Real-World Understanding of the Prevalence of Potentially Targetable DNA Damage Repair Alterations – The PROMISE Registry – Heather Cheng

March 10, 2022

Heather Cheng joins Alicia Morgans to discuss the trial in progress poster presented at GU ASCO 2022 on the PROMISE Registry. The goal of the PROMISE registry is to offer genetic testing for men with prostate cancer regardless of the stage of their disease. The registry will recruit over five years, with fifteen years of planned follow-up.

Biographies:

Heather H. Cheng, MD, PhD, Director, Seattle Cancer Care Alliance Prostate Cancer Genetics Clinic, Division of Medical Oncology, University of Washington School of Medicine

Alicia Morgans, MD, MPH, Genitourinary Medical Oncologist, Medical Director of Survivorship Program at Dana-Farber Cancer Institute, Boston, Massachusetts


Read the Full Video Transcript

Alicia Morgans: Hi, my name is Alicia Morgans, and I am a GU Medical Oncologist at Dana-Farber Cancer Institute. I'm so excited to talk today with Dr. Heather Cheng, who is an Associate Professor of Medicine at the University of Washington and the Fred Hutchinson Cancer Center. Thank you so much for being here with me today.

Heather H. Cheng: It's a pleasure, Alicia.

Alicia Morgans: Wonderful. Well, so glad to talk to you about the presentation that you and your team had at GU ASCO 2022. You presented a trial in progress poster on the PROMISE Registry. Can you tell me a little bit about it?

Heather H. Cheng: Yes. I'm so excited to present or discuss the team effort, which is PROMISE. It's a registry for men with prostate cancer, and the goal of the study is to offer men genetic testing regardless of their stage of the disease. Now, the NCCN guidelines include metastatic disease, high-risk localized disease, and node-positive disease, but we are still learning about biochemical recurrence, active surveillance populations, and so this really is an opportunity for patients to participate. It is web-based and so they can do it from their own home, and it's free of cost and really convenient. They do not have to change doctors, and then they enroll and share that information with their physicians and their family members.

The really nice thing about it also is that we are going to follow men long-term if they have certain variants we are particularly interested in, and there's going to be a partnership to return that information back to the patients and participants. That is kind of the study in a nutshell.

Alicia Morgans: That's fantastic, and I love your focus on men who wouldn't necessarily be included in the guidelines, because this is really a group that needs some consideration, maybe some characterization, which is exactly what you are doing, so we understand if we should be doing testing. The low-hanging fruit, there from my perspective is certainly the biochemical recurrent population. Why we don't have guidelines there yet, is only because we do not have the data.

Heather H. Cheng: Right.

Alicia Morgans: So I think this is a phenomenal way for us to acquire the data, and I love that it's free and patient-driven. So I wonder for patients who are interested, what is the turnaround time? They engage, they go through this process. Maybe their doctor even said, "You should think about this registry because you do not fit the guidelines." Maybe there are insurance hurdles. What do they have to consider in terms of how long it takes for them to get those results back so they can share those with their doctor?

Heather H. Cheng: Yeah, it's a great question. So it's really quite simple, I think. They go to the website, which is prostatecancerpromise.org, and we will put the link-up, but they can visit that and learn about the study. And the study team actually can help them with some of the survey information, and then they will mail the saliva test kit to their home, and then the turnaround time should be somewhere around four to eight weeks. Then they can share that with their physicians and then use that information for their care, and they do have access and they will talk with a genetic counselor if they would like, or if they have a variant or if they do not have the variant.

So I think that's a really nice service, and then there is also follow-up information as well with clinical trials, and so that's part of it, is to let patients know the state of the art for new trials because that landscape is also changing pretty rapidly.

Alicia Morgans: Absolutely. So from a clinical perspective, if I'm a doc who wants to do genetic testing, but I do not have a genetic counselor in my clinic, this sounds like a great way to ensure access to my patients who need that additional step if they maybe have a pathogenic mutation. So it's all built into the study? Can you elaborate on that?

Heather H. Cheng: Yeah, so I think your question is if patients already have a pathogenic variant. Well, there are two. Men who do. not have access to testing can get the testing done as part of the study, and men who already know they may have a family mutation or familial mutation can also participate, because one half of it is access to testing and genetic counseling, and then the other half of it is long-term follow-up and treatment outcomes for people who have variants, like BRCA2, for example.

So even if somebody knows they have a mutation, they can participate because that will help them and other people like them learn what happens with, for example, PARP inhibitors or abiraterone, and there is so much discussion at this meeting about the combination of abiraterone with olaparib and abiraterone with PROpel and MAGNITUDE, and a lot more we still need to learn. So this study is going to also help us begin to unpack some of that complexity.

Alicia Morgans: That's really fantastic. So if you had a message to clinicians, to patients to consider enrolling in this registry, which provides access to testing, which provides long-term follow-up, and some understanding for us as a community of what happens to patients, as well as counseling, what would that message be to those clinicians who are listening?

Heather H. Cheng: This is such an exciting opportunity, the PROMISE study, to partner with patients and partner with the research community and be part of, I think, a new era of clinical trials, really like what you talked about in your amazing study of just partnering with patients. I think now, COVID has really challenged a lot of the ways we think about things, but some opportunities are there with patient empowerment and enrollment from a national perspective. So we can reach people in rural areas and that is really exciting, that we can hopefully gather more involvement, and more learning can be escalated for patients.

Alicia Morgans: That is a fantastic message. And this is really an innovative study that I think is just what our community needs. So thank you so much to you, to the team, Dr. Paller, of course, as well.

Heather H. Cheng: Yeah.

Alicia Morgans: It's a phenomenal effort and I congratulate you and look forward to the results.

Heather H. Cheng: Thank you so much. It's an honor to be here.
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