones, stronger versions, called enzalutamide (Xtandi), apalutamide (Erleada), and darolutamide (Nubeqa). For most patients who present with advanced prostate cancer, I think this is much easier, ADT along with either abiraterone or one of the newer, stronger anti-androgens, is the standard of care for most advanced prostate cancer patients with metastatic disease.  

And then, sometimes for patients with higher volume or more aggressive cancers even in the group with metastatic disease, we even add on another treatment, usually chemotherapy, something called docetaxel for what we call triple therapy. And then, maybe that’s a segue to chemotherapy, so docetaxel chemotherapy is a common chemotherapy used for prostate cancer, certainly advanced prostate cancers. Cabazitaxel (Jevtana) is also a common chemotherapy in this situation. These two are related drugs in a family of drugs called taxane chemotherapies and basically they kind of block the trafficking of important components within cancer cells and cause the cancer cell death.  

Docetaxel (Taxotere) is the more commonly used one. It’s typically used earlier, before cabazitaxel. And like I said earlier, for certain patients with what we call high volume metastatic prostate cancer, it’s often used in combination with hormonal therapies early on, what we call upfront therapy for six cycles. If a patient doesn’t receive docetaxel up front, docetaxel is commonly used after progression, after the cancer has progressed on ADT and one of the oral hormone medications.  

Cabazitaxel is more commonly used after a patient has previously received or progressed on docetaxel. Both drugs have been evaluated in randomized Phase III clinical trials and have shown to provide efficacy for patients with advanced prostate cancers.  

In addition to these taxane chemotherapies, platinum chemotherapy, such as carboplatin or cisplatin, are sometimes used for advanced prostate cancers as well, especially for certain neuroendocrine or small cell prostate cancers. These are rarer cancers, but they tend to respond better to platinum-based chemotherapies.   

Or for certain what we call aggressive variant prostate cancers, these platinum-based chemotherapies are also used in combination with either one of the taxanes or with another chemotherapy drug called etoposide. In terms of other treatment modalities, I think recently what we call radiotherapeutics or radioligand therapies have gotten a lot of press with the approval of a new medication called lutetium PSMA or 177 lutetium PSMA 617 (Pluvicto). 

The brand name for that in the U.S. is Pluvicto and what this is is a drug that’s a small molecule that binds to PSMA, which is a protein highly expressed in close to 90% of prostate cancer, advanced prostate cancers. And the small molecule will home to the cancer and it’s linked to radioactive lutetium and the lutetium will decay in that area and lead to cancer cell death.  

So, Pluvicto or lutetium was FDA approved in spring of 2022 based on randomized Phase III trials that show significant efficacy for patients with metastatic castration-resistant prostate cancer who have previously received a second-generation androgen receptor pathway inhibitor, such as abiraterone and enzalutamide, as well as a taxane chemotherapy, like docetaxel or cabazitaxel.  

The medication is given intravenously, once every six weeks, for up to six doses, and there are ongoing clinical trials, actually, that are trying to evaluate this medication in earlier settings where patients haven’t gotten prior chemotherapy before. There was a press release from about half a year ago stating that they’re seeing some early encouraging signs of efficacy with this drug, even in patients who had never received chemotherapy before, so it may be a medication that is going to be used more and more so in more patients even earlier in their course of disease. they’ve shown pretty solid activity for those kinds of cancers. 

What Are Current Prostate Cancer Treatment Options?

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What Are Current Prostate Cancer Treatment Options? from Patient Empowerment Network on Vimeo.

What treatment options are available for prostate cancer patients? Expert Dr. Channing Paller shares an overview of prostate cancer treatment options including surgery, radiation, combination therapies, hormonal therapies, and the PEACE-1 clinical trial.

Dr. Channing Paller is Director of Prostate Cancer Clinical Research at Johns Hopkins Medicine. Learn more about Dr. Paller.

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Transcript:

Katherine:

What are other options that are available now, for patients? 

Dr. Paller:

For curative intent, the main two treatment options are surgery, radiation. Many people for very localized disease are trying other therapies, such as cryotherapy, and more focal therapies. But really, for curative, the standard is surgery or radiation. And as it gets more advanced, circling back to advanced prostate cancer, we are learning that combination therapy is better. So, adding pills like abiraterone, adding systemic therapies, help patients do better. 

So, there’s a big, long list of therapies upfront that we use for metastatic hormone-sensitive prostate cancer. There’s abiraterone, there is apalutamide (Erleada), there’s enzalutamide, and now, darolutamide (Nubeqa).  

And in fact, in fit patients that can tolerate chemotherapy for metastatic high-volume prostate cancer patients, we always recommend triple therapy, either with abiraterone, docetaxel, and ADT, or with darolutamide, docetaxel, and ADT, and these patients really seem to do better for longer. The other thing I would add is the PEACE-1 trial, which looked at abiraterone and docetaxel, found that patients would do best by adding growth factor support. And so, that is recommended. 

The other thing I want to point out to patients is, I know we’re all eager to get started when we find out we have a diagnosis of metastatic prostate cancer, but sometimes, these therapies are quite tough on the system when you have a lot of cancer in your body, and my recommendation to everybody is, one thing at a time. 

So, start the hormone therapy and wait at least 30 days, and in fact, in the PEACE-1 trial, they waited 45 days, right? That allows the testosterone levels to fall, it allows you to adjust to the side effects of hormone deprivation therapy, and it allows your body to be ready for the next line of therapy. And you can add the ADT to second line, such as abiraterone or daro during that time, but not adding the chemo all at once, that really makes a difference. 

I find, unfortunately, when patients and their providers don’t follow those strict criteria, as they did in the trial, meaning they start chemo and abiraterone and ADT on day one, the levels of chemotherapy get higher in the bloodstream because testosterone regulates that, and we’ve published on that before. And they end up with terrible side effects from the chemotherapy, such as neutropenic fever, which means you end up in the hospital with a bloodstream infection and a fever, and more neuropathy, meaning numbness and tingling in your hands and feet. 

And so, I really caution people to spread those therapies out over the first 90 days, and you’ll do better in terms of side effects, and just as well in terms of overall survival. 

Katherine:

Where does hormonal therapy fit into the treatment options, and have there been any advances in hormonal therapy? 

Dr. Paller:

Yes. So, hormonal therapy is the mainstay of how we take care of prostate cancer patients, whether we do this with surgical castration, which is not done very often anymore, or we do it with an LHRH agonist, or we do it with an LHRH antagonist. So, that means that we can do it with medicines that block the signaling, but that tells your body to produce testosterone in various ways. What’s really neat is we’ve made advances, that there are now oral options for some of these therapies. 

In particular, there’s a new therapy called Orgovyx, or relugolix, that is an oral LHRH antagonist that locks testosterone and allows us to stop prostate cancer growth. In addition, there are a variety of LHRH agonists that can be given as subcutaneous shots. 

Prostate Cancer Research: Updates From ASCO 2023

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Prostate Cancer Research: Updates From ASCO 2023 from Patient Empowerment Network on Vimeo.

Expert Dr. Channing Paller shares prostate cancer research news, including updates on the PEACE-1 and STAMPEDE clinical trials, FDA treatment approvals, PARP inhibitors, PSMA-targeted imaging, and educational resources.

Channing Paller, MD is the Director of Prostate Cancer Clinical Research at Johns Hopkins Medicine. Learn more about this Dr. Paller.

Download Resource Guide

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Transcript:

Katherine:

Dr. Paller, in June, prostate cancer researchers from around the world met to discuss their findings at the annual American Society of Clinical Oncology, or ASCO meeting, in Chicago. Would you walk us through the highlights from that meeting that patients should know about? 

Dr. Paller:

Absolutely. 

We’ve had a exciting time for prostate cancer in June. So, I’d say, the first thing I would bring up is, the PEACE-1 trial was discussed again, and more data came out from that trial. That trial originally supported what we found, the STAMPEDE trial, to say, yes, we should add abiraterone (Zytiga) to androgen deprivation therapy and chemotherapy in helping de novo metastatic patients live longer and do better overall. And it also, this time around, showed us that combining abiraterone with radiation, plus or minus chemo, had patients do better. So, they had a longer progression-free survival, or metastasis-free survival. 

And also, the neat thing was, patients had fewer local symptoms in the long run. So, it prevented catheters being needed later, prevented blockages. It prevented local side effects from their cancer, which was really terrific to know, because that helps with patients’ quality of life. 

That was one of the main, personally. Go ahead. 

Katherine:

Yeah, I was just going to ask, anything else? 

Dr. Paller:

Yes. So, the second big headline, which is one of my dear loves, is all of the PARP inhibitor data. So, there were a couple trials presented, and this month has been terrific in terms of, there have been two drug approvals. So, let me talk through a couple of those. 

So, one of the big ones that was presented at ASCO was looking at talazoparib (Talzenna) and enzalutamide (Xtandi) in patients with metastatic castration-resistant prostate cancer, and it showed that the combination of those two drugs helped patients do better than enzalutamide alone, in that setting. What was also interesting is a subset of patients with DNA repair mutations did even better. 

June 20th, the FDA approved that combination for patients with metastatic castration-resistant prostate cancer with DNA repair mutations. (Lynparza) in the same space of metastatic castration-resistant prostate cancer for patients with BRCA mutations. That was a more narrow approval, but it was still very important. 

And what’s exciting here is, we’re really learning more about targeted therapy, precision medicine, for our prostate cancer patients. When I started treating prostate cancer patients back in 2005, the main drug approved was chemotherapy, docetaxel (Taxotere), and hormone deprivation therapy. And in the last almost 20 years, or 18 years, we’ve had 10 drug approvals, and we’re really starting to have multiple drugs approved based on people’s genetics.  

Katherine:

What is advanced prostate cancer? And is any of the research you mentioned focused on this stage of disease? 

Dr. Paller:

Well, advanced prostate cancer includes any prostate cancer that was extended outside the prostate, really, that’s spread to the nodes, even to the lymph nodes, to the liver, to the lungs, to the bones. And so, we have a lot of new findings, looking at this space, and that was a lot of what they showed at the ASCO conference. 

The other thing we’re learning is that we really want to get genetic testing on everybody. And so, in addition to your regular, “How do you feel?” “What do your labs show?” “What is your PSA doing?” 

We also want to get imaging, right? So, we want to look at imaging, in terms of, what did your CT and bone scan show? And nowadays, we’re moving into PSMA, or prostate-specific membrane antigen, PET scans. 

And so, that’s the new main way people look at where their prostate cancer has gone, and help them decide, what is the best treatment for me? Is it to get surgery locally, or has it advanced now, and I really need to do hormone therapy and radiation, or some other combination of systemic therapy, meaning more hormones, or more chemotherapy, with targeted therapies such as radiation? 

Katherine:

Beyond ASCO, Dr. Paller, are there other research or treatment advances that patients should know about? Anything other than what you’ve mentioned already? 

Dr. Paller:

Oh, yes. So, the other headline that I was really excited about at ASCO is watching medicine adopt the world of artificial intelligence. There was a great abstract, looking at how we can use artificial intelligence to look up pathology slides. 

So, in the past, we would always want to go to a top academic center to have your pathology reviewed by a top expert and make sure we were treating the right cancer, and make sure we really understand your risk. What we’re finding is, we can create biomarkers, and we’re understanding not just genetic, genomic biomarkers, but also pathology biomarkers, and age, and PSA, and risk, and comorbidities, and we can combine them all together and use AI to help us better stratify patients. 

And so, although it’s early, I think this is going to be an explosion in terms of helping us better define risk for patients in advanced prostate cancer, and help them figure out, do they need intensification of treatment, or can we de-intensify treatment? Can we not cause as much toxicity, and they’ll do just as well? And so, I was really excited to see that data as well. 

Katherine:

How can patients stay up to date on evolving research? 

Dr. Paller:

There are many ways to stay up to date. There are nice summaries at ASCO. There are nice summaries through the Prostate Cancer Foundation. There are good summaries at each of the institutions with whom you work. 

One of my favorite ways to stay up to date on precision medicine is one of these registries that I am co-leading, which is called the PROMISE registry. This is a wonderful opportunity which was conceived in the pandemic. 

And so, it’s pandemic friendly, and that is called the PROMISE registry. And what you can do is go to prostatecancerpromise.org and sign up if you have prostate cancer. And you say, “Hey, I have prostate cancer. This is my address. Please ship me a kit where I can do saliva testing of my genes.” And once you get your tests sent in, they’ll send you a kit, you send it back, you’ll get an email, and you can go over your results with a genetic counselor. 

And then, once you get enrolled in this program, it is really just a free information source. And so, you can learn more about the clinical trials around the country for patients with different mutations. And so, I love that as, whether or not you have a mutation and you’re going to follow with us for 20 years, because we’re going to offer you opportunities and let you be the first to know about new drug approvals, you can still hear about all of the new research. 

And I think that’s a wonderful, free resource that we’ve done for our patients to help them understand more about what’s out there. Another opportunity to learn more about prostate cancer is the prostate cancer clinical trial consortium. They have a nice website looking at germline genetics, looking at diversity, looking about clinical trial design. And so, there’s lots of different places to learn more about prostate cancer. 

Treatment Options for Advanced Prostate Cancer

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Treatment Options for Advanced Prostate Cancer from Patient Empowerment Network on Vimeo.

What are treatment options for advanced prostate cancer? Expert Dr. Maha Hussain provides a breakdown of hormone therapy and explains how targeted therapy is used in prostate cancer care.

Dr. Maha Hussain is the Deputy Director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. Learn more about this expert here.

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Transcript:

Katherine:

Now that we understand how test results can help inform a patient’s cancer and how it may behave. Let’s discuss how they can affect treatment options for men with advanced disease. First, let’s do a brief review of the treatment types currently available. There’s hormone therapy, right. What else?

Dr. Hussain:

Perhaps, it’s simpler if we focus on advanced disease, specifically metastatic disease.

So, if that’s the deal, then the backbone of treatment is hormone treatment. And it really is. We call it hormone, but technically it’s an anti-hormone. What we’re trying to do is shut down the hormonal pathway that stimulate the testes, which is the factory that makes testosterone. So, we are looking at shutting down testosterone production from the testes in order to starve the cancer.

Now, the male hormone is produced predominantly – somewhere about 95 percent of it is made by the testes, and then there are about 5 percent-ish that comes from other sources. These are, again, male hormones like the adrenal gland and so on. And there was a while ago some research – I want to say from the MD Anderson crowd, but this is two years ago – that suggested also that the tumor may start to make sort of in-house production of male hormone to support itself.

Now, having said that, again, testes continue to be the source of the majority of the male hormone. And so, historically, the first data that showed benefit was actually by surgically removing the testes, which is what we call orchiectomy or bilateral orchiectomy. And then medications began hitting the market and were evaluated in the late ’80s and then 1990s, beginning with Lupron – which by the way, in the ’80s, it was an injection that the patient had to give themselves every day, which is remarkable.

But even then, there is a personal preference by patients to go and take injections as opposed to go through surgery with orchiectomy. But still, I would say for some patients it may be an option until it ought to be discussed as an option. Then what we know is this, is because of the potential other sources for the male hormone, the concept of what we call combined androgen depravation was being evaluated.

And again, this goes back to the ’80s when the first drug was flutamide and then bicalutamide, and there are other drugs that became. And they kind of added a sprinkle, I call it, to survival. But it wasn’t dramatic, huge differences in survival. And so, generally, while we used it, everybody believed in using it. Moving forward, the drugs like abiraterone, enzalutamide, apalutamide are the three hormonal drugs that have demonstrated conclusively really an advantage in terms of prolonging life when added to the Lupron.

So, what I tell my patients is that, when it comes to hormone treatment there is really no way around it. You can delay it. Some people are exploring for some patients who don’t have a lot of cancer, maybe a couple of areas, maybe just do targeted radiation and then leave the person alone to buy them some treatment-free time.

And, to me, this is where the discussion that has to happen with the patient. What is the objective? Is the objective to kind of be ahead of the game and maximally treat the cancer with the hope of prolonging life? Or is the objective to delay treatment? And I would tell you that, with these types of conversation, nine out of 10 or 9.5 out of 10 men opt for moving aggressively up front with management. So, that’s that.

Now, the one thing I should point out, one of the trials that also was a landmark trial in this disease was the study CHAARTED, which was an intergroup clinical trial at the time it was designed, led by ECOG, and the PI was Dr. Chris Sweeney. I was part of the team that worked on the design also of the study.

And that was a trial that looked at adding docetaxel to hormone therapy, versus hormone therapy alone, to try to see if it adds something. Historically, all the chemotherapies prior to that that were added to hormone treatment for patients with newly diagnosed metastatic disease had not delivered. And docetaxel did.

However, one thing I should point out, based on that trial – and I don’t want to go into too much details for the sake of time – the patients that seemed to be benefiting were the patients that had more aggressive, more disease in their system. And so, liver metastases, lung metastases spread in the bone at different areas, not like few isolated areas in the spine or the pelvis, but much more than that.

And so, for the patients who have what we call high-volume prostate cancer based on scans – and I’m happy to explain what that means if it’s needed – these are the patients that I would offer either the docetaxel plus hormone treatment, which is the injection, or the injection plus the hormonal pills that I mentioned earlier.

Katherine:

What about targeted therapy? How is that used?

Dr. Hussain:

Okay. So, let’s begin with the molecularly targeted therapy. So, as we speak right now, for patients who have newly diagnosed metastatic disease that we call hormone-sensitive, molecularly targeted therapy is not standard of care. So, I would encourage patients who may qualify for clinical trial to be involved in those. The flipside is – we can talk about it – is that molecularly targeted therapies, specifically with PARP inhibitors have pretty much entered in the space of prostate cancer with a couple of drugs that were FDA-approved.

The other way of targeted treatment, which would be what we refer to targeted radiation, this would be a different story. This is not systemic treatment. This is a local treatment. And what is done is basically if patients do not have a lot of cancer in their body based on scans, and only certain areas, and they are starting systemic therapy, they can certainly consult with a radiation oncologist to target radiation to areas that are visible on scan. So, if somebody has a couple of, let’s say, pelvic bone lesions, maybe a lymph node, and they are already starting systemic therapy, they can consult with a radiation oncologist focal radiation. And so, that would be the general scheme.