Very occasionally, there is a death or colostomy. It is right there in the fda in database and several articles . Is a human life offset by saving hundreds of men from giving their anus a good scratch? If a hemorrhoid cream had a 1/50000 chance of blowing up your rectum would it be pulled from the market?I know of 2 different major cities where space oar was basically halted because of such events.
As Amar K has shown, nice potential side effect decrease if you shave 2mm off your 5mm PTVs
It’s also (medically) logical not to insert a foreign body in between an organ and a lumen… so there’s logical conflict
I think the whole country of Norway took an opposite stance
BMT ended because an investigation showed the first randomized trial completely fabricated data/there was no randomization and a second randomized trial showed no benefit…
The study you quoted shows, without a doubt, that SpaceOAR does NOT... checks notes.... improve erectile dysfunction. Enough to justify a socialist country to pay for it, anyway.
I’m not disregarding the trial. I was a true believer until I studied the results in detail. It’s because I’m regarding the trial that I came to this decision.
That's just one factor. What about the ****ing elective colostomies and rectal abscesses/IV abx issue??
Sure I’ll answer. Point 1: Yes, I guess you could call a needle in the taint a toxicity. But you don’t hear folks calling Fiducials a grade 2 tox (which is more uncomfortable than most because deeper/more needle pokes, than SpaceOAR, in my experience. I no longer do Fiducials). I tell folks, “SpaceOAR does take an ultrasound in the rectum and a needle poke after I numb up the area. It is uncomfortable. The risk of rectal side effects with radiation is low in general with radiation, but there is a risk of both short term side effects and long term side effects like rectal bleeding or rectal urgency can happen in 1-2% of patients down the line. SpaceOAR separates the rectum from the prostate and it does decrease your short term rectal side effects, if any, and provides a small long term benefit for a very small percentage of patients as well. Like any procedure, it comes with risks of major complications or infections, but in my personal experience, I have not seen much side effects for most except some occasional feeling of rectal fullness for a couple days. I do think it provides a benefit and if your insurance pays for it, I personally would do it. If you’re averse to needles or insurance doesn’t pay for it, which I see with a couple insurance companies unfortunately, it is certainly not required and probably not worth it”
Fair enough! I have (personally) been surrounded by more vocal naysayers about SpaceOAR than ardent supporters (most, like me, believe the data/think it’s the right thing to offer but do not think it is absolutely necessary or dramatic in its impact).You’re not going about this in good faith
It’s not ever personal when it’s about science. I’m not saying you are like them.
The comparison to BMT is because in the moment, if you were not for it, you were a cretin. The magazine covers, the media stories, everything. Everybody decided that it was the way to cure people. The lawsuits against the insurers, the way people that questioned it got treated.
Let’s focus on the nature of the debate. If it is true that it decreases toxicity in a meaningful way, then it means those that don’t use it are causing undue toxicity. Those that use it are safer.
My review of the evidence, my own experience and after discussion with many colleagues is that 1) with modern technique and planning my toxicity rate is nowhere near the control arm toxicity rate 2) it’s expensive to the system (if not individual patients) 3) the review of the literature shows statistical chicanery 4) every author is getting large amounts of money. Know the proctors? You’d be fascinated to know just how much they make per hour 5) modern results (such as PACE B) have rates of toxicity nowhere near the control arm.
I can’t wait for that institution to publish their results. And others when they actually review their cases. At least the debate can be much more thorough.
Fiducials? Don’t use em. I have cbct and use it like I use MSG. On everything
Honest question, what is the problem with Hamstra's study? That's the one that changed my practice and I was unaware of this newer study until reading about it on this thread.
Will get to that.
It would have never even been a study if the trialists hadn’t been paid a lot of dough. Is that a “problem” though… or cunningness?!
I absolutely think there's a faction of folks who don't want to do the procedure, and are finding ways to justify that desire.
yeah i think this is bigger than the rad onc sometimes. our system has dragged their feet on pluvicto for example. I have a fleeting suspicion this is because it wont make enough $$ for it to be worth it to them.
Xofigo is fine, data is good. Bottom line though is that it's basically like med onc, giving a 5 figure drug and trying to make a profit on the drug margin. And if you screw up the billing on even 1/6 doses, you're hosed
I think I recall @OTN does radiopharm, but if you’re a PSA group I think starting a RP program is a good way to demonstrate value to the hospital. You eat it in your end because of the low professional RVU, but I believe the hospital makes a lot off technical.
I don’t think hospitals get 340b prices for radio pharm. there is close to 0 profit. Waiting 90 days to get paid also really cuts into the 5% margin.
Totally agree.
It's not technical. It's drug margin. Different business and economics. I think it's better then med onc drugs like asp+4-6% but the problem is you get screwed if you don't get reimbursed completely since you are fronting cash for the drug first, unlike ebrt
Good question. It's more strategic than anything, as I want referring MDs to just assume we do it all so they can send patients our way no matter what. Same reason we treat patients who cannot pay for free.
I am guessing that the pluvicto is not given by the radoncs at the Ivory Tower, so hopefully they should come back.
Real issues with getting the product produced supposedly so not a lot of product or tx sites out doing it right now
The issues that I have with spacers has to do with publishing bias, industry funded studies, and academic agendas.
Is there a single grade 3/4 spacer placement related toxicity in any of the triaLs?
I'm not sure, but anecdotally I have seen SpaceOARs so poorly placed that they make absolutely no difference and I have seen two patients with abscesses from SpaceOAR requiring prolonged treatment breaks that likely will affect oncologic outcome.
Great analysis. Emblematic of a system that keeps raising reimbursement for hospitals and others with inflation and cuts physician pay every year. And let’s large academic systems buy out small community hospitals, employ all the docs, and charge private payers 2x (for no better/different care)
Agreed and have also seen plenty of badly placed spacers. I assume many radoncs are hesitant to communicate this with the urologists.
In my limited experience of talking to rad onc residents about SoaceOAR, even they are suspicious of the SpaceOAR data and don’t love the toxicities from SpaceOAR they see and hear from patients. And when I hear them say that I think: you know what, I probably had more face time with patients as a resident than I do now as a practicing rad onc so it makes sense they’d pick up on subtle (chronic pelvic discomfort eg) SpaceOAR complaints. DSpratt needs to “ketchup” with all his SpaceOAR patients in clinic routinely to see if everyone is well and truly happy with their perirectal “prosthetics.”
Physicians have also reported this problem when administrators are nearby.
