Radiation proctitis is a problem that doesn't exist? As for the bleeding, infection, risk, etc, do you take the same stance on fiducial marker placement? What if the SpaceOAR is placed without general anesthesia?
I've never had a patient get hit with an unexpected charge for this and, if they did, our department would eat it as is our practice. SpaceOAR vue has contrast in the gel and thus a second MRI is not necessary.
I have yet to see an adverse event as a result of a gel placement (though I'm sure if we do enough of them I will see one), so I suppose you have a point there; though again, if you don't summarily dismiss the randomized data, there are likely more adverse events (grade 2+ 5% vs 0% from the Hamstra study) from not using the gel then using it.
Contributes to erosion of public trust? Come on, man. You obviously have a stance that you've taken here, but... possibly a wee bit of hyperbole?
The issues that I have with spacers has to do with publishing bias, industry funded studies, and academic agendas.
This is an industry sponsored study designed to show spacer superiority. The outcome was a foregone conclusion, because that's what the publishers are incentivized to show. This isn't a study asking the question "is spacer better?" but a study designed to generate evidence that spacer is better. By some arbitrary metrics there is improvement in acute toxicity, even though there is unlikely to be a statistically significant difference in late toxicity, so spacers are good! The proponents say "it's better for patients" because of trials like this.
When the hypofractionation studies came out, they showed similar efficacy but small increases in GU/GI toxicity that was deemed to be "unlikely to be clinically relevant." Conventional fractionation was equivalent at worst (similar oncologic outcome) but objectively better from a toxicity standpoint. One could argue that conventional fractionation was a better oncologic treatment (same outcome with less toxicity), but barring some catastrophic toxicity difference, the outcome of these studies were also a foregone conclusion. It's "cheaper for the healthcare system, less time consuming for patients, and thus better for patient care."
So here we have two examples of trials, both showing "a small increase in acute toxicity that is unlikely to be clinically relevant," that reach opposite conclusions based on the agenda of the publishers. Imagine if this was a Canadian trial designed the exact same way without the industry sponsorship, where the agenda is to determine if the Canadian healthcare system should make spacers the standard of care. What do you think the outcome would be?
The difference in
total reimbursement (based on RO-APM numbers) for conventional (39 fractions) vs. hypofractionated (28 fractions) prostate treatment is ~$30k vs. ~$20k. Spacers cost ~$3-5k but reimburse us (as physicians) almost nothing. Prostate MRIs cost $1-2k. We've come full circle. We've cut our prostate
reimbursement down by 30% but found a way for our
treatment cost to creep back up to close to what it used to be in order to compensate for the increased acute toxicity of hypofractionation. However, now we're donating a portion of that money to radiology and to big pharma, putting patients through an extra procedure with a non-zero catastrophic toxicity risk (colostomy, abscess, fistula), all to save them from ~2 weeks of treatment.
