SpaceOAR - Augmenix, Boston Scientific, and Conflicts of Interest

[elementaryschooleconomics]

SpaceOAR is discussed often here on SDN. In the summer of 2021 (in the "RadOnc Twitter" thread), @TheWallnerus et al calculated how much the authors of the 2015 SpaceOAR Phase III trial paper (crucial for FDA approval) were paid. To recap:

Neil Mariados received $100,000.
John Sylvester received $210,000.
Dhiren Shah received $100,000.
David Beyer received $2500.
Steven Kurtzman received $25,000.
Rodney Ellis $7,000.
Edward Soffen $56,000.
Peter Rossi $220,000.
Daniel Hamstra $100,000.
Jeff Michalski received $9000.

TOTAL: ~$830K to the SpaceOAR authors.

All of this is verifiable on openpayments.org (as in, I want to be clear - no one is hiding anything).

Other interesting items from the internet:

Using OpenPayments, Augmenix has made $1,659,900.87 in general payments (mostly to physicians) since 2015.

From 2015-2017, you can see how much Augmenix paid in ownership and investment interest. Starting in 2018, that information is no longer available. Why? Because Boston Scientific acquired Augmenix in September 2018 for $500 million in up-front cash and up to $100 million for reaching sales-based milestones.

Again looking at OpenPayments, 2017 is the busiest/"most expensive" year for Augmenix, which makes sense - SpaceOAR had FDA approval at that point, and it was the last full calendar year before being acquired by Boston Scientific.

In 2017, Augmenix made 1,110 payments to JUST physicians. Some of these are multiple payments to the same person. You can download all this data in Excel. So, that's what I did. Drilling down further, it appears that 1,110 payments were made to 727 physicians in 2017 alone. It's the government, and they make you report payments for even a $2 coffee. Excluding those small $2-$5 payments...you can see a lot of $200 dinners. Excluding those payments, we're still left with ~112 payments of at least $300, with the highest payment being $28,228. This is JUST for 2017.

But who are these physicians? Are they "just" those greedy private practice docs no one has ever heard of? Of course not.

Sorting through the Augmenix and Boston Scientific OpenPayments data, some of the highest paid folks from 2015 to now include:

Peter Orio - Vice Chair of Network Operations for Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC) Department of Radiation Oncology (formerly Assistant Chief of Radiation Oncology at Brooke Army Medical Center) - $285,045 from Boston Scientific, $213,135 from Augmenix

Daniela Hamstra - Chair, Department of Radiation Oncology, Baylor - $100,961 from Augmenix, $6,426 from Boston Scientific

Michael J. Zelefsky - Vice Chair, Department of Radiation Oncology, Clinical Research; Chief, Brachytherapy Service; Steven A. Greenberg Chair in Prostate Cancer Research - $356,681 from Boston Scientific, $132,570 from Augmenix

Paul L. Nguyen - DF/BWCC Genitourinary Clinical Center Director for Radiation Oncology, Vice-Chair for Clinical Research in the Department of Radiation Oncology, and Professor at Harvard Medical School - $300,744 from Boston Scientific, $132,575 from Augmenix

Brian Davis - Mayo, committee member of American Board of Radiology on certification exams and member of the American College of Radiology Appropriateness Criteria Committee on Prostate Cancer - $28,512 from Augmenix, $7,243 from Boston Scientific

James Yu - Professor and Executive Vice Chair, Department of Radiation Oncology, Columbia (formerly Associate Chief Medical Officer for Radiation Oncology, Yale) - $84,388 from Boston Scientific, $57,616 from Augmenix

I think SpaceOAR is a very useful tool. I like that we have it. However, there is literally nothing like this in modern Radiation Oncology. Our treatment does not generally revolve around drugs or multiple medical devices. Unlike other specialties, we are rarely targeted by pharma/device companies and offered consulting fees for our efforts. Enter: Augmenix.

Augmenix starts generating seed funding in the late 2000s/early 2010s. OpenPayments only goes back to 2015, so who knows what happened before then. What is clear is that Augmenix and Boston Scientific have paid literally thousands of physicians (mostly Radiation Oncologists) literally millions of dollars over the last 7 years (at the very least, maybe longer).

The people listed above, some of whom have personally received several hundred thousand dollars from Augmenix/Boston Scientific, hold a lot of influence. At the very least, they have trained (and continue to train) a significant number of residents. At most, they are KOLs, Chairs of Departments, invited faculty delivering the GU ASTRO Spring Refresher lectures, and ABR board examiners. Just these six people alone have a tremendous impact on how Radiation Oncology is practiced in 2022. These are six people out of literally thousands who have received some form of payment from Augmenix/Boston Scientific.

Prostate cancer is one of (if not the) most common diseases treated by Radiation Oncologists. The payments by Augmenix/Boston Scientific is unrivaled in Radiation Oncology.

Why am I posting this? Because everywhere I turn, there's a near universal application of SpaceOAR in prostate cancer in America. EPE, covering nodes - doesn't matter, SpaceOAR! What about the hundreds of thousands of prostate patients treated between the development of IMRT and the release of SpaceOAR, or the prostate patients treated in other counties where SpaceOAR hasn't been approved/adopted to this degree? Were their outcomes SO BAD that near universal application of SpaceOAR was required? I don't think so.

Really, to reiterate - this is a useful tool. I don't want it to go anywhere. What I do want, however, is for everyone to think a little harder about the use of SpaceOAR in their own practice and department. If you really think putting SpaceOAR in a guy with EPE who you're planning on covering nodes is worth it, then I have no problem with your personal practice. If, however, you're putting SpaceOAR in everyone simply because one of the faculty members in your department receives A LOT of money from Augmenix/SpaceOAR and it's now the culture to just put the gel in every prostate patient...are you choosing wisely?

---

Members don't see this ad.

 

[RickyScott]

SpaceOAR is discussed often here on SDN. In the summer of 2021 (in the "RadOnc Twitter" thread), @TheWallnerus et al calculated how much the authors of the 2015 SpaceOAR Phase III trial paper (crucial for FDA approval) were paid. To recap:

Neil Mariados received $100,000.
John Sylvester received $210,000.
Dhiren Shah received $100,000.
David Beyer received $2500.
Steven Kurtzman received $25,000.
Rodney Ellis $7,000.
Edward Soffen $56,000.
Peter Rossi $220,000.
Daniel Hamstra $100,000.
Jeff Michalski received $9000.

TOTAL: ~$830K to the SpaceOAR authors.

All of this is verifiable on openpayments.org (as in, I want to be clear - no one is hiding anything).

Other interesting items from the internet:

Using OpenPayments, Augmenix has made $1,659,900.87 in general payments (mostly to physicians) since 2015.

From 2015-2017, you can see how much Augmenix paid in ownership and investment interest. Starting in 2018, that information is no longer available. Why? Because Boston Scientific acquired Augmenix in September 2018 for $500 million in up-front cash and up to $100 million for reaching sales-based milestones.

Again looking at OpenPayments, 2017 is the busiest/"most expensive" year for Augmenix, which makes sense - SpaceOAR had FDA approval at that point, and it was the last full calendar year before being acquired by Boston Scientific.

In 2017, Augmenix made 1,110 payments to JUST physicians. Some of these are multiple payments to the same person. You can download all this data in Excel. So, that's what I did. Drilling down further, it appears that 1,110 payments were made to 727 physicians in 2017 alone. It's the government, and they make you report payments for even a $2 coffee. Excluding those small $2-$5 payments...you can see a lot of $200 dinners. Excluding those payments, we're still left with ~112 payments of at least $300, with the highest payment being $28,228. This is JUST for 2017.

But who are these physicians? Are they "just" those greedy private practice docs no one has ever heard of? Of course not.

Sorting through the Augmenix and Boston Scientific OpenPayments data, some of the highest paid folks from 2015 to now include:

Peter Orio - Vice Chair of Network Operations for Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC) Department of Radiation Oncology (formerly Assistant Chief of Radiation Oncology at Brooke Army Medical Center) - $285,045 from Boston Scientific, $213,135 from Augmenix

Daniela Hamstra - Chair, Department of Radiation Oncology, Baylor - $100,961 from Augmenix, $6,426 from Boston Scientific

Michael J. Zelefsky - Vice Chair, Department of Radiation Oncology, Clinical Research; Chief, Brachytherapy Service; Steven A. Greenberg Chair in Prostate Cancer Research - $356,681 from Boston Scientific, $132,570 from Augmenix

Paul L. Nguyen - DF/BWCC Genitourinary Clinical Center Director for Radiation Oncology, Vice-Chair for Clinical Research in the Department of Radiation Oncology, and Professor at Harvard Medical School - $300,744 from Boston Scientific, $132,575 from Augmenix

Brian Davis - Mayo, committee member of American Board of Radiology on certification exams and member of the American College of Radiology Appropriateness Criteria Committee on Prostate Cancer - $28,512 from Augmenix, $7,243 from Boston Scientific

James Yu - Professor and Executive Vice Chair, Department of Radiation Oncology, Columbia (formerly Associate Chief Medical Officer for Radiation Oncology, Yale) - $84,388 from Boston Scientific, $57,616 from Augmenix

I think SpaceOAR is a very useful tool. I like that we have it. However, there is literally nothing like this in modern Radiation Oncology. Our treatment does not generally revolve around drugs or multiple medical devices. Unlike other specialties, we are rarely targeted by pharma/device companies and offered consulting fees for our efforts. Enter: Augmenix.

Augmenix starts generating seed funding in the late 2000s/early 2010s. OpenPayments only goes back to 2015, so who knows what happened before then. What is clear is that Augmenix and Boston Scientific have paid literally thousands of physicians (mostly Radiation Oncologists) literally millions of dollars over the last 7 years (at the very least, maybe longer).

The people listed above, some of whom have personally received several hundred thousand dollars from Augmenix/Boston Scientific, hold a lot of influence. At the very least, they have trained (and continue to train) a significant number of residents. At most, they are KOLs, Chairs of Departments, invited faculty delivering the GU ASTRO Spring Refresher lectures, and ABR board examiners. Just these six people alone have a tremendous impact on how Radiation Oncology is practiced in 2022. These are six people out of literally thousands who have received some form of payment from Augmenix/Boston Scientific.

Prostate cancer is one of (if not the) most common diseases treated by Radiation Oncologists. The payments by Augmenix/Boston Scientific is unrivaled in Radiation Oncology.

Why am I posting this? Because everywhere I turn, there's a near universal application of SpaceOAR in prostate cancer in America. EPE, covering nodes - doesn't matter, SpaceOAR! What about the hundreds of thousands of prostate patients treated between the development of IMRT and the release of SpaceOAR, or the prostate patients treated in other counties where SpaceOAR hasn't been approved/adopted to this degree? Were their outcomes SO BAD that near universal application of SpaceOAR was required? I don't think so.

Really, to reiterate - this is a useful tool. I don't want it to go anywhere. What I do want, however, is for everyone to think a little harder about the use of SpaceOAR in their own practice and department. If you really think putting SpaceOAR in a guy with EPE who you're planning on covering nodes is worth it, then I have no problem with your personal practice. If, however, you're putting SpaceOAR in everyone simply because one of the faculty members in your department receives A LOT of money from Augmenix/SpaceOAR and it's now the culture to just put the gel in every prostate patient...are you choosing wisely?

Space oar had a very minor absolute benefit in G1/G2 toxicity assuming you don’t count the actual placement of the space oar as a “toxicity” (in that case, it is an added toxicity)
I don’t think it is useful outside of dose escalated sbrt. Never seen G3 or G4 rectal toxicity from conventional ebrt, but certainly happens with placement of space oar.

 

[RadOncMegatron]

SpaceOAR is discussed often here on SDN. In the summer of 2021 (in the "RadOnc Twitter" thread), @TheWallnerus et al calculated how much the authors of the 2015 SpaceOAR Phase III trial paper (crucial for FDA approval) were paid. To recap:

Neil Mariados received $100,000.
John Sylvester received $210,000.
Dhiren Shah received $100,000.
David Beyer received $2500.
Steven Kurtzman received $25,000.
Rodney Ellis $7,000.
Edward Soffen $56,000.
Peter Rossi $220,000.
Daniel Hamstra $100,000.
Jeff Michalski received $9000.

TOTAL: ~$830K to the SpaceOAR authors.

All of this is verifiable on openpayments.org (as in, I want to be clear - no one is hiding anything).

Other interesting items from the internet:

Using OpenPayments, Augmenix has made $1,659,900.87 in general payments (mostly to physicians) since 2015.

From 2015-2017, you can see how much Augmenix paid in ownership and investment interest. Starting in 2018, that information is no longer available. Why? Because Boston Scientific acquired Augmenix in September 2018 for $500 million in up-front cash and up to $100 million for reaching sales-based milestones.

Again looking at OpenPayments, 2017 is the busiest/"most expensive" year for Augmenix, which makes sense - SpaceOAR had FDA approval at that point, and it was the last full calendar year before being acquired by Boston Scientific.

In 2017, Augmenix made 1,110 payments to JUST physicians. Some of these are multiple payments to the same person. You can download all this data in Excel. So, that's what I did. Drilling down further, it appears that 1,110 payments were made to 727 physicians in 2017 alone. It's the government, and they make you report payments for even a $2 coffee. Excluding those small $2-$5 payments...you can see a lot of $200 dinners. Excluding those payments, we're still left with ~112 payments of at least $300, with the highest payment being $28,228. This is JUST for 2017.

But who are these physicians? Are they "just" those greedy private practice docs no one has ever heard of? Of course not.

Sorting through the Augmenix and Boston Scientific OpenPayments data, some of the highest paid folks from 2015 to now include:

Peter Orio - Vice Chair of Network Operations for Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC) Department of Radiation Oncology (formerly Assistant Chief of Radiation Oncology at Brooke Army Medical Center) - $285,045 from Boston Scientific, $213,135 from Augmenix

Daniela Hamstra - Chair, Department of Radiation Oncology, Baylor - $100,961 from Augmenix, $6,426 from Boston Scientific

Michael J. Zelefsky - Vice Chair, Department of Radiation Oncology, Clinical Research; Chief, Brachytherapy Service; Steven A. Greenberg Chair in Prostate Cancer Research - $356,681 from Boston Scientific, $132,570 from Augmenix

Paul L. Nguyen - DF/BWCC Genitourinary Clinical Center Director for Radiation Oncology, Vice-Chair for Clinical Research in the Department of Radiation Oncology, and Professor at Harvard Medical School - $300,744 from Boston Scientific, $132,575 from Augmenix

Brian Davis - Mayo, committee member of American Board of Radiology on certification exams and member of the American College of Radiology Appropriateness Criteria Committee on Prostate Cancer - $28,512 from Augmenix, $7,243 from Boston Scientific

James Yu - Professor and Executive Vice Chair, Department of Radiation Oncology, Columbia (formerly Associate Chief Medical Officer for Radiation Oncology, Yale) - $84,388 from Boston Scientific, $57,616 from Augmenix

I think SpaceOAR is a very useful tool. I like that we have it. However, there is literally nothing like this in modern Radiation Oncology. Our treatment does not generally revolve around drugs or multiple medical devices. Unlike other specialties, we are rarely targeted by pharma/device companies and offered consulting fees for our efforts. Enter: Augmenix.

Augmenix starts generating seed funding in the late 2000s/early 2010s. OpenPayments only goes back to 2015, so who knows what happened before then. What is clear is that Augmenix and Boston Scientific have paid literally thousands of physicians (mostly Radiation Oncologists) literally millions of dollars over the last 7 years (at the very least, maybe longer).

The people listed above, some of whom have personally received several hundred thousand dollars from Augmenix/Boston Scientific, hold a lot of influence. At the very least, they have trained (and continue to train) a significant number of residents. At most, they are KOLs, Chairs of Departments, invited faculty delivering the GU ASTRO Spring Refresher lectures, and ABR board examiners. Just these six people alone have a tremendous impact on how Radiation Oncology is practiced in 2022. These are six people out of literally thousands who have received some form of payment from Augmenix/Boston Scientific.

Prostate cancer is one of (if not the) most common diseases treated by Radiation Oncologists. The payments by Augmenix/Boston Scientific is unrivaled in Radiation Oncology.

Why am I posting this? Because everywhere I turn, there's a near universal application of SpaceOAR in prostate cancer in America. EPE, covering nodes - doesn't matter, SpaceOAR! What about the hundreds of thousands of prostate patients treated between the development of IMRT and the release of SpaceOAR, or the prostate patients treated in other counties where SpaceOAR hasn't been approved/adopted to this degree? Were their outcomes SO BAD that near universal application of SpaceOAR was required? I don't think so.

Really, to reiterate - this is a useful tool. I don't want it to go anywhere. What I do want, however, is for everyone to think a little harder about the use of SpaceOAR in their own practice and department. If you really think putting SpaceOAR in a guy with EPE who you're planning on covering nodes is worth it, then I have no problem with your personal practice. If, however, you're putting SpaceOAR in everyone simply because one of the faculty members in your department receives A LOT of money from Augmenix/SpaceOAR and it's now the culture to just put the gel in every prostate patient...are you choosing wisely?

Tremendous post.

 

[evilbooyaa]

ESE with the hard hitting facts.
First off, kudos to you for finding this.
Second off, how do you have the time to go on deep dives for this? Scarbrtj junior, my dude.

 

[elementaryschooleconomics]

ESE with the hard hitting facts.
First off, kudos to you for finding this.
Second off, how do you have the time to go on deep dives for this? Scarbrtj junior, my dude.

1) I literally have no hobbies outside of getting annoyed at random RadOnc things and having access to the internet.

2) This particular topic has consumed a large amount of my professional life for several years now. I've been sitting on this for awhile, hoping someone else would post/publish/Tweet etc. But the combo of the posts over the last few days of high risk/nodal coverage + SpaceOAR and using SpaceOAR with EPE coincided with some spirited chart rounds debates and admin doing admin stuff at me so...this was the coping mechanism I chose.

 

[Palex80]

1) I literally have no hobbies outside of getting annoyed at random RadOnc things and having access to the internet.

2) This particular topic has consumed a large amount of my professional life for several years now. I've been sitting on this for awhile, hoping someone else would post/publish/Tweet etc. But the combo of the posts over the last few days of high risk/nodal coverage + SpaceOAR and using SpaceOAR with EPE coincided with some spirited chart rounds debates and admin doing admin stuff at me so...this was the coping mechanism I chose.

Send it to the Red Journal. Fast track approval. All they need to do is find a reviewer without a COI … oh wait …

 

[TheWallnerus]

I think SpaceOAR is a very useful tool. I like that we have it. However, there is literally nothing like this in modern Radiation Oncology. Our treatment does not generally revolve around drugs or multiple medical devices. Unlike other specialties, we are rarely targeted by pharma/device companies and offered consulting fees for our efforts. Enter: Augmenix.

If you try to convince me that it’s pure coincidence that the first medical device company to come in to rad onc and lavish its top docs with handsome sums of money gets 1) a positive result in a later randomized trial, and 2) high levels of MD use/acceptance on the SOLE basis of that trial (because what else reason would there be?), I would say: can’t we be honest? Dost thou take me for a fool?

You can not pay, and pay, and pay, doctors and then have them publish a (weakly) positive trial later and expect me to believe the trial, right? I mean, I get to remain skeptical. Right? Aren’t we in medicine to remain skeptical, or are we like the lonely guy at the dance who never got a speck of female attention but when the first pretty girl comes along for a dance we want to marry her that night.

The sky is not falling because rad oncs use SpaceOAR. I do however feel a little badly for patients; I can’t agree it’s a “great tool” and perhaps I never will. That many docs do use SpaceOAR to ubiquity-reaching levels, and especially our “leaders,” it is sad. And it is the definition of venality. Fact: rad onc has been venal in regards to SpaceOAR. And that means rad onc can’t honestly lay claim to being the best field in medicine. (Tied for best, at best.) Well, this is just the nagging thought I have in my own mind.

 

[elementaryschooleconomics]

You can not pay, and pay, and pay, doctors and then have them publish a (weakly) positive trial later and expect me to believe the trial, right? I mean, I get to remain skeptical. Right? Aren’t we in medicine to remain skeptical, or are we like the lonely guy at the dance who never got a speck of female attention but when the first pretty girl comes along for a dance we want to marry her that night.

There's also this underrated post by @SneakyBooger, where I will steal the graphics:

Going into the Phase III trial used for its approval:

Really??? Part of the entire rationale for using SpaecOAR is the reduction in rectal toxicity. While the DVH looked better (I mean, how could it not) the primary safety endpoint was not met, there was NOT a difference in rectal side effects, and this is literally spun as a positive in the Discussion.

Send it to the Red Journal. Fast track approval. All they need to do is find a reviewer without a COI … oh wait …

I have thought about publishing this "the traditional way" for quite some time. This is not something I just discovered yesterday, this is data I have sitting in an old Dropbox folder. However, given the people involved...why would I want to publish this non-anonymously?

Again, to be very clear, I don't think anyone did anything wrong. I know a lot of the people who have received money from Augmenix/Boston Scientific. They sincerely believe in SpaceOAR. I also know people who sincerely believe in SpaceOAR who haven't received any money (well...the reps have taken them to dinner, and they have provided the equipment at a steep discount...).

The only people I know who are very pro-SpaceOAR who don't have financial COI are the residents and junior faculty who either trained under, or work directly with, influential faculty who have significant financial COI with SpaceOAR. I find that to be a problem.

SpaceOAR can be good in the right situation. I just want people to think critically about why they are using SpaceOAR - especially residents working with these faculty.

Resident lurkers: do you use SpaceOAR in your department? Go to openpayments.org and look up the faculty advocating for SpaceOAR's use. If Urology places it and not RadOnc at your institution, make sure you look up your Urologists as well. If junior faculty instituted SpaceOAR in your department and don't have COI, look at where they trained - I can almost guarantee they're from an institution with a "big-name" faculty who has received a lot of money from Augmenix.

 

[Mandelin Rain]

Incredible thread. Stay woke out there rad onc. Wolves are circling.

 

[TheWallnerus]

I know a lot of the people who have received money from Augmenix/Boston Scientific. They sincerely believe in SpaceOAR.

I reflexively ignore these people. I get the same warning light kicking in like I do for a politician who gets NRA donations telling me about the second amendment ... or Florida politicians ostensibly telling me how great proton therapy is. I think you have to ignore and/or discount the "beliefs" of those who receive suspicously large largesse from an entity in which they "believe." Jesus didn't have a single one of the twelve disciples on payroll.

 

[Mandelin Rain]

I would guess that this guy held the patent and his big payoff in 2018 was from the sale of the company:

Open Payments Data - CMS

openpaymentsdata.cms.gov

Good for him

EDIT: Here's the pilot study of 11 men that lead to the whole thing

Human collagen injections to reduce rectal dose during radiotherapy - PubMed

The transperineal injection of human collagen for the purpose of tissue displacement is well tolerated in the outpatient setting. The increased separation between the prostate and rectum resulted in a significant decrease in radiation dose to the rectum while receiving IMRT and was associated...

pubmed.ncbi.nlm.nih.gov

 

[elementaryschooleconomics]

I would guess that this guy held the patent and his big payoff in 2018 was from the sale of the company:

Open Payments Data - CMS

openpaymentsdata.cms.gov

Good for him

EDIT: Here's the pilot study of 11 men that lead to the whole thing

Human collagen injections to reduce rectal dose during radiotherapy - PubMed

The transperineal injection of human collagen for the purpose of tissue displacement is well tolerated in the outpatient setting. The increased separation between the prostate and rectum resulted in a significant decrease in radiation dose to the rectum while receiving IMRT and was associated...

pubmed.ncbi.nlm.nih.gov

Uh...wow. I didn't catch that. Good find.

 

[TheWallnerus]

Uh...wow. I didn't catch that. Good find.

View attachment 348283

 

[ramsesthenice]

I think the OP did a great job discussing COI. For me, an issue that hasn’t been discussed is the lack of thought that many people give to using new technology. As I have posted before, I think rectal spacers can be helpful but only for very specific indications. There is absolutely no data or even plausible rationale they are universally helpful or expected to do almost anything suggested on the website. But it’s not universal to Rad Onc or rectal spacers. Protons come to mind right away. There are clear examples where protons can offer meaningful advantages to patients. But 90% (ok, made up, but probably in the right zip code) of proton treatments are delivered simply because someone has a proton unit that needs to get used. The sad thing is that inevitably the true utility of these technologies gets lost as outside confidence is eroded.

I run into this a lot with industry trials and people picking mind numbing endpoints which are destined to fail and don’t align with what is know about the natural history of the condition, underlying pathophysiology, the mechanism of action, or an understanding of available endpoints.

 

[deleted941485]

We have it at our institution. Urology puts them in. They were recently bought by the hospital. Done in the office. They’ll line up 5-9 cases and just go to work.

It’s not going away. ROs May consider it because now we have so little else that we do. Urologists didn’t ask about the EBM when they embarked in this journey.

 

[elementaryschooleconomics]

I think the OP did a great job discussing COI. For me, an issue that hasn’t been discussed is the lack of thought that many people give to using new technology. As I have posted before, I think rectal spacers can be helpful but only for very specific indications. There is absolutely no data or even plausible rationale they are universally helpful or expected to do almost anything suggested on the website. But it’s not universal to Rad Onc or rectal spacers. Protons come to mind right away. There are clear examples where protons can offer meaningful advantages to patients. But 90% (ok, made up, but probably in the right zip code) of proton treatments are delivered simply because someone has a proton unit that needs to get used. The sad thing is that inevitably the true utility of these technologies gets lost as outside confidence is eroded.

I run into this a lot with industry trials and people picking mind numbing endpoints which are destined to fail and don’t align with what is know about the natural history of the condition, underlying pathophysiology, the mechanism of action, or an understanding of available endpoints.

Completely agree.

The rise of SpaceOAR - and lack of critical evaluation of its adoption - is so paradoxical to me. The group of GU RadOncs who embraced it with open arms are the same people who will debate to death how long and what type of ADT to use, whether or not you should cover pelvic nodes, when to use Axumin/PSMA and how to interpret it, etc.

I have a hard time reconciling someone injecting SpaceOAR in a very high risk patient while dissecting the nuance of mpMRI in the staging and prognosis of that same patient.

 

[deleted1111261]

Dirty.

 

[BobbyHeenan]

The reps (at least the ones that trained me) dropped a lot of names - Zelefsky and Michalski get mentioned a lot in the training.

Anecdotally, talking with a number of proton docs they have noted a big improvement in rectal toxicity with use, but I never noticed much on the photon side. I know a couple of proton centers that use it on the VAST majority of their patients.

I use it (and by "use it" I mean the urologists put it in) probably 1/5 cases. Patients need to be motivated IMO because those rare case reports of bad things happening are scary, so I don't want to feel like I talked someone into a procedure where they aren't on board for it. I tend to like it more when doing SBRT, but that is probably more "hand holding" me because the data is not for use in SBRT (was standard frac, bigger margin on the trial) and the very scary case report (kudos to Dr. Desai for publishing) is in an SBRT case, not a hypofrac case.

In fact, in off the record discussions with some spaceOAR SBRT gurus I've been told if they think gel infiltrating into rectum some they will switch to hypofrac.

 

[elementaryschooleconomics]

The reps (at least the ones that trained me) dropped a lot of names - Zelefsky and Michalski get mentioned a lot in the training.

Anecdotally, talking with a number of proton docs they have noted a big improvement in rectal toxicity with use, but I never noticed much on the photon side. I know a couple of proton centers that use it on the VAST majority of their patients.

I use it (and by "use it" I mean the urologists put it in) probably 1/5 cases. Patients need to be motivated IMO because those rare case reports of bad things happening are scary, so I don't want to feel like I talked someone into a procedure where they aren't on board for it. I tend to like it more when doing SBRT, but that is probably more "hand holding" me because the data is not for use in SBRT (was standard frac, bigger margin on the trial) and the very scary case report (kudos to Dr. Desai for publishing) is in an SBRT case, not a hypofrac case.

In fact, in off the record discussions with some spaceOAR SBRT gurus I've been told if they think gel infiltrating into rectum some they will switch to hypofrac.

"I make sure to place SpaceOAR before each of my proton prostate cases" - America

 

[TheWallnerus]

THERE IS NO DATA SUPPORTING THE USE OF PROTON THERAPY AND SPACEOAR

There is only data supporting 44 fractions of IMRT

(Ok, sure, you can do a V70 extrapolation.)

 

[ramsesthenice]

"I make sure to place SpaceOAR before each of my proton prostate cases" - America

View attachment 348287

I can hear it now:

Surgery! F'yeah!!!
Hypofrac! F'yeah!!!
Protons! F'yeah!!!
SpaceOAR! F'yeah!!!
Conventional! .....
SBRT! F'yeah!!!!

 

[TheWallnerus]

I can hear it now:

Surgery! F'yeah!!!
Hypofrac! F'yeah!!!
Protons! F'yeah!!!
SpaceOAR! F'yeah!!!
Conventional! .....
SBRT! F'yeah!!!!

They only do conventional fractionation in the Islamic Republic of Durkadurkastan

 

[communitydoc13]

Super interesting thread. Going back a little further, below is the link to the patent.

US Patent for Fillers and methods for displacing tissues to improve radiological outcomes Patent (Patent # 8,257,723 issued September 4, 2012) - Justia Patents Search

Certain embodiments include a method of improvising radiological outcomes by introducing a filler to between a first tissue location and a second tissue location to increase a distance between the first tissue location and the second tissue location, and administering a dose of radioactivity to...

patents.justia.com

Below is the link to a dosimetric paper from 2010 using cadaveric models. I knew the first author. As conscientious and bright as could be. Augmenix made a gift covering the research costs.

Effects of prostate-rectum separation on rectal dose from external beam radiotherapy - PubMed

Prostate-rectum spacers can allow for reduced rectal toxicity rates, treatment intensification, and/or reduced dependence on complex planning and treatment delivery techniques.

pubmed.ncbi.nlm.nih.gov

The dosimetric paper came out in 2010. There were already earlier clinical series with hyaluronic acid spacer papers out of Europe in 2007. The small 11 patient clinical series from Noyes was for human collagen, which is mad expensive I believe. This is not used in SpaceOAR.

The interesting part is the patent initially filed in 2003 and what patents mean (this I don't know). The patent is for a strategy. It is not regarding a specific formulation or protocol creating the rectal prostate space. Other people figured out what formulation worked for creating the space at relatively low cost. I do not know if there was any remuneration to the Hopkins folks who tried the PEG concept for spacer.

Wondering where the money came from circa 2005-2010? Looking at Board, CEO, etc of Augmenix prior to sale so interesting. Private equity at work.

 

[communitydoc13]

https://www.linkedin.com/in/john-pedersen-0660669

 

[DoctwoB]

2 studies that come to mind based on the data

1. COI study. Get a dataset of who is paid by the company as you have here. Get a dataset of medicare charges for spaceOAR. Anonymize it and correlate industry payments to spaceoar USE. Would be interesting to do it with and without low payment amounts, like does the $50 dollar dinner have an effect compared to the the 100,000 consulting fee.

2. Cost per QALY. Take the original spaceoar studies, use that data to estimate a difference in QALY, then look at cost effectiveness.

 

[medgator]

They only do conventional fractionation in the Islamic Republic of Durkadurkastan

Crazy to think it's almost 2 decades old

 

[elementaryschooleconomics]

2 studies that come to mind based on the data

1. COI study. Get a dataset of who is paid by the company as you have here. Get a dataset of medicare charges for spaceOAR. Anonymize it and correlate industry payments to spaceoar USE. Would be interesting to do it with and without low payment amounts, like does the $50 dollar dinner have an effect compared to the the 100,000 consulting fee.

2. Cost per QALY. Take the original spaceoar studies, use that data to estimate a difference in QALY, then look at cost effectiveness.

I had similar thoughts, I just don't have the bandwidth to do it myself. Someone do this! One of those financial toxicity people. They love this stuff.

 

[TheWallnerus]

2 studies that come to mind based on the data

1. COI study. Get a dataset of who is paid by the company as you have here. Get a dataset of medicare charges for spaceOAR. Anonymize it and correlate industry payments to spaceoar USE. Would be interesting to do it with and without low payment amounts, like does the $50 dollar dinner have an effect compared to the the 100,000 consulting fee.

2. Cost per QALY. Take the original spaceoar studies, use that data to estimate a difference in QALY, then look at cost effectiveness.

Norway did a SpaceOAR QALY analysis. And subsequently banned all SpaceOAR from importation!

Hydrogel rectal spacer SpaceOA

 

[elementaryschooleconomics]

Norway did a SpaceOAR QALY analysis. And subsequently banned all SpaceOAR from importation!

Hydrogel rectal spacer SpaceOA

Wait wait wait - what is this? This seems like witchcraft.

In America, we would simply send an email with a SurveyMonkey link asking nurses working in RadOnc clinics if they thought SpaceOAR was worth it or not, and extrapolate the results from there as "best available economic data".

 

[Mandelin Rain]

0.008 QALY gained! That's almost 3 days of better living over a lifetime you socialists!

 

[TheWallnerus]

Wait wait wait - what is this? This seems like witchcraft.

In America, we would simply send an email with a SurveyMonkey link asking nurses working in RadOnc clinics if they thought SpaceOAR was worth it or not, and extrapolate the results from there as "best available economic data".

America’s rad onc patients: the women have stinky armpits and men get foreign objects in the buttal region.

 

[elementaryschooleconomics]

America’s rad onc patients: the women have stinky armpits and men get foreign objects in the buttal region.

You'd think we'd have developed something better than the routine use of ring+tandem +/- interstitial needles before finding something with a 0.008 QALY gain for the men but...alas...

 

[radiation]

I would put SpaceOAR on the level of fiducial placements for prostate. Theoretically should have near negligible risk for a skilled person doing high volume number of procedures and can theoretically be helpful. On the other hand, given that there are many people who get great results without ever using them, you could probably get rid of them completely and the treatment for prostate cancer would remain exactly the same

 

[medgator]

I would put SpaceOAR on the level of fiducial placements for prostate. Theoretically should have near negligible risk for a skilled person doing high volume number of procedures and can theoretically be helpful. On the other hand, given that there are many people who get great results without ever using them, you could probably get rid of them completely and the treatment for prostate cancer would remain exactly the same

Not even close....

 

[RickyScott]

Not even close....

I have zero skills, but can easily place fiducials (although one pt ended up on iv abx.) More realistic to compare space oar with calypso, although calypso never caused fistulas as far as I know.

 

[elementaryschooleconomics]

I would also disagree with the comparison of SpaceOAR and fiducials, for a few reasons:

1) You're (theoretically) working in a distinct anatomical space. The prostate is as clear as day on a TRUS, and placing fiducials is relatively "easy" in as far as invasive procedures go. I do think placing SpaceOAR is also relatively "easy", but...it's the rectum we're talking about here. It's not nicely contained in its own little orange peel capsule. While I definitely acknowledge the risk is very small (especially in skilled hands), you're far more likely to injure the rectal wall in some way with SpaceOAR vs fiducials.

2) Again, while the risk is very small, if there's EPE (especially posterior/lateral EPE), you could be mixing cancer in with the gel and unintentionally sparing it. I'm not aware of any published reports of this yet - but we all know how prostate cancer goes. It would take a decade for us to catch this. Why take the chance?

3) Fiducials can be very helpful with shrinking PTV margins and improving accuracy, ESPECIALLY with new or inexperienced therapists.

Full disclosure: I don't routinely use fiducials for mod hypo or conventional patients either, I do daily CBCT. For SBRT or if I'm placing SpaceOAR, then I almost always place fiducials simultaneously (in my neck of the woods, both the RadOncs and the Urologists can do this so we're not hurting for options/scheduling issues).

For your "average" prostate patient, I'll fuse the MRI, do an 8mm/5mm PTV expansion, create a PTV overlap structure with the PTV and rectum, ask for 100% of the PTV to get at least 95% of the dose, and ask Dosimetry make sure that 5% underdose region is in the PTV overlap region. Unless the anatomy is very unusual, this is pretty easy to accomplish. The guys who I do this with seem to do just as well as my SpaceOAR guys (because again, I don't want SpaceOAR banned, I just want people to be thoughtful in their application of it, and I will continue to use SpaceOAR in men who I think will benefit).

I think that's part of why the universal adoption of SpaceOAR is so confusing to me. If you're thoughtful in your sim setup, your contouring, your plan review - this is a pretty "easy" treatment to get through.

(I say that as the person pushing the buttons, not the one on the table, though)

 

[Ray D. Ayshun]

Tbh, I've used space oar once. in a fav int risk 75 yo who wanted rt. Dosimetry was wonderful. Virtually no acute bowel tox beyond going to the bathroom alit because of my laxative regimen. I definitely recommend space oar for men who likely won't benefit from treatment in the first place.

 

[TheWallnerus]

For your "average" prostate patient, I'll fuse the MRI, do an 8mm/5mm PTV expansion, create a PTV overlap structure with the PTV and rectum, ask for 100% of the PTV to get at least 95% of the dose, and ask Dosimetry make sure that 5% underdose region is in the PTV overlap region. Unless the anatomy is very unusual, this is pretty easy to accomplish. The guys who I do this with seem to do just as well as my SpaceOAR guys (because again, I don't want SpaceOAR banned, I just want people to be thoughtful in their application of it, and I will continue to use SpaceOAR in men who I think will benefit).

Let's say what you see below is what I see in my hands. Any time I look at data, I guess I always assume the person showing me the data is honest. Then after that, I think one of two things: what do I think if this data is real(ly different), and what do I think if this data is a random false fluke. So if the data below is real, and it's what I see (I use smaller PTVs than 8/5 even), why would I want SpaceOAR? If you look at the SpaceOAR paper, they allowed margins up to 1 cm!

Like SO MUCH in radiation oncology, the devil is in the details. If you use big margins that ignore the ability of IGRT to reduce margins, then you need the spacer. If you use protons that are known to cause more rectal side effects, you need the spacer.

 

[radiation]

I would also disagree with the comparison of SpaceOAR and fiducials, for a few reasons:

1) You're (theoretically) working in a distinct anatomical space. The prostate is as clear as day on a TRUS, and placing fiducials is relatively "easy" in as far as invasive procedures go. I do think placing SpaceOAR is also relatively "easy", but...it's the rectum we're talking about here. It's not nicely contained in its own little orange peel capsule. While I definitely acknowledge the risk is very small (especially in skilled hands), you're far more likely to injure the rectal wall in some way with SpaceOAR vs fiducials.

2) Again, while the risk is very small, if there's EPE (especially posterior/lateral EPE), you could be mixing cancer in with the gel and unintentionally sparing it. I'm not aware of any published reports of this yet - but we all know how prostate cancer goes. It would take a decade for us to catch this. Why take the chance?

3) Fiducials can be very helpful with shrinking PTV margins and improving accuracy, ESPECIALLY with new or inexperienced therapists.

Full disclosure: I don't routinely use fiducials for mod hypo or conventional patients either, I do daily CBCT. For SBRT or if I'm placing SpaceOAR, then I almost always place fiducials simultaneously (in my neck of the woods, both the RadOncs and the Urologists can do this so we're not hurting for options/scheduling issues).

For your "average" prostate patient, I'll fuse the MRI, do an 8mm/5mm PTV expansion, create a PTV overlap structure with the PTV and rectum, ask for 100% of the PTV to get at least 95% of the dose, and ask Dosimetry make sure that 5% underdose region is in the PTV overlap region. Unless the anatomy is very unusual, this is pretty easy to accomplish. The guys who I do this with seem to do just as well as my SpaceOAR guys (because again, I don't want SpaceOAR banned, I just want people to be thoughtful in their application of it, and I will continue to use SpaceOAR in men who I think will benefit).

I think that's part of why the universal adoption of SpaceOAR is so confusing to me. If you're thoughtful in your sim setup, your contouring, your plan review - this is a pretty "easy" treatment to get through.

(I say that as the person pushing the buttons, not the one on the table, though)

My main point is that fiducials became widely adopted with pretty negligible data. At least spaceOAR has a trial. If you talk to a spaceOAR disciple, they will give you the same spiel about how easy it is and how great it is with negligible toxicity rates.


They will tell you the same thing you are saying about fiducials -SpaceOAR can be very helpful with shrinking rectum doses, ESPECIALLY with new or inexperienced planners for SBRT. Are people only using fiducials if they have a new therapist on staff?

Fiducial toxicity is also underreported

Infections after fiducial marker implantation for prostate radiotherapy: are we underestimating the risks?

The use of gold fiducial markers (FM) for prostate image-guided radiotherapy (IGRT) is standard practice. Published literature suggests low rates of serious infection following this procedure of 0-1.3%, but this may be an underestimate. We aim to report ...

www.ncbi.nlm.nih.gov

If it were up to me I would say the default should be to not use either, unless you have compelling reason

 

[elementaryschooleconomics]

If it were up to me I would say the default should be to not use either, unless you have compelling reason

Completely agree!

 

[TheWallnerus]

My main point is that fiducials became widely adopted with pretty negligible data. At least spaceOAR has a trial. If you talk to a spaceOAR disciple, they will give you the same spiel about how easy it is and how great it is with negligible toxicity rates.


They will tell you the same thing you are saying about fiducials -SpaceOAR can be very helpful with shrinking rectum doses, ESPECIALLY with new or inexperienced planners for SBRT. Are people only using fiducials if they have a new therapist on staff?

Fiducial toxicity is also underreported

Infections after fiducial marker implantation for prostate radiotherapy: are we underestimating the risks?

The use of gold fiducial markers (FM) for prostate image-guided radiotherapy (IGRT) is standard practice. Published literature suggests low rates of serious infection following this procedure of 0-1.3%, but this may be an underestimate. We aim to report ...

www.ncbi.nlm.nih.gov

If it were up to me I would say the default should be to not use either, unless you have compelling reason

What is the cost of fiducials... about $800-$1000 total. SpaceOAR is about $2500 to $3500, or more. So there's that. In addition, fiducials were absolutely necessary before CBCT (e.g. Exactrac existed before CBCT) and substantially and mathematically significantly (p<0.001... good data) reduced setup error (versus port films, or versus ultrasound). SpaceOAR aimed itself at solving a clinical problem: reducing rectal toxicity. Perhaps fiducial placement did too, but that was not the primary mindset of fiducial placers, at least not in the early going days.

 

[medgator]

My main point is that fiducials became widely adopted with pretty negligible data. At least spaceOAR has a trial. If you talk to a spaceOAR disciple, they will give you the same spiel about how easy it is and how great it is with negligible toxicity rates.


They will tell you the same thing you are saying about fiducials -SpaceOAR can be very helpful with shrinking rectum doses, ESPECIALLY with new or inexperienced planners for SBRT. Are people only using fiducials if they have a new therapist on staff?

Fiducial toxicity is also underreported

Infections after fiducial marker implantation for prostate radiotherapy: are we underestimating the risks?

The use of gold fiducial markers (FM) for prostate image-guided radiotherapy (IGRT) is standard practice. Published literature suggests low rates of serious infection following this procedure of 0-1.3%, but this may be an underestimate. We aim to report ...

www.ncbi.nlm.nih.gov

If it were up to me I would say the default should be to not use either, unless you have compelling reason

That's a fair point, TRUS placement of fiducials vs transperineal placement with spaceOAR +/- fiducials does carry a higher infection rate based on the available data of TRUS vs transperinal prostate bx out there, but the severity of what has been reported as spaceOAR toxicity cannot be understated, not to mention the increased financial toxicity.

I've personally seen a pretty bad rectal abscess requiring long-term colostomy for several months (not my placement thankfully) by a GU who was fairly well experienced with the procedure when it occured (in retrospect, pt was a N+ high gleason pt, probably not the best candidate for it). Fairly certain I've never seen fiducial markers either TR or TP causing anywhere near that type of complication and I don't think the data supports it either

 

[radiation]

What is the cost of fiducials... about $800-$1000 total. SpaceOAR is about $2500 to $3500, or more. So there's that. In addition, fiducials were absolutely necessary before CBCT (e.g. Exactrac existed before CBCT) and substantially and mathematically significantly (p<0.001... good data) reduced setup error (versus port films, or versus ultrasound). SpaceOAR aimed itself at solving a clinical problem: reducing rectal toxicity. Perhaps fiducial placement did too, but that was not the primary mindset of fiducial placers, at least not in the early going days.

To be clear, I am not an advocate for spaceOAR as a standard. I just saying in the same vein we should also maybe also scrutinize routine fiducial placement. I get that fiducials were necessary back then, but now? Why even add that cost if CBCT alone is a good option? If you are at a place that routinely does fiducials nowadays, is there ever a discussion if CBCT alone is an option? I'm genuinely curious - if presented with CBCT alone vs. fiducials, I can't imagine many patients picking fiducials no matter how trivial or low toxicity rates are at the institution. People probably aren't telling pts 'fiducials will be better in case an inexperienced therapist is taking care of you that day'. I'm sure the politics of fiducial placement and Urology referral patterns play a role too.

I'm guessing if there were a CBCT alone option that had an extra billing code on top of IGRT (with some kind of Urology involvement) it would be the most common thing. Someone should call it TPT (taint preservation therapy) and get a CPT code

 

[medgator]

To be clear, I am not an advocate for spaceOAR as a standard. I just saying in the same vein we should also maybe also scrutinize routine fiducial placement. I get that fiducials were necessary back then, but now? Why even add that cost if CBCT alone is a good option? If you are at a place that routinely does fiducials nowadays, is there ever a discussion if CBCT alone is an option? I'm genuinely curious - if presented with CBCT alone vs. fiducials, I can't imagine many patients picking fiducials no matter how trivial or low toxicity rates are at the institution. People probably aren't telling pts 'fiducials will be better in case an inexperienced therapist is taking care of you that day'. I'm sure the politics of fiducial placement and Urology referral patterns play a role too.

I'm guessing if there were a CBCT alone option that had an extra billing code on top of IGRT (with some kind of Urology involvement) it would be the most common thing. Someone should call it TPT (taint preservation therapy) and get a CPT code

You think cbct costs the same as kV? In the hospital standing igrt is bundled but that's not the case in freestanding and there's quite a disparity in reimbursement. Moreover it is in fact more difficult to line up a CBCT than to match fiducials for an inexperienced therapist

 

[radiation]

You think cbct costs the same as kV? In the hospital standing igrt is bundled but that's not the case in freestanding and there's quite a disparity in reimbursement. Moreover it is in fact more difficult to line up a CBCT than to match fiducials for an inexperienced therapist

So your rationale to routinely use fiducials is because it’s cheaper than cbct and because it’s easier for inexperienced therapists?

 

[medgator]

So your rationale to routinely use fiducials is because it’s cheaper than cbct and because it’s easier for inexperienced therapists?

You prefer to inflict more financial toxicity without a clear benefit? Where's that kv+fiducials vs cbct rct when you need it.

Nothing makes a man happier than keeping a full bladder with all that extra table time lining up a daily CBCT for 4-9 weeks.

 

[communitydoc13]

My main point is that fiducials became widely adopted with pretty negligible data. At least spaceOAR has a trial. If you talk to a spaceOAR disciple, they will give you the same spiel about how easy it is and how great it is with negligible toxicity rates.


They will tell you the same thing you are saying about fiducials -SpaceOAR can be very helpful with shrinking rectum doses, ESPECIALLY with new or inexperienced planners for SBRT. Are people only using fiducials if they have a new therapist on staff?

Fiducial toxicity is also underreported

Infections after fiducial marker implantation for prostate radiotherapy: are we underestimating the risks?

The use of gold fiducial markers (FM) for prostate image-guided radiotherapy (IGRT) is standard practice. Published literature suggests low rates of serious infection following this procedure of 0-1.3%, but this may be an underestimate. We aim to report ...

www.ncbi.nlm.nih.gov

If it were up to me I would say the default should be to not use either, unless you have compelling reason

Agree with your take home point. Spratt's tweet here is the definition of specious. It is reasonable to compare rare, severe acute toxicity and even death for surgery vs. brachy vs. EBRT, but the comparison to MRI is bogus (just follow the link, overwhelmingly these are safety reports not related to significant patient harm) and the real comparison arm is EBRT without SpaceOAR. We really almost never cause severe acute toxicity with EBRT without SPACEOAR in the modern era. This is the overwhelming reason for recommending this modality. Are we really looking to accept some degradation of this?

The data from the paper is poor and I'm not sure why the 2:1 randomization. You are looking at very small numbers of events in both arms. The fact that there were deviations in toxicity other than late GI actually makes the data less plausible (less likely to reflect reality).

I have been using SPACEOAR for about a year and will likely use in SBRT cases going forward but little else.

What I have noticed:

1. SPACEOAR placement often not nearly as beautiful as you would hope. Some portion of lower rectum often with zero spacing. It also infiltrates into weird spaces around the SV.

2. Some level of rectal infiltration is not that rare when you look close. Only one patient where I suspected acute toxicity from this (early rectal symptoms, perianal pain, tenesmus). This resolved in time.

 

[elementaryschooleconomics]

1. SPACEOAR placement often not nearly as beautiful as you would hope. Some portion of lower rectum often with zero spacing. It also infiltrates into weird spaces around the SV.

So, I came from a place where SpaceOAR (+fiducials) were done by the Urologists. Placement was often...not ideal, for both.

Currently, I'm at a place where the person who usually places SpaceOAR is someone with extensive prostate brachy experience. The difference is night and day.

(that being said, even if you have someone who is very thoughtful about placement...the goo is gonna do what the goo is gonna do, and sometimes it is DEFINITELY bad)

 

[radiation]

So you are telling me you think the standard of care for prostate IGRT is kv/kv match with fiducials and no cbct because of financial toxicity? That is great. You don't care about rectal or bladder filling? The majority of radiation oncologists in this country are using CBCT with or without fiducials, being concerned about the financial toxicity of a CBCTs in prostate cancer is certainly a novel take

 

[Mandelin Rain]

CBCT without fiducials for mine.

The goal is to do the most with the least potential for harm. SpaceOAR and fiducials are invasive procedures with rare but bad/potentially catastrophic side effects that add next to nothing.