Jan Manarite joined the prostate cancer community in 2000 when her husband Dominic was diagnosed with advanced prostate cancer. She has gone on to become one of the most recognized advocates in the prostate cancer community today.
Prostatepedia spoke with her about questions prostate cancer patients may want to ask when considering joining a clinical trial.
Why might a patient want to consider joining a clinical trial?
Ms. Manarite: A clinical trial decision is just another treatment option. That’s all it is. It’s still a risk versus benefit decision, just like choosing hormone therapy or surgery. That’s what it has to be.
One of the risks involved in a clinical trial is that it can take you a month to get in. You should definitely plan on it taking three weeks, though it could be longer. There’s a screening process. You have to fill out paperwork, make sure you qualify, get your medical records, check their boxes, cross their Ts, and dot their Is.
If your PSA is doubling every three weeks, and you’re metastatic, you have to factor that in: is it worth it for you to wait three weeks to see if you even qualify? That’s one of the risks. I don’t think people know it takes awhile to get into a clinical trial.
No. I don’t think they do at all.
Ms. Manarite: The other risk is the side effects. That’s always part of your treatment decision. The side effects can be tricky if you’re considering a clinical trial with a drug that we don’t know a lot about yet. However, there is a way to dig for that information. I don’t think patients realize this. If it’s in the early stages of the clinical trial, the name of the trial drug is going to be an acronym.
For examples, MDV-3100 is now Xtandi (enzalutamide), and ARN-509 was apalutamide and is now Erleada. If you Google that acronym adding the words discussion, forum, and side effects, you’ll find people who are on a clinical trial for this drug talking about the side effects in forums.
That’s a fantastic tip.
Ms. Manarite: Adding the word discussion to Google searches directs your results to discussion forums, where probably you’re going to find conversation. Data is important, but so is conversation. Honestly, if these are your peers, it’s your own peer-review. Data is never everything. Sometimes you find information through word of mouth. Sometimes you have to search discussions to dig up things to help you make your personal decision. No information is perfect, but sometimes that’s what you need.
In an early clinical trial, this can be helpful. You need a basic understanding of the side effects. Ask your doctor about them. If something happens, knowing it was a side effect for someone else is helpful.
What about the issue of a placebo? Many patients are afraid that if they join a trial, they’re just going to get the placebo.
Ms. Manarite: Great question. Placebo is another risk involved in a trial. You have to evaluate if you are willing to take that risk. But not every clinical trial has placebo. Let’s look at them by phase.
Almost every Phase III trial has placebo. However, even then, sometimes two-thirds of the patients get the drug and only one-third gets placebo. That’s kind of interesting, and right off the bat, it gives you a question to ask and clarify.
Almost all Phase II trials have no placebo. There are always exceptions, but most of them do not. That would make Phase II really interesting to me if I were a patient.
No Phase I trials have placebo (that I’ve heard of) because they’re busy doing things like giving patients the drug and kicking the dose up as high as they can to see what patients cannot tolerate. There is some risk involved in what they call dose escalation. Again, you need to be informed about what that means. That all being said, here’s another thing patients don’t realize. You can stop the clinical trial at any moment you want. You are 100% in control of whether and when you enter or exit. That makes it a little less scary.
Are there any other areas of misinformation that you feel are important to highlight?
Ms. Manarite: There are a few Phase III trials—not many, but a few—in which you may get a placebo.
If, during the trial, your disease progresses on the drug, you may be able to come out of the placebo and get treatment. That’s called a crossover provision. Unless you ask, you may not get that information up front. Again, that changes your perspective on the risk versus benefit. A great example of this is the Erleada (apalutamide) trial. They had a crossover provision in the Phase III trial so that if your disease progressed on placebo, you got free Zytiga (abiraterone). At the time, Zytiga (abiraterone) cost maybe $5,000-$7,000 a month. That is a big benefit to a patient. “I’m going to get free Zytiga (abiraterone) if I fail the trial drug or placebo. I don’t have to put it through Medicare or my insurance. That’s kind of interesting. Now I’m listening.” A crossover provision in a Phase III trial that has placebo is a great question to ask.
Do you have any thoughts or advice about the financial end of clinical trials?
Ms. Manarite: Yes. Make that a question. In most clinical trials, especially Phase III drug company driven trials, the treatment is going to be free. You may also be covered for travel, including compensation for long drives. You can’t assume you know the answer because they’re all different. The point is: ask.
Is travel frequently covered?
Ms. Manarite: Frequently, yes, but not always. You have to ask. That becomes part of your decision, your risk versus benefit. If you don’t live in a town that has a large institution or university where they’re more likely to be doing clinical trials, you may have to drive. There are exceptions. That’s another good question to ask.
I drove my husband to Miami once every two weeks for a Phase II Xinlay (atrasentan) trial. He got sick of it. He really didn’t want to do it, but I wanted him to do it. He didn’t feel good enough to get in a car, travel for two hours, sit in the clinic for an hour, and drive back for two hours. We did it for a while, but then he’d had enough, and he pulled out.
Another question to ask is if the clinical trial requires a CAT scan, bone scan, or blood test to qualify. They almost always do, but they aren’t always covered by the trial. Some are covered by your insurance, but if you don’t have insurance, will you have to pay? Again, this is a good question to ask. For someone who does not have insurance, accessing a clinical trial with potentially free treatment can be a huge benefit considering the risk/ benefit profile.
Especially for the imaging. That comes up a lot.
Ms. Manarite: That’s why you have to ask if imaging is covered.
What about finding trials? Do you recommend patients go to clinicaltrials.gov and look through there?
Ms. Manarite: You can definitely search http://www.clinicaltrials.gov. It has the largest selection. And they recently made their website a little more user-friendly.
But it’s not easy.
Here’s an example. I just went on clinicaltrials.gov and searched prostate cancer in Florida. Because I chose recruiting and not other criteria, I got 66 studies that are recruiting. Then I can filter down from there. That’s definitely better than it used to be.
They also have an 800-number you can try, which is new. I’m not sure if it’s general help or disease-specific.
Do you think if someone had a specific trial they were curious about, their experience might be different rather than just calling up and asking what’s available?
Ms. Manarite: Yes. That may be a better question. I would try (800) 4-Cancer.
My feeling is that most people find out about trials through their doctors, if at all.
Ms. Manarite: Most of the time. I think that’s fair. You’re right about that.
This happens all the time: people will call me, and they’ll say, “My doctor wants to put me in a clinical trial. I’m not sure if it makes sense, but he seems to like it. I’m going to try it.” I’ll ask them for more information on the trial—what it’s even called—and they’ll have no idea.
So, if your doctor’s talking to you about a clinical trial, walk out of there with a paper about it. Don’t leave without some kind of paper that has the name of the drug, the name of the trial, or something because you’ll never be able to research it when you get home. Walk out of there with a paper.
At least the name of the trial so you can go home and Google it.
Ms. Manarite: They should give you a 1-page printout at least. Also, if you’re going into a clinical trial, you will probably meet a new medical professional, such as a clinical trial nurse or the research nurse. It’s a whole new person. If you develop a relationship with them in the beginning, it might help expedite your enrollment. One of the tips I always tell people is: hand the clinical trial nurse your medical records. They won’t have to look for your information because you’ve given them your file already. It might speed things up.
Aren’t most medical records electronic right now, or are you suggesting people keep a print copy?
Mr. Manarite: Either or. Whatever works for you. If you’re going into a clinic for a doctor’s appointment, and you have this specific question, having a printed medical record on you that you can ask about is exactly what you need to be doing. There’s a time and a place for both types of medical records (online and printed) depending on what you’re doing.