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Alicia Morgans: Hi, I'm so excited to be here with Dr. Veda Giri, who is the director of the Cancer Genetics and Prevention Program at the Yale Cancer Center. Thank you so much for being here with me.

Veda Giri: It's a pleasure to be here with you. Thank you.

Alicia Morgans: Wonderful. Veda, you've done some amazing work in genetics. Now, you're taking your work and your learnings from prostate cancer across your whole cancer center, which is wonderful. Congratulations.

Veda Giri: Thank you.

Alicia Morgans: But today, I wanted to talk with you about the TARGET study, which you presented as a poster at ASCO 2023. Can you tell me a little bit about it?

Veda Giri: Yes. The TARGET study is a national prospective randomized trial. This was funded by a Prostate Cancer Foundation Challenge Award. This was a study that really was looking at exploring ways for how to enhance access to genetic testing for men with prostate cancer. We know that really there has been this expanded role of germline genetic testing in prostate cancer for treatment and metastatic disease, certainly to help inform tailored screening strategies and for hereditary cancer assessment. Really, the indications for prostate cancer genetic testing have just exploded.

However, the ability for genetic counselors to always see patients is really not sustainable. There have to be new ways developed and studied to see how men can engage in the process of genetic evaluation and then choose genetic testing. The TARGET study was one opportunity to test a technology-based approach for studying that against genetic counseling to see if this would be a viable option for providers in practices, such as urologists, oncologists, to be able to use a tool to introduce genetic testing to their patients, go through and understand what does this process entail, and then make a decision for genetic testing.

We were very excited to have multiple academic centers and enroll to the TARGET study with my collaborators and investigators as well as a large urology community practice. We had some really interesting representation of patients for this randomized trial.

Alicia Morgans: Wow. What did you find?

Veda Giri: What we wanted to look at was is the... We developed a nine-module web tool, a patient-driven web tool. Men could be directed to a website. They would listen to information about genetic testing, including information about what does genetic testing mean, what information can be returned from genetic results, what does this mean to men for treatment, for screening, and for their families from a hereditary perspective.

There were nine modules that men would go through to learn this information. After every module, there was a quiz to ensure that they understood the information. This was the tool that was developed that was the patient-driven web tool. This was compared to the classical approach, which is referring patients to a genetic counselor and receiving this information from a trained genetics professional. What we were looking at to make sure was is the web tool not inferior to genetic counseling. We assessed this by patient-reported outcomes.

Our primary outcome was looking at non-inferiority for decisional conflict, so to make a decision for genetic testing. We also looked at other secondary outcomes like patient satisfaction with the process, knowledge of cancer, genetics, attitudes towards genetic testing. Overall, what we found is that the web tool, actually, is not inferior to seeing a genetic counselor. We met our primary endpoint for the non-inferiority design.

For the secondary endpoints, what was interesting is we actually had approximately 86 or 87% overall in the cohort uptake of genetic testing, which we were pleased to see. There was a little bit of a lower uptake, about 79%, in the web tool arm. We are going to be exploring that just to see what were some of the reasons for maybe some lower uptake of genetic testing in the web tool arm, but it was still hovering around 80%. We were still pleased to see that.

We also saw that, interestingly, cancer genetics knowledge was higher among men who went through the web tool. We would like to build upon that just to see if there are ways to enhance knowledge or knowledge retention, sharing of results with family members, et cetera. When thinking about some of the other... Satisfaction was similar between the two arms.

Another interesting point was that there was some lower feelings about the potential benefit of genetic testing for men who went through the web tool. We don't know if that correlates with lower uptake of genetic testing. These are some follow-on studies that we would like to do. Overall was that we vet our primary endpoint for non-inferiority with the web tool.

Alicia Morgans: That's fantastic. Now, how many people actually engaged in this study? Because one of the benefits I can envision for the web tool is that this is certainly scalable. Whereas we know that there's a shortage of genetic counselors available in many, many areas around the country. Certainly, genetic testing is applying to increasing numbers of patients and patients with different cancers. What were the numbers really that engaged?

Veda Giri: Right. We had designed the study so that it would be 346 men to take part in the study, equal. 173 in each arm. That was designed around what endpoint we wanted to meet. It was a sizeable number. It also was, as I mentioned, across Philadelphia, New York, Seattle, and then one of the practices in New York as well in a community practice, a urology practice. We were really hoping to see how this would potentially be more generalizable across the United States and thinking about this from a scalable option as well. One of the things that we do recognize is that it really still had majority of white Caucasian males in the study. We definitely recognize that there has to be a follow on study to see how we can address greater engagement of Black men in processes like this for engagement in genetic testing and perhaps how the tools can be adapted to resonate more across populations.

Alicia Morgans: Well, that's a great point. Where do you go from here? What are the next studies? Of course, this one was funded by the Prostate Cancer Foundation, which is fantastic, and, hopefully, more can be funded by them because these are sometimes challenging grants to get as a non-therapeutic intervention.

Veda Giri: Right. Exactly. We actually have another study that's designed building off of the TARGET study where we propose to develop a culturally tailored web tool specifically to engage Black African-American males. What we would be doing is designing it with audio, visual, cultural relatability. We're hoping that something like this... and actually doing it in a patient choice fashion because we've already done the randomized trial. Now, what we'd like to do is see how can we generalize this to be more accessible and chosen by patients.

That's the next study that we've already designed. It's under review. Hopefully, we'll be able to get more funding to be able to study this across more diverse populations. We also would like to do more across language translations as well. We'd like to design a web tool with Spanish translations and other key languages, particularly as different cancer centers have different catchment areas. We want to make sure that we're capturing what are some of the key language barriers that might impact engagement.

Alicia Morgans: Fantastic. As you think about this, though, in your clinical practice and how this might integrate, what is your take home there, and where do you think we might go just in clinic?

Veda Giri: Yeah. I think that oncologists and urologists that really want to have a major emphasis in their practice for engaging their patients in genetic testing for prostate cancer... This could be one option to help them deal with the volumes of patients, and introduce this concept of genetic testing. They could steer their patients towards something like a web tool to be able to have the information delivered, have real meaningful informed consent for genetic testing. They could even get the genetic testing going so that that way the results could come back in a rapid fashion for them to make decisions for their care.

It's still really important to engage and collaborate with genetic counselors or genetic specialists. I still urge any physician that wants to do this from their own practice to build those collaborations proactively. As results come back, it becomes really important that men hear about some of these results, like for genetic mutations or complex genetic findings or just anything that's concerning from a hereditary standpoint, as well, to meet with genetic counselors. I would say this helps to generalize and scale up the access. But it's really important for practitioners to have collaborations with genetics teams.

Alicia Morgans: Absolutely. Well, thank you so much for the work that you're doing. I really look forward to your continued work. Certainly, let us know so we can advertise your ongoing studies. Thank you so much for your time today.

Veda Giri: Thank you very much. It's been a pleasure to be here.