Alicia Morgans: Hi, my name is Alicia Morgans and I'm a GU medical oncologist and Associate Professor of Medicine at Northwestern University in Chicago in the United States. I am so excited to have here with me today, a friend and colleague, Dr. Rahul Aggarwal, who's an Associate Professor of Medicine, a GU medical oncologist, and the Program Leader of GU Medical Oncology at UCSF and the Helen Diller Family Comprehensive Cancer Center. Thank you so much for being here with us today, Rahul.

Rahul Aggarwal: Thanks Alicia, it's great to be here.

Alicia Morgans: Wonderful. So, Rahul, you have had so much going on in the last few years in terms of really exciting clinical trials and trying to make progress for your patients. I'm just wondering if you can give us a little bit of a high-level overview of one of your trials, AFT-19, which is really looking at intensive androgen deprivation in high-risk biochemically recurrent prostate cancer patients. Can you tell us a little bit about that?

Rahul Aggarwal: Sure, this is a study that we've had ongoing for a couple of years, which we're really excited about. It's as you said, a study for patients that have high-risk rising PSA after prior surgery. So for patients who had a radical prostatectomy and then have a fast PSA doubling time, we know that such patients are at increased risk of subsequent development and metastases. And so what we're looking to do with this trial is really see if we can intensify our hormonal therapy, but give it for a finite treatment period of one year and see if that translates into improved long-term outcomes for patients.

Alicia Morgans: Wonderful. So what does the randomization look like? What would a patient potentially face if he was trying to enroll in the trial?

Rahul Aggarwal: Yeah, so there are three treatment arms. It's basically a one in three chance of being assigned to one of the three arms. It's open-label, so there's no placebo. In all three treatment arms, patients are getting active hormonal therapy. In the standard of care arm, patients get hormonal injections, which can take the form of degarelix or Lupron® or Eliguard®, using various schedules, so there's a fair amount of flexibility built in there. And then there are two study arms or experimental arms that are basically add-on strategies. So there's arm B, where patients get the hormone injections coupled with apalutamide, which is an oral hormonal therapy that blocks the testosterone receptor. And then in the third arm, arm C, there's an additional add on. So patients get the hormone injections and apalutamide, but in addition, get abiraterone plus low dose prednisone, which is further trying to block testosterone production within the tumor in other parts of the body.

Alicia Morgans: Fantastic. So, I think importantly, any patient going on this study should know that he is getting some kind of treatment and that we're using just this graduated, increasing intensity to see which one is best, because it might be that most is best. It might be that injections or your basal sort of GnRH agonist or antagonist, androgen deprivation is sufficient. We don't know. And I think that's a really important question to answer in this patient population. Can you just clarify the population a little bit? Who are these high-risk patients that you're looking for?

Rahul Aggarwal: Yeah, yeah. So these are patients that have had prior radical prostatectomy. So prior surgery to try to eliminate their prostate cancer, who unfortunately have a subsequent rise in PSA. The study allows but does give some wiggle room in terms of prior salvage or adjuvant radiation treatment. So certainly, patients who had surgery followed by salvage radiation to the prostate area who subsequently have a rise in PSA, such patients would be eligible. But also those patients who have surgery, who for one reason or another, are not candidates to receive radiation, but they could also go on.

And then we try to select amongst those patients, those that are really at higher risk of developing metastases or clinical consequence. So we picked a PSA doubling time of nine months or less, and there are pretty easy to use online calculators to look at that. And then the minimum PSA for patients to go on would be a PSA of 0.5 or higher. And then we do require sort of regular imaging with a CAT scan and bone scan to make sure there's no evidence of cancer spread to distant parts of the body. So those are the main eligibility criteria.

Alicia Morgans: Perfect. Perfect. Thank you. So if a patient wants to get involved, I'm sure that there are different locations where he could participate, and we can certainly put those locations up with a link for the clinicaltrials.gov website that will share that. Can you tell us kind of where are these sites generally, how many sites are there?

Rahul Aggarwal: Yeah, so it's actually pretty broadly distributed across the Alliance clinical trial network across the US. And so it is a US-only study, but many sites across the country. I think there's probably close to 50 with pretty good geographical representation in different parts of the country. And then the other thing I would highlight is that we are, especially now with COVID-19, there's quite a bit of flexibility built-in within the study in terms of patients being able to receive their hormone injections locally, have study medication shipped out to patient's homes and trying to make it as feasible as we can. And I think that's really helped actually increase the accessibility of the trial for patients.

Alicia Morgans: Fantastic. Well, thank you so much for sharing this. We will make sure that we post a schema so that everyone can see exactly how these arms break out. And I appreciate the work that you're doing and look forward to talking to you more as the time comes. As we finish things up, can you let us know how many patients are enrolled and how many more do we need?

Rahul Aggarwal: Yeah, so we've enrolled about 420 out of about 500 patients. So we're actually a little over 80% done, but we're still actively looking for patients. And I really appreciate the opportunity to get to discuss the trial. And there's a central contact through the Alliance Network that can be contacted if patients or providers are interested.

Alicia Morgans: Great. And we'll make sure that that's available as well. Well, thank you so much. I look forward to seeing how this study will continue to shape the way that we care for men with prostate cancer. Congratulations on getting the study up, running, and nearly accrued. Thank you again for your time today, too.

Rahul Aggarwal: Thank you so much.