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.
At what point should a prostate cancer patient consider participating in a clinical trial?
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.
Yes. What would you say to someone who might be hesitant to participate in a trial?
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.