Dr. Murphy highlights study of a genomic assay in prostate cancer

During an interview at SUO, Adam B. Murphy, MD, MBA, MSCI, highlights how to create successful inclusive clinical trials based on the study, “Impact of genomic testing on urologists’ treatment preference in favorable risk prostate cancer: A randomized trial,” for which he served as the senior author. Murphy is an assistant professor of urology at Northwestern University in Chicago, Illinois.

Video Transcript:

So, in yesterday's session, they were asking about how we did our investigator-initiated studies. Mine was interesting in that we paired it with a DOD-funded grant from the outset. The company provided a letter of support for our grant, and when it got funded, they decided to provide the cost of all the assays that they produced for free. In exchange, we did some additional analyses for them. So, that was one of the angles, that they were going down to teach new investigators, new trialists how to get involved. The other angle that we had was about how we completed a clinical trial on a clinical utility study for an archetype DX genomics assay. The genomics assay was using biopsy tissue to help patients make decisions for the treatment choices. We also tested the effect of the assay on provider choice.

So, it's a unique assay where we recruited 200 men from 3 safety net hospitals: Cook County Health, Jesse Brown VA, and the University of Illinois in Chicago, which are minority-serving institutions, with a 70% of African American, or Black, population. Only about 12% of the men were privately insured or college educated. So, it was a very underserved population we were getting. The idea is how do we get these men in trial without dropping out and completing the end points? I gave them several points. One, we had a team of 2 leaders, Dr. Peter Gann and myself, who both had experience with health disparities, prostate cancer biomarkers, and also working across multiple institutions. The team came with some expertise, leaders in urology, either the chairs or are championing urologic oncologists.

We also had stellar research coordinators who've been experienced with patient care. Since a couple of them were nurses, they were used to minority interaction, so they were used to working with diverse populations. There were 3 females, 1 was African American, 1 was Ukrainian, and 1 was American White. I made a joke that they also were able to field marriage proposals from some of the veterans. They knew how to set their own boundaries and not feel overwhelmed. And they also felt comfortable. They were socially justice minded, and they knew that it was important for us to increase our enrollment on minorities into prostate cancer trials.

An additional thing that we talked about was just the fact that we had trained these coordinators to act as patient navigators. They did a lot of reminder phone calls. They also did a lot of education for the patients, so they were aware of what was going on. They would shift appointment times if patients called and said, "I can't make it to the next visit". They also worked well with a very busy pathology department to make sure that our samples of tissue cores went out to the company so that we could get the results back in time for them to be used for their treatment discussions for their prostate cancer. I think some other things were that we aligned our incentives with the company because they wanted urologists to use their test more and show that it was accurate and it impacted treatment decisions. So, that was their angle; we wanted to make sure that we knew the effect on actual patients' and providers' choice. We were worried that these assays that were thought to increase the uptake of active surveillance, in some populations may not have the same effect, [such as] in an African American heavy population or a population in safety net hospitals where the risk is higher. So, it could be shifting them more towards surgery or radiation, and less towards adoption of active surveillance. And we actually found that.

This transcription has been edited for clarity.