SPACEOAR complications

[RickyScott]

regarding space oar, one DEATH was reported: we should continue to check the MAUDE database. Almost certainly underestimates number of true vs reported events. There were basically no events on the trial? Sketchy AF

Considering benefit and risk before routinely recommending SpaceOAR - PMC

www.ncbi.nlm.nih.gov

"To accomplish this, on May 15, 2020, the MAUDE database, which houses medical device reports submitted to the FDA by mandatory and voluntary reporters, was accessed via a publicly available online interface and events were searched for from May 1, 2015, to May 1, 2020, using the search term “SpaceOAR”. The description of each event was reviewed and scored by two independent radiation oncologists (WAH and CAFL). The results were then compared collectively, and a final adjudication of scored toxicity events was created. A total of 85 reported events in the MAUDE database were available for review. Among these, 80 (94%) had event descriptions that could be characterised using the Common Terminology Criteria for Adverse Events (version 5.0). Of the toxicity events, 59 (69%) were grade 3, 4, or 5. 20 (24%) were grade 4 events, including multiple independent descriptions of colostomy, anaphylactic events, rectal wall injection, or pulmonary emboli requiring hospital admission. One death was reported. The toxicity score distribution can be seen in the appendix (p 2).

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[RickyScott]

colostomies are being performed monthly: just put in "spaceoar" for brand name and expand date range
MAUDE - Manufacturer and User Facility Device Experience

3/22 colostomy
MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER

BOSTON SCIENTIFIC CORPORATION SPACEOAR VUE SYSTEM ABSORBABLE PERIRECTAL SPACER​ Back to Search Results​

​ Model Number SV-2101 Device Problem Positioning Problem (3009) Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Ulcer (2274); Discomfort (2330) Event Date 03/01/2022 Event Type Injury Manufacturer Narrative The complainant was unable to provide the suspect device lot number. Therefore, the expiration and device manufacture dates are unknown. (b)(4). The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed. Event Description It was reported to boston scientific corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on (b)(6) 2021. Fiducials were administered transperineally and the procedure was done under general anesthesia. Low dose rate brachytherapy boost seeds were placed in the same procedure prior to the spaceoar vue placement. The patient experienced pain and discomfort a week after the placement procedure. During a 30 post placement computed tomography (ct) scan, on (b)(6) 2021, the patient was experiencing pain, bleeding, ulcer and evidence of the gel misplaced in the rectal wall. An endoscopy was performed, and it was noted that the last image slice showed some of the spaceoar vue hydrogel was injected in the rectal wall. The patient was treated with hyperbaric oxygen and will receive sucralfate enemas. The patient received 28 fractions of radiation treatment and received a diverting colostomy, which has reduced discomfort significantly. The patient reportedly, feels better.

 

[elementaryschooleconomics]

"But the DVH..."

- SpaceOAR apologists

 

[RickyScott]

"But the DVH..."

- SpaceOAR apologists

same for protons. Large number of events in last year, and these are probably only a fraction of what actually occurred, considering "none" occurred on the clinical trials

MAUDE - Manufacturer and User Facility Device Experience​

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500 records meeting your search criteria returned. The results are incomplete - please narrow your search.​

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New Search Export to Excel | Help​ Manufacturer​ Brand Name​ Date Report Received​ BOSTON SCIENTIFIC CORPORATION​ SPACEOAR SYSTEM​ 07/12/2021​ BOSTON SCIENTIFIC CORPORATION​ SPACEOAR SYSTEM​ 07/09/2021​ BOSTON SCIENTIFIC CORPORATION​ SPACEOAR SYSTEM​ 07/09/2021​ BOSTON SCIENTIFIC CORPORATION​ SPACEOAR SYSTEM​ 07/09/2021​ BOSTON SCIENTIFIC CORPORATION​ SPACEOAR SYSTEM​ 07/07/2021​ BOSTON SCIENTIFIC CORPORATION​ SPACEOAR SYSTEM​ 07/06/2021​ BOSTON SCIENTIFIC CORPORATION​ SPACEOAR SYSTEM​ 07/01/2021​ BOSTON SCIENTIFIC CORPORATION​ SPACEOAR SYSTEM​ 07/01/2021​ BOSTON SCIENTIFIC CORPORATION​ SPACEOAR SYSTEM​ 07/01/2021​ BOSTON SCIENTIFIC CORPORATION​ SPACEOAR SYSTEM​ 07/01/2021​

New Search Export to Excel | Help​
Manufacturer​	Brand Name​	Date Report Received​
BOSTON SCIENTIFIC CORPORATION​	SPACEOAR SYSTEM​	04/28/2022​
BOSTON SCIENTIFIC CORPORATION​	SPACEOAR SYSTEM​	04/28/2022​
BOSTON SCIENTIFIC CORPORATION​	SPACEOAR SYSTEM​	04/28/2022​
BOSTON SCIENTIFIC CORPORATION​	SPACEOAR VUE SYSTEM​	04/28/2022​
BOSTON SCIENTIFIC CORPORATION​	SPACEOAR SYSTEM​	04/28/2022​
BOSTON SCIENTIFIC CORPORATION​	SPACEOAR VUE SYSTEM​	04/28/2022​
BOSTON SCIENTIFIC CORPORATION​	SPACEOAR SYSTEM​	04/27/2022​
BOSTON SCIENTIFIC CORPORATION​	SPACEOAR SYSTEM​	04/26/2022​
BOSTON SCIENTIFIC CORPORATION​	SPACEOAR VUE SYSTEM​	04/26/2022​
BOSTON SCIENTIFIC CORPORATION​	SPACEOAR VUE SYSTEM​	04/21/2022​

 

[TheWallnerus]

I wish my competitors would start doing SpaceOAR. I really feel that it would eventually help my business.

Fool me once, shame on you; colostomize a patient or give them nausea/intense rectal pain, shame on me.

 

[OTN]

I know personally of one Grade 5 event that did not make it into the database

 

[Mandelin Rain]

I know personally of one Grade 5 event that did not make it into the database

With the reported "benefit" being so insignificant, I just can't imagine doing SpaceOAR.

 

[RickyScott]

I know personally of one Grade 5 event that did not make it into the database

So 2 deaths due to spaceoar. Wouldnt that negate all possible “benefit” from here to eternity ?

 

[RadRadRad]

I’ve seen one abscess/fistula requiring colostomy from another center

 

[jondunn]

proton lobby is probably in bed with SPACE_OAR also

 

[thesauce]

Sorry to be the opposition here, but I have done spaceoar a tremendous number of times (literally hundreds) and honestly have never seen anything remotely concerning. Some part of this may be technique - I know I have gotten a lot better over time.

 

[jondunn]

Sorry to be the opposition here, but I have done spaceoar a tremendous number of times (literally hundreds) and honestly have never seen anything remotely concerning. Some part of this may be technique - I know I have gotten a lot better over time.

I definitely believe the risk is low

my question is WHY? SBRT is one thing, but WHY for conventional frac or hypofrac?

 

[RickyScott]

I definitely believe the risk is low

my question is WHY? SBRT is one thing, but WHY for conventional frac or hypofrac?

Plenty of sbrt performed without spaceoar. Spaceoar definitely needed for protons.

 

[deleted1116990]

I definitely believe the risk is low

my question is WHY? SBRT is one thing, but WHY for conventional frac or hypofrac?

Phase 3 randomized data.

Whether that answer is satisfying to you or not is a different story, but that's the answer to the specific question you just posed.

 

[imhopeful432]

Sorry to be the opposition here, but I have done spaceoar a tremendous number of times (literally hundreds) and honestly have never seen anything remotely concerning. Some part of this may be technique - I know I have gotten a lot better over time.

If I were a patient or my father were being treated, I would want SpaceOAR (from someone with experience placing them). This is from both from the clinical data available, the dosimetric changes I can see, and the anecdotal clinical difference I see in patients for SBRT/brachy/moderate hypofx.

The risk is much greater with TRUS biopsy (0.1-0.3% risk of septic shock). If you want to improve the therapeutic ratio, giving everyone a transperineal biopsy + SpaceOAR > giving everyone TRUS bx and no SpaceOAR.

Of course, very reasonable to omit SpaceOAR after discussion of extremely rare (but major) risks in patients who want to avoid it. I tell all patients that there is a very small risk of infection/major complication but I have not personally seen it.

 

[OTN]

If I were a patient or my father were being treated, I would not want SpaceOAR. This is both from the clinical data available and the anecdotal evidence I see in patients for SBRT/moderate hypofractionation/standard fractionation.

 

[RickyScott]

If I were a patient or my father were being treated, I would want SpaceOAR (from someone with experience placing them). This is from both from the clinical data available, the dosimetric changes I can see, and the anecdotal clinical difference I see in patients for SBRT/brachy/moderate hypofx.

The risk is much greater with TRUS biopsy (0.1-0.3% risk of septic shock). If you want to improve the therapeutic ratio, giving everyone a transperineal biopsy + SpaceOAR > giving everyone TRUS bx and no SpaceOAR.

Of course, very reasonable to omit SpaceOAR after discussion of extremely rare (but major) risks in patients who want to avoid it. I tell all patients that there is a very small risk of infection/major complication but I have not personally seen it.

Very legitimate point, but clearly in some hands, it is not safe.

 

[radoncftw]

Very legitimate point, but clearly in some hands, it is not safe.

problem is complications can happen with very skilled people as well. There is some randomness to this. one of our GU attendings who is known for being the most skilled brachytherapist and proceduralist in general is the one who has had the most G3/4 complications.

 

[TheWallnerus]

Phase 3 randomized data.

Whether that answer is satisfying to you or not is a different story, but that's the answer to the specific question you just posed.

It's times like this where I like to say something generically provocative... like: "Negative phIII randomized trials have very high negative predictive values, but positive phIII trials have as much as a 25% false positive rate and 50% reproducibility rate especially with p-values in the 0.03-0.05 range."

problem is complications can happen with very skilled people as well. There is some randomness to this. one of our GU attendings who is known for being the most skilled brachytherapist and proceduralist in general is the one who has had the most G3/4 complications.

I bet someone somewhere sometime said "John Gochnaur is known as a skilled baseball player and shortstop in general." 😉

 

[RickyScott]

It's times like this where I like to say something generically provocative... like: "Negative phIII randomized trials have very high negative predictive values, but positive phIII trials have as much as a 25% false positive rate and 50% reproducibility rate especially with p-values in the 0.03-0.05 range."

I bet someone somewhere sometime said "John Gochnaur is known as a skilled baseball player and shortstop in general." 😉

Because the phase 3 trial did not involve a sham procedure, the difference in g1 toxicity can easily be explained by placebo effect. Per vinay prassad podcast

With antidepressants, 40%-50% cured by placebo; meds adds something like 10%. This has been seen in cardiac stents for angina and knee surgeries. Both showed no benefit vs sham.

 

[medgator]

Sorry to be the opposition here, but I have done spaceoar a tremendous number of times (literally hundreds) and honestly have never seen anything remotely concerning. Some part of this may be technique - I know I have gotten a lot better over time.

I think the proctorship process is way too easy and it's a product that lends itself to toxicity if done improperly with marginal benefit to begin with (outside of protons or sbrt/hdr). Why would Boston scientific want to make it really hard to get people certified to place their $3k hydrogel product?

Still bad imo on net

 

[medgator]

problem is complications can happen with very skilled people as well. There is some randomness to this. one of our GU attendings who is known for being the most skilled brachytherapist and proceduralist in general is the one who has had the most G3/4 complications.

The only elective colostomy complication i have seen is from a GU who had placed dozens before hand. Pt did have high risk disease, so who knows

 

[elementaryschooleconomics]

Sorry to be the opposition here, but I have done spaceoar a tremendous number of times (literally hundreds) and honestly have never seen anything remotely concerning. Some part of this may be technique - I know I have gotten a lot better over time.

I completely agree the toxicity risk is very low.

But, not using it is even lower.

Do you think we could get the ole EBCTCG gang back together, you know, the ones who came up with the 4 recurrences/10 years = save 1 life/15 years peak RadOnc voodoo to do another calculation on hydrogel placements?

Actually, Norway already did just that, it pretty much says everything that needs to be said.

From the body of the report:

 

[elementaryschooleconomics]

Put another way:

 

[imhopeful432]

Because the phase 3 trial did not involve a sham procedure, the difference in g1 toxicity can easily be explained by placebo effect. Per vinay prassad podcast

With antidepressants, 40%-50% cured by placebo; meds adds something like 10%. This has been seen in cardiac stents for angina and knee surgeries. Both showed no benefit vs sham.

"Using an aseptic transperineal technique, we placed at least 3 gold intraprostate fiducial markers, and patients were immediately randomized (envelope opened) to receive transperineal injection of spacer or no injection as a control. Patients were blinded to randomization."

I have a colleague who participated in the trial. Patients did not know whether they got SpaceOAR or not. Could they have found out by the doctor telling them afterwards/when they got radiation? Sure....but the methods seem pretty airtight to me compared to any other sham intervention trial.

 

[RickyScott]

"Using an aseptic transperineal technique, we placed at least 3 gold intraprostate fiducial markers, and patients were immediately randomized (envelope opened) to receive transperineal injection of spacer or no injection as a control. Patients were blinded to randomization."

I have a colleague who participated in the trial. Patients did not know whether they got SpaceOAR or not. Could they have found out by the doctor telling them afterwards/when they got radiation? Sure....but the methods seem pretty airtight to me compared to any other sham intervention trial.

Following Doc would still know and this could also give small bias generating that tiny absolute G1 benefit.

 

[ramsesthenice]

problem is complications can happen with very skilled people as well. There is some randomness to this. one of our GU attendings who is known for being the most skilled brachytherapist and proceduralist in general is the one who has had the most G3/4 complications.

Sadly, many, many people don’t know how many grade 3/4 complications they actually have in prostate patients. Late rectal complications (which account for a fair bit of these) require following the patient > 1 year after treatment and not just turning them over to urology or a mid level which is what a lot of people do for favorable risk patients. Easiest way to have low complications is to not look for them. They still shouldn’t be too common…no matter how hard you look. But they do happen from time to time.

 

[RickyScott]

Sadly, many, many people don’t know how many grade 3/4 complications they actually have in prostate patients. Late rectal complications (which account for a fair bit of these) require following the patient > 1 year after treatment and not just turning them over to urology or a mid level which is what a lot of people do for favorable risk patients. Easiest way to have low complications is to not look for them. They still shouldn’t be too common…no matter how hard you look. But they do happen from time to time.

I had access to one of largest single institution prostate databases. No colostomies from ebrt.

Also saw a lot of very late follow ups. Pts did very well as a whole. Have a frenemy relationship with urologists in my system. They would love to let me know!

 

[TheWallnerus]

Sadly, many, many people don’t know how many grade 3/4 complications they actually have in prostate patients. Late rectal complications (which account for a fair bit of these) require following the patient > 1 year after treatment and not just turning them over to urology or a mid level which is what a lot of people do for favorable risk patients. Easiest way to have low complications is to not look for them. They still shouldn’t be too common…no matter how hard you look. But they do happen from time to time.

Btw aren’t we supposed to be favoring WW for favorable risk nowadays

 

[RadRadRad]

Sorry to be the opposition here, but I have done spaceoar a tremendous number of times (literally hundreds) and honestly have never seen anything remotely concerning. Some part of this may be technique - I know I have gotten a lot better over time.

I think you are probably correct. I’ve done about 20 and there is a learning curve. Also quality of ultrasound makes huge difference. Modern probes have insane image quality and much easier to see the area for hydro dissection….but the reported complications have made me shy away

 

[RickyScott]

I think you are probably correct. I’ve done about 20 and there is a learning curve. Also quality of ultrasound makes huge difference. Modern probes have insane image quality and much easier to see the area for hydro dissection….but the reported complications have made me shy away

The learning curve is a problem if average radonc sees 1-2 prostate cases or less per month.

 

[thesauce]

Btw aren’t we supposed to be favoring WW for favorable risk nowadays

Depends on who you ask

 

[Burt Radnolds]

We see a lot of prostate cancer in our group and are closely aligned with the main urologic provider in our region. Personally, I think some of the discussion here regarding extremely low late toxicity for prostate radiotherapy is a bit overstated. I see a not insignificant # of patients getting kicked back for g3 proctitis or cystitis that we assist in managing. Granted, this is a small % of hundreds (thousand+?) of patients that have been treated over the last decade, but also not the 0% that I see many on here claim. Every single one I do a robust dosimetry and IGRT analysis on and can tell you it is mostly biologic predispostion, not bad planning/setup. Early on I was a believer in SpaceOAR and discussed it with every patient. However, I have also seen several SpaceOAR trainwrecks even with high volume providers and personally sounded the alarm years back on this. I don't even offer it to conventional/hypofx patients anymore. The therapeutic ratio is negative to me on the whole. We do still offer it to SBRT patients who are getting fiducials anyways and do it in a single procedure.

 

[ramsesthenice]

I had access to one of largest single institution prostate databases. No colostomies from ebrt.

Also saw a lot of very late follow ups. Pts did very well as a whole. Have a frenemy relationship with urologists in my system. They would love to let me know!

Colostomies should never happen for prostate cancer. Ever. I do more re-irradiation than most and I’ve never seen one.

Bleeding requiring APC or HBO…that will happen from time to time. In the neighborhood of 1-2%. We can all agree that’s a low number. But it’s not zero. Is there anything you can do to make it better? With such a low baseline, it would be very hard to prove.

Btw aren’t we supposed to be favoring WW for favorable risk nowadays

Technically no. WW is not the same as AS but we all know what you meant 😉. It’s an option but patients have the final say. A lot of people for one reason or another just want to be done for one reason or another. Also, favorable includes favorable IR and while AS is an option for them, even plenty of urologists I know don’t love AS for IR disease. Doesn’t usually kick the can that far down the road.

 

[medgator]

Colostomies should never happen for prostate cancer. Ever. I do more re-irradiation than most and I’ve never seen one.

Which is all the more reason it's shocking to see it as a complication of something done in preparation for treatment

 

[TheWallnerus]

Bleeding requiring APC or HBO…that will happen from time to time.

I see a not insignificant # of patients getting kicked back for g3 proctitis or cystitis

Two comments:

1) Rectal/bladder DVH metrics are directly proportional to prostate PTV size choice and thus directly proportional to those organs’ post RT toxicities. We can’t have a toxicity discussion in prostate cancer, or even about SpaceOAR, unless we explicitly state “volume decisions” in the discussion. Now here millimeters DO matter. And you’re going to find 5 different approaches/decisions in 5 different rad oncs.
2) Ripley’s Believe it or Not: no APC or HBO in a prostate patient since… 2004?

 

[RickyScott]

Two comments:

1) Rectal/bladder DVH metrics are directly proportional to prostate PTV size choice and thus directly proportional to those organs’ post RT toxicities. We can’t have a toxicity discussion in prostate cancer, or even about SpaceOAR, unless we explicitly state “volume decisions” in the discussion. Now here millimeters DO matter. And you’re going to find 5 different approaches/decisions in 5 different rad oncs.
2) Ripley’s Believe it or Not: no APC or HBO in a prostate patient since… 2004?

Two comments:

1) Rectal/bladder DVH metrics are directly proportional to prostate PTV size choice and thus directly proportional to those organs’ post RT toxicities. We can’t have a toxicity discussion in prostate cancer, or even about SpaceOAR, unless we explicitly state “volume decisions” in the discussion. Now here millimeters DO matter. And you’re going to find 5 different approaches/decisions in 5 different rad oncs.
2) Ripley’s Believe it or Not: no APC or HBO in a prostate patient since… 2004?

I haven’t had a carb since 2004.

 

[Palex80]

Just a stupid question, after reading that incident report: If you were planning to perform SpaceOAR placement and the seeds placement during one procedure together, why would one first place the seeds and then the SpaceOAR afterwards?

If you do encounter an issue with SpaceOAR placement that you would become aware of during placement, would it not be better if you did not have the seeds in place already?

 

[medgator]

Just a stupid question, after reading that incident report: If you were planning to perform SpaceOAR placement and the seeds placement during one procedure together, why would one first place the seeds and then the SpaceOAR afterwards?

If you do encounter an issue with SpaceOAR placement that you would become aware of during placement, would it not be better if you did not have the seeds in place already?

Generally do fiducials before spaceoar if single procedure is done

 

[Palex80]

Generally do fiducials before spaceoar if single procedure is done

Well yes, I totally understand doing fiducials prior to SpaceOAR. Fiducials are harmless.

The issue I see in this case is that they placed LDR-brachytherapy seeds PRIOR to the SpaceOAR-placement.
"It was reported to boston scientific corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on (b)(6) 2021. Fiducials were administered transperineally and the procedure was done under general anesthesia. Low dose rate brachytherapy boost seeds were placed in the same procedure prior to the spaceoar vue placement. "
If you end up hurting the rectal wall due to a misplaced SpaceOAR, you already have the fiducials in, which in turn:
a) means dose to the rectal wall that is under stress due to to the misplaced SpaceOAR
b) unnecessary dose to staff (especially surgery, gastroenterology), in case you need to perform any procedures on that rectum in the first days/weeks afrer implantation

I presume that SpaceOAR placement only marginally alters the prostate form, but are there any issues with dosimetry when you place the SpaceOAR after you just placed the brachytherapy seeds?

 

[Burt Radnolds]

Two comments:

1) Rectal/bladder DVH metrics are directly proportional to prostate PTV size choice and thus directly proportional to those organs’ post RT toxicities. We can’t have a toxicity discussion in prostate cancer, or even about SpaceOAR, unless we explicitly state “volume decisions” in the discussion. Now here millimeters DO matter. And you’re going to find 5 different approaches/decisions in 5 different rad oncs.
2) Ripley’s Believe it or Not: no APC or HBO in a prostate patient since… 2004?

Yeah when I was speaking to the observed toxicity, I was commenting group wide over the last 10 years, as these cases are rare and typically discussed among us. Its a big pool of patients and simple statistics coupled with time are going to bring a few out of the woodwork. Personally, maybe 1 was mine and often its a retired partner's.

Clearly there is a correlation between DVH, target volume, and toxicity. There is also an element of patient sensitivity though. I have reviewed cases getting 66Gy to the fossa with excellent posterior fall off that needed multiple APC from anterior rectal wall bleeding. Careful planning, margin selection, and localization avoids much but not all.

You can deliver bad radiation with minimal toxicity in someone with "good biology" and can deliver a "perfect" plan with moderate late toxicity in someone who happens to be more sensitive. The catastrophic situation is bad treatment in a sensitive patient. Would be nice if there was a test to tell us these things, maybe the "sensitive" patients would be good SpaceOAR candidates.

 

[imhopeful432]

Well yes, I totally understand doing fiducials prior to SpaceOAR. Fiducials are harmless.

The issue I see in this case is that they placed LDR-brachytherapy seeds PRIOR to the SpaceOAR-placement.
"It was reported to boston scientific corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on (b)(6) 2021. Fiducials were administered transperineally and the procedure was done under general anesthesia. Low dose rate brachytherapy boost seeds were placed in the same procedure prior to the spaceoar vue placement. "
If you end up hurting the rectal wall due to a misplaced SpaceOAR, you already have the fiducials in, which in turn:
a) means dose to the rectal wall that is under stress due to to the misplaced SpaceOAR
b) unnecessary dose to staff (especially surgery, gastroenterology), in case you need to perform any procedures on that rectum in the first days/weeks afrer implantation

I presume that SpaceOAR placement only marginally alters the prostate form, but are there any issues with dosimetry when you place the SpaceOAR after you just placed the brachytherapy seeds?

SpaceOAR obliterates the US image for brachy seed placement if done immediately before brachy.
Your two choices are: do SpaceOAR ~1 week before brachy OR do SpaceOAR at the end of the brachy case after placing brachy seeds.

I tend to do the former (spaceOAR under local 1 week prior to brachy)

 

[Mandelin Rain]

SpaceOAR obliterates the US image for brachy seed placement if done immediately before brachy.
Your two choices are: do SpaceOAR ~1 week before brachy OR do SpaceOAR at the end of the brachy case after placing brachy seeds.

I tend to do the former (spaceOAR under local 1 week prior to brachy)

Your patients just requesting an extra TRUS and needle in perineum procedure?

 

[evilbooyaa]

Well yes, I totally understand doing fiducials prior to SpaceOAR. Fiducials are harmless.

The issue I see in this case is that they placed LDR-brachytherapy seeds PRIOR to the SpaceOAR-placement.
"It was reported to boston scientific corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on (b)(6) 2021. Fiducials were administered transperineally and the procedure was done under general anesthesia. Low dose rate brachytherapy boost seeds were placed in the same procedure prior to the spaceoar vue placement. "
If you end up hurting the rectal wall due to a misplaced SpaceOAR, you already have the fiducials in, which in turn:
a) means dose to the rectal wall that is under stress due to to the misplaced SpaceOAR
b) unnecessary dose to staff (especially surgery, gastroenterology), in case you need to perform any procedures on that rectum in the first days/weeks afrer implantation

I presume that SpaceOAR placement only marginally alters the prostate form, but are there any issues with dosimetry when you place the SpaceOAR after you just placed the brachytherapy seeds?

Generlaly after SpaceOAR the visualization of the prostate (especially the anterior aspect) is worse. LDR brachy gets seeds first followed by spaceOAR.

 

[cancer_doc]

If you place Seeds --> SpaceOAR on same day, there's going to be a combination of prostate displacement and compression (primarily of the posterior gland). Any compression may alter your dosi, regardless if you preplan or intraOP, and worse, if your pt's urethra courses more posteriorly in the prostate, you risk some extrinsic urethral flow restriction.

 

[mavrik13]

I do a not insignificant amount of LDR prostate (though not as a boost)... I can't fathom why you would want SpaceOAR with LDR. Maybe it is just me, but rectal toxicity is rarely if ever a major concern.
For boost, I prefer HDR.
Either way, with brachy, I find rectal toxicity to be less than EBRT/SBRT.

 

[thesauce]

I do a not insignificant amount of LDR prostate (though not as a boost)... I can't fathom why you would want SpaceOAR with LDR. Maybe it is just me, but rectal toxicity is rarely if ever a major concern.
For boost, I prefer HDR.
Either way, with brachy, I find rectal toxicity to be less than EBRT/SBRT.

And LDR is the only scenario where I’ve seen colostomies

 

[salubalu]

I saw case with a patient with muscle invasive bladder cancer. The patient had ldr for prostate and has several seeds in the bladder which was also the location of his bladder tumor…

 

[ramsesthenice]

I saw case with a patient with muscle invasive bladder cancer. The patient had ldr for prostate and has several seeds in the bladder which was also the location of his bladder tumor…

There is a reason I converted to HDR. It’s more work for me (at least as a mono therapy) but the needles never go quite where you want and the seeds then have some migration.

I can tell you from experience if you are doing combo Brachy/EBRT with a spacer do the Brachy first if you really think you need it. Imaging is fine but the anterior displacement of the prostate if you get good spacer placement will bring the pubic arch into play for all but the smallest of prostates. You end up with worse prostate coverage far more often than significantly better rectal dose.

And surprise to no one, you loose out on procedural charges if you try to do the spacer and Brachy on the same day.

I agree with the above. If you are doing Brachy (boost or mono) I really don’t see a role for spacer. Rectal tox should be low unless you manage to put a seed in the rectal wall which, well, dose happen sometimes with LDR.

 

[DoctwoB]

Colostomies should never happen for prostate cancer. Ever. I do more re-irradiation than most and I’ve never seen one.

Bleeding requiring APC or HBO…that will happen from time to time. In the neighborhood of 1-2%. We can all agree that’s a low number. But it’s not zero. Is there anything you can do to make it better? With such a low baseline, it would be very hard to prove.


Technically no. WW is not the same as AS but we all know what you meant 😉. It’s an option but patients have the final say. A lot of people for one reason or another just want to be done for one reason or another. Also, favorable includes favorable IR and while AS is an option for them, even plenty of urologists I know don’t love AS for IR disease. Doesn’t usually kick the can that far down the road.

I offer all my favorable intermediate risk patients AS. I steer most of the younger folks away from it do the small but non-zero risk of progression to Mets (1-10% depending on the series you look at) and very high rates of conversion to radical therapy (~50-60% at 5 years). I also get edgy with higher volumes of disease, even if it’s a 1-2 cores of GG2 in a background of 8/12 cores with GG1 (though that’s technically unfavorable IR per NCCN, which tbh I disagree with)

Incidentally I think this is the one area where focal therapy be beneficial. If you have low volume Gleason 7 disease and you can reduce their risk of progression to therapy from 60% to 20% with minimal ADRs that’s a potential benefit.