Tag Archive for: advanced prostate cancer clinical trials

Advanced Prostate Cancer Clinical Trials | Access and NRG-GU008 Trial

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Advanced Prostate Cancer Clinical Trials | Access and NRG-GU008 Trial from Patient Empowerment Network on Vimeo.

What’s the latest in ongoing advanced prostate cancer clinical trials? Expert Dr. Ronald Chen from KU Medical Center discusses ongoing trials, the INNOVATE trial and NRG-GU008 trial, clinical trial benefits, and patient advice for gaining clinical trial access.

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“…ask if clinical trial is not available at your local cancer center, see if a second opinion through telehealth with a larger cancer center is possible, so that you can learn about clinical trial options and see if that’s something that you want to pursue.”

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Transcript:

Lisa Hatfield:

Dr. Chen, can you talk about any clinical trials that are ongoing for people who are living with advanced prostate cancer? And in particular, any trials that you or your colleagues are doing right now that would be of interest to this audience? And my last part to that question is, if they are not able to access those easily, do you have suggestions for patients to access those clinical trials if they’re working with a local community cancer center?

Dr. Ronald Chen:

I think having access to clinical trials is very important for every cancer patient and especially patients who have advanced cancer. And the reason I think this is really important is because in advanced cancer, we’re not doing as well as we want to in terms of extending survival and potentially even curing some patients. We’re not doing as well as we want to, and there’s a lot of room for improvement. And the only way to improve the outcomes for patients with advanced cancer is through clinical trials. Clinical trials is where patients can access first new promising treatments that are not currently available widely because it’s not yet FDA-approved.

And so, I think access to clinical trials is important and often offers a hope for patients because of a new promising agent that they could access through the trial. So I think that’s really important. And there are actually multiple…there are actually a lot of open clinical trials ongoing around the U.S. for patients with advanced cancer, testing new drugs, testing new ways to deliver treatment. I absolutely believe that there will be a new treatment approved for advanced prostate cancer probably every year for years to come because of all the new trials that are happening because of all the new promising agents that have been developed, being tested right now. So I think that’s really important.

I want to highlight a couple of examples of trials, but again, there’s so many, it’s hard to talk about all of them. But I’ll highlight a couple. There’s one trial sponsored by the National Cancer Institute for patients with no positive prostate cancer, which is when prostate cancer has spread to the lymph nodes, and the trial is called NRG-GU008, we call it the INNOVATE trial; and for patients with no positive prostate cancer, even though the cancer has spread to lymph nodes, this is actually a group of stage IV prostate cancer patients where there actually is still a hope for cure. We could actually still cure some patients with no positive prostate cancer. And the goal of this trial is to improve that cure rate.

So maybe right now, with aggressive treatment for these patients, maybe we can cure 50 percent of these patients in this trial that will incorporate a new drug that seems promising, we’re hoping that maybe improves the cure rate higher, maybe to 70 percent or higher. And so, I think that is a really important trial for patients who have that specific diagnosis.

In terms of for patients who live maybe in an area that…where the local cancer center does not offer clinical trials, I think there’s still opportunity for them to learn about clinical trials and even participate. And what I would advocate for is to ask for a second opinion.

Second opinions in cancer is now actually pretty commonly available because of the arrival of telehealth. Even if you live in maybe a small rural area, you can still request a telehealth consultation from a larger cancer center by telephone, by video, and through that, you can ask about clinical trials that are available. And I think it’s important to pursue that, to learn about the options, to learn if there’s a new treatment that could be available to you before you make a final decision on choosing treatment. So with telehealth, second opinion, learning about options, I think there’s actually opportunities to access clinical trials that way.

So my activation tip for this question is, ask if a clinical trial is not available at your local cancer center, see if a second opinion through telehealth with a larger cancer center is possible, so that you can learn about clinical trial options and see if that’s something that you want to pursue.

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Advanced Prostate Cancer Treatments on the Horizon

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Advanced Prostate Cancer Treatments on the Horizon from Patient Empowerment Network on Vimeo.

 What advanced prostate cancer treatments are on the horizon? Expert Dr. Ronald Chen discusses emerging treatments that are under study, the advantages that the treatments might offer, and how patients can potentially gain access to the therapies.

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Transcript:

Lisa Hatfield:

Are there any promising treatments on the horizon that you are particularly excited about for advanced prostate cancer? And what types of questions do you recommend patients and their care partners ask of their providers?

Dr. Ronald Chen:

I want to answer this question from the perspective of a…as a radiation oncologist. I am often involved in a lot of research and clinical trials related to how we can potentially better use the tool of radiation for patients with prostate cancer and advanced prostate cancer. And there’s actually quite a bit of exciting development in radiation that I think I’m really looking forward to seeing the results of those types of research. One area of, I think, promising treatment is something called radiopharmaceutical therapy.

So oftentimes, we think of radiation as a patient…there’s a machine that delivers a targeted beam of radiation to a particular tumor. And that’s what we usually think about. But actually, there’s a new wave of radiation and how we deliver it called radiopharmaceuticals. And radiopharmaceuticals is almost like getting chemotherapy. It’s something that’s infused into the bloodstream, almost like chemotherapy, but the way this treatment work called radiopharmaceuticals is that you’re actually infusing molecules that will actually tag on to tumor cells in the body, and then as it tags onto tumor cells in the body, deliver radiation to that tumor cell.

And they’re actually…so actually, it’s kind of like chemotherapy delivering actually radiation instead of a drug. And there are actually already are several of these radiopharmaceutical agents that have been proven to be effective. And two of these have already been FDA approved that are now in use for prostate cancer. And we know they work and they extend survival. And so, I think that’s very exciting.

And one of them is called lutetium Lu 177 vipivotide tetraxetan (Pluvicto). You’re infusing a molecule that specifically tags on to prostate cancer cells in the body and delivers a little bit of radiation to that cell. And that extends survival for patients. It’s actually a very well-tolerated treatment as well as actually now commonly in use FDA-approved. And I think that now that we have a couple of these FDA-approved, they were proven to work, I really do think that this field of radiopharmaceutical treatment will continue to expand. There’ll be more and more of these in the future. There’s more in clinical trials, and I think there’ll be more and more available options in the future. And I think it’s really going to be a great way to potentially use radiation to help patients with advanced prostate cancer and other cancers in the future.

Another thing that I’m really excited about is, again, I think the balance between extending a patient’s life expectancy and balancing the quality of life impact. We know that for patients with advanced prostate cancer, a common way to treat this disease is with hormone therapy. And oftentimes, people are on hormone therapy for years and years and maybe lifelong. And we also know that hormone therapy in patients with prostate cancer can also have really quite a bit of side effects. It can make people fatigued, weight gain, it may have cardiovascular disease impact. And so hormone therapy, even though it’s effective for prostate cancer, really has a big quality of life impact on patients.

So one of the current years of research and in clinical trials is, can we, instead of having patients with metastatic prostate cancer, instead of having them on hormone therapy for life, could we potentially use radiation selectively in the spots of metastasis? And if we’re able to use radiation to treat particular spots of metastasis and that’s controlled, can we let the patient then have a break from hormone therapy, which I think would really have an important quality of life improvement.

And so selectively using radiation to treat a few spots, allowing patients a break from hormone therapy is another area of research. There’s actually a couple of clinical trials already done on this. And what it’s shown so far is that if patients have one to three to five, a few spots of metastasis, using radiation can actually give patients a break from hormone therapy for two, three or four years for many patients. And that can really have a major impact on improving quality of life without compromising their survival outcomes. So I think I’m really excited about those kinds of areas of research.

One more treatment option like radiopharmaceuticals, two treatments that not compromise the patient’s survival, but improve quality of life. I’m excited about those directions. Oftentimes, the new developments and new treatments, the promising treatments are first available through clinical trials, and only through participating in clinical trials do you have access to that before it becomes FDA-approved. And oftentimes, that could be a really good option to consider. So that’s why I think it’s really important to ask that for every patient.

Advanced Prostate Cancer Clinical Trials | Why Black and Latinx Participation Is Vital

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Advanced Prostate Cancer Clinical Trials | Why Black and Latinx Participation Is Vital from Patient Empowerment Network on Vimeo.

Why is advanced prostate clinical trial participation important for Black and Latinx patients? Expert Dr. Yaw Nyame with the University of Washington explains how clinical trial participation helps patients and solutions toward removing barriers to participation.

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Transcript:

Lisa Hatfield:

Dr. Nyame, the importance of clinical trial participation can’t be underscored enough in cancer care. Can you speak to advanced prostate cancer clinical trials specifically for Black and Latinx men, and critically important, how are you and your colleagues removing barriers to accessing care and underrepresented communities, including the access to those clinical trials?

Dr. Yaw Nyame:

Yeah, I can’t state this enough. Clinical trials are a form of high-quality care, and I think a lot of people don’t understand that clinical trials don’t just test you in a vacuum with something that we think is really promising versus nothing at all. Clinical trials often are going to test a standard of care, so what we do currently versus something standard of click care and something that we think has benefit, and so at the very least, when you participate in the clinical trial, you are going to get what we think works best currently.

And then there’s the additional benefit that you might get something that we think works a little bit better or a lot better than what we do currently, and you do it in a space where people are monitoring you really closely, right? Because the clinical trial needs to collect data and understand how things work and how well they work. So it is a form of really high quality care, and I urge Black, Latino, and other minoritized patient populations to find ways to get access to this really high quality care. Now, what we have to do as medical institutions, as cancer center, is figure out ways to remove the barriers that limit people’s ability to participate in clinical trials.

Those barriers are usually social barriers, right? It is the, do I have the ability to take off time from work to participate in this trial? How’s this going to affect my household if I’ve got to come in my case to Seattle and take a whole day off from work to participate? Can I afford transportation to be coming to the cancer center every week? You know, do I have child care to participate in this trial? And so we as cancer centers are starting to think more holistically about how we can remove social barriers to clinical trial participation. And I do think until we get that right a lot of the inability for marginalized and minoritized populations to participate in clinical trials falls at our feet. So what are we doing to address barriers? Well, I think we’re trying to think about ways of putting clinical trials directly in communities.

So some of those social barriers are removed so that it’s not always on the patient to come to us. We’re thinking of ways to support those patients that have to absolutely come to us for a variety of reasons for a clinical trial so that there isn’t that financial and social burden. But it’s very much a work in progress. And I think we’re really in the early phases of understanding how we can support people. My activation tip when it comes to clinical trials and prostate cancer is to ask for them and to demand opportunities to participate in them because they are such high, they’re such incredible forms of high quality care.

And I think by participating in a clinical trial, you’re giving yourself and future versions of yourself and your community opportunities to have better outcomes when it comes to these cancers. And I think the second portion of that is to demand and ask from your cancer centers that they find ways to support you in participating in those clinical trials. Because as a cancer center and as an academic clinical institution, our mission is to serve. And we do have resources that we can sometimes make available to make sure that you can afford to and not be put out by participating in a clinical trial.

[ACT]IVATED Prostate Cancer Post-Program Survey

Prostate Cancer Clinical Trials: What Are the Benefits?

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Prostate Cancer Clinical Trials: What Are the Benefits? from Patient Empowerment Network on Vimeo. 

Prostate cancer expert Dr. Channing Paller shares an overview of what occurs in each clinical trial phase and discusses the role of surgery and radiation in patient care.

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

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Transcript:

Katherine:

Dr. Paller, let’s talk about what goes into deciding on a treatment path. First, what testing helps you understand the patient’s individual disease? 

Dr. Paller:

Great question. 

When I meet a patient, we talked about a few variables. First is, how do they feel? Are they in pain? Are they losing weight? Are they fatigued all the time? Are they able to do things that they enjoy, or not? So, that’s the most important, in terms of, how do they feel, and what are their symptoms? 

The next thing we looked at is, what are their labs, right? We look at PSA, but we also look at, is the prostate cancer affecting their organs? Is it affecting their red blood cells, their platelets, their white blood cells? And very importantly, it tells us, by looking at their alkaline phosphatase, if it’s in their bones or not. And we also can look at their labs to see, is it affecting their liver or not. Another thing we monitor is their creatinine or kidney function. Is there a blockage of their important organs down there because the prostate cancer has grown? So, the labs tell me a lot about their body function, and making sure their body is still functioning well.  

After we do how they feel, and what their labs are, we also look at imaging. And then, the previous years, we’ve always looked at a standard nuclear medicine bone scan, and also, a CAT scan. And nowadays, we’re really moving towards PSMA, or prostate specific membrane antigen, to help us really identify, at a much more sensitive level, where prostate cancer cells are expressed. 

And after we do those main three key things, we start to look at diagnostic tests. We look at different ways of assessing what are their genes. So, one of the first things we do is looking at germline genetic testing to see, what were the genes they were born with? And can those genes help us learn more about their cancer, and how it might progress? And also, how we might treat it better if they have certain genes like BRCA. 

The other nice thing about genetic testing, or germline genetic testing, is looking at, if they do have a genetic mutation, or a pathologic variant like BRCA, we are always, always telling families that they should get cascade testing for their family, right? So, if they have a mutation, we recommend that their family members get tested to make sure that they’re not at risk for a cancer. And so, we have them meet with a genetic counselor. 

So, in addition to what you’re born with, we also want to know what your cancer has developed, because cancer cells are growing quickly, and they can develop a mutation. And so, we also test the cancer, get genomic testing of the cancer, to look for mutations that we can target with our multiple drugs that we’ve approved to target cancers in certain mutations. So, you have something called MSII, we have immunotherapy for you. If you have DNA repair mutations, we have PARP inhibitors for you, or even carboplatin (Paraplatin) can be added to target patients with DNA repair mutations as well. 

And so, there’s a whole variety of tests out there by a multitude of providers, that help us really better understand your cancer. 

Katherine:

And the treatment options, by the sounds of it. 

Dr. Paller:

And the treatment options. Yes, there is. There’s a whole variety of it. Yeah. 

Katherine:

So, what is personalized medicine, Dr. Paller? And how is it achieved? 

Dr. Paller:

Personalized medicine means many things to many different people. I find the most important thing is not forgetting the patient. The patient needs to be their own advocate, and have an advocate there with them, right? Because maybe the best treatment is chemotherapy, hormone therapy, radiation, etc., etc., but maybe you’re 92, and you’ve lived a good life, and you have heart disease, and you might not die of your prostate cancer. And so, overtreating people is just as dangerous as undertreating people. 

And so, precision medicine is a whole variety of things, of looking at the whole person, looking at their genes, looking at biomarkers their cancers produce, and looking at what comorbidities they have, right? If you have really bad diabetes, maybe you don’t want me to add steroids to your regimen. If you have a seizure disorder, maybe you don’t want me to add insulin. I wouldn’t, because there’s a seizure risk. If you have various problems, we just need to take those into account and find the best therapy for each individual. 

Katherine:

I think you’ve covered this, in a sense, but I’m going to ask you the question anyway. Why is it important that patients have a role in making decisions about their care? 

Dr. Paller:

Patients are different, just like everybody – let me start over. 

It is essential that patients have a role in their care so that they are taking ownership and being part of the team, to care for themselves, not to put extra weight or work on the patient, but really, so that they know they’ve made the right choice for them. 

Understanding a patient’s priorities are essential. Some patients may not want the side effects of hormone therapy, and they may say, “Hey, I have oligometastatic disease, meaning I just have one spot to my bones, and I’m 80 years old. And Dr. Paller told me that the sub analysis of this triple therapy, new trial, showed that, I’m over 75, I may not benefit as much. And you know what? I don’t want to have the side effects of hormone therapy. I don’t want to lose muscle mass. I don’t want to have hot flashes. I don’t want to have erectile dysfunction.” 

“I want to enjoy my life, even if it’s slightly shorter, and it might not be slightly shorter.” And so, I find, having a partnership with a patient to really understand their priorities makes life worth living more, right? So, maybe a patient’s priority is finding time with their grandchildren. Maybe a patient’s priority is getting a PhD. Whatever their patient’s priority is, it is important that we put that to the context of their whole being and helping them really find the best therapy for them, to help them do as well as they can, as long as they can. 

When Should Advanced Prostate Cancer Patients Consider a Clinical Trial?

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When Should Advanced Prostate Cancer Patients Consider a Clinical Trial? from Patient Empowerment Network on Vimeo.

Where do clinical trials fit into a prostate cancer treatment plan? Dr. Rana McKay shares her perspective on when patients should consider trial participation, as well as the benefits of joining a trial.

Dr. Rana McKay is a medical oncologist at UC San Diego Health and an associate professor in the Department of Medicine at the UC San Diego School of Medicine. Learn more about Dr. McKay, here.
 
 

Katherine Banwell:

When should a patient consider a clinical trial as a treatment option? 

Dr. Rana McKay:

So, I generally think that a patient should consider a clinical trial at almost every juncture that a – a clinical decision is being made. I think sometimes there’s this misperception that, “Oh. Clinical trials should only be utilized when I don’t have any other options.” Where, in fact, I would say clinical trials should be an option to discuss every single time a treatment is being changed. Because you know the ultimately the goal is to make sure patients are as I said, living longer and living better and, you know, making sure that clinical trials are an option on the table at every juncture is really a key step in that process. 

Katherine Banwell:

What are the benefits of being part of a clinical trial? 

Dr. Rana McKay:

So, I think there’s a lot of benefits. I think, you know, for patients with advanced disease it may provide access to drugs that they otherwise not necessarily have access to. So the standard of care therapies you know, we can prescribe those at any juncture. They’re standard of care. But clinical trials really offer an opportunity to experiment with another agent and doesn’t necessarily take away from the standard of care options.  

I think the other thing is you know, I think a lot of patients with advanced prostate cancer, they – want to give back to the community. They want to leave a legacy. They want to contribute to the science. They want to be a part of that mission to make tomorrow better than today for men with prostate cancer, and I think participating in clinical trials can really help achieve that goal and also benefit the individual as well. 

Katherine Banwell:

What about emerging treatments? Are there any that patients should know about?  

Dr. Rana McKay:

Absolutely. So, there’s a lot of treatments that I think are currently undergoing extensive testing. There’s additional targeted therapies, for example, CDK46 inhibitors that are being tested broadly in the hormone-resistant space and the newly diagnosed setting. There’s also AKT inhibitors. There are other targeted therapies that are being tested. There’s novel hormonal treatments that target resistant pathways like the antigen receptor degraders. There’s a slew of immunotherapy options cell therapy, bi-specific antibodies that are also being tested. So, there’s a lot of really exciting and novel treatments that are looking at overcoming resistance for people with advanced disease.