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Alicia Morgans: Hi. I’m so excited to be here today with Dr. Rana McKay, who’s joining me from UCSD after GU ASCO 2025 to talk about the PREDICT trial and a trial-in-progress poster that she presented. Thank you so much for being here with me today, Dr. McKay.

Rana McKay: Oh, it’s my absolute pleasure. Thanks for having me.

Alicia Morgans: Wonderful. Well, tell me a little bit about the PREDICT trial. Why should we be excited?

Rana McKay: Well, we are so excited about this study because this study really developed from an unmet need of how to better personalize therapy for patients with advanced prostate cancer. We know that the NCI-MATCH study has been going on for some time, accruing patients onto biomarker-selected treatments based off of DNA alterations. And quite honestly, given the status of the location of metastasis for patients who have bone-predominant prostate cancer, NCI-MATCH hasn’t been really reflective of a large prostate cancer population.

Patients need to have measurable disease to be able to enroll onto the trial. And it hasn’t really been leveraged to the extent that it probably should be for advanced prostate cancer patients. So out of this unmet need actually evolved PREDICT. And what I will say is that the conception of PREDICT actually initiated from a Prostate Cancer Foundation-supported working group that was started, probably in 2020, of how do we develop n-of-1 studies and biomarker-selected studies in people with advanced prostate cancer?

And this was the evolution of many minds coming together. My co-chair and colleague, Himisha Beltran, has been amazing with helping kind of carve out and design the study. So in essence, this trial is designed for patients who have advanced mCRPC, who have received a prior ARPI. And patients basically enroll on the trial. There are two steps to the study:

There’s a preregistration and a registration step. If they’ve had any CLIA-based NGS testing from tissue at any time or blood within 12 months, they’re allowed to preregister for the study. Their genomics get reviewed by a molecular tumor board that meets fairly regularly—weekly—and then allocates them into a select arm based off of the biomarker that they have.

At the present time, there are two therapeutic arms and a no DNA biomarker arm. The two therapeutic arms are valemetostat, which is an EZH2 inhibitor, and that’s particularly targeting neuroendocrine differentiated prostate cancer, either molecularly or by various signatures (ARPI loss on the DNA level). In addition, there’s a carboplatin–cabazitaxel arm specifically targeting tumor-suppressor loss gene alterations and platinum-sensitive tumors, and then the no biomarker arm, with an intention to actually add in additional arms specifically looking at the AR pathway with AR-selected therapies.

The other unique aspect of this study is that in addition to the DNA for allocating patients into a treatment arm, it’s also looking at RNA as well and various RNA signatures, which have been validated in prostate cancer for arm allocation. We have a partnership with Caris for this study, and as part of the study, tumor tissue is to be submitted centrally.

The Caris MI Tumor Seek assay will be run on all of the specimens for both DNA alterations and RNA alterations. And if we do find something on the submitted tissue, actually, patients are allowed to re-enroll onto the study. So people that get allocated into the no biomarker arm could re-enroll into one of the other two arms if they have a qualifying RNA signature.

Similarly, if there’s somebody that’s in one of the treatment arms, and then they can potentially go into an alternate treatment arm, they’re allowed to do that. So this is a pretty pragmatic trial. Now that NGS testing is standard of care for patients with advanced prostate cancer, our hope is to roll out precision medicine across the entire NCTN community network and really bring it to the community sites. So we’re super excited about the trial.

Alicia Morgans: It is a really exciting trial, I have to say. It’s complex in terms of all of the pieces that come together to give patients options, and we’ll make sure that we post the NCT number and link so that people can get there quickly.

So just from a very basic perspective, if somebody is thinking about, “What do I do for my patient with prostate cancer?” what are the steps that one would take to actually get the information needed, submit the information, and then hopefully get that patient onto trial?

Rana McKay: So to answer the question about if you have the trial already open at your institution, what the steps are, and then we can talk about how to get it open at your institution. But if you have the trial open at your institution, anybody who has metastatic prostate cancer that has seen an ARPI could be preregistered for the trial. And the preregistration doesn’t necessarily have to happen at the time that you want to enroll them.

So it could happen six months ahead of time as you’re trying to plan out what you’re going to do for this individual. The preregistration is super simple. They basically need a pathology report and an NGS report. And there’s really not a lot of other criteria.

They do need to have tissue procured from within 12 weeks because the RNA signatures can change dramatically based off of the treatments that patients have been exposed to. So RNA signatures from somebody’s radical prostatectomy aren’t going to help inform what we’re going to do for them at this exact juncture. So that’s all that’s needed for preregistration.

You submit everything through Medidata Rave. And then that flags things on the internal side, on the ALLIANCE side, that somebody has been preregistered for the study. The molecular tumor board reviews the data, and within five business days, the site will know what arm they’re allocated to.

They can then elect to wait until they’re ready to register that patient when they’re ready to enroll them onto treatment. Or, if they’re ready right then and there, they can go ahead very seamlessly into the actual registration, where we’re really working hard to minimize the eligibility criteria to make it a super feasible trial for getting people on treatment.

So it’s to be super simple. And then to actually get the study open at your site, everything is available on CTSU— all the protocol materials. We actually just hosted a webinar a couple of weeks ago. The live recording from that webinar and slide deck are available with just some operational steps and tips and also tips for the trial, and we are eager to have you on as partners.

Alicia Morgans: Wonderful. Well, Rana, this is an extremely exciting trial. We’ll make sure to have that link. We’ll make sure that we can maybe post the schema so that everyone has access to that, and of course continue to talk about the study in our circles and beyond just to share the information. Congratulations on getting this study open. I cannot wait to see these arms report out. Thank you so much for your time.

Rana McKay: Thanks, Alicia.