Tag Archive for: Phase II trials

Tackling Obstacles That Impact Access to Prostate Cancer Care

Tackling Obstacles That Impact Access to Prostate Cancer Care from Patient Empowerment Network on Vimeo.

What obstacles may block access to prostate cancer care? Expert Dr. Channing Paller explains some common issues when seeking care and what is being done in the medical community to improve access.

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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Dr. Paller, what about clinical trials? Why should patients consider enrolling, and what are the benefits for them? 

Dr. Paller:

I like to tell my patients that once you have metastatic or advanced prostate cancer, we’re not doing placebo on you. If we’re doing placebo, it’s the standard of care plus a new drug, and we want to know if the new drug in combination with the old drug is better than the old drug alone. 

And so, I find those patients heroes, in one sense, for the future, right? They’re helping to approve the new drugs of the future, and I also find, oftentimes, those are the patients that do best, because they’re getting to try all of the new drugs of the future before they’re approved. And so, I will have patients that are, I call them chronic trialists because they’ll go through all my new drugs before they’re even approved. 

And I love it, and they love it, because they do better than the average, because they’re exploring all of the new therapies. And so, I find those patients heroes, and I really appreciate their efforts. I would say, the most important thing about clinical trials is learning about them, right? And being able to ask the questions. “Well, what phase is that trial?” So, Phase I is really testing safety, and finding the right dose for patients. And so, that’s usually a small number of patients, and looking exactly at, does this work? Do we have a biomarker to follow? What’s the best way to use this new drug?

Phase II starts to look at efficacy, as well as looking at side effects. And so, with Phase II, we really look at, what is the effect? Is it better than what we expected? Does it help these patients – is it better than some of the other drugs? 

And then, Phase III are usually large trials that are looking at FDA approval. They’re looking for registration with the FDA, getting approval, and being the new standard of care that’s paid for by insurance companies. 


I’d like to back up a bit and talk about the treatments that are currently available. Let’s start with surgery. What role does that play in treating advanced disease?  

Dr. Paller:

Surgery is one of the key tools that we use when we’re trying to cure prostate cancer when it’s localized, or just starting to spread. But if it’s too advanced, meaning, spreading to the lymph nodes, we usually don’t recommend surgery. So, surgery is usually used for curative intents, although there is a trial ongoing now, looking at the same question of, is adding surgery to systemic therapy helpful in terms of long-term cure rate, in terms of decreased side effects later, and local symptoms later?  

And so, we are asking that question. That is one of the ongoing clinical trials that we’re looking at right now, as a group. 

Surgery is terrific. Radiation is terrific. Really working with your team to understand for you, what are the side effects that you would undergo? What are the risks and benefits of each modality that you would like to, or that you’re willing to tolerate? And so, I think the differences between surgery and radiation, for curing patients, are really something that you need to discuss with your provider. The risk of erectile dysfunction, the risk of the local symptoms from the radiation, the risk of having bleeding from your bladder, the risk of bowel problems. Those are all things that that you – urinary incontinence – that you need to discuss with your physician.