“Testing and Treatment Roadmap (NCCN Guidelines)”

“Testing and Treatment Roadmap (NCCN Guidelines)” (Rick Stanton) [#6] April 27, 2022 Brad Power Meeting Summary Advanced prostate cancer patient Rick Stanton walked through a one-page summary of the NCCN (National Comprehensive Cancer Network) guidelines for advanced prostate cancer and illustrated it with his and Brian McCloskey’s treatment journeys.

The NCCN guidelines are the “standard of care” - the evidence-based protocol for deciding on treatments for patients with prostate cancer. Rick started his summary of the NCCN guidelines after the prostatectomy step since he is focusing on the journey for advanced prostate cancer.

From there, most branches in the NCCN decision tree depend on whether the patient’s PSA (prostate specific antigen, a blood test result), is rising or not, and whether their cancer has spread outside the prostate (metastasized).

Rick and Brian’s PSA rose after their prostatectomy, so they switched from observation (“watchful waiting”) and had the next recommended treatment: radiation and drugs (Lupron and bicalutamide/Casodex) that suppress androgen, the hormone that feeds the cancer. This androgen suppression treatment worked for about a year for Rick and Brian.

Brian was doing so well, he and his medical team decided to take a holiday from the androgen suppressing drugs, and then after several months his PSA started rising rapidly. Rick’s PSA started rising rapidly after about a year.

At this point for both, with PSA rising, and now both with metastases (cancer in other places besides their prostate), the NCCN treatment recommendation is to try one of several drug options. Rick chose a next generation androgen blocker (darolutamide).

After a few months, it was clear that this wasn’t working for him, so he joined a clinical trial that had two arms: one for chemotherapy (docetaxel) and another with that same chemotherapy plus two other drugs (a PD1 inhibitor and an adenosine inhibitor). Unfortunately, Rick got the clinical trial control arm with chemotherapy only, which he has stayed on until today. It has knocked down his PSA.

Brian chose another androgen-suppressing drug (abiraterone), which he is on now. It is keeping his PSA at a very low level. The first four or five rounds of decisions in the NCCN guidelines are largely not personalized. They depend on whether the cancer has metastasized and the PSA level.

It is only in the very advanced stages of prostate cancer that personalization (decisions which draw on genomic tests) enters.

In an upcoming meeting Rick and Brian will continue to talk about ways to (a) enhance the NCCN guidelines to refine this overview of the whole journey - a roadmap for communication between patients and doctors, (b) bring more testing and associated personalization earlier in the decision process, (c) add data on the efficacy of the treatment options, and (d) add a roadmap for steps beyond the end of the current guidelines.

“Testing and Treatment R

or communication between patients and doctors, (b) bring more testing and associated personalization earlier in the decision process, (c) add data on the efficacy of the treatment options, and (d) add a roadmap for steps beyond the end of the current guidelines. Requests

“Testing and Treatment Roadmap (NCCN Guidelines)” (Rick Stanton) [#6] ●Do you have any feedback on Rick’s presentation on the decision tree for advanced prostate cancer testing and treatments? How could we improve it? ●Do you have contacts at the NCCN whom we could contact to explore the possibility of collaboration?

The information and opinions expressed on this website or platform, or during discussions and presentations (both verbal and written) are not intended as health care recommendations or medical advice by Cancer Patient Lab/Prostate Cancer Lab, its principals, presenters, participants, or representatives for any medical treatment, product, or course of action.

You should always consult a doctor about your specific situation before pursuing any health care program, treatment, product or other course of action that might affect your health.

“Testing and Treatment Roadmap (NCCN Guidelines)” (Rick Stanton) [#6] — The information and opinions expressed on this website or platform, or during discussions and presentations (both verbal and written) are not intended as health care recommendations or medical advice by Cancer Patient Lab/Prostate Cancer Lab, its principals, presenters, participants, or representatives for any medical treatment, product, or course of action.

You should always consult a doctor about your specific situation before pursuing any health care program, treatment, product or other course of action that might affect your health. Meeting Transcript Brad Power: Today we’re focusing on advanced prostate cancer testing and treatment decisions and a decision tree that Rick has been working on with help from Brian.

We want to get your feedback on how we can make it better. Some of you may know about the NCCN (National Comprehensive Cancer Network) guidelines. These guidelines are the standard of care for treatment. They are updated every six months. The NCCN publishes guidelines for a variety of cancers, including for advanced prostate cancer.

Given all the learning that we’ve been doing, we thought we might be able to help in advancing the guidelines, and we could use it to illustrate where Rick and Brian have been on their cancer journeys and the decisions they face. Rick Stanton: A little background: when I first got prostate cancer and had my prostate removed, I was at CIty of Hope. I talked to my medical oncologist, Dr.

Lyou, who told me my next therapy steps were going to be completely in line with the NCCN guidelines. He said, “This is a comprehensive cancer center, and we do not follow ‘Wild West’ oncology guidelines.” I didn’t know what the NCCN guidelines were.

my next therapy steps were going to be completely in line with the NCCN guidelines. He said, “This is a comprehensive cancer center, and we do not follow ‘Wild West’ oncology guidelines.” I didn’t know what the NCCN guidelines were. We are advocating for advanced testing and personalized medicine that help direct patient care. I wanted to know the value of advanced testing. What are these guidelines? Are they good enough? Where do they end?

“Testing and Treatment Roadmap (NCCN Guidelines)” (Rick Stanton) [#6] Rick Stanton: This image says 2020, but the guidelines I will be discussing are from January 2022. This is my interpretation of about a 60-page document. There are two documents. One is for physicians and one is for advanced patients.

“Testing and Treatment Roadmap (NCCN Guidelines)” (Rick Stanton) [#6] Rick Stanton: A shout-out: I noticed (and I didn’t know this before I started laying out this decision tree) that Tanya Dorff, who is guiding me and Brian, is one of the authors, and so is Rana McKay, who is also guiding us. I look across this list of authors, and it’s just about as prestigious as it gets. Rick Stanton: So here’s my interpretation of the NCCN guidelines for advanced prostate cancer.

“Testing and Treatment Roadmap (NCCN Guidelines)” (Rick Stanton) [#6] This is a decision tree. It’s boiling down 50 or 60 pages of therapeutic decisions provided in the NCCN guidelines into one page. I start with “prostate removed” because it’s for advanced prostate cancer. There is more in the guidelines about when to take out a prostate.

If your PSA is stable after your prostate is removed, then you’re called “castration-naive prostate cancer” (CNPC) and M0 means that there is no evidence of metastases. (There are some acronyms here, which I have spelled out in the notes at the bottom.

) At this point – if there is no evidence of metastases and you are “castration naive”, which means you have not yet gone on androgen-deprivation therapies, and your PSA is stable – then you wait. Brian and I were both unstable. When my prostate was removed my PSA was 0.6. 0.2 and above is the definition of recurrence. Right after I had my prostate removed I was not stable. My PSA was going up.

I fell into this next category: my prostate is removed and my PSA is rising. So now, what do we do about it? This is Guide 9 in the NCCN guidelines. There are two choices here. Again this is castration naive prostate cancer and M0 (no evidence of direct concentrated metastases on the imaging), but I did have a rising PSA. M1 means that there is evidence of metastases.

The guidelines say, and this is what Dr. Shen (UCLA) told me, put me on apalutamide. The bold is the NCCN “preferred” options. Within these options there is a lot of bold.

“Testing and Treatment Roadmap (NCCN Guidelines)” (Rick Stanton) [#6] In this depiction, both Brian and I shared the first step, which is shown in purple. In the second step, we deviated. I’m in red.

tamide. The bold is the NCCN “preferred” options. Within these options there is a lot of bold.

“Testing and Treatment Roadmap (NCCN Guidelines)” (Rick Stanton) [#6] In this depiction, both Brian and I shared the first step, which is shown in purple. In the second step, we deviated. I’m in red. Apalutamide is an androgen-deprivation therapy. Lupron is another. Lupron is a shot.

Darlutamide is an expensive pill (~$18K per month - Bayer - the cost for me was totally covered by a combination of Cigna insurance and Bayer patient assistance program - THANK YOU!!). Lupron is meant to knock down the androgen feeding the cancer, and Darlutamide is a pill that blocks the adrogen receptor on the tumor cells.

This should look very familiar to many advanced prostate cancer patients. Saed Sayad: Do you have any statistical information about the success or failure rate at each stage? Brian McCloskey: I was surfing yesterday with one of my dear friends, Ryon Graf, of Foundation Medicine. In between catching waves we were talking about how to improve the NCCN guidelines.

He has his hands on tons and tons of data. And that’s one of the directions we want to go. We discussed bringing more data to the guidelines. I’m getting to the punch line here. This is such a rudimentary guide, and we think there are opportunities for us – I’ll keep it high level here – to bring more data into this, and response data is part of what we would love to add.

Ryon could help us tremendously in that effort by looking at real world evidence to determine what the response rates are for each of these different scenarios. Saed Sayad: And also if we can find any genotypes for success or failure? Brian McCloskey: He’s the guy. He has a lot of information. We need to peel the onion on that to understand exactly what genomic information they do have.

But, at a minimum, it’s going to be a great place for us to start. Rick Stanton: As we go across this chart, from left to right, you’ll see that the rightmost is the second line therapies, and within the NCCN guidelines that’s where genomic indications first come into the decision-making. It doesn’t kick in until you are castrate resistant and metastatic and at the second line.

For example, taking pembro, which is a PDL1 blocker, is based on genomic information. We’ll get there. Both Brian and I got external beam radiation therapy (EBRT) as our next step, called “salvage” radiation (radiation given after a prostatectomy), and I also had SBRT (Stereotactic Body Radiation Therapy). We were hopeful that this would clean things up and confine this to the pelvis area.

But it didn’t for us. After we left this box, we were told, “You have an incurable disease. You will manage this until the end.” For me bicalutamide and Lupron lasted for about a year before my PSA started rising. Brian: How was that for you? Brian McCloskey: It was about the same for me.