What Should Prostate Cancer Patients Know About Clinical Trials?

What Should Prostate Cancer Patients Know About Clinical Trials? from Patient Empowerment Network on Vimeo.

Clinical trials may be intimidating to some prostate cancer patients, so what do they need to know to address their concerns? Dr. Sumit Subudhi explains clinical trials and discusses the benefits of participation.

Dr. Sumit Subudhi is an Associate Professor in the Department of Genitourinary Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. Learn more about Dr. Subudhi.

See More From Prostate Clinical Trials 201

Related Resources

Prostate Cancer Clinical Trial Safety and Protocols

Prostate Cancer Clinical Trial Safety and Protocols

Understanding Prostate Cancer Clinical Trial Phases and Types

Understanding Prostate Cancer Clinical Trial Phases and Types

What Questions Should Prostate Cancer Patients Ask About Clinical Trials

What Questions Should Prostate Cancer Patients Ask About Clinical Trials?


Transcript:

Katherine:

Prostate cancer research really can only move forward through clinical trials and patient participation in those trials. Can you briefly explain what a trial is for people who may not be familiar with the term? 

Dr. Subudhi:

That’s a great question. My own father has prostate cancer. And he had the same exact question when he started his journey in that. 

And so, what I explained to him is that clinical trials are experiments. They’re experiments that are done in our patients.  

So, they’re drugs that are thought to mechanistically kill the cancer cell or at least change the environment around the cancer cell to help people live longer. But these drugs were actually tested in mouse models or in tissue models. And we don’t know if they actually work in patients. 

And so, in clinical trials, we’re actually testing whether these drugs are safe and whether they’re efficacious or beneficial to our patients. So, I want to be very clear. When patients go on clinical trials, we don’t know if it’s going to work on them. And that’s something that they should know that they’re showing a lot of courage and risk in joining these trials.  

But the other point I want to make is that every standard of care drug that is out there actually went through the clinical trial process, and they were approved because they showed benefit in a group of patients. 

Katherine:

Well, how can a prostate cancer patient benefit from participating in a trial? 

Dr. Subudhi:

One of the key benefits is that you get access to drugs that may actually prolong your life or even cure you and that you wouldn’t have access to in trials.  

And so, some of my patients, unfortunately, they’ve exhausted all the standard of care choices that are out there. And the trial’s the only option left versus leaving it up to natural causes of demise from prostate cancer. And so, clinical trials give other opportunities to potentially live longer and have a great quality of life. 

Katherine:

So, they could offer some hope. 

Dr. Subudhi:

Definitely. As far as I’m concerned, yes. And, actually, with my patients, I try to not wait while they’ve exhausted all the treatments to start them on clinical trials, because I feel like we may be able to save some of these treatments in our back pocket for when they’re too exhausted to be coming to our clinic so often. And so, I like to actually try to get them enrolled in clinical trials early on in their journey with prostate cancer. 

Should Prostate Cancer Patients Consider a Treatment in Clinical Trials?

Should Prostate Cancer Patients Consider a Treatment in Clinical Trials? from Patient Empowerment Network on Vimeo.

Prostate cancer expert Dr. Andrew Armstrong explains how prostate cancer clinical trials work and discusses why patients should feel confident exploring this option at any stage of their cancer journey.

Dr. Andrew J. Armstrong is a medical oncologist and director of clinical research at the Duke Cancer Institute’s Center for Prostate and Urologic Cancers. For more information on Dr. Armstrong here.

See More From Prostate Clinical Trials 201

Related Resources

An Overview of Prostate Cancer Treatment Approaches

An Overview of Prostate Cancer Treatment Approaches

Why Should Prostate Cancer Patients Be Empowered

Why Should Prostate Cancer Patients Be Empowered?

Key Questions for Prostate Cancer Patients to Ask Before Joining a Clinical Trial

Key Questions for Prostate Cancer Patients to Ask Before Joining a Clinical Trial


Transcript:

Katherine Banwell:

At what point should a prostate cancer patient consider participating in a clinical trial? 

Dr. Armstrong:

Sure. If you look at the National Comprehensive Cancer Network, NCCN guidelines, you’ll see that clinical trials should be discussed along all parts of the journey. 

And that’s because clinical trials often can change how we think about cancer, how we treat cancer, can improve cure rates, can improve survival. Most of our drugs and treatments that have been successful in all cancer have been the result of clinical trials. 

And it’s not always appropriate, though. We have very many treatments that can cure patients, and we don’t want to interfere with that, but sometimes a clinical trial can layer on top of that cure rate. 

But many patients, their cancer becomes resistant to proven therapies. That’s certainly an area where clinical trials can make a big difference, either to put off chemotherapy or more toxic therapies, or in patients who have exhausted proven therapies. That’s certainly appropriate. 

But sometimes clinical trials do not involve placebos. They involve combination therapies, they involve layering on top several approaches to try to improve the survival on top of standard of care.  

And so as a director of a research program, we have all sorts of trials. They come in Phase I, Phase II, Phase III. Really only the Phase IIIs involve placebo controlled or controlled trials. Phase II tend to be early studies, where everybody gets a therapy and it’s preliminary to determine efficacy. Phase I is really trying to determine the safety and dosing of an experimental drug. But patients can benefit across the spectrum. 

So, it’s important, particularly if you have advanced disease, to go to a site, like a comprehensive cancer center, for a second opinion to see if there is alternatives to what you might get in the community.  

Katherine Banwell:

Yes. What would you say to someone who might be hesitant to participate in a trial? 

Dr. Armstrong:

Participation in a trial involves shared decision-making, just like being diagnosed, embarking on initial treatment, even embarking on standard of care treatment. Everything is shared decision-making in terms of risks and benefits.  

Sometimes a trial is not in a patient’s best interest, and it’s important for a physician to be upright about that and up front about the risks of a trial. 

I think when patients have exhausted proven therapies, it’s quite appropriate to talk about therapies that might be in the research pipeline that are showing some promise, that have demonstrated at least success in the laboratory or in small numbers of patients coming before.  

For example, in 2022, a brand-new drug just got approved called Pluvicto, or PSMA lutetium. This is a new smart bomb for prostate cancer. Just last year it was a research drug, but this year it’s successful and being used in the clinic. All those hormone drugs I mentioned earlier, those were research drugs five years ago. So, we don’t make advanced, we don’t extend lives without participating in research. We’re not happy with the way things are, we want them to be better. 

And the only way to make them better is by studying them. And not all of these trials are successful, unfortunately, but many are, and that’s why we are seeing men live longer and have better survivorship nowadays.