Yippee another Spacer trial

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I would argue that most trials are done to generate “X” intervention is better (see: VISION trial and others for Pluvicto, huge problems with the control arms for those trials…designed that way to show superiority of Pluvicto). Relatively speaking, the designs and analysis of the 2 spacing trials are reasonable.
It is true that most trials are designed to determine if X intervention is better, but they should not be designed in a way that this outcome is pre-ordained.

In my neck of the woods, there are more people doing spacing in the community than academics (I would guess 50% patients in community, 25% in academics - mostly for SBRT). Are your all experiences the opposite?
In my neck of the woods, everyone does it. Urorads, every academic center/satellite, just about everyone. I don't do them personally and have no interest in learning to do so. I send most of our patients to have it done because it's our standard institutional practice and our urologists actually do a really good job with them, but 50% of the Urorads patients that somehow make it to me have terrible spacers. The money trickling out of boston scientific is diminishing since they have mostly cornered the market. However, now that barrigel is approved and trying to gain market share they're wining and dining our admin and providing consulting fees to some of our radoncs and there's now a push to change over. It's insane how much money is involved in this stuff and the vast majority of us never see a penny.

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I ain't doin it, and won't do it.

Uh Oh No GIF
 
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One thing not well-captured in the spacer trials IMO is immediate bowel-related QOL after the spacer placement but before XRT. I’ve seen a lot of patients at first OTV who complain of a strange sensation in their pelvis/rectum and bothersome change in their bowel habits as they feel like they need to have a bowel movement but then nothing comes out. This is entirely related to the spacer and is at minimum a grade 1 toxicity but gets ignored since QoL is measured following RT on study.

Anecdotally have also seen a case where the gel infiltrated down into the scrotum which caused long lasting severe discomfort for the patient

I havent looked at the protocol. Does anyone know if they collected this and then just didnt report it? That would be possible.

If they don't capture it, it's hard not to believe that's on purpose.
 
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Would love to what the Spacer deniers think about the long term data from the randomized trial posted above. Not just dosimetric data. Do you believe the long term bowel QOL results are fabricated due to COI? Do you just believe there is no bowel impact of radiation and they used outdated radiation techniques?

COI play a significant, significant role when you scrutinize the data. Look at how commercialized the whole spacer industry has become. The Red Journal literally comes wrapped in Barrigel ads. It's sad.

I have a very busy SBRT and SRS practice. Currently, all of my prostate patients are treated without spacer or fiducials. I stopped using fiducials last year because I was still modifying my CBCT match based on rectal filling to the prostate interface (even when fiducials are present and in patients that had good prep). So, begs the question, if the match with CBCT is prioritized over fiducials, why even put the fiducials in?

We tried SpaceOAR VUE. I would say 50% of patients had an uncomfortable/odd sensation in how they emptied after the spacer was placed. Many patients just wanted to get started on treatment and not have to have an extra procedure, do extra prep, hold blood thinners, imaging, blah blah blah. Long story short, we stopped doing spacer as well. I guess if you really believe in the spacer, you'd probably push a lot harder to offer it.

Patients do fine btw if you meet constraints and limit margins to 3 mm posteriorly. We see outcomes similar to PACE-B, where reported 2 year toxicity has been minimal and no spacer in a well-conducted trial.
 
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Anecdotally have also seen a case where the gel infiltrated down into the scrotum which caused long lasting severe discomfort for the patient

This. Is. Horrible.

Just. Say. No.
 
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Anecdotally have also seen a case where the gel infiltrated down into the scrotum which caused long lasting severe discomfort for the patient

This. Is. Horrible.

Just. Say. No.
That or elective colostomy in the case of one of my patients along with long course abx for an abscess. Terrible, terrible complications which were unheard of in the pre-hydrogel/spacer era
 
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PACE-A (SBRT vs surgery) another study showing there is long term, measurable bowel QOL impact of radiation. I would wager that if the trial was done with spacing, there would be no statistically significant diff ends in bowel QOL between SBRT and Surgery.
 
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PACE-A (SBRT vs surgery) another study showing there is long term, measurable bowel QOL impact of radiation. I would wager that if the trial was done with spacing, there would be no statistically significant diff ends in bowel QOL between SBRT and Surgery.
1676608146155.png


88.7 vs 97.3

With the pre-specified significance set at 5%

1676608327601.png


The majority of the difference comes from "very small problem" and "small problem".

1) I would personally class "RadOnc encouraged bonus rectal ultrasounds and giant needles" as "big problem"

2) What are we throwing down for this wager? I'd definitely take you up on that bet.
 
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View attachment 366314

88.7 vs 97.3

With the pre-specified significance set at 5%

View attachment 366315

The majority of the difference comes from "very small problem" and "small problem".

1) I would personally class "RadOnc encouraged bonus rectal ultrasounds and giant needles" as "big problem"

2) What are we throwing down for this wager? I'd definitely take you up on that bet.
Haha I believe you would take that bet based on your analysis of the data. Of course not a trial that’s actually going to be conducted.
 
View attachment 366314

88.7 vs 97.3

With the pre-specified significance set at 5%

View attachment 366315

The majority of the difference comes from "very small problem" and "small problem".

1) I would personally class "RadOnc encouraged bonus rectal ultrasounds and giant needles" as "big problem"

2) What are we throwing down for this wager? I'd definitely take you up on that bet.
PACE-A (SBRT vs surgery) another study showing there is long term, measurable bowel QOL impact of radiation. I would wager that if the trial was done with spacing, there would be no statistically significant diff ends in bowel QOL between SBRT and Surgery.
THE
MOST
IMPORTANT
FACTOR
IN MODERN PROSTATE RADIOTHERAPY
RECTAL TOXICITY
IS
PTV MARGIN CHOICE

If you choose a small enough PTV margin you can get 95% or better grade zero rectal toxicity sans SpaceOAR. With a big enough PTV you can still “ruin” the rectal DVH of even a SpaceOAR patient.

So it’s weird, or scientifically amateurish, that we don’t discuss PTV margins for either SpaceOAR trials or PACE-A.

PACE-A used “3 to 5 mm” PTV margins posteriorly. (Plus, the proximal 1cm of SVs was included in the CTV of intermediate risk patients.) Only people who haven’t been paying recent attention will think the 2mm spread in “3-5 mm” doesn’t matter for rectal toxicity. Or doesn’t matter versus 2mm PTV margins.

*I* wager if 2mm margins were used (and the prox SVs were not treated thereby effectively irradiating an extra cm plus of anterior rectum cranially), the bowel bother would not be statistically significantly different than surgery. Adding SpaceOAR with 2mm PTV margins (or less PTV if some very logical and smart rad onc gets the courage to do this with real time tracking)? If we were being honest, SpaceOAR would be a toxicity causer in those folks. I further wager SpaceOAR merely exists as a device to cover the sin of PTV over-margination.
 
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THE
MOST
IMPORTANT
FACTOR
IN MODERN PROSTATE RADIOTHERAPY
RECTAL TOXICITY
IS
PTV MARGIN CHOICE

If you choose a small enough PTV margin you can get 95% or better grade zero rectal toxicity sans SpaceOAR. With a big enough PTV you can still “ruin” the rectal DVH of even a SpaceOAR patient.

So it’s weird, or scientifically amateurish, that we don’t discuss PTV margins for either SpaceOAR trials or PACE-A.

PACE-A used “3 to 5 mm” PTV margins posteriorly. (Plus, the proximal 1cm of SVs was included in the CTV of intermediate risk patients.) Only people who haven’t been paying recent attention will think the 2mm spread in “3-5 mm” doesn’t matter for rectal toxicity. Or doesn’t matter versus 2mm PTV margins.

*I* wager if 2mm margins were used (and the prox SVs were not treated thereby effectively irradiating an extra cm plus of anterior rectum cranially), the bowel bother would not be statistically significantly different than surgery. Adding SpaceOAR with 2mm PTV margins (or less PTV if some very logical and smart rad onc gets the courage to do this with real time tracking)? If we were being honest, SpaceOAR would be a toxicity causer in those folks. I further wager SpaceOAR merely exists as a device to cover the sin of PTV over-margination.
Including 1 cm sv is strange. I think 90% of sv involvement is within 0.3 cm of prostate. I wouldn’t cover any sv for sbrt.
 
Including 1 cm sv is strange. I think 90% of sv involvement is within 0.3 cm of prostate. I wouldn’t cover any sv for sbrt.

I was just having this discussion with my partner. All of it is strange! But a lot of people are trained that way. I was trained 1/3, my partner was trained 1 cm, Ive seen people practice covering all of them.

My question is do they ever need to be covered at all if the MRI is negative for SV involvement?

Its worth remembering that the quality of radiotherapy varies quite a bit across centers. Its reasonable to protocolize slightly larger volumes in SBRT studies so that centers can be protocol compliant. If 2 mm were used across the trial, its possible there could have been worse control outcomes.
 
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If 2 mm were used across the trial, its possible there could have been worse control outcomes
This is possible (even though they used fiducial based IGRT… the literal gold standard!). It’s also possible that if you don’t do weekly OLA tests after you pass your boards you’ll become a bad rad onc.
 
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I was just having this discussion with my partner. All of it is strange! But a lot of people are trained that way. I was trained 1/3, my partner was trained 1 cm, Ive seen people practice covering all of them.

My question is do they ever need to be covered at all if the MRI is negative for SV involvement?

Its worth remembering that the quality of radiotherapy varies quite a bit across centers. Its reasonable to protocolize slightly larger volumes in SBRT studies so that centers can be protocol compliant. If 2 mm were used across the trial, its possible there could have been worse control outcomes.
certainly, if you have an mri, it is justifiable to cover the nearest 0.3 cm of SV where almost all involvement is contained (maybe a single slice?)
 
Surgeons take it out don't they? I've treated a few salvage cases where they clearly weren't
Was just having this discussion with someone. Vast majority of time, they take it out, even for lower risk. It gives a lot of prognostic info after all. One can argue you can't get a true pT stage without SV removal. No one without a prostate needs SVs. I imagine there's a minor increase in morbidity with SV removal than without... that's the only rationale I can think of. FWIW I do think the highest incidence of "retained SVs at time of prostatectomy" in the USA is in Florida.
 
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Including 1 cm sv is strange. I think 90% of sv involvement is within 0.3 cm of prostate. I wouldn’t cover any sv for sbrt.
I do 1cm of SV for all intermediate risk patients. 0cm for low-risk patients. This is doable even in prostate SBRT. This is in part why I don't routine offer prostate SBRT for high-risk patients (even in those with sufficiently low LN risk to avoid ENI), given the dogma (that I have not seen successfully challenged) recommending coverage of 3cm of SV. I do turn the dose down a bit from full Rx dose for the distal SVs in high-risk patients

If people have data suggesting that 1cm of SV is too much for intermediate risk (and not just feelings/how they were trained) I'd be happy to be educated.
 


So, now Boston Scientific is promoting SBRT?
 
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I do 1cm of SV for all intermediate risk patients. 0cm for low-risk patients. This is doable even in prostate SBRT. This is in part why I don't routine offer prostate SBRT for high-risk patients (even in those with sufficiently low LN risk to avoid ENI), given the dogma (that I have not seen successfully challenged) recommending coverage of 3cm of SV. I do turn the dose down a bit from full Rx dose for the distal SVs in high-risk patients

If people have data suggesting that 1cm of SV is too much for intermediate risk (and not just feelings/how they were trained) I'd be happy to be educated.
I was trained on/per the Accuray Cyberknife protocol. On protocol, intermediate risk received 1 cm proximal SV. Low risk - no SV. I have seen (rare) recurrences in proximal SV after brachy and in practice try to get some dose to prox SV when doing brachy nowadays.

If anyone has evidence to not cover SV, would love to hear that and change my SBRT protocol to not include SV or do 1 slice.
 
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Was just having this discussion with someone. Vast majority of time, they take it out, even for lower risk. It gives a lot of prognostic info after all. One can argue you can't get a true pT stage without SV removal. No one without a prostate needs SVs. I imagine there's a minor increase in morbidity with SV removal than without... that's the only rationale I can think of. FWIW I do think the highest incidence of "retained SVs at time of prostatectomy" in the USA is in Florida.
That surgeon in Orlando?
 
Not a hill I want to die on, but I think the burden is on those radiating the sv to justify it not visa verse.
Fair! I will dig into the data on my own - willing to change my mind and scale back on SV coverage (to 0.3 cm, for example) if most/many of the SBRT trials do not include SV and/or that is common practice and evidence based. Anecdotally, I have salvaged 2 SV only recurrences and 1 SV and nodal recurrence.
 
Actual patient I am seeing next week (referred to me from our urology group). A different RO from another center saw at initial consultation, and placed SpaceOAR.

"The patient had SpaceOAR placed prior to radiation. This was complicated by a necrotizing soft tissue infection causing sepsis and he was admitted to hospital. He required a total of four debridements in the OR with general surgery during his hospitalization. Found to have rectal perforation and had diverting colostomy. Prolonged hospitalization, then transferred to SNF for wound care afterward."

I bet the rectal DVH looked pretty good.

Is there a process for reporting this?
 
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Not a hill I want to die on, but I think the burden is on those radiating the sv to justify it not visa verse.


1% of low-risk patients had pathological SV involvement. 27% of high-risk patients (defined as anyone who was not 'low-risk', which encompasses both intermediate and high-risk patients) had SV involvement, with a median length of involvement of 1.0cm. 7% of patients had SV involvement beyond 1.0cm. If you look at figure 3, significant portions of the disease went between 1 and 2 cm of SVI, with a smaller proportion up to 3. One data point beyond 3cm

They say 92% of positive cases (or 99% of all patients) only proximal 2.0cm needs to be included.

Perhaps the 3cm for high-risk patients is a bit high, but 0.3cm of SV for non low-risk patients is, IMO, insufficient.
 
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1% of low-risk patients had pathological SV involvement. 27% of high-risk patients (defined as anyone who was not 'low-risk', which encompasses both intermediate and high-risk patients) had SV involvement, with a median length of involvement of 1.0cm. 7% of patients had SV involvement beyond 1.0cm. If you look at figure 3, significant portions of the disease went between 1 and 2 cm of SVI, with a smaller proportion up to 3. One data point beyond 3cm

They say 92% of positive cases (or 99% of all patients) only proximal 2.0cm needs to be included.

Perhaps the 3cm for high-risk patients is a bit high, but 0.3cm of SV for non low-risk patients is, IMO, insufficient.
Thank you! Re-affirms my practice then. Will continue to include prox 1 cm and PTV will cover a bit beyond that for intermediate risk. I cover more SV for high risk.
 
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1% of low-risk patients had pathological SV involvement. 27% of high-risk patients (defined as anyone who was not 'low-risk', which encompasses both intermediate and high-risk patients) had SV involvement, with a median length of involvement of 1.0cm. 7% of patients had SV involvement beyond 1.0cm. If you look at figure 3, significant portions of the disease went between 1 and 2 cm of SVI, with a smaller proportion up to 3. One data point beyond 3cm

They say 92% of positive cases (or 99% of all patients) only proximal 2.0cm needs to be included.

Perhaps the 3cm for high-risk patients is a bit high, but 0.3cm of SV for non low-risk patients is, IMO, insufficient.
Great post.
And vaguely remember from residency.
 
1% of low-risk patients had pathological SV involvement. 27% of high-risk patients (defined as anyone who was not 'low-risk', which encompasses both intermediate and high-risk patients) had SV involvement, with a median length of involvement of 1.0cm. 7% of patients had SV involvement beyond 1.0cm. If you look at figure 3, significant portions of the disease went between 1 and 2 cm of SVI, with a smaller proportion up to 3. One data point beyond 3cm
The problem I have with all this fancy-sounding mental masturbation is that rad oncs seem to believe that the bottom of the SVs always start at the top (base) of the prostate. Every time I have been in surgery for a prostatectomy, the SVs start much lower down on the prostate than the top. I have seen some SVs almost insert close to the apex of the prostate. The way PACE-A, and most other rad oncs too, cover the "proximal SVs" probably winds up treating the proximal 2cm of the SVs. This is very untalked about and I am just offering an opinion that probably no one else will share. But beyond my wacky opinion... the whole of CTV-covering decisions in prostate cancer (especially proximal vs all vs how much of SVs to cover) is very unvalidated. Also just because someone sees cancer on pathological accessioning doesn't mean not covering it with radiation will lead to failure. Even the recurrence rate of margin positive head neck cancer is not 100%.



2023-02-17 16_25_14-Ductus deferens _ anatomy _ Britannica.png
 
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The problem I have with all this fancy-sounding mental masturbation is that rad oncs seem to believe that the bottom of the SVs always start at the top (base) of the prostate. Every time I have been in surgery for a prostatectomy, the SVs start much lower down on the prostate than the top. I have seen some SVs almost insert close to the apex of the prostate. The way PACE-A, and most other rad oncs too, cover the "proximal SVs" probably winds up treating the proximal 2cm of the SVs. This is very untalked about and I am just offering an opinion that probably no one else will share. But beyond my wacky opinion... the whole of CTV-covering decisions in prostate cancer (especially proximal vs all vs how much of SVs to cover) is very unvalidated. Also just because someone sees cancer on pathological accessioning doesn't mean not covering it with radiation will lead to failure. Even the recurrence rate of margin positive head neck cancer is not 100%.



View attachment 366360

This is a very important point. Prostate and SV are co-planar with each other. Basic anatomy. It's visible on MRI (and to a lesser extent, CT scan, I think, if you squint and use proper windowing)
My SV contour frequently is co-planar with the prostate contour for at least 2 slices (5mm). Last intermediate case I had, the true prostate went further superiorly in the patient than the 1cm of SV did due to anatomical differences.
 
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68/25 and you get as much SV 'included' at 68 as the prostate plan gives (often 1.5-2 cm).. then 56 to the remainder. No bowel issues. Extremely well tolerated. Why bother with SBRT, gel, etc. meh.
 
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Supports exclusion of SV in FIR
Without mri fusion,you are probably contouring 1cm of sv as ctv anyway and then with ptv expansion are covering more still, and there will still be substantial dose to a few more mm given set up variatiation and fall off, so most of the sv at risk for extension is unitentionally covered.
If you have an mri, I would have a hard time believing that 1 cm of sv extension could be missed.
 
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Nice thing about arguing for or against elective SV coverage in lower risk disease strata is no one has any convincing data with which to defeat you in said argument. Like Steve Rogers said, “I could do this all day!”
 
Actual patient I am seeing next week (referred to me from our urology group). A different RO from another center saw at initial consultation, and placed SpaceOAR.

"The patient had SpaceOAR placed prior to radiation. This was complicated by a necrotizing soft tissue infection causing sepsis and he was admitted to hospital. He required a total of four debridements in the OR with general surgery during his hospitalization. Found to have rectal perforation and had diverting colostomy. Prolonged hospitalization, then transferred to SNF for wound care afterward."

I bet the rectal DVH looked pretty good.

Is there a process for reporting this?
holy ****... yeah should be reported to MAUDE: MAUDE Adverse Event Report: AUGMENIX, INC. SPACEOAR HYDROGEL HYDROGEL SPACER
 
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I still struggle with how much elective SV coverage I need to do. All of those SV papers are pre MRI/PSMA PET era.

Not that they’re “wrong,” but I think elective SV coverage in a patient that has had an MRI or advanced imaging PET is different than just a dude with Gleason 8 at the base of prostate on biopsy and just a CT and bone scan.
 
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I still struggle with how much elective SV coverage I need to do. All of those SV papers are pre MRI/PSMA PET era.

Not that they’re “wrong,” but I think elective SV coverage in a patient that has had an MRI or advanced imaging PET is different than just a dude with Gleason 8 at the base of prostate on biopsy and just a CT and bone scan.
have to wonder, what is the morbidity of a little extra SV coverage if the DVH still looks great otherwise? dry ejac risk maybe....
 
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have to wonder, what is the morbidity of a little extra SV coverage if the DVH still looks great otherwise? dry ejac risk maybe....
Provably not much. Only time I would really care would be sbrt. I think the superior margin on sbrt is very important. I don’t do a lot of sbrt but have heard of a number of cases of late bladder effects.
 
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Supports exclusion of SV in FIR
Can we equate biopsy Gleason 3+4=7 (what we know clinically) to post-RP Gleason 3+4=7?
How many of the post-RP Gleason 3+4=7 were actually biopsy Gleason 3+3=6? I don't know this percentage of pathological upstaging off the top o fmy head, but i's probably pretty significant, especially in pre-MRI era?
How many of the post-RP Gleason 4+3=7 were biopsy Gleason 3+4=7?
have to wonder, what is the morbidity of a little extra SV coverage if the DVH still looks great otherwise? dry ejac risk maybe....

Have seen some number of SV failures either post-RP or post-initial RT. I don't know what the denominator is. Was always in scenarios where SV was not contoured separately on the initial plan, although I'm not remembering the Gleason scores off the top of my head...
Provably not much. Only time I would really care would be sbrt. I think the superior margin on sbrt is very important. I don’t do a lot of sbrt but have heard of a number of cases of late bladder effects.
For me, who uses SpaceOAR VUE for SBRT, coverage more superiorly becomes an issue given issues with getting spacing up near the SVIs, and can require underdosing below my usual 40/5 at that interface. For that reason, combined with the fact I usually treat up to 3cm of SV for HR disease, I don't routinely offer SBRT for high-risk pCA patients (even if I'm not covering LNs)
 
I would offer SBRT for low risk disease in lieu of mod hypofrac, but reality says, it ain't happening. Patients do well with mod hypofrac, and unless travel or setups are a huge issue..

Eric Cartman GIF by South Park
 
I would offer SBRT for low risk disease in lieu of mod hypofrac, but reality says, it ain't happening. Patients do well with mod hypofrac, and unless travel or setups are a huge issue..

Eric Cartman GIF by South Park
This can work unless you have a guy across town doing lots of SBRT. Or really not work at all if somehow SBRTing all low risk becomes Our Culture.
 
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Nearest competition is almost 100 miles away. Life be good.

What’s the plan there? SBRT everything till you put everyone out of business and then what? Go back to conv frac when nobody is around?
 
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Where is 'there' ? I don't do SBRT. And I def don't don't do da colostomy gel.

I'm here, I'm doing hypofrac.. but I'd offer conv for a patient who has...

a) large prostate (100 cc? or so), some folks say 100, some say 125 or even 150..
b) aua 15+ and bothered
c) UTI history
d) other relevant history (Pelvic surgery with GU issues)

or combinations.. which I just did, a few minutes ago.
 
I do think five fraction “rather side effectless” radiation would cause a flat tire in the wahhmbulance of the low risk over treatment crowd.
 
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