SpaceOAR - Augmenix, Boston Scientific, and Conflicts of Interest

[TheWallnerus]

i always liked the balloon, but staff not so much. Patients didn’t complain (I would ask - there were jokes, but no one said painful).

But why both spacer and balloon??

The balloon is going to be a random error decreaser (which, in theory, for every 1mm decrease in random error is a 0.7mm decrease in PTV)

The spacer is going to be a rectal sparer/use your larger margins at same time/have larger margin cake/conformal cake and eat it too

In a way it’s like lobbing a MOAB *and* tactical nuke at a city block… should definitely work!

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[RickyScott]

The balloon is going to be a random error decreaser (which, in theory, for every 1mm decrease in random error is a 0.7mm decrease in PTV)

The spacer is going to be a rectal sparer/use your larger margins at same time/have larger margin cake/conformal cake and eat it too

In a way it’s like lobbing a MOAB *and* tactical nuke at a city block… should definitely work!

Would the balloon reduce error when using a cbct w/fiducials?

 

[radoncftw]

Oh yeah my fury isn't necessarily at the FDA...well, at least my opinion and emotions about the FDA are not limited to SpaceOAR.

My fury comes from the incredibly obvious and blatant infiltration of Augmenix/BostonSci/Palette into the hearts and minds of RadOnc via bank accounts.

There aren't that many of us (compared to other specialties). Because of the nature of our work, we get virtually zero pharma reps banging on our doors. We don't have any framework/defense mechanisms for the scripted pitch of someone wielding HubSpot-powered CRM data for their cold outbound strategy.

I've been digging around this, obsessively, for literally years now. The word "scandal" is too extreme, and describing what's happened in "per capita" terms also doesn't work but - I don't think there's anything else in medicine which can rival what has happened with hydrogel COI and American Radiation Oncology.

For anyone who thinks this is hyperbole: go to OpenPayments. Look at all the RadOncs who have been paid (either personally or via research funding) by the hydrogel companies as far back as the data goes. Reflect on the positions those RadOncs hold and, importantly, how many residents they have personally trained over the last 10 years.

Then think about how many residents those residents trained, and so on.

If anyone can think of a drug or device as insidious as the hydrogels in a different specialty, I'd love to hear it. Maybe what happened with Oxycontin? Obviously that's apples/oranges and I'm not presuming to conflate the two. But I can't think of another example of something that has dug so deeply into a specialty through targeted efforts of industry.

we get a ton of pharma reps. we are in a large multi-disciplinary cancer center with med onc urology ENT etc, but 50% of the reps we get are for drugs like durvalumab or for cabazitaxel. I am kind of perplexed, but i sign my name, smile and listen to their pitch, grab my JJ/potbellys/panera sandwich and a fat choc chip cookie and go back to my office.

 

[TheWallnerus]

Would the balloon reduce error when using a cbct w/fiducials?

… probably, and it would likely make cine MRI’ing (or calypso’ing etc) moot. “Needed” or not, I cannot say.

 

[evilbooyaa]

i always liked the balloon, but staff not so much. Patients didn’t complain (I would ask - there were jokes, but no one said painful).

But why both spacer and balloon??

Daily balloon especially for 5.5 - 9 weeks seems worse than 1-time spaceOAR injection to me...

 

[deleted1111261]

Daily balloon especially for 5.5 - 9 weeks seems worse than 1-time spaceOAR injection to me...

Have you had one up there ?? Lol

 

[evilbooyaa]

Have you had one up there ?? Lol

No.... and I would hope anyone that I went to for prostate radiation (conventional fx + FLAME boost for me most likely, with consideration of EBRT + HDR boost if I was young or potentially SBRT with flame style boost) would not in a million years advocate for a rectal balloon. It pushes the rectum closer to the prostate. When we're talking about SBRT and constraints to cc of rectum, I can't imagine that would improve an outcome...

 

[deleted1111261]

No.... and I would hope anyone that I went to for prostate radiation (conventional fx + FLAME boost for me most likely, with consideration of EBRT + HDR boost if I was young or potentially SBRT with flame style boost) would not in a million years advocate for a rectal balloon. It pushes the rectum closer to the prostate. When we're talking about SBRT and constraints to cc of rectum, I can't imagine that would improve an outcome...

I imagine we are using it in different ways - I don’t use it to increase rectal dose.

It takes much of the rectum out of the way.

It also acts as immobilization.

 

[evilbooyaa]

I imagine we are using it in different ways - I don’t use it to increase rectal dose.

It takes much of the rectum out of the way.

It also acts as immobilization.

Never used it in training, never felt that it was worthwhile in any patient receiving weeks of RT. SpaceOAR at least makes sense by displacing the entirety of the rectum away. Balloon pushes the anterior wall of the rectum anteriorly and closer to the prostate. Why do balloon at every fraction instead of SpaceOAR once?

I think doing it for SBRT could be reasonable, but then you're pushing CC of Rectum up into the prostate/SV PTV, which seems counter-intuitive.

 

[deleted1111261]

Never used it in training, never felt that it was worthwhile in any patient receiving weeks of RT. SpaceOAR at least makes sense by displacing the entirety of the rectum away. Balloon pushes the anterior wall of the rectum anteriorly and closer to the prostate. Why do balloon at every fraction instead of SpaceOAR once?

I think doing it for SBRT could be reasonable, but then you're pushing CC of Rectum up into the prostate/SV PTV, which seems counter-intuitive.

I hear what you're saying, but I think you missed my above part. The patients don't care about the balloon. I felt the same way before, because of my difficulty with the thought of putting something up there (thanks, conservative Indian upbringing).

SpaceOAR - 1) extra procedure 2) anesthesia 3) pain from procedure 4) risk of badness/rectal wall infiltration/fistula.

Say they did the same thing (they don't). But, if they did - as a patient I would way rather not go through anesthesia, US up the bunghole, needles through perineum.

The insertion of a balloon, seriously, when you ask the patient themselves - I have a lot of times, because I don't want to do things to make them uncomfortable. Almost every single patient said - "it's not bad, it's just a little embarrassing at first".

Anyway, I think it is moot - b/c it costs the center money and they never did the COI as well as spacer folks. Gotta dish that money out!

I'd love a study comparing the approaches, though.

 

[evilbooyaa]

I hear what you're saying, but I think you missed my above part. The patients don't care about the balloon. I felt the same way before, because of my difficulty with the thought of putting something up there (thanks, conservative Indian upbringing).

SpaceOAR - 1) extra procedure 2) anesthesia 3) pain from procedure 4) risk of badness/rectal wall infiltration/fistula.

Say they did the same thing (they don't). But, if they did - as a patient I would way rather not go through anesthesia, US up the bunghole, needles through perineum.

The insertion of a balloon, seriously, when you ask the patient themselves - I have a lot of times, because I don't want to do things to make them uncomfortable. Almost every single patient said - "it's not bad, it's just a little embarrassing at first".

Anyway, I think it is moot - b/c it costs the center money and they never did the COI as well as spacer folks. Gotta dish that money out!

I'd love a study comparing the approaches, though.

That's an interesting viewpoint. I thought insertion of daily rectal balloon was billable though? Can't say I'm an expert in this, but I thought that was at least a part of the draw.

I get what you're saying in regards to comparison to spaceOAR.

IDK, maybe it's just icky to me. I guess I could put this in line with 'daily rectal enema' for prostate RT. Maybe it's not so bad, but is it really necessary?

Would a patient rather do daily rectal ballon x 28 treatments or conventional fx x 44 to avoid the acute GI toxicity?

 

[deleted1111261]

That's an interesting viewpoint. I thought insertion of daily rectal balloon was billable though? Can't say I'm an expert in this, but I thought that was at least a part of the draw.

I get what you're saying in regards to comparison to spaceOAR.

IDK, maybe it's just icky to me. I guess I could put this in line with 'daily rectal enema' for prostate RT. Maybe it's not so bad, but is it really necessary?

Would a patient rather do daily rectal ballon x 28 treatments or conventional fx x 44 to avoid the acute GI toxicity?

It’s huge “icky” factor. That’s what stopped me from doing until 8 years out.

No, you have to pay for it ! And either charge patient or eat it. The cost, not the balloon

 

[evilbooyaa]

It’s huge “icky” factor. That’s what stopped me from doing until 8 years out.

No, you have to pay for it ! And either charge patient or eat it. The cost, not the balloon

Woof. Not that I was seriously interested before that post, but hurting the instituton's bottom line to shove more things in butts than I need to? No thanks.

 

[Mandelin Rain]

I've used the balloon before. With it, I (anecdotally) saw less toxicity than no balloon. Essentially no diarrhea unless treating pelvis. Patients didn't hate it (also didn't love it). Makes the setup very easy for RTTs with CBCT. Only downside, besides cost, is that external hemorrhoids can be inflamed by insertion. It is indeed expensive for the center.

If, for whatever reason, a guy doesn't want it or can't tolerate it at sim you can just punt and omit. No biggie. Happened a handful of times.

 

[WanderingRad3]

I hear what you're saying, but I think you missed my above part. The patients don't care about the balloon. I felt the same way before, because of my difficulty with the thought of putting something up there (thanks, conservative Indian upbringing).

SpaceOAR - 1) extra procedure 2) anesthesia 3) pain from procedure 4) risk of badness/rectal wall infiltration/fistula.

Say they did the same thing (they don't). But, if they did - as a patient I would way rather not go through anesthesia, US up the bunghole, needles through perineum.

The insertion of a balloon, seriously, when you ask the patient themselves - I have a lot of times, because I don't want to do things to make them uncomfortable. Almost every single patient said - "it's not bad, it's just a little embarrassing at first".

Anyway, I think it is moot - b/c it costs the center money and they never did the COI as well as spacer folks. Gotta dish that money out!

I'd love a study comparing the approaches, though.

I mean...an extra 15 minute procedure under just local lidocaine. Most of my patients say "that wasn't bad." If you can visualize and have a good set up, not hard to do it right with Barrigel or SpaceOAR. Yes, 5-10% are uncomfortable, and I say ah maybe I should have given them some ativan...

Plus I don't do fiducials and can use SpaceOAR vue to help to line up with CBCTs as well.

Now the reimbursement unfortunately is not great in the office setting unless you are in a few geographic areas with high reimbursement, so unfortunately (as with many things in medicine), I see it being used more in high reimbursement areas whereas much less so in low reimbursement areas (unless you're doing it in a hospital setting, in which case it can be $$$ for the hospital but still very little $ for the MD)

 

[OTN]

I mean...an extra 15 minute procedure under just local lidocaine. Most of my patients say "that wasn't bad." If you can visualize and have a good set up, not hard to do it right with Barrigel or SpaceOAR. Yes, 5-10% are uncomfortable, and I say ah maybe I should have given them some ativan...

Plus I don't do fiducials and can use SpaceOAR vue to help to line up with CBCTs as well.

Now the reimbursement unfortunately is not great in the office setting unless you are in a few geographic areas with high reimbursement, so unfortunately (as with many things in medicine), I see it being used more in high reimbursement areas whereas much less so in low reimbursement areas (unless you're doing it in a hospital setting, in which case it can be $$$ for the hospital but still very little $ for the MD)

But why do any of it?

 

[medgator]

I mean...an extra 15 minute procedure under just local lidocaine. Most of my patients say "that wasn't bad." If you can visualize and have a good set up, not hard to do it right with Barrigel or SpaceOAR. Yes, 5-10% are uncomfortable, and I say ah maybe I should have given them some ativan...

Plus I don't do fiducials and can use SpaceOAR vue to help to line up with CBCTs as well.

Now the reimbursement unfortunately is not great in the office setting unless you are in a few geographic areas with high reimbursement, so unfortunately (as with many things in medicine), I see it being used more in high reimbursement areas whereas much less so in low reimbursement areas (unless you're doing it in a hospital setting, in which case it can be $$$ for the hospital but still very little $ for the MD)

No comment on the rare potential adverse effects (some of which can be quite severe... I've personally seen an elective diverting colostomy be required along with iv abx for a pt that developed an abscess) that have been well documented?

Major Complications and Adverse Events Related to the Injection of the SpaceOAR Hydrogel System Before Radiotherapy for Prostate Cancer: Review of the Manufacturer and User Facility Device Experience Database - PubMed

<span><b><i>Purpose:</i></b> SpaceOAR^® is a Food and Drug Administration-approved hydrogel injection used to create space between the prostate and rectum during prostate radiotherapy. It has shown to significantly reduce the rectal radiation dose with lower rates of rectal toxicity...

pubmed.ncbi.nlm.nih.gov

Hydrogel Spacer Rectal Wall Infiltration Associated With Severe Rectal Injury and Related Complications After Dose Intensified Prostate Cancer Stereotactic Ablative Radiation Therapy - PubMed

The risk of rectal toxicity during and after prostate cancer radiation therapy is common to all treatment regimens. Hydrogel rectal spacers are increasingly being used to mitigate this risk and to facilitate dose-escalation, but also may infiltrate the rectal wall, with unclear clinical...

pubmed.ncbi.nlm.nih.gov

 

[WanderingRad3]

But why do any of it?

Because there are randomized data showing decreased GI toxicity. I tell them 98% of patients won't have significant GI issues without spaceOAR, some will have some GI issues. SpaceOAR reduces it for those small % of patients. I don't push it hard on my patients but tell them I would do have it for myself if it is paid for by insurance. Most say yes, let's do it, some (10%) say I don't like needles and extra procedures, let's skip it

 

[OTN]

Because there are randomized data showing decreased GI toxicity. I tell them 98% of patients won't have significant GI issues without spaceOAR, some will have some GI issues. SpaceOAR reduces it for those small % of patients. I don't push it hard on my patients but tell them I would do have it for myself if it is paid for by insurance. Most say yes, let's do it, some (10%) say I don't like needles and extra procedures, let's skip it

By my read of the data, I am concerned it is possible that (Placement of the SpaceOAR causing its own problems and side effects) > (GI side effects from prostate radiation).

 

[Mandelin Rain]

Because there are randomized data showing decreased GI toxicity.

But, is there?

 

[deleted1111261]

But, is there?

Didn’t someone just show that it didn’t really help?

 

[WanderingRad3]

DEFINE_ME

There you go.

Crazy to me that we as a field don’t use a technology which has PHASE 3 data of benefit (and a rationale for that benefit to be seen). And when we do, we refer out to urologists to do it rather than building it as our own service line (unless urologists want to keep it/helps build relationship, which is fine). I don’t think any other interventional surgical speciality would do the same…

Totally reasonable to not use it for some patients or debate the data and potential (sometimes very severe but very rare) toxicity with SpaceOAR.

Barrigel phase 3 data I imagine will be published soon as well.

 

[elementaryschooleconomics]

I don't use SpaceOAR.

I don't use fiducials.

I give patients specific instructions about empty rectum + comfortably full bladder.

I wrote the handout myself, patients get it at consult, when staff do the reminder call the day before the instructions are reiterated.

I do daily CBCT and the therapists know what to look for regarding rectum and bladder.

Even with treating pelvic nodes, I have very few issues with GI/GU tox.

Now...perhaps I work with a boomer or two, and they trained long before the IMRT era. Their contouring and plan evaluation leave something to be desired.

I think SpaceOAR is helpful for THEIR patients.

Feel free to steal that from me, hydrogel companies:

"Are you bad at drawing circles? Use this invasive procedure to compensate for it!"

 

[NotMattSpraker]

DEFINE_ME

There you go.

Crazy to me that we as a field don’t use a technology which has PHASE 3 data of benefit (and a rationale for that benefit to be seen). And when we do, we refer out to urologists to do it rather than building it as our own service line (unless urologists want to keep it/helps build relationship, which is fine). I don’t think any other interventional surgical speciality would do the same…

Totally reasonable to not use it for some patients or debate the data and potential (sometimes very severe but very rare) toxicity with SpaceOAR.

Barrigel phase 3 data I imagine will be published soon as well.

Statistically significant phase 3 data that is clinically unimpressive. Not many trials report out grade 1+ toxicity.

I don't use SpaceOAR.

I don't use fiducials.

I give patients specific instructions about empty rectum + comfortably full bladder.

I wrote the handout myself, patients get it at consult, when staff do the reminder call the day before the instructions are reiterated.

I do daily CBCT and the therapists know what to look for regarding rectum and bladder.

Even with treating pelvic nodes, I have very few issues with GI/GU tox.

Now...perhaps I work with a boomer or two, and they trained long before the IMRT era. Their contouring and plan evaluation leave something to be desired.

I think SpaceOAR is helpful for THEIR patients.

Feel free to steal that from me, hydrogel companies:

"Are you bad at drawing circles? Use this invasive procedure to compensate for it!"

I like SpaceOAR for SBRT. Im looking forward to those results to see if I will still like it.

 

[WanderingRad3]

I also use SpaceOAR for SBRT...but if we believe the PACE-B trial results (GI toxicity essentially the same as conventionally fractionated IMRT, or actually 1% less but not statistically significant), I don't get why SpaceOAR should be more or less important for SBRT. I (personally) do not push SpaceOAR more or less on patients doing SBRT (have some patients who say they do not want extra procedure for SBRT and I say that's fine, but majority for SBRT or moderate hypofx or brachy get SpaceOAR in my practice).

Grade 2 GI was reduced from 6% to 0% in the Phase 3 SpaceOAR RCT. Cheaper/more widely accessible than MR-LINAC for similar results to MIRAGE trial MR-Linac results? Also measurable differences in bowel QOL.

I 100% agree that better contouring/plan eval probably make a bigger difference and I don't think SpaceOAR is absolutely necessary....but again, there is a clear benefit, probably based on (soon) 2 published phase 3 trials. Better than most data I see and certainly I think part of the problem in rad onc (as a specialty) is we don't want to be interventionalists even if data is staring us in the face (when surgeons will adopt the new extra $5k per patient toy on a single retrospective 5 patient study and will not turf that out to another specialty to perform)

 

[deleted1111261]

Isn’t the benefit of spacer about the same as benefit of doing conventional fx, basically? About 5% absolute difference in grade 2 toxicity.

 

[TheWallnerus]

Isn’t the benefit of spacer about the same as benefit of doing conventional fx, basically? About 5% absolute difference in grade 2 toxicity.

The Norwegians report, you decide

 

[RickyScott]

DEFINE_ME

There you go.

Crazy to me that we as a field don’t use a technology which has PHASE 3 data of benefit (and a rationale for that benefit to be seen). And when we do, we refer out to urologists to do it rather than building it as our own service line (unless urologists want to keep it/helps build relationship, which is fine). I don’t think any other interventional surgical speciality would do the same…

Totally reasonable to not use it for some patients or debate the data and potential (sometimes very severe but very rare) toxicity with SpaceOAR.

Barrigel phase 3 data I imagine will be published soon as well.

Benefit comes from very slight G1 toxicity improvement . If you define placement of spaceoar as g1/2 toxicity, there is no benefit. Also, no deaths in the trial due to the device but there has been one or two documented cases as well as a number of colostomies per the fda website. How much improvement in G1 toxicity do you think a human life is worth? 100,000 , 1 million …. men could suffer g1 toxicity as far as I am concerned to save one life?(which btw would entail 1 billion placements of space oar)
If space oar has already killed 1- 2 pts, it can probably never recoup the benefit in terms of improved g1 toxicity and has been a net negative for humanity.

 

[NotMattSpraker]

I also use SpaceOAR for SBRT...but if we believe the PACE-B trial results (GI toxicity essentially the same as conventionally fractionated IMRT, or actually 1% less but not statistically significant), I don't get why SpaceOAR should be more or less important for SBRT. I (personally) do not push SpaceOAR more or less on patients doing SBRT (have some patients who say they do not want extra procedure for SBRT and I say that's fine, but majority for SBRT or moderate hypofx or brachy get SpaceOAR in my practice).

Grade 2 GI was reduced from 6% to 0% in the Phase 3 SpaceOAR RCT. Cheaper/more widely accessible than MR-LINAC for similar results to MIRAGE trial MR-Linac results? Also measurable differences in bowel QOL.

I 100% agree that better contouring/plan eval probably make a bigger difference and I don't think SpaceOAR is absolutely necessary....but again, there is a clear benefit, probably based on (soon) 2 published phase 3 trials. Better than most data I see and certainly I think part of the problem in rad onc (as a specialty) is we don't want to be interventionalists even if data is staring us in the face (when surgeons will adopt the new extra $5k per patient toy on a single retrospective 5 patient study and will not turf that out to another specialty to perform)

This is better than most data you see? I strongly disagree. Like other trials that were clearly designed to bring a treatment/device to market, I value it less than other well-designed interventional trials. The Norwegians have it right. You are observing a statistical benefit that is barely clinically relevant.

I'm not sure why you think Rad Onc has not "adopted" SpaceOAR. A lot of people offer it. If someone comes to me for a second opinion and was offered SpaceOAR, I just explain that I don't recommend it to my patients. I don't trash the prior doctor or block the patient from getting it if they want it. I take them through the paper and results, and in my experience most agree that the juice isn't worth the squeeze.

The reason I think it might be more beneficial in SBRT is that it is harder to deliver well.

 

[OTN]

Benefit comes from very slight G1 toxicity improvement . If you define placement of spaceoar as g1/2 toxicity, there is no benefit. Also, no deaths in the trial due to the device but there has been one or two documented cases as well as a number of colostomies per the fda website. How much improvement in G1 toxicity do you think a human life is worth? 100,000 , 1 million …. men could suffer g1 toxicity as far as I am concerned to save one life?(which btw would entail 1 billion placements of space oar)
If space oar has already killed 1- 2 pts, it can probably never recoup the benefit in terms of improved g1 toxicity and has been a net negative for humanity.

I know of one patient who died on the table immediately after it was placed, so you can add that case to your analysis.

 

[communitydoc13]

Benefit comes from very slight G1 toxicity improvement . If you define placement of spaceoar as g1/2 toxicity, there is no benefit. Also, no deaths in the trial due to the device but there has been one or two documented cases as well as a number of colostomies per the fda website. How much improvement in G1 toxicity do you think a human life is worth? 100,000 , 1 million …. men could suffer g1 toxicity as far as I am concerned to save one life?(which btw would entail 1 billion placements of space oar)
If space oar has already killed 1- 2 pts, it can probably never recoup the benefit in terms of improved g1 toxicity and it has been a net negative for humanity.

I like the way radoncs think. For all the grumbling about how no other interventional specialty would turn their backs on this or that money making intervention, there are many positives to radonc culture.

We are obsessed with quantifying benefit. This is rarely done by other specialists and is critical to "shared decision making" in the modern era. It is never wrong for an 80 year old to decide not to do anything. Radoncs seem to be the rare specialists that can let them know how much benefit and cost (toxicity) there is to a given intervention. Maybe some PCPs discuss absolute benefit of statins, but not many.

We are obsessive about seeking reasonable consensus and require chart rounds. Chart rounds are good. When you have chart rounds every week and you actually look at your colleagues plans, you are remarkably protected regarding outlier practices. With the present market of medoncs coming and going from practices, it is remarkable how much trouble I am seeing regarding docs taking over each others panels. With so little oversight, that discretionary aspect of care can get out of control.

Not sure why we think well, but I think we do!

It's just time for us to apply that quantitative and collaborative thinking to things like systemic therapy.

 

[deleted1111261]

I like the way radoncs think. For all the grumbling about how no other interventional specialty would turn their backs on this or that money making intervention, there are many positives to radonc culture.

We are obsessed with quantifying benefit. This is rarely done by other specialists and is critical to "shared decision making" in the modern era. It is never wrong for an 80 year old to decide not to do anything. Radoncs seem to be the rare specialists that can let them know how much benefit and cost (toxicity) there is to a given intervention. Maybe some PCPs discuss absolute benefit of statins, but not many.

We are obsessive about seeking reasonable consensus and require chart rounds. Chart rounds are good. When you have chart rounds every week and you actually look at your colleagues plans, you are remarkably protected regarding outlier practices. With the present market of medoncs coming and going from practices, it is remarkable how much trouble I am seeing regarding docs taking over each others panels. With so little oversight, that discretionary aspect of care can get out of control.

Not sure why we think well, but I think we do!

It's just time for us to apply that quantitative and collaborative thinking to things like systemic therapy.

I love this.

People think people just talk **** on the specialty. Nope. We actually all are pretty into it and enjoy talking about it and treating patients.

You're right - we know pros/cons of treatments better than most. We have many safeguards in place - RO malpractice premiums reflect this.

These are very good aspects of our field.

 

[imhopeful432]

Isn’t the benefit of spacer about the same as benefit of doing conventional fx, basically? About 5% absolute difference in grade 2 toxicity.

Well conventional fx has a benefit in acute grade 2 toxicity, SpaceOAR has a benefit in late grade 2 toxicity. Most of my patients choose moderately hypofx with SpaceOAR (Norway would probably recognize 28 fx w/ SpaceOAR as more cost effective than 44 fx without SpaceOAR...) - although you are right, 28 fx with SpaceOAR would be the most cost effective since marginal benefit to coventional fx or to SpaceOAR are both relatively low!

 

[deleted1111261]

Well conventional fx has a benefit in acute grade 2 toxicity, SpaceOAR has a benefit in late grade 2 toxicity. Most of my patients choose moderately hypofx with SpaceOAR (Norway would probably recognize 28 fx w/ SpaceOAR as more cost effective than 44 fx without SpaceOAR...) - although you are right, 28 fx with SpaceOAR would be the most cost effective since marginal benefit to coventional fx or to SpaceOAR are both relatively low!

I wonder if Norway has a payment system that is like ours. 44 with spacer May be best if they are on APM?

 

[RickyScott]

I wonder if Norway has a payment system that is like ours. 44 with spacer May be best if they are on APM?

Does spacer oar have late 2 statistically sig benefit? I was just counting the colostomies on the fda web site and there seem to be around one per month reported.

 

[TheWallnerus]

Does spacer oar have late 2 statistically sig benefit? I was just counting the colostomies on the fda web site and there seem to be around one per month reported.

If true this is scandalous

 

[RickyScott]

If true this is scandalous

In first 3 months I looked at. Have also heard of several cases in my state that did not make the website. In order to get the product out as quickly as possible, company has rep supervise just several cases and urologists encouraged to do the procedure in their office. Busy urologist trained on 2 or 3 pts by a rep would be expected to have some casualties during his first 50?

 

[imhopeful432]

Does spacer oar have late 2 statistically sig benefit? I was just counting the colostomies on the fda web site and there seem to be around one per month reported.

That's what the RCT shows yes. 6% vs. 0% late grade 2 GI tox. Barrigel study (per press release, not yet published) shows long term GI toxicity of 2.9% vs. 13.8%.

The colostomies are insane indeed if really that prevalent...

 

[deleted1111261]

In first 3 months I looked at. Have also heard of several cases in my state that did not make the website. In order to get the product out as quickly as possible, company has rep supervise just several cases and urologists encouraged to do the procedure in their office. Busy urologist trained on 2 or 3 pts by a rep would be expected to have some casualties during his first 50?

Link ??
Eeeeek

 

[imhopeful432]

Link ??
Eeeeek

Is this fundamentally different than rare, extreme complications in the hands of inexperienced users with other new devices in other interventional specialties? Honestly asking because I don't know.

As someone who does SpaceOAR in the office fairly often myself (and have not personally seen these complications), I feel very, very comfortable doing it and offering it to patients but would certainly want SpaceOAR by someone with experience if it was for myself or a family member.

 

[deleted1111261]

Is this fundamentally different than rare, extreme complications in the hands of inexperienced users with other new devices in other interventional specialties? Honestly asking because I don't know.

As someone who does SpaceOAR in the office fairly often myself (and have not personally seen these complications), I feel very, very comfortable doing it and offering it to patients but would certainly want SpaceOAR by someone with experience if it was for myself or a family member.

I doubt it is - and I bet you are good at it.

I think that many people do not see 5-6% patients ending up with a long term GI toxicity.

Maybe there are differences in outcomes with people that do a lot of prostate cancer consistently with best practices and they would not have a substantial reduction in toxicity?

I am "just asking questions"

I have not found the problem with prostate IMRT to be late GI issue. But, I don't treat very much any more.

 

[RickyScott]

Here is a link to the database

Post in: 'SPACEOAR complications'


SPACEOAR complications

Post in: 'SPACEOAR complications'
SPACEOAR complications

 

[windcolour99]

Any one with good experience for prosate SBRT by Linac with fiducial only?

Most of the published data used Cyberknife.

No interest on SPACOAR;

 

[TheWallnerus]

Any one with good experience for prosate SBRT by Linac with fiducial only?

Most of the published data used Cyberknife.

No interest on SPACOAR;

What can I say. It works great. I’ve been doing fiducials since 2004. I didn’t dip toe into SBRT prostate water until about 2013. Have always used fiducial matching with CBCT internal anatomy confirmation but the fiducials determine the X, Y, and Z. I could never try SpaceOAR because not only am I too happy with outcomes as they are, I feel like you need to do a procedure 20 or more times to get good at it and I don’t feel like using my patients as my training ground for this.

 

[Gfunk6]

Any one with good experience for prosate SBRT by Linac with fiducial only?

Most of the published data used Cyberknife.

No interest on SPACOAR;

Donald Fuller has published extensively on his community experience re: prostate SBRT. It has been used as primary treatment and also salvage in previously irradiated patients. I don't recall SpaceOAR being uniformly used.

fuller d prostate sbrt - Search Results - PubMed

fuller d prostate sbrt - Search Results - PubMed

pubmed.ncbi.nlm.nih.gov

 

[windcolour99]

What can I say. It works great. I’ve been doing fiducials since 2004. I didn’t dip toe into SBRT prostate water until about 2013. Have always used fiducial matching with CBCT internal anatomy confirmation but the fiducials determine the X, Y, and Z. I could never try SpaceOAR because not only am I too happy with outcomes as they are, I feel like you need to do a procedure 20 or more times to get good at it and I don’t feel like using my patients as my training ground for this.

That is great.

I would appreciate if you could help to conform the protocol:
1. plan with MRI?
2. Dose 36.25 Gy in 5 fx, every other day?
3. Expansion 5mm except 3mm posterior?
4. treat with empy rectum and full bladder?

Thank you so much!

 

[windcolour99]

Donald Fuller has published extensively on his community experience re: prostate SBRT. It has been used as primary treatment and also salvage in previously irradiated patients. I don't recall SpaceOAR being uniformly used.

fuller d prostate sbrt - Search Results - PubMed

fuller d prostate sbrt - Search Results - PubMed

pubmed.ncbi.nlm.nih.gov

Thank you so much. I will look into the detail for sure.

 

[OTN]

That is great.

I would appreciate if you could help to conform the protocol:
1. plan with MRI?
2. Dose 36.25 Gy in 5 fx, every other day?
3. Expansion 5mm except 3mm posterior?
4. treat with empy rectum and full bladder?

Thank you so much!

40 Gy in 5 weekly fx. Fuse a prostate MRI to help with contouring.

Full bladder, empty rectum. No SpaceOAR.

No fiducials. CBCT at start of tx and halfway through. 3mm expansion all around.

 

[TheWallnerus]

40 Gy in 5 weekly fx. Fuse a prostate MRI to help with contouring.

Full bladder, empty rectum. No SpaceOAR.

No fiducials. CBCT at start of tx and halfway through. 3mm expansion all around.

Did you hack my EMR

But seriously, there is some data that fiducials provide lower systematic error. On paper this allows a tighter PTV by margin recipes. In real life, it very well not matter at all. There is probably a lot of “pseudoPTV” by calling the entire prostate gland the CTV.

 

[windcolour99]

Thank you two so much! My urologists do a very good job for fiducials.

Just curious about the planning:
the rectum is so close to the prostate. Without hydrgel, how easy is it to achieve the constraints for rectum? Do your dosimetriests use non-coplanar beams?