Prostate NCCN Guideline Changes (Risk Stratification)

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fiji128

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I was going through the NCCN guidelines and noticed some pretty substantial changes in version 4.2024. Mainly there is now the whole new section on risk stratification and how this now affects treatment decisions regarding AS, Tx +/- ADT and duration of ADT instead of just the old NCCN risk categories. This seems to be pushing the Decipher test pretty hard to make these decisions. What is everyone's thoughts on this?

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I was going through the NCCN guidelines and noticed some pretty substantial changes in version 4.2024. Mainly there is now the whole new section on risk stratification and how this now affects treatment decisions regarding AS, Tx +/- ADT and duration of ADT instead of just the old NCCN risk categories. This seems to be pushing the Decipher test pretty hard to make these decisions. What is everyone's thoughts on this?
I had been using decipher quite a bit, a lot of payors cover it and sometimes I just need a tie breaker, nice to see an oncotype DX type thing finally make it into the guidelines for PCa

I'll have to check out the update, thanks
 
I don’t think they are mandating or pushing Decipher, but they are providing support if you would like to further risk stratify using genomics. I continue to go primarily by risk category, but if someone is borderline, I like a test to help my decision making. Also, if someone is adamant about not taking ADT, then they are usually ok with getting more information about the potential benefit or lack thereof for ADT.
 
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I was going through the NCCN guidelines and noticed some pretty substantial changes in version 4.2024. Mainly there is now the whole new section on risk stratification and how this now affects treatment decisions regarding AS, Tx +/- ADT and duration of ADT instead of just the old NCCN risk categories. This seems to be pushing the Decipher test pretty hard to make these decisions. What is everyone's thoughts on this?
I was excited that they included ArteraAI. Data is stronger for unfav intermediate risk than with Decipher. More data will come for the other risk groups. It’s easier to run and cheaper than Decipher.
 
I was excited that they included ArteraAI. Data is stronger for unfav intermediate risk than with Decipher. More data will come for the other risk groups. It’s easier to run and cheaper than Decipher.
Artera is PREDICTIVE and prognostic which is what you need for decision-making. Very easy to use the portal. Results in 2 weeks.

COI: I am not receiving $$ from Artera
 
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Artera is PREDICTIVE and prognostic which is what you need for decision-making. Very easy to use the portal. Results in 2 weeks.

COI: I am not receiving $$ from Artera

Link on how to actually start using it? I have not seen any widespread roll out. Would love to start using.

I was more impressed with ArteraAI than I was Decipher based on that ability to be PREDICTIVE about benefit.
 
Link on how to actually start using it? I have not seen any widespread roll out. Would love to start using.

I was more impressed with ArteraAI than I was Decipher based on that ability to be PREDICTIVE about benefit.

If you contact them rest assured they will reach out to you.

Good luck.

FYI Medicare covers
 

If you contact them rest assured they will reach out to you.

Good luck.

FYI Medicare covers
In awe of the co-founder. Talk about synergies.
 
I was going through the NCCN guidelines and noticed some pretty substantial changes in version 4.2024. Mainly there is now the whole new section on risk stratification and how this now affects treatment decisions regarding AS, Tx +/- ADT and duration of ADT instead of just the old NCCN risk categories. This seems to be pushing the Decipher test pretty hard to make these decisions. What is everyone's thoughts on this?
Man. I sense under the table stuff on this Decipher and NCCN thing. But hate the game and not the player I guess.
 
Man. I sense under the table stuff on this Decipher and NCCN thing. But hate the game and not the player I guess.
Decipher makers have done a good job accumulating prognostic information across a variety of data sets. I think the reason they haven’t been able to run a predictive study post-hoc like ArteraAI is the RNA in many RTOG archive samples is degraded. All ArteraAI needs is the slides, which are all pristine condition even for old trials. Boosts their sample size and makes the results more valid
 
All ArteraAI needs is the slides, which are all pristine condition even for old trials. Boosts their sample size and makes the results more valid
Man. I sense under the table stuff on this Decipher and NCCN thing. But hate the game and not the player I guess.
Artera is PREDICTIVE and prognostic which is what you need for decision-making. Very easy to use the portal. Results in 2 weeks.

COI: I am not receiving $$ from Artera
It is going to be very interesting.

As @grenz states above, ArteraAI is not doing anything novel to specimens. There is no molecular assay. It's a data processing tool.

Looking at the seminal papers and the ROC curves, the tool as it stands is a bit better than the NCCN model. It is not killer. Presumably these tools will continue to get better with more data. As an aside, I am curious what the epistemic limit is for stuff like this. It is not really personalized medicine in way that testing for ALK mutation is (or better let a gene fusion related to oncogene addiction). These ROC curves are far from perfect.

But here is the thing...I am dubious that there is any proprietary "special sauce" for running deep learning/multiple neural network type AI on large volume clinical/pathologic data. While I appreciate the small scale of startups for getting stuff off the ground, I am very worried about how patents will be filed and stakes will be claimed regarding "intellectual property". It makes sense that these models are an improvement over traditional algorithms. That these models will be claimed to be "uniquely appropriate" for given clinical scenario is unlikely to be a real thing fairly quickly. I'd hate for us to pay a lot for these tools on a per patient basis.

In principal the NIH could be continuously updating deep learning models for any number of clinical scenarios and making these tools free for practitioners. I would not be surprised if this is feasible fairly quickly.

Of course this is an exciting space for academics. All the young academic prostate bucks are on the papers.

Edit: I did find a CMS schedule for AlteraAI test. Seems to be ~$770. Compared to ADT pricing, it is reasonable. Potential market is large (~40K intermediate risk patients per year). Overhead must be quite small after initial investment.
 
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I am very worried about how patents will be filed and stakes will be claimed regarding "intellectual property"
The landscape for neural network patents is messy, and it's changing by the year. Just because someone gets a patent issued doesn't mean that it would be honored in court. It does mean that any would-be infringers have to think carefully about toeing the line, though.

An example I sometimes go back to is Mayo vs Prometheus, a landmark case that made its way to the Supreme Court. Prometheus had a patent that went like, "Take a blood test to measure X, where we want X to be at this level Y, and titrate your drug accordingly." (A Prometheus clinical study had identified an optimal value Y, and that was the nature of the patent.) It appears that Mayo looked at that patent and said, "That's hogwash, you can't patent that" and proceeded to infringe. Courts went back and forth on appeal before the Supreme Court ultimately sided with Mayo; the final verdict proved divisive. I sympathize with the "that's hogwash" viewpoint but also understand that there is a need to provide incentives short of a 20-year monopoly and if I were a benevolent dictator I would have trouble coming up with a general rule.

Neural networks are the same category. If we end up with half a dozen models by competing companies that are all reasonably priced, then society will be better off for it. My opinion is that a fast moving startup deserves some reward, but not a monopoly. Presumably at some point, larger companies will invest in getting new complementary sources of data (like, maybe a prospective data gathering effort that also measures RNA, and the company applies its secret sauce to these RNA samples that it does not share) and that will continue to move the needle forward with even better models.
 
I did find a CMS schedule for AlteraAI test. Seems to be ~$770. Compared to ADT pricing, it is reasonable. Potential market is large (~40K intermediate risk patients per year). Overhead must be quite small after initial investment.
Roughly 2/3 of men with intermediate risk disease DON'T need ADT according to the test. Pretty straightforward that makes economic sense in most cases. Additionally with competition price may fall
 
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Presumably at some point, larger companies will invest in getting new complementary sources of data (like, maybe a prospective data gathering effort that also measures RNA, and the company applies its secret sauce to these RNA samples that it does not share) and that will continue to move the needle forward with even better models.
I’m sure Decipher is working on it right now. Until they have the data from the current NRG trials though, I think their limitation of post-hoc RNA sample viability will limit their ability to prove its predictive.
 
Roughly 2/3 of men with intermediate risk disease DON'T need ADT according to the test. Pretty straightforward that makes economic sense in most cases. Additionally with competition price may fall
The value has to be measured relative to what the docs would do without the tool, including using free online nomograms. Most of us (hopefully) are not reflexively recommending ADT to all intermediate risk patients and we may be fairly close to the 60% mark not getting ADT even without the tool.

The question for me with any of these tools is "when there is discordance, who is right". It's much easier to be confident in the new tool when there is a discrete new piece of information provided (e.g. this looks like a low grade CA but has a particular gene expression that is very, very strongly associated with aggressive behavior).

Still, I do believe there is value regarding AI pouring over high volumes of pathologic slides and correlating with clinical outcomes. I would anticipate such tools being integrated into pathology labs in real time in the future.
 
I have a love/hate here. I have absolutely no doubt that genomic/transcriptomic phenotyping will improve our characterization and treatment recommendations for prostate cancer. There is already president in other solid tumors. I also realize it takes a lot of data to characterize predictive/prognostic tools. But I don’t love how these tests are frequently being presented to patients and used. Among the “recommendations” I’ve seen:

People with very high decipher scores need surgery because their tumor is too aggressive to leave in place.

People with intermediate risk disease and a high decipher score need ADT and hence shouldn’t have surgery.

Active surveillance is not recommended for patients with low risk disease and a high decipher score.

I could go on all day. The first two (which unfortunately I have seen documented in patients charts multiple times) are almost laughable. The third might be true, but we don’t know yet. It irks me because patients trust us and too many times they are told we have this test which will do X for them when in reality, we are still in the phase of using their data to help people in the future. If a regulator could document me telling a potential trial subject because they “needed” an experimental therapy because of the hypothesized benefit, I’d be lucky to practice medicine again at all.
 
I have a love/hate here. I have absolutely no doubt that genomic/transcriptomic phenotyping will improve our characterization and treatment recommendations for prostate cancer. There is already president in other solid tumors. I also realize it takes a lot of data to characterize predictive/prognostic tools. But I don’t love how these tests are frequently being presented to patients and used. Among the “recommendations” I’ve seen:

People with very high decipher scores need surgery because their tumor is too aggressive to leave in place.

People with intermediate risk disease and a high decipher score need ADT and hence shouldn’t have surgery.

Active surveillance is not recommended for patients with low risk disease and a high decipher score.

I could go on all day. The first two (which unfortunately I have seen documented in patients charts multiple times) are almost laughable. The third might be true, but we don’t know yet. It irks me because patients trust us and too many times they are told we have this test which will do X for them when in reality, we are still in the phase of using their data to help people in the future. If a regulator could document me telling a potential trial subject because they “needed” an experimental therapy because of the hypothesized benefit, I’d be lucky to practice medicine again at all.

They may have taken it off the newer Decipher print outs (?I thought I missed seeing it on my last case?) but they used to print off that "predictor" of response to different therapies like radiation or ADT or chemo.

I don't recall those having robust validation...but lack of ADT response and/or XRT response predictor was often used as a reason for surgery in urology notes.
 
I have a love/hate here. I have absolutely no doubt that genomic/transcriptomic phenotyping will improve our characterization and treatment recommendations for prostate cancer. There is already president in other solid tumors. I also realize it takes a lot of data to characterize predictive/prognostic tools. But I don’t love how these tests are frequently being presented to patients and used. Among the “recommendations” I’ve seen:

People with very high decipher scores need surgery because their tumor is too aggressive to leave in place.

People with intermediate risk disease and a high decipher score need ADT and hence shouldn’t have surgery.

Active surveillance is not recommended for patients with low risk disease and a high decipher score.

I could go on all day. The first two (which unfortunately I have seen documented in patients charts multiple times) are almost laughable. The third might be true, but we don’t know yet. It irks me because patients trust us and too many times they are told we have this test which will do X for them when in reality, we are still in the phase of using their data to help people in the future. If a regulator could document me telling a potential trial subject because they “needed” an experimental therapy because of the hypothesized benefit, I’d be lucky to practice medicine again at all.
Great points. The times I’ve suggested doing one of these tests, the patients are extremely enthusiastic, and I think it’s easy for doctors of all specialties to feed into that
 
I was going through the NCCN guidelines and noticed some pretty substantial changes in version 4.2024. Mainly there is now the whole new section on risk stratification and how this now affects treatment decisions regarding AS, Tx +/- ADT and duration of ADT instead of just the old NCCN risk categories. This seems to be pushing the Decipher test pretty hard to make these decisions. What is everyone's thoughts on this?
v4.2024 has classic high risk criteria: T3, GS 8+, PSA > 20. Doubt molecular tests are ready to change that
 
v4.2024 has classic high risk criteria: T3, GS 8+, PSA > 20. Doubt molecular tests are ready to change that
They have a section on “advanced risk stratification.” It is buried way back in the guidelines.
 
So what’s going to happen with the ongoing NRG trials using Decipher?
It will continue. As cool as this is (and I think it has a lot of value), it’s essentially a big retrospective modeling study. GU10 is a prospective study that will hopefully prove it is safe to guide therapy with a genomic predictor.
 
So what’s going to happen with the ongoing NRG trials using Decipher?
The intensification arms of GU009 and GU010 should close this year; accruing very very well. Non-intensification next year roughly
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Anybody notice NCCN guidelines are listing SBRT boost as an option instead of brachy boost in high risk? I've done this a handful of times before to 20 Gy in 2 fractions focal boosting to 22 with good results. NCCN lists 19 Gy in 2 fractions.

How is this paid for? If you do 23 fractions of IMRT preceded or followed by (I've done it both ways but usually follow this protocol) SBRT boost, do you just get paid for 25 fractions of IMRT? Or can you successfully bill 2 separate plans with an SBRT management code for the boost?
 
Anybody notice NCCN guidelines are listing SBRT boost as an option instead of brachy boost in high risk? I've done this a handful of times before to 20 Gy in 2 fractions focal boosting to 22 with good results. NCCN lists 19 Gy in 2 fractions.

How is this paid for? If you do 23 fractions of IMRT preceded or followed by (I've done it both ways but usually follow this protocol) SBRT boost, do you just get paid for 25 fractions of IMRT? Or can you successfully bill 2 separate plans with an SBRT management code for the boost?
I haven’t looked at Evicore guidelines on this lately, but helped take care of few pts in whom SBRT boost did not pass prior auth
 
Anybody notice NCCN guidelines are listing SBRT boost as an option instead of brachy boost in high risk? I've done this a handful of times before to 20 Gy in 2 fractions focal boosting to 22 with good results. NCCN lists 19 Gy in 2 fractions.

How is this paid for? If you do 23 fractions of IMRT preceded or followed by (I've done it both ways but usually follow this protocol) SBRT boost, do you just get paid for 25 fractions of IMRT? Or can you successfully bill 2 separate plans with an SBRT management code for the boost?
I think it'd count as VMAT and not SBRT from a billing standpoint
 
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I think it's count as VMAT and not SBRT from a billing standpoint
That’s unfortunate because it’s a lot more work on both the pro and tech side. And it’s probably the right thing to do for high risk patients if you can’t brachy boost
 
That’s unfortunate because it’s a lot more work on both the pro and tech side. And it’s probably the right thing to do for high risk patients if you can’t brachy boost
Not that it'd matter with ROCR coming (not meant to derail) but I feel like the whole lack of standard insurance definition for SBRT and the arbitrary 5 fraction cut off would be a great thing to revisit
 
Not that it'd matter with ROCR coming (not meant to derail) but I feel like the whole lack of standard insurance definition for SBRT and the arbitrary 5 fraction cut off would be a great thing to revisit
How many rad oncs are going to treat with 23 pelvic imrt pelvic + 2 sbrt prostate fractions vs. 45 fractions of imrt if the former only pays as 25 fractions of imrt? Perverse incentives. The latter should pay more.
 
How many rad oncs are going to treat with 23 pelvic imrt pelvic + 2 sbrt prostate fractions vs. 45 fractions of imrt if the former only pays as 25 fractions of imrt? Perverse incentives. The latter should pay more.
Most common fractionation in my neighborhood is 28 fx. 25 isn't too far off from that.

But I agree there's always been perverse incentives in this space
 
How many rad oncs are going to treat with 23 pelvic imrt pelvic + 2 sbrt prostate fractions vs. 45 fractions of imrt if the former only pays as 25 fractions of imrt? Perverse incentives. The latter should pay more.
Simul DMed me regarding this:

"my company OncoHealth is approving ebrt + SBRT boost for prostate, bc the NCCN changed recently. Paid separately, but need to get approval for both. I don’t know what other companies are doing.

We look at it as same as brachy boost - which is paid separately"

Fyi. So at least there is support from (some/one) PA companies
 
Simul DMed me regarding this:

"my company OncoHealth is approving ebrt + SBRT boost for prostate, bc the NCCN changed recently. Paid separately, but need to get approval for both. I don’t know what other companies are doing.

We look at it as same as brachy boost - which is paid separately"

Fyi. So at least there is support from (some/one) PA companies
Thanks, will try to fight it in p2p quoting NCCN.

It’s insane UHC would pay for Brachy boost but only consider SBRT as 2 extra imrt fractions on the same plan.
 
Simul DMed me regarding this:

"my company OncoHealth is approving ebrt + SBRT boost for prostate, bc the NCCN changed recently. Paid separately, but need to get approval for both. I don’t know what other companies are doing.

We look at it as same as brachy boost - which is paid separately"

Fyi. So at least there is support from (some/one) PA companies
This is extremely interesting

My billers default to "it's one course so you can't have separate SBRT"

Please share results and specific insurers if this can be done!!
 
This is extremely interesting

My billers default to "it's one course so you can't have separate SBRT"

Please share results and specific insurers if this can be done!!
If they pay brachy separate they should pay sbrt. What is the global difference between LDR implant and 2 fractions of SBRT?
 
If they pay brachy separate they should pay sbrt. What is the global difference between LDR implant and 2 fractions of SBRT?
Not that it'd matter with ROCR coming (not meant to derail) but I feel like the whole lack of standard insurance definition for SBRT and the arbitrary 5 fraction cut off would be a great thing to revisit

This is where a real definition of SBRT that isn't simply # of fractions would go a long way.

It's its own technique. It should be recognized as such, even if it's 7 fractions, or you're doing consecutive SBRTs.
 
Evicore and UHC need to change their guidelines to allow separate billing for sbrt boost now that it’s in NCCN. The data is good for it, both cyberknife and traditional linac. And from an RVU standpoint 23-28 of IMRT plus 2 fractions of SBRT is about the same as 45 fraction of IMRT. If anyone is doing this please fight them on p2p until they change guidelines. I know I will.
 
Evicore and UHC need to change their guidelines to allow separate billing for sbrt boost now that it’s in NCCN. The data is good for it, both cyberknife and traditional linac. And from an RVU standpoint 23-28 of IMRT plus 2 fractions of SBRT is about the same as 45 fraction of IMRT. If anyone is doing this please fight them on p2p until they change guidelines. I know I will.
Somehow I feel if RTOG 9508 had had staying power we wouldn’t be arguing with the insurances over this. Fractionated cranial SRS and SBRT are the same CPT code, and afaik I have never had a MAC deny payment when IMRT treatment codes and SBRT codes happened consecutively and very close together in time.
 
Somehow I feel if RTOG 9508 had had staying power we wouldn’t be arguing with the insurances over this. Fractionated cranial SRS and SBRT are the same CPT code, and afaik I have never had a MAC deny payment when IMRT treatment codes and SBRT codes happened consecutively and very close together in time.
They will say you need a separate consult note and the two treatments have to be sequential events and unrelated.
 
If they pay brachy separate they should pay sbrt. What is the global difference between LDR implant and 2 fractions of SBRT?
You are being too logical. I've had this problem from the GYN world for ages. I don't think that SBRT is equivalent as a boost for most GYN cancers (though if done right, it probably could be) so it is not my preference but every now and then you get a patient who can't get brachy (usually its a case that would need interstitial and they have issues with bleeding, anesthesia, etc) and I have not found a payor who will approve an SBRT boost. Heck, some won't even approve increasing to just 33 fractions of IMRT to try for a conventional boost because "we don't do that for cervical cancer". I am not at all surprised to hear of PA denying SBRT for prostate even though in this instance, there is pretty good data for it.
 
Anybody notice NCCN guidelines are listing SBRT boost as an option instead of brachy boost in high risk? I've done this a handful of times before to 20 Gy in 2 fractions focal boosting to 22 with good results. NCCN lists 19 Gy in 2 fractions.

How is this paid for? If you do 23 fractions of IMRT preceded or followed by (I've done it both ways but usually follow this protocol) SBRT boost, do you just get paid for 25 fractions of IMRT? Or can you successfully bill 2 separate plans with an SBRT management code for the boost?
I don’t see where it references SBRT boost in the nccn guidelines (just searched all mentions of ‘SBRT’) - do you have a page # so I can reference? I use a lot of SBRT boost in my practice but occasionally get denied by insurance so this would be very helpful to have.
 
They will say you need a separate consult note and the two treatments have to be sequential events and unrelated.

You are being too logical. I've had this problem from the GYN world for ages. I don't think that SBRT is equivalent as a boost for most GYN cancers (though if done right, it probably could be) so it is not my preference but every now and then you get a patient who can't get brachy (usually its a case that would need interstitial and they have issues with bleeding, anesthesia, etc) and I have not found a payor who will approve an SBRT boost. Heck, some won't even approve increasing to just 33 fractions of IMRT to try for a conventional boost because "we don't do that for cervical cancer". I am not at all surprised to hear of PA denying SBRT for prostate even though in this instance, there is pretty good data for it.
Great examples of where ASTRO could get off its a$$ and be a force for good. But they would have to be abrasive toward the precious payors and their friends at Medicare. However obsequiousness is a hard habit to break.
 
Never understood why it was preferred to begin with....
Agreed - studies either show more toxicity or at best neutral. None better.

I don’t see where it references SBRT boost in the nccn guidelines (just searched all mentions of ‘SBRT’) - do you have a page # so I can reference? I use a lot of SBRT boost in my practice but occasionally get denied by insurance so this would be very helpful to have.
Principles of radiation section. At the bottom of the table listing different fractionations. PROS-I, 4 of 8.
 
Agreed - studies either show more toxicity or at best neutral. None better.


Principles of radiation section. At the bottom of the table listing different fractionations. PROS-I, 4 of 8.
Yes, the fractionation is 9.5 x 2 you can search for that.
 
You are being too logical. I've had this problem from the GYN world for ages. I don't think that SBRT is equivalent as a boost for most GYN cancers (though if done right, it probably could be) so it is not my preference but every now and then you get a patient who can't get brachy (usually its a case that would need interstitial and they have issues with bleeding, anesthesia, etc) and I have not found a payor who will approve an SBRT boost. Heck, some won't even approve increasing to just 33 fractions of IMRT to try for a conventional boost because "we don't do that for cervical cancer". I am not at all surprised to hear of PA denying SBRT for prostate even though in this instance, there is pretty good data for it.
In my case the patient has gg5 dz with PSA > 100 but no nodal or bone dz and gross disease in the seminal vesicle and low lying bowel abutting the SV. No amount of bladder filling will move the bowel away. I don’t know what else to do at this point and am thinking 2 fractions of sbrt with extremely tight margins peeling off bowel is my best options vs. going to 80 gy with god knows what kind of daily match. Thoughts?
 
In my case the patient has gg5 dz with PSA > 100 but no nodal or bone dz and gross disease in the seminal vesicle and low lying bowel abutting the SV. No amount of bladder filling will move the bowel away. I don’t know what else to do at this point and am thinking 2 fractions of sbrt with extremely tight margins peeling off bowel is my best options vs. going to 80 gy with god knows what kind of daily match. Thoughts?
I wouldn't dose escalate here. I doubt it does anything regarding the natural history of GG5/PSA 100 disease based off of the prospective data. The early progression with GG5 patients happens independent of dose escalation. You might save a few later biochemical failures, but not sure how relevant that is for this patient?

My general feeling about dose escalation is that it may actually benefit the unfavorable intermediate or GG4 patient the most. Still good prognosis and lower risk of distant dissemination. You expect your benefit 5 years down the road.
 
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