Tag Archive for: placebo-controlled trials

When Should Prostate Cancer Patients Consider a Clinical Trial?

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

Prostate cancer clinical trials can advance research and expand treatment options, but where does participation fit into a treatment plan? Expert Dr. Rana McKay explains the benefits of joining clinical trials, common misconceptions, clinical trial phases, monitoring, and key questions to ask your healthcare team.

Dr. Rana McKay is an associate clinical professor of medicine at Moores Cancer Center at UC San Diego Health. Learn more about Dr. McKay.

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 Overcoming Barriers | Advice for Accessing Prostate Cancer Clinical Trials

Overcoming Barriers | Advice for Accessing Prostate Cancer Clinical Trials

Transcript:

Katherine:

But progress can only be made with patient participation in clinical trials, as we know. So, when should a patient consider participating in a trial? 

Dr. McKay:

Thank you so much for bringing this point up. I think our clinical research is critically important to advancing the field. Clinical trials, I think, are really – they offer our patients the treatments of tomorrow today, quite honestly. And I think the way trials are designed, they’re designed to test different treatment modalities, test in reference to the standard of care. I think at any point in time, anybody can think about enrolling on a clinical trial. I think sometimes there’s this false notion that, “I’m not going to enroll in a trial until later on, until I’ve failed all different kinds of treatments.” That’s not true.  

I think at any juncture along the way where a decision is being made around initiating a systemic therapy, or proceeding with a surgical intervention, or radiation intervention it’s always worthwhile to stop and ask, “Are there any clinical trials that I could be eligible for right now? And if so, what are they? So, I think it’s really important, I think, for patients to know that and to ask of their clinicians that are caring for them, “Are there any clinical trials?”  

And it may be that patients, not to say, may need to travel, but if they’re not necessarily at that institution where somebody may be receiving their care with a clinician asking their doctor, “Are there other trials at places close by where I can go and explore?” I think that’s a really important thing. 

Katherine:

What about common misconceptions? What are you hearing from patients about their fears and hesitations about participating in the trial? 

Dr. McKay:

Yeah. I think a lot of patients have a fear of, “I don’t want to be a hamster or a guinea pig. I don’t want to get placebo. I don’t want to get suboptimal care.” So, I think, to step back, I think the clinical trials are designed where actually patients are followed very, very closely, probably even more closely than I think would be in general with laboratory tests, PSA testing, imaging, at critical time points to assess that any therapies or strategies is working. Many trials are not necessarily placebo-controlled trials.  

Placebo-controlled trials are really only utilized in the context when somebody may – where the standard of care is to either do nothing or do one drug alone, not two drugs, and then, somebody’s getting one drug and getting a placebo. So, the placebo-controlled trials are really, first off, they’re later-staged studies, they’re usually Phase III studies, or large Phase II studies that have gotten pretty far on the runway of clinical trial and clinical drug development.  

And it’s in the context of, you know, “Well, if I didn’t do the clinical trials, I’m probably not going to do anything,” or I’m not going to – you know, “If I decided to not do the trial, I would get no treatment, but if I’m doing the trial, there’s a 50 percent chance I’ll get no treatment and 50 percent chance I may get something. So, we have to think about, “Well, what is the standard of care?” and the standard of care matters because that is what it’s being compared to. If the clinical situation is that the standard of care is to monitor, then that’s where a placebo may be utilized.  

But if a standard of care is that somebody should get treatment with X drug, then that X drug would be in the controlled arm of the study.  

Katherine:

Yeah.  

Dr. McKay:

But not every trial has a placebo.  

Katherine:

What would you say to someone who is nervous or hesitant about participating in a trial?  

Dr. McKay:

Yeah. Very good question, I think. Talk to your clinician. Talk to your doctors about those fears. What are the reservations? What are the concerns? Sometimes, I think the unknown is always – the fear of the unknown kind of causes a lot of angst. But when people are on a clinical trial, when you’re on a clinical trial, you are in control. Some people don’t believe that, but you are, at any point in time, you can decide to stop. You don’t even need to have a reason for why you decide to stop. At any point in time, if something is not working for you, you have choice.  

And so, I think that is something that is really important for patients to know that you’re actually in control, you’re being watched very closely, being watched very carefully for safety toxicity. If there’s a toxicity, people are not going to – you’re not going to just stay getting the same regiment in the exact same way if you’re not tolerating it. If something isn’t working, you’re not going to continue receiving the therapy that’s no longer working just because you’re on a clinical trial. 

Katherine:

Right.  

Dr. McKay:

And you’re in control; at any point in time, you could say, “I don’t want to participate anymore.” 

Emerging Approaches in Bladder Cancer Treatment

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Emerging Approaches in Bladder Cancer Treatment from Patient Empowerment Network on Vimeo.

Dr. Shilpa Gupta of the Cleveland Clinic shares a promising update in bladder cancer treatment and research, including the benefits of patient participation in clinical trials. 

Dr. Shilpa Gupta is the Director of the Genitourinary Medical Oncology at Taussig Cancer Institute and Co-Leader of the Genitourinary Oncology Program at Cleveland Clinic. Dr. Gupta’s research interests are novel drug development and understanding biomarkers of response and resistance to therapies in bladder cancer. Learn more about Dr. Gupta, here.

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Transcript:

Katherine:                  

So, Dr. Gupta, are there emerging approaches for treating bladder cancer that patients should know about?

Dr. Gupta:                  

Yes, absolutely. I would say that the field is so rife with so many different treatment approaches and ways to offer more personalized medicine. We know, for example chemotherapy followed by surgery has been the gold standard, but we have seen data that there are certain genes in some patients’ tumors which may predict how well they will respond and potentially we could avoid a life-changing surgery like cystectomy.

And we have trials with immunotherapy adding to chemotherapy in bladder preservation approaches along with radiation. So, these are some of the new work that’s been done. Approaches to intensify the effect of BCG in newly diagnosed non-muscle invasive bladder cancer patients are also ongoing. Then, in the metastatic setting, we have so many treatment options that have become approved in the last couple of years, now the goal is, well, how to sequence the therapies best for the patient and whether in the front-line therapy we can actually get rid of chemotherapy.

Some of these antibody drug conjugates and immunotherapy combinations are proving to be very effective and the hope is that one day patients may not need chemotherapy because we have chemo-sparing regimens. So, there’s a lot going on and I think the progress has been tremendous in the past few years.                                            

Katherine:                  

Some patients may be fearful when it comes to clinical trials. So, what would you say to someone who might be hesitant to consider participating in one? 

Dr. Gupta:                  

I would say there’s a lot of misconceptions out there that going on a trial is like being a guinea pig or you get a placebo. For the most part, patients are getting active drugs whenever possible. The only time where we have placebo-controlled trials is if, for that particular setting, there is no approved treatment. But I think patients should get all the information from their doctors and the study teams about the pros and cons.

Many times, it’s about – you could do the study because the patients meet the criteria and are fit to do it and if they wait for later, they may not be eligible anymore for whatever reasons.

I always put it this way, that standard of care therapies will still be available, but studies are sometimes with a tight window and tight criteria. So, I think patients should know that all these studies that are out there are very ethical and use the best possible control arm. So that even if they don’t get that experimental drug, they still get what is the standard of care unless it is something really being compared to nothing.    

What Should CLL Patients Know About Clinical Trial Treatment Options?

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What Should CLL Patients Know About Clinical Trial Treatment Options? from Patient Empowerment Network on Vimeo.

What do chronic lymphocytic leukemia (CLL) patients need to know about clinical trial treatment options? Dr. Matthew Davids explains how clinical trials fit into the array of CLL treatments, the benefits of speaking to a CLL specialist, and online resources for finding clinical trials.

Dr. Matthew Davids is Director of Clinical Research in the Division of Lymphoma at Dana-Farber Cancer Institute. Learn more about Dr. Davids here.

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Transcript:

Katherine:

Right. Where do clinical trials fit in with the treatment approaches?

Dr. Davids:

So, clinical trials are really how we’ve made all these advances in CLL over the last decade. It’s how we learn about new treatments. It’s how we learn about how to optimize the treatments that we have. I think sometimes patients have a misconception that clinical trials are a last resort, the idea that you’ve exhausted all the standard options and then you go to a clinical trial as your last hope. But I actually like to kind of turn that on its head and say that clinical trials are actually the first resort, the first best option for patients. Whenever patients can get access to a clinical trial at any stage of their disease, I would really encourage them to consider it.

We have quite a few clinical trials now in the frontline setting, meaning as an initial treatment for CLL, including some that are in development and will open soon. And these are the studies that are going to really help us define what the optimal regimens are. What’s the optimal sequence of these different novel agents?

And in CLL, really, we’re at a point where the research on the disease is so mature that when you’re in a clinical trial you’re either going to be on one regimen that you know you’re getting and you know it’s going to be an effective regimen, or you might be in a comparative trial where you could be randomized to one of two or three different regimens, but you know that each one of those regimens is one that we think is a great regimen. We just don’t know which one is optimal for individual patients. So, this is not a situation where there’s placebo-controlled trials where you don’t know if you’re going to get an active treatment or not. CLL is an area where we design our clinical trials so that all patients are going to be benefiting from cutting-edge approaches.

And so, not all patients have access to trials, and that’s okay. Again, we’re fortunate that we have many good options that can be given locally, but I do encourage patients even if they’re only able to travel to a CLL specialist once to have an initial consultation to think about doing that to get a CLL specialist on your team, so to speak. That way they can identify clinical trial options that may be a good fit, and even if not, they can advise on what the optimal treatment options are to receive locally with your own oncologist.

Katherine:

How do patients find out about these clinical trials?

Dr. Davids:

I do think the best way is through a CLL specialist because certainly they would have a great pulse on the trials, they have available at their own center. They should also have a sense for what trials are available maybe at other centers. Some of that can also be, there’s a great resource through The Leukemia & Lymphoma Society where they can help navigate patients toward specific trials that may be applicable to them.

There’s also a website called clinicaltrials.gov. It can be a little challenging if you’re not familiar with it to navigate the site, but it is actually pretty straightforward. You can put in the disease and look at different options for trials based on different drugs, for example. They’ll list the eligibility criteria for the trial. That’s often I find a way that patients can begin to identify whether they may be a candidate. You can’t tell from the website whether you’re definitely a candidate or not. You really need to partner with an investigator who’s on the trial to learn that, but it certainly can be a good starting point to figure out what’s out there.