Use of Microboost

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Are you microboosting your UIR and HR prostate patients (>0 in the last 6 months)?


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Hey there -

I wrote a post about microboosting. Rationale, evidence, outcomes, "how to". There are great resources out there (Green Journal "how to", PRO contour clinic, etc), but I wanted to write an approachable / all in one article about it. I think it came out pretty good.

Are you all using it ? What dose levels are you prescribing? I am curious, because I rarely see it when reviewing auth cases, when I query colleagues and friends, very few seem to use.

 
I like the FLAME data for high risk so I've been using it. I do have barrier gel placed.
 
Hey there -

I wrote a post about microboosting. Rationale, evidence, outcomes, "how to". There are great resources out there (Green Journal "how to", PRO contour clinic, etc), but I wanted to write an approachable / all in one article about it. I think it came out pretty good.

Are you all using it ? What dose levels are you prescribing? I am curious, because I rarely see it when reviewing auth cases, when I query colleagues and friends, very few seem to use.

I still argue prostate-only MRI/CT matching is far more fidelitous with fiducials. Frankly.
 
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Gel and fiducials for all micro boost patients (usually high risk, sometimes UIR). FLAME when anatomy is favorable and/or large GTV and/or high grade disease. If FLAME dose is unfavorable then I do the DELINEATE 37fx regimen, which is a more modest mb dose than FLAME.
 
I microboost a fair percentage of patients that are UIR or high risk with dominant lesion(s). Especially adamant about it when biopsy cores, PSMA pet, and MRI all are showing bad disease in same area.

I'm fine with gel, but no one had gel on FLAME trial. Agree if lesion is midline posterior it can be helpful. I don't mandate gel but discuss it with patient. I have mixed feelings but I do think it slightly helps. The train wreck bad problems with gel are real but rare.
 
I think it makes sense to consider what you're doing and why you need a spacer rather than blindly following bad studies. Just because a study exists doesn't mean it should be followed to a tee. Big margins, weird toxicity analysis, no accounting for the toxicity of the experience of the procedure.

Look at the target and anatomy. Estimate if you can make constraints. With 70 / 28 with modern tx planning, we are seeing 3-5% of contoured rectum getting Rx dose. Rarely needed. If going to 84 in 28 or whatever and that lesion is posterior and will be hard to meet the constraints, consider it.

"one size fits all" is not my style of medicine
 
Well, that’s flippant 🙂

Do you think the plans from 10-15 years ago are equivalent to today, on average ?

I am noticing significantly better. I am not sure what point you’re driving at and not sure how else to say it. Yes, of course they have rectums. Do you suggest that the data says that every single patient will have greater pros than cons with a spacer ?

My presumption is that some are at greater risk than others - anatomy based, what dose going to, what technology / margins are used, inherent radio sensitivity.

Every breast has skin. And many studies show steroid cream reduces skin toxicity, but if I’m doing 26/5 apbi , I don’t see almost anything more severe than Gr1. Hence, those patients don’t get steroids.
 
Do you suggest that the data says that every single patient will have greater pros than cons with a spacer ?
The randomized data which established rectal spacers as standard of care seemed to draw the conclusion that spacers were a class solution for those undergoing prostate RT.
Every breast has skin

My point. Which should have meant IMRT becoming the standard of care for breast (the randomized trials supported IMRT as a class solution for decreasing skin toxicity). Alas…

 
so you’re saying you’re using 1cm margins and not using modern constraints ?

I’m trying to understand, bc if it’s a class solution it’s for the class of patients treated in the same way as that study

I agree - if using 1cm margins, please put in a spacer !
 
so you’re saying you’re using 1cm margins and not using modern constraints ?

I’m trying to understand, bc if it’s a class solution it’s for the class of patients treated in the same way as that study

I agree - if using 1cm margins, please put in a spacer !
As a strict textualist, yes one can raise a point that "I use tight margins so the phase III data establishing rectal spacers as standard of care do not apply to me/my patients."

However, that said, is the use of rectal spacer where it has not been established as standard of care based on any clinical outcomes data that shows the spacer is improving clinical outcomes? The use of a spacer to improve the isodose lines is self-evident; you don't need a trial for that. If that is the reason to use spacers, I don't think there is any clinical data supporting that though. A line from the piece reads "The need for a spacer is often tricky to determine a priori... If the lesion is posterior, I tend to have a spacer placed... But if not, it is typically not difficult to meet the rectal constraints." That strikes me as using rectal spacer in a non-standard-of-care fashion (no judgment!) since by definition (I think?) standards-of-care are applied a priori.

Keep in mind "meeting constraints"... or not... essentially is non-predictive for spacer clinical benefit; i.e., dosimetry is a bit divorced from clinical outcomes in the "spacer space."

 
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Sir Wallnerus,

As doctors we can interpret the literature based on our own experience. If I am poor at radiation and use 1cm margins I should probably use in all.

If I see a study with excellent outcomes that does not utilize spacers and uses the margins I use - Flame , PACE B, etc., I tend to believe those outcomes as they reflect the way I practice

Are you suggesting we use the spacer literature in a vacuum as the only data point when making treatment decisions?

Because then I will have to spit out my gum before going on a stroll.

One can understand that dosimetry will be improved if rectal - prostate distance is increased and at the same time be comfortable that the dosimetric benefit may not influence the clinical outcome - and also may have higher risk to patient than not having a spacer

Seems like we practice in different ways. I think spacers in most or all is defensible and in none is defensible and selective usage also defensible. But I hesitate to use solely spacer data and ignore excellent outcomes seen in thousands of patients in multi institution, multi national studies. And the cool thing is that your way of thinking works for your patients and the way I use it works for my patients!
 

For the primary outcome, 131 of 133 (98.5%; 95% CI, 94.7%-99.8%) patients in the spacer group experienced a 25% or greater reduction in rectum V54, which was greater than the minimally acceptable 70% (P < .001). The mean (SD) reduction was 85.0% (20.9%). For the secondary outcome, 4 of 136 patients (2.9%) in the spacer group and 9 of 65 patients (13.8%) in the control group experienced acute grade 2 or higher GI toxic effects (difference, -10.9%; 95% 1-sided upper confidence limit, -3.5; P = .01).


A significant reduction in late (3-15 months) rectal toxicity severity in the spacer group was observed (P=.04), with a 2.0% and 7.0% late rectal toxicity incidence in the spacer and control groups, respectively. There was no late rectal toxicity greater than grade 1 in the spacer group. At 15 months 11.6% and 21.4% of spacer and control patients, respectively, experienced 10-point declines in bowel quality of life. MRI scans at 12 months verified spacer absorption.


Conclusion: These are actual clinical endpoints, not dosimetric "protons and parachutes" arguments.
 
Does anyone use the constraints on this study -

(V57 < 15%, V53 < 20%, V49 < 25%, V45 < 35%, and V38 < 50%)

Where do these come from? What about high dose constraints?
 
Sir Wallnerus,

As doctors we can interpret the literature based on our own experience. If I am poor at radiation and use 1cm margins I should probably use in all.

If I see a study with excellent outcomes that does not utilize spacers and uses the margins I use - Flame , PACE B, etc., I tend to believe those outcomes as they reflect the way I practice

Are you suggesting we use the spacer literature in a vacuum as the only data point when making treatment decisions?

Because then I will have to spit out my gum before going on a stroll.

One can understand that dosimetry will be improved if rectal - prostate distance is increased and at the same time be comfortable that the dosimetric benefit may not influence the clinical outcome - and also may have higher risk to patient than not having a spacer

Seems like we practice in different ways. I think spacers in most or all is defensible and in none is defensible and selective usage also defensible. But I hesitate to use solely spacer data and ignore excellent outcomes seen in thousands of patients in multi institution, multi national studies. And the cool thing is that your way of thinking works for your patients and the way I use it works for my patients!
I am simply saying that in order to derive the maximum benefit from spacer use, one should at least in theory be needing to use it--regardless the dosimetry--"liberally"/constantly (microboost or not). Again, I believe the data has shown that dosimetry is a poor predictor of spacer's rectal clinical benefit.

This kind of reminds me of the "argument" people get into about DRE for initial consult prostate XRT patients and when anyone says "I like the DRE because it has allowed me to catch a few anal cancers." The logical conclusion of that argument is therefore needing DRE for your lung cancer patients, your breast patients, your lymphoma patients, etc. Especially cervical or penile or oropharyngeal cancer patients. Just imagine how may anal cancers you could detect with liberal DRE use across all rad onc patients... you could catch more vs just using the DRE for prostate patients.

And just imagine how many rectums you could save with routine spacer use (surely the rad onc and his/her subjective assessment of dosimetry doesn't PERFECTLY suss who can get the benefit or not). This is the natural, logical conclusion of the SpaceOAR data. (I am not picking on SpaceOAR. I could say this about any X-control vs Y-new-treatment randomized trial where Y was proven clinically superior to X.)

Presumably this is why spacer is touted as a "class solution" for all men undergoing prostate RT, and why coverage policies cover the spacer for the whole class too.

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Again, if you use the spacer data as the sole rationale for the decision making, that’s up to the treating physician. I choose to use the data from thousands vs a few hundred.

I know people that order CBC during prostate and breast RT. “You may find something”. I would never do that. I don’t know the numbers, but I can take a look at a chart and patient and make a guess about which patients would benefit from a CBC. Same for DRE. If a rectal patient is saying he can’t piss or is having hematospermia, I’ll do the DRE. Maybe your hypothetical doctor does it on all prostate patients or all cancer patients. That’s fine. Doesn’t make sense to me and there is no national guidance to do it, so I don’t do unless I have a reason to.

Have written about DRE…

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about 30% of my patients get space oar mostly because urologist preference. Most do great, but one nearly died. Radoncs have been sued for failing to notice rectal infiltration on planning and cbct.

It’s that one in 50 or 100 that scares me and the fda database reflects this. As a junior attending at a center with one of the largest prostate data bases (years ago), I can attest that no patient had a grade 4 toxicity with 80/40 and generous margins.
 
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People are tallking a lot about the rectum in those cases, but what about the urethra? Do you contour it when microboosting, and do you put a constraint on it?
 
People are tallking a lot about the rectum in those cases, but what about the urethra? Do you contour it when microboosting, and do you put a constraint on it?
Rectum and urethra kind of dovetail though no? Doesn't SpaceOAR help with GU toxicity too? People don't seem to mention it much, or at all, I suppose because one sounds wacky, but that's the data. I guess in the "spacer culture" there is a nice spiel explaining this finding away to which I am not privy 🙂

At the end of the day we are spending a lot of time as angels dancing on the head of the microboost pin when iirc microbosting has not been shown to increase toxicity...
 
People are tallking a lot about the rectum in those cases, but what about the urethra? Do you contour it when microboosting, and do you put a constraint on it?
With LDR. Doesn’t urethra get 2x prescription dose. Probably gets smoked during hdr for cervix. On pace trial urethra received minimum of 40gy. Not sur e where contraints are coming from. My guess is that bladder neck is where toxicity comes from.
 
With LDR. Doesn’t urethra get 2x prescription dose. Probably gets smoked during hdr for cervix. Not sur wheee contraints are coming from.
There was a post-hoc analysis of Flame showing increased toxicity with high doses to the urethra and bladder.
 
There was a post-hoc analysis of Flame showing increased toxicity with high doses to the urethra and bladder.

Oh wow, I hadn't seen that. Thanks for posting.
As I recall on the trial they had no urethra constraint, so I typically use urethra plus 2mm prv max < 110% of 77 Gy (which I just made up). I want to say their high dose bladder constraint was 80 Gy to bladder < 1 cc. But in the supplement different centers had their own bladder constraints.
 
TANSTAAFL

Dose escalation = increased GU toxicity. No surprises there. True for brachy boost, true for FLAME. Still very much worthwhile in GG3 and above in patients with appropriate longevity IMO.

Any of you folks who do brachy boost reducing ADT duration to 6-12 months based on the TRIP trial results showing equivalence to 30 months when using brachy boost? I have a whole lot of patients who would take brachy boost and additional GU tox over 18 months more of ADT.
 
TANSTAAFL

Dose escalation = increased GU toxicity. No surprises there. True for brachy boost, true for FLAME. Still very much worthwhile in GG3 and above in patients with appropriate longevity IMO.

Any of you folks who do brachy boost reducing ADT duration to 6-12 months based on the TRIP trial results showing equivalence to 30 months when using brachy boost? I have a whole lot of patients who would take brachy boost and additional GU tox over 18 months more of ADT.
Flame is isotonic …
 
There was a post-hoc analysis of Flame showing increased toxicity with high doses to the urethra and bladder.
Flame is isotonic …

Palex is saying that FLAME is not *really* isotoxic; I was not aware of that (posthoc) analysis. But no surprise, there is no (dosimetric) free lunch.

However you could place a rectal spacer (which has been associated with significant decrease in GU toxicity risk) on all mocroboost patients to really discount the price of the lunch?

Wizard Of Oz GIF
 
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Flame is isotonic …
Yes. @DoctwoB FLAME trial does NOT show increased GU toxicity with microboost escalation.

That paper above pooled all the patients (standard dose and dose escalation) from the trial and then looked at dosimetric parameters and correlated them to GU outcomes.

In the actual trial, there was no difference in GU toxicity between focal dose escalation and homogeneous prostate dose. I think there is especially interest in that paper because per protocol in the trial there were not published urethral constraints that I'm aware of and bladder constraints were somewhat variable across enrolling centers.
 
Rectum and urethra kind of dovetail though no? Doesn't SpaceOAR help with GU toxicity too? People don't seem to mention it much, or at all, I suppose because one sounds wacky, but that's the data. I guess in the "spacer culture" there is a nice spiel explaining this finding away to which I am not privy 🙂
When they first came to pitch me like 8 years ago, they touted this finding from their initial data. When I gave a highly dubious look that shoving the prostate anteriorly into the bladder would improve urinary function with radiation and started to question the veracity of the rest of their data, there was an immediate backtracking. To your question, they posited an explanation of, "because it was so easy to meet rectal constraints, it opened new beam angles for bladder avoidance." During that pitch, they also flashed a slide that indicated potency was also improved (over pre-radiation baseline) among patients with SpaceOAR. I suggested they offer it as an alternative to Viagra. They didn't appreciate that comment.

I left that meeting VERY skeptical of SpaceOAR and associated data.
 
Not a big spacer user but is there evidence in practice people have seen that it’s ‘pushing’ prostate anteriorly? That seems hard to believe
 
Not a big spacer user but is there evidence in practice people have seen that it’s ‘pushing’ prostate anteriorly? That seems hard to believe
It pretty much has to be displacing the prostate anteriorly and/or rectum posteriorly within the pelvis. I assume it does a bit of both. You can't increase the separation between the organs without the organs moving.
 
It pretty much has to be displacing the prostate anteriorly and/or rectum posteriorly within the pelvis. I assume it does a bit of both. You can't increase the separation between the organs without the organs moving.
sure the physical distance with rectum is the point and I understand theoretically what you are saying re bladder but is there actual dosimetric or experiential data on this from super users is my question. even if there is marginal, I guess the point of avoiding high dose to GI mucosal is outweighed by high dose to bladder mucosa.
 
If SpaceOAR is beneficial, why Europe is not using it? Or is it using?

Cost/different reimbursement models I am confident plays a part there.

There is a ?dutch? policy paper about cost effectiveness, etc I recall reading. They deemed it not worthy.

It would have to be dramatic improvement for them to start using. My monkey brain way of thinking about it is in the trial, with big margins, it takes your late rectal bleeding from high single digits to low single digits with a tiny chance though of a catostrophic event (see MAUDE database). Is that worth it? The Euros say no.

I overall believe the rectal toxicity data. I do agree with @Mandelin Rain I cannot reconcile their GU/ED data...especially the ED stuff their reps will tell you about if you let them.
 
Cost/different reimbursement models I am confident plays a part there.

There is a ?dutch? policy paper about cost effectiveness, etc I recall reading. They deemed it not worthy.

It would have to be dramatic improvement for them to start using. My monkey brain way of thinking about it is in the trial, with big margins, it takes your late rectal bleeding from high single digits to low single digits with a tiny chance though of a catostrophic event (see MAUDE database). Is that worth it? The Euros say no.

I overall believe the rectal toxicity data. I do agree with @Mandelin Rain I cannot reconcile their GU/ED data...especially the ED stuff their reps will tell you about if you let them.
This is the case, indeed. Coverage varies across countries, but basically it's difficult to get reimbursement.

Just out of curiosity: What does a physician in the US earn by placing a SpaceOAR? Can anyone quantify this in numbers? I am talking about the procedure itself, not the cost of the device itself.
 
This is the case, indeed. Coverage varies across countries, but basically it's difficult to get reimbursement.

Just out of curiosity: What does a physician in the US earn by placing a SpaceOAR? Can anyone quantify this in numbers? I am talking about the procedure itself, not the cost of the device itself.
I believe in a professional fee only model it is around $200 for placement of the gel by the physician. It is assigned I believe 2.95 wRVU's.

Depending upon the insurance status of the patient, the doc reimbursement probably on average is around $180-200 but on a case by case basis could fluctuate between $90-300.
 
even if not microbosting, it is helpful to identify the target lesions on mri. Not infrequently, I have found the target lesion could have been underdosed or not had adequate margin if all contours were done on ct. usually I put 5-6 mm on margin on gtv even if my posterior margin is 3 mm. Trials and practice will probably evolve in which microboost dose is escalated and rest of prostate receives less. If I have large median lobe, and imaging and biopsy show no disease , i will place almost no margin on it.
 
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I hate to push a specific product but Barigel and SpaceOAR are not even comparable. I’m not even sure why SpaceOAR exists anymore. Anyone who has used a significant number of either can attest to this. I thought I had completely given up on spacers until I moved to a center that does Barigel. People just don’t feel it and their physical properties make this plausible.

Do I believe for even a microsecond that any spacer will reduce ED or GU toxicity? Nope. There is no rational basis and I havnt noticed any hint of this in personal experience.

Do I think everyone getting a microboost (or SBRT) needs a spacer. Again, nope. Look at their anatomy and honestly ask yourself how at risk a patient really is for significant rectal injury. If it’s average or low, a spacer probably won’t do anything.

I also use them 0% of the time when doing Brachy as primary therapy or boost. I’ve literally never seen a late rectal toxicity in either case without one so I don’t see any reasonable chance for a clinically meaningful outcome.

This isn’t rocket science. With any technology it’s the same formula: what is the expected benefit and is it applicable to this particular patient. Nothing is universally good or bad.
 
I don't place them, but the VUE is so nice for me. I really like how it shows up on tx planning scan. I've heard that the formulation of Barrigel is often preferred. BS is doing something similar soon.

But, what @ramsesthenice is saying is exactly how I think.

As far as reps, I guess I'm in the minority. I enjoy meeting most reps that come by. They are just doing their job and I have not found them to be deceitful. In fact, many seem more honest than he doctors that shill for them.

I was 100% anti spacer and the Boston Scientific rep contacted me. She was very friendly and recommended a restaurant I love, because she knew I was skeptical. It was one of the higher ups and her and a colleague. I was mostly doing to troll them, but I learned some things and figured I should try to figure out a use case, rather than just saying blanket no. After that, we became great friends and my wife and I socialize with her. I've had similar interactions with many reps. Friendly, interested in medicine/clinical stuff, provide great meals for our staff.
 
I hate to push a specific product but Barigel and SpaceOAR are not even comparable. I’m not even sure why SpaceOAR exists anymore. Anyone who has used a significant number of either can attest to this. I thought I had completely given up on spacers until I moved to a center that does Barigel. People just don’t feel it and their physical properties make this plausible.

Do I believe for even a microsecond that any spacer will reduce ED or GU toxicity? Nope. There is no rational basis and I havnt noticed any hint of this in personal experience.

Do I think everyone getting a microboost (or SBRT) needs a spacer. Again, nope. Look at their anatomy and honestly ask yourself how at risk a patient really is for significant rectal injury. If it’s average or low, a spacer probably won’t do anything.

I also use them 0% of the time when doing Brachy as primary therapy or boost. I’ve literally never seen a late rectal toxicity in either case without one so I don’t see any reasonable chance for a clinically meaningful outcome.

This isn’t rocket science. With any technology it’s the same formula: what is the expected benefit and is it applicable to this particular patient. Nothing is universally good or bad.
Agreed. Barrigel sounds like the much better product, the rep also seems to know the issues with spaceoar etc