James Kearns: Thank you for having me this morning.
Leslie Ballas: Why don't you tell me a little bit about the Copper PSMA and the AMPLIFY trial?
James Kearns: So the AMPLIFY trial is a trial of a dual-moiety copper-based PSMA ligand and evaluating biochemical recurrence for prostate cancer. The unique aspect of the dual-moiety copper is that it has much higher binding affinity for PSMA. And so previous studies have shown that next-day imaging actually shows higher sensitivity for prostate cancer recurrence. And the goal of this trial is really to evaluate whether this moiety is basically to validate it for biochemical recurrence in prostate cancer.
Leslie Ballas: And is the hope that because of the dual moiety and the higher affinity that you'll be able to detect disease at a lower PSA?
James Kearns: Yes. I think that's the exact point. I think that many of us who are, especially postoperatively, a PSA of 0.2, which is biochemical recurrence, we rarely see PSMA positivity on the traditional scans. And I know even in many practices, sometimes while not on the trial, which does require biochemical recurrence of 0.2, I think there's even a movement among some urologists to go even earlier than that. So having a new moiety that might actually detect specific areas of recurrence at these much lower PSA levels, I think could be really beneficial for patients.
Leslie Ballas: And what is the lowest PSA that the AMPLIFY trial allows for enrollment?
James Kearns: So for enrollment, the AMPLIFY trial falls along the established criteria. So post-prostatectomy, biochemical recurrence of at least 0.2 nanograms per milliliter and for patients fed radiation treatment NADER+ two.
Leslie Ballas: If you're looking at next day PSMA scanning, what does that mean for patients?
James Kearns: So it does mean patients are going to need to make one additional trip into the hospital or imaging center where they're going to have their PSMA scan done, but I think weighed against the potential benefit of earlier detection, hopefully the inconvenience isn't too much for them.
Leslie Ballas: How widely available are copper PSMA scanners?
James Kearns: As of now, the copper PSMA ligand is available on trial only. And once FDA approval is eventually sought and achieved, then we anticipate that the pipeline for manufacturer will be able to make it readily available nationwide.
Leslie Ballas: What is the target accrual for this study?
James Kearns: What's really exciting about this study is that this study didn't exist a year ago at the AUA and in the past year it has been fully recruited and enrolled with all scans already having happened. It was 232 patients.
Leslie Ballas: Wow. And what is the primary endpoint?
James Kearns: So the primary endpoint is confirmation of prostate cancer recurrence on PSMA imaging. It's a composite score. So for patients where biopsy is feasible, biopsy is the correct answer. For patients where biopsy is not feasible, basically patients will receive local therapy for salvage and if the PSMA signal basically goes away following the salvage treatment, that's considered to be a positive study of confirmation that this was actually disease recurrence. And one of the limitations that goes along with that is that patients are not allowed to get systemic therapy while on this trial, really to hopefully hone in on the idea that local therapy with prostate cancer will provide more of a confirmatory finding if it goes away on subsequent imaging.
Leslie Ballas: What is the median or do you know yet what the median PSA is at enrollment?
James Kearns: I don't have that information available quite yet.
Leslie Ballas: Well, this is very exciting. When should we expect results?
James Kearns: Hoping to get results back in the next several months. It's 180-day follow-up period, so we do have to wait for that to close out before we can begin really delving into the data.
Leslie Ballas: Well, congratulations. Hopefully next year at AUA, we'll look forward to results.
James Kearns: I'm very much looking forward to it. Thank you so much.