Yippee another Spacer trial

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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.

No reason to change fractionation based on prostate size.
Same with AUA.
Same with UTI history
Same with pelvic surgery with GU issues.

If ya disagree, show me the evidence that literally any of the above matters in terms of offering mod hypofrac.

I'm offering mod hypofx to all patients. I'm more strongly recommending it in those with baseline GI issues given that's what the data shows. And even that is a discussion. I feel like we got people saying "mod hypo is the only SOC" and old-school folks "I only offer conventional" and the right answer is in the middle, but I'm still not a fan of the above.

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No reason to change fractionation based on prostate size.
Same with AUA.
Same with UTI history
Same with pelvic surgery with GU issues.

If ya disagree, show me the evidence that literally any of the above matters in terms of offering mod hypofrac.

I'm offering mod hypofx to all patients. I'm more strongly recommending it in those with baseline GI issues given that's what the data shows. And even that is a discussion. I feel like we got people saying "mod hypo is the only SOC" and old-school folks "I only offer conventional" and the right answer is in the middle, but I'm still not a fan of the above.

Many of my peers feel strongly that moderate hypofrac may increase the risk of GU complications for patients who have those features. I'm in that group. We don't have data for everything, but we do have common sense. Swelling is likely to cause obstruction which is likely to cause urinary difficulties and for those with a higher risk profile to begin with, it seems prudent to avoid poking the bear.

Yes, I'd prefer a nice randomized trial. Let me know when that happens.. for as you know, prostate has a high track record of accomplished randomized trials ;)
 
Many of my peers feel strongly that moderate hypofrac may increase the risk of GU complications for patients who have those features. I'm in that group. We don't have data for everything, but we do have common sense. Swelling is likely to cause obstruction which is likely to cause urinary difficulties and for those with a higher risk profile to begin with, it seems prudent to avoid poking the bear.

Yes, I'd prefer a nice randomized trial. Let me know when that happens.. for as you know, prostate has a high track record of accomplished randomized trials ;)

Feelings are great and all.... but show me the money.

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No reason to change fractionation based on prostate size.
Same with AUA.
Same with UTI history
Same with pelvic surgery with GU issues.

If ya disagree, show me the evidence that literally any of the above matters in terms of offering mod hypofrac.

I'm offering mod hypofx to all patients. I'm more strongly recommending it in those with baseline GI issues given that's what the data shows. And even that is a discussion. I feel like we got people saying "mod hypo is the only SOC" and old-school folks "I only offer conventional" and the right answer is in the middle, but I'm still not a fan of the above.

I tend to agree with you, but I recall the Pollock trial had AUA IPSS score > (?12?) shake out on post hoc multi variable analysis as a predictor of worse GU toxicity with hypofrac vs. conventional.

I mean that's not exactly a slam dunk, but it was in the paper as I recall. My memory is a fuzzy though, but I remember those slides at ASTRO saying something like that...
 
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SDN sometimes feels like I'm back arguing with my buddies in the resident office.

Do you think we could get the Red Journal to accept papers where we write like how we talk in real life?

I can't be certain, but I feel pretty confident that if the final publication for an NRG trial ended with a SpongeBob Meme, the Impact Factor for that journal would SKYROCKET.
 
I tend to agree with you, but I recall the Pollock trial had AUA IPSS score > (?12?) shake out on post hoc multi variable analysis as a predictor of worse GU toxicity with hypofrac vs. conventional.

I mean that's not exactly a slam dunk, but it was in the paper as I recall. My memory is a fuzzy though, but I remember those slides at ASTRO saying something like that...

Yes this was shown on posthoc analysis. To date the only randomized data I’m aware of to associate higher AUA with worse GU tox.

There’s also been data correlating larger prostate size with higher late GU tox, though it is very possible this same correlation exists for standard frac. Effect of Large Prostate Volume on Efficacy and Toxicity of Moderately Hypofractionated Radiation Therapy in Patients With Prostate Cancer - PubMed

My default as well is moderate hypofrac. That being said, given that prostate hypofrac has never in the history of anything improved oncologic outcomes, I have an extremely low threshold to offer someone standard frac if I suspect they could be at elevated risk for acute or late toxicity (large prostate > 100 cc, baseline AUA > 20).
 
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Do any of the studies mention fatigue analyzed in a good way (PROs or something better than just asking)

I have a suspicion that 5-28 fractions has more fatigue than 39-45 fractions
 
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Depends how nice your staff is.. if they love coming to your department.. maybe more is.. less (fatigue). I guess it depends on your department so..
Kinda GIF
 
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I think the European term for this AE is better: lethargy.
Heavily depends on things like weather and driving distance.
Can be approached by having more donuts and racy magazines in the waiting area.
And no, I have not noticed worse lethargy with hypofrac
Depends how nice your staff is.. if they love coming to your department.. maybe more is.. less (fatigue). I guess it depends on your department so..
Kinda GIF
 
I tend to agree with you, but I recall the Pollock trial had AUA IPSS score > (?12?) shake out on post hoc multi variable analysis as a predictor of worse GU toxicity with hypofrac vs. conventional.

I mean that's not exactly a slam dunk, but it was in the paper as I recall. My memory is a fuzzy though, but I remember those slides at ASTRO saying something like that...

Fair enough. I'd seen that paper but not done a deep dive on toxicity. Not one of the major ones, but it's out there. Randomized data. Nice. IPSS >= 12 predicted for worse late GU tox in hypofrac but NOT in conventional.


Guess we shouldn't be doing prostate hypofrac for patients aged 67 or older OR getting nodes treated, like the trial showed (similarly to IPSS cut-off), right guys?

I guess the latter some actually do advocate for. Anyone telling their 70+ year olds that they're not a good candidate for hypofx? I mean 70.2/26 is kinda dose-escalated compared to other regimens, so should we even be using it?
 
Yes this was shown on posthoc analysis. To date the only randomized data I’m aware of to associate higher AUA with worse GU tox.

There’s also been data correlating larger prostate size with higher late GU tox, though it is very possible this same correlation exists for standard frac. Effect of Large Prostate Volume on Efficacy and Toxicity of Moderately Hypofractionated Radiation Therapy in Patients With Prostate Cancer - PubMed

My default as well is moderate hypofrac. That being said, given that prostate hypofrac has never in the history of anything improved oncologic outcomes, I have an extremely low threshold to offer someone standard frac if I suspect they could be at elevated risk for acute or late toxicity (large prostate > 100 cc, baseline AUA > 20).
Before my previous post, this was my general thought - men with larger IPSS (but not like too big like 25) at higher risk for late GU toxicity. Maybe IPSS score is predictive of toxicity only for hypofrac patients....
 
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Before my previous post, this was my general thought - men with larger IPSS (but not like too big like 25) at higher risk for late GU toxicity. Maybe IPSS score is predictive of toxicity only for hypofrac patients....
I haven't done a deep dive into the literature but I imagine there's been a correlation between large prostate size and late GU tox for standard frac. That being said, I feel like the universal adoption of hypofrac in prostate cancer, without fully understanding the late effects on all subsets of patients, has been somewhat detrimental. The trials included all-comers, without really stratifying by characteristics that might predict for worse toxicity apriori. How many AUA > 20 are on these trials? How many prostate > 100 cc? And this is coming from someone whose default offering is hypofrac. During training I heard countless times that we should try and prioritize treatments that extend either quantity or quality of life. I can't say for certain that hypofrac is doing either besides saving some retirees from coming in for an extra month.
 
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I haven't done a deep dive into the literature but I imagine there's been a correlation between large prostate size and late GU tox for standard frac. That being said, I feel like the universal adoption of hypofrac in prostate cancer, without fully understanding the late effects on all subsets of patients, has been somewhat detrimental. The trials included all-comers, without really stratifying by characteristics that might predict for worse toxicity apriori. How many AUA > 20 are on these trials? How many prostate > 100 cc? And this is coming from someone whose default offering is hypofrac. During training I heard countless times that we should try and prioritize treatments that extend either quantity or quality of life. I can't say for certain that hypofrac is doing either besides saving some retirees from coming in for an extra month.
Now, how really common is prostate vol > 100cc? Our Urology lurkers may chime in
 
Now, how really common is prostate vol > 100cc? Our Urology lurkers may chime in
Agreed, large prostate size not super common. I maybe see one of those whopping mega prostates every 2-3 months. But I'd venture to guess that > 50% of your patients have AUA > 15, and a non-significant proportion with AUA > 20. I'm not sure if we truly know whether hypofrac is the best option for these dudes. Maybe the absolute difference in late tox between conventional and hypofrac is small where we're not really noticing a substantial difference in our anecdotal experience. Certainly would be an interesting project for a resident, and more practical than 99% of the stuff that comes out in Red J these days...
 
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I haven't done a deep dive into the literature but I imagine there's been a correlation between large prostate size and late GU tox for standard frac. That being said, I feel like the universal adoption of hypofrac in prostate cancer, without fully understanding the late effects on all subsets of patients, has been somewhat detrimental. The trials included all-comers, without really stratifying by characteristics that might predict for worse toxicity apriori. How many AUA > 20 are on these trials? How many prostate > 100 cc? And this is coming from someone whose default offering is hypofrac. During training I heard countless times that we should try and prioritize treatments that extend either quantity or quality of life. I can't say for certain that hypofrac is doing either besides saving some retirees from coming in for an extra month.
So the interesting thing (in regards to the bolded) about the Pollack analysis is that they didn't see a correlation between IPSS and late GU tox for standard frac, but did for hypofrac.

Could be a statistical error (type I or type II, I don't feel like looking up what this situation would be), but it's the data we have.

AUA > 20 is rare. AUA > 12 is probably 1/3 to 1/2 of my patients.

I still don't see any data on prostate size as a predictor for toxicity only in hypofrac (not in standard)...

Probably see a > 100ccer once every 1-3 months on average... just had a guy > 300cc
 
Probably see a > 100ccer once every 1-3 months on average... just had a guy > 300cc
This tracks with my experience...except I don't know if I've seen a 300cc honker in real life.

SpaceOAR reps: "Not a problem! We recommend the insertion of two units of our product for prostates of this size..."
 
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This tracks with my experience...except I don't know if I've seen a 300cc honker in real life.

SpaceOAR reps: "Not a problem! We recommend the insertion of two units of our product for prostates of this size..."

I don't push for ADT downstaging pretty much ever.... but no complaints with this guy getting a few months or hormones before we get things going

All this confirms - never say never in cancer management.

Most interest bit for me - AUA 11 not on Rx'd meds for LUTS. Prostate size != AUA score
 
Don't push for ADT downstaging either, though you could arguably justify ADT in any intermediate risk now based on RTOG 0815.

I recently had a guy with a 120 cc prostate ask for SBRT. I politely declined, and then he came back with 2 articles showing safety and tolerability with large prostates and SBRT. I declined again and he received his SBRT elsewhere out of state, and now I have the good fortune of now following him long-term. Hoping this all works out...
 
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Thats a metro thing with patients demanding this or that treatment. In ruralamerica they are just polite and quite trusting. Its a nice relationship model to have.. as opposed to demanding or suspicious.
 
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Don't push for ADT downstaging either, though you could arguably justify ADT in any intermediate risk now based on RTOG 0815.

I recently had a guy with a 120 cc prostate ask for SBRT. I politely declined, and then he came back with 2 articles showing safety and tolerability with large prostates and SBRT. I declined again and he received his SBRT elsewhere out of state, and now I have the good fortune of now following him long-term. Hoping this all works out...
What is everyone's threshold for ADT in intermediate-risk? Assuming hypofractionated to everyone.

All intermediates?
Unfavorable only?
Young guys?
Comorbid status?

I've pretty much gone to a gestalt recommendation, that isn't exactly scientific.
 
Unfavorable, although if its a young guy who is sexually active.. or anyone who is really sexually active.. then a longer discussion ensues.
 
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What is everyone's threshold for ADT in intermediate-risk? Assuming hypofractionated to everyone.

All intermediates?
Unfavorable only?
Young guys?
Comorbid status?

I've pretty much gone to a gestalt recommendation, that isn't exactly scientific.
I get a decipher
 
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Don't push for ADT downstaging either, though you could arguably justify ADT in any intermediate risk now based on RTOG 0815.

I recently had a guy with a 120 cc prostate ask for SBRT. I politely declined, and then he came back with 2 articles showing safety and tolerability with large prostates and SBRT. I declined again and he received his SBRT elsewhere out of state, and now I have the good fortune of now following him long-term. Hoping this all works out...

Don't see a reason not to offer if you can meet constraints and keep the plan more homogenous. Size is just a number, IMO, but I'll never fault someone for doing something they aren't comfortable with. If you offer prostate SBRT (like in general) I'm not sure that size on its own is a contraindication.

What is everyone's threshold for ADT in intermediate-risk? Assuming hypofractionated to everyone.

All intermediates?
Unfavorable only?
Young guys?
Comorbid status?

I've pretty much gone to a gestalt recommendation, that isn't exactly scientific.
FIR - RT Alone. 100% of the time. I don't offer ADT. Who is giving ADT for FIR?

UIR gets ADT. If you're closer to FIR, 4 months. Closer to high-risk, 6 months.
If there's a question of whether you're FIR or UIR (say Gleason 3+4=7 in 1 or 2 cores, Gleason 3+3=6 in another 6 or 7, no other IR factors) I'll discuss potentially skipping ADT.

Young guys/comorbid status doesn't really matter - Gonna live > 10 years or nah? If no, can discuss observation vs ADT alone vs RT alone.
 
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FIR - RT Alone. 100% of the time. I don't offer ADT. Who is giving ADT for FIR?

UIR gets ADT. If you're closer to FIR, 4 months. Closer to high-risk, 6 months.
If there's a question of whether you're FIR or UIR (say Gleason 3+4=7 in 1 or 2 cores, Gleason 3+3=6 in another 6 or 7, no other IR factors) I'll discuss potentially skipping ADT.

Young guys/comorbid status doesn't really matter - Gonna live > 10 years or nah? If no, can discuss observation vs ADT alone vs RT alone.
Local academic center.

I almost exclusively follow the FIR = no ADT, UIR = ADT paradigm. I do tend to push harder on younger guys who will probably rebound their testosterone sooner and "may" have more aggressive disease/longer horizon for recurrence. Trend the opposite with the older guys, especially with comorbid metabolic syndrome.
 
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Local academic center.
sheila broflovski hous GIF by South Park


Literally goes against NCCN. I mean I get NCCN is not the end all be all, and sure, maybe there's the rare FIR guy out there who maybe would benefit from hormones, but to tell NCCN to habitually just **** off on literally one of the most common diagnoses we treat.... seems unwise.
 
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So what if the patient is truly average FIR and.. then has a high decipher risk (.75 etc)? I would do ADT 4-6 months. You?

Lets up the ante:

Now make it an average UIR patient with a high decipher.. do they get bumped to ADT 18-24 months?

"Make up your own rules"

(insert SDH caveat here regarding hormonal deprivation)
 
So what if the patient is truly average FIR and.. then has a high decipher risk (.75 etc)? I would do ADT 4-6 months. You?

Lets up the ante:

Now make it an average UIR patient with a high decipher.. do they get bumped to ADT 18-24 months?

"Make up your own rules"

(insert SDH caveat here regarding hormonal deprivation)

Patient has FIR disease on clinicopath. I don't get a decipher. RT alone.

UIR patient, I don't get a decipher. 4-6 months ADT.

Why you would take a test that has mostly been evaluated in the post-op setting and make treatment decisions based on that.... is unclear.

It may get us to a point better than traditional risk classification, but if someone has something really compelling to make me start ordering this expensive test on all patients.... I'm happy to read it.

Idk, NCCN isn't using it except in post-RP setting yet. Maybe we'll start reflexing it on all of our definitive cases at some point. I'm just not there, yet.
 
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Proven value in upfront setting? Predictive of response? I know Dan Spratt loves Decipher but I haven't been super impressed by the limited amount I've looked into it.
I use it as a tie breaker, but yes the data is most solid in the post RP setting. Some also use it for deciding on as/ww vs getting treatment
 
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I use it as a tie breaker, but yes the data is most solid in the post RP setting. Some also use it for deciding on as/ww vs getting treatment
This is how I use it as well. Note: patients come to me with it already ordered. I don't typically order myself unless someone really wants AS and I disagree.
 
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Don't see a reason not to offer if you can meet constraints and keep the plan more homogenous. Size is just a number, IMO, but I'll never fault someone for doing something they aren't comfortable with. If you offer prostate SBRT (like in general) I'm not sure that size on its own is a contraindication.


FIR - RT Alone. 100% of the time. I don't offer ADT. Who is giving ADT for FIR?

UIR gets ADT. If you're closer to FIR, 4 months. Closer to high-risk, 6 months.
If there's a question of whether you're FIR or UIR (say Gleason 3+4=7 in 1 or 2 cores, Gleason 3+3=6 in another 6 or 7, no other IR factors) I'll discuss potentially skipping ADT.

Young guys/comorbid status doesn't really matter - Gonna live > 10 years or nah? If no, can discuss observation vs ADT alone vs RT alone.

Sure it’s not wrong either. It really boils down to comfort. Most of the sbrt trials excluded patients with large prostates > 70 cc so the data for sbrt in this population is scant. I don’t see a strong reason to push for sbrt in this cohort given the lack of oncologic benefit and since you can easily give 4 weeks of mod hypofrac which is just a few extra weeks of RT.

Regarding FIR, I don’t think it’s necessarily wrong to offer STADT based on interim results of rtog 0815. I get that this trial started in the Paleolithic era and many aren’t quite sure what to do with this data, but the MFS benefit was real and seen across all strata of IR, including only 1 intermediate risk factor. Despite being in the nccn guidelines, The data for no adt in FIR vs stadt in UIR is mainly through retrospective data and posthoc analyses. That being said, in my practice I generally don’t offer STADT for FIR because of the uncertainties with translating number of risk factors from 0815 to modern day FIR/UIR designation. But again, I don’t think it’s wrong to offer ADT for FIR.

 
Sure it’s not wrong either. It really boils down to comfort. Most of the sbrt trials excluded patients with large prostates > 70 cc so the data for sbrt in this population is scant. I don’t see a strong reason to push for sbrt in this cohort given the lack of oncologic benefit and since you can easily give 4 weeks of mod hypofrac which is just a few extra weeks of RT.

Regarding FIR, I don’t think it’s necessarily wrong to offer STADT based on interim results of rtog 0815. I get that this trial started in the Paleolithic era and many aren’t quite sure what to do with this data, but the MFS benefit was real and seen across all strata of IR, including only 1 intermediate risk factor. Despite being in the nccn guidelines, The data for no adt in FIR vs stadt in UIR is mainly through retrospective data and posthoc analyses. That being said, in my practice I generally don’t offer STADT for FIR because of the uncertainties with translating number of risk factors from 0815 to modern day FIR/UIR designation. But again, I don’t think it’s wrong to offer ADT for FIR.

Eat Grilled Cheese GIF by Dietz & Watson
 
Sure it’s not wrong either. It really boils down to comfort. Most of the sbrt trials excluded patients with large prostates > 70 cc so the data for sbrt in this population is scant. I don’t see a strong reason to push for sbrt in this cohort given the lack of oncologic benefit and since you can easily give 4 weeks of mod hypofrac which is just a few extra weeks of RT.

Regarding FIR, I don’t think it’s necessarily wrong to offer STADT based on interim results of rtog 0815. I get that this trial started in the Paleolithic era and many aren’t quite sure what to do with this data, but the MFS benefit was real and seen across all strata of IR, including only 1 intermediate risk factor. Despite being in the nccn guidelines, The data for no adt in FIR vs stadt in UIR is mainly through retrospective data and posthoc analyses. That being said, in my practice I generally don’t offer STADT for FIR because of the uncertainties with translating number of risk factors from 0815 to modern day FIR/UIR designation. But again, I don’t think it’s wrong to offer ADT for FIR.

This is the case where we should focus on ARR and NNT instead of p-values and HR.
 
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I do believe this may be one of my favorite trials of late.

A trial done specifically because hypofractionation has greater toxicities. :love:

From the article:
"Importance Hypofractionated radiation therapy (RT) for prostate cancer has been associated with greater acute grade 2 gastrointestinal (GI) toxic effects compared with conventionally fractionated RT."

Boston Scientific even has an "MS2" in there:

Neil F. Mariados, MD1;
Peter F. Orio III, DO, MS2,3;
Zvi Schiffman, MD4;
Thanh John Van, MD4;
Alexander Engelman, MD5;
Rizwan Nurani, MD6,7;
Steven M. Kurtzman, MD6;
Escarlata Lopez, MD, PhD8;
Michael Chao, DMedSc9;
Thomas P. Boike, MD10;
Alvaro A. Martinez, MD10;
Glen Gejerman, MD, MBA11;
John Lederer, MD12;
John E. Sylvester, MD13;
Gregory Bell, MD14;
Douglas Rivera, MD14;
Neal Shore, MD15;
Katie Miller, MS16;
Boris Sinayuk, MD17;
Michael L. Steinberg, MD18;
Daniel A. Low, PhD18;
Amar U. Kishan, MD18;
Martin T. King, MD, PhD2,3

(Disclaimer: I received $830K in consulting fees from Boston Scientific to say this but it had no influence on my opinion)
 
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I do believe this may be one of my favorite trials of late.

A trial done specifically because hypofractionation has greater toxicities. :love:

From the article:
"Importance Hypofractionated radiation therapy (RT) for prostate cancer has been associated with greater acute grade 2 gastrointestinal (GI) toxic effects compared with conventionally fractionated RT."

Boston Scientific even has an "MS2" in there:

Neil F. Mariados, MD1;
Peter F. Orio III, DO, MS2,3;
Zvi Schiffman, MD4;
Thanh John Van, MD4;
Alexander Engelman, MD5;
Rizwan Nurani, MD6,7;
Steven M. Kurtzman, MD6;
Escarlata Lopez, MD, PhD8;
Michael Chao, DMedSc9;
Thomas P. Boike, MD10;
Alvaro A. Martinez, MD10;
Glen Gejerman, MD, MBA11;
John Lederer, MD12;
John E. Sylvester, MD13;
Gregory Bell, MD14;
Douglas Rivera, MD14;
Neal Shore, MD15;
Katie Miller, MS16;
Boris Sinayuk, MD17;
Michael L. Steinberg, MD18;
Daniel A. Low, PhD18;
Amar U. Kishan, MD18;
Martin T. King, MD, PhD2,3

(Disclaimer: I received $830K in consulting fees from Boston Scientific to say this but it had no influence on my opinion)
Peter Orio is trying to hit Danny Dosoretz levels of cash thanks to THE GOO.
 
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Sure it’s not wrong either. It really boils down to comfort. Most of the sbrt trials excluded patients with large prostates > 70 cc so the data for sbrt in this population is scant. I don’t see a strong reason to push for sbrt in this cohort given the lack of oncologic benefit and since you can easily give 4 weeks of mod hypofrac which is just a few extra weeks of RT.

Regarding FIR, I don’t think it’s necessarily wrong to offer STADT based on interim results of rtog 0815. I get that this trial started in the Paleolithic era and many aren’t quite sure what to do with this data, but the MFS benefit was real and seen across all strata of IR, including only 1 intermediate risk factor. Despite being in the nccn guidelines, The data for no adt in FIR vs stadt in UIR is mainly through retrospective data and posthoc analyses. That being said, in my practice I generally don’t offer STADT for FIR because of the uncertainties with translating number of risk factors from 0815 to modern day FIR/UIR designation. But again, I don’t think it’s wrong to offer ADT for FIR.

Would like to inject (pun intended) an observation that it seems to me a lot of our discussions in rad onc these days end with “I don’t think it’s wrong.” Which hey isn’t that nice and non confrontational. It just seems that so many of the newer non-wrong things or approaches seem to be more expensive and/or come with increased side effects and complications. We are gonna “it’s not wrong” ourselves into some weird corners if not careful.
 
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Would like to inject (pun intended) an observation that it seems to me a lot of our discussions in rad onc these days end with “I don’t think it’s wrong.” Which hey isn’t that nice and non confrontational. It just seems that so many of the newer non-wrong things or approaches seem to be more expensive and/or come with increased side effects and complications. We are gonna “it’s not wrong” ourselves into some weird corners if not careful.

Sir, I believe we've passed that point. Also, this is a Wendy's.
 
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isnt there a new product, a "total game changer" a degradable balloon that is inserted through an incision in the perineum, coming out?
Was a needle in the perineum too small for your self-masochism? Now we can shove an entire balloon through your perineum!
 
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