Hydrogel Spacer: Hi to all. My husband... - Advanced Prostate...

Advanced Prostate Cancer
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Hydrogel Spacer

Hi to all. My husband will have the hydrogel spacer placed this Thursday in anticipation of EBRT. We’ve been told it’s a simple procedure but does require sedation. The RO told us that the spacer is a hard sell with many of his patients. If it’s a simple, low cost procedure that protects the anus during radiation treatments, why is it a “hard sell?” Now I’m chewing on that thought. The RO was very positive about its benefits. Does anyone have experience with this? What can my spouse expect during and after the gel insertion? Thank you!

Mary

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Google "spaceOAR" and you will get lots of related results, including this one:

spaceoar.com/patients/faqs/

Charles

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Thank you, Charles. I couldn’t recall the trade name so the link was helpful.

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It's not inexpensive. Cost is over $3000 plus the surgical and anesthesia fees. And it does very little. I call it a solution in search of a problem. Here's an article that digs into the actual research on it, not just the hype:

pcnrv.blogspot.com/2017/01/...

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The "article that digs into the actual research" is an opinion piece written by Allen Edel, aka Tall Allen.

Quoting your own opinions without disclosing that you are the author is dishonest.

Ignoring or misrepresenting the results, this hit piece doesn't bother to note that the study demonstrated "that the hydrogel spacer was safe to apply and well tolerated and resulted in a significant rectal dose reduction." emphasis added.

It works. It reduces radiation to the rectal tissues, and those reductions in radiation have been proven to be clinically significant and have measurable impacts on patient Quality of Life (QOL).

The discussion on number needed to treat (NTT) conveniently omitted the strongest result:

"The NNT to prevent 1 detectable change in bowel QOL at 3 years (5-point threshold) was 3.7."

Funny how NTT gets trotted out to attack results the author doesn't like, but aren't mentioned when discussing treatments that are favored.

The results of the PROTECT Trail (quote from the paper)

===================

"Numbers Needed to Treat

On the basis of our results, we estimated that 27 men would need to be treated with prostatectomy rather than receive active monitoring to avoid 1 patient having metastatic disease, and 33 men would need to be treated with radiotherapy rather than receive active monitoring to avoid 1 patient having metastatic disease. "

nejm.org/doi/full/10.1056/N...

So if an NTT of 6 or 17 is used as an argument against the spacer, why would anyone submit to prostatectomy or radiotherapy, where the numbers are 27 and 33, and the QOL effects are horrendous?

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Dishonest? That's just plain silly - my name and picture are on the blog! In fact, I also write for another well-respected PC blog, "The New Prostate Cancer Infolink' and my name appears there as well. Rather than retype my blogs here, it's much more convenient for me to provide a link.

In fact, I reported all the things you say I left out:

"We notice that the spacer moderated the declines in the rectal scores. There was a 16 percentage point improvement in late term rectal evaluations due to the spacer. However, we also saw that the relative decline was not very bothersome to the patients (96% did not find it even moderately bothersome)."

Here's the NNT analysis:

"The cost of the SpaceOAR hydrogel injection is about $2,500. IMRT patients should not expect any amelioration of bothersome acute rectal symptoms. A cost/value analysis depends upon which toxicity numbers one wants to focus upon.

"Even if the difference were statistically significant (and it's not), only 2.2% would avoid bothersome late-term rectal symptoms by using the gel. So to spare one patient bothersome rectal symptoms, 45 patients would have to be treated at a cost of over $90,000. "

"If we focus on the late-term toxicity improvement, 6% avoided late-term grade 2 or higher rectal symptoms by using a spacer. To spare one patient such symptoms, 17 patients would have to be treated at a cost of $42,500."

"If we use the 2x MID difference as our guide, 16% would avoid low grade late-term rectal symptoms. So to spare one patient those symptoms, 6 patients would have to be treated at a cost of $15,000. "

And here's what it says about safety:

"Safety must be considered as well. The risks are not large, but neither are they non-existent. In addition to the dangers of anesthesia and infection, there is a small danger that the injection will penetrate the rectal wall or cause a rectal ulcer. Such dangers are small, and undoubtedly diminish with clinician experience."

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To: Tall_Allen and FCoffey,

It's my humble (but valuable) opinion that both of you are without a doubt very competent and learned gentlemen on this forum. It just drives me nuts to see you two go after each other (like a pissing contest). It's like watching a great tennis match, my head moving side to side not knowing who to root for. So shake hands (and come out fighting LOL). All kidding aside we all appreciate your knowledge and posts, just dial it down a notch. Thanks.

🙈🙉🙊

Good Luck and Good Health.

j-o-h-n Thursday 05/03/2018 12:09 PM EDT

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It's likely but not guaranteed to protect the rectum and anus from injury. It's rather unlikely to hurt.

The full text of the Phase III clinical trial can be found at

redjournal.org/article/S036...

The spacer emphatically does work. Here's a quote from the abstract:

=============

Results

The 3-year incidence of grade ≥1 (9.2% vs 2.0%; P=.028) and grade ≥2 (5.7% vs 0%; P=.012) rectal toxicity favored the spacer arm. Grade ≥1 urinary incontinence was also lower in the spacer arm (15% vs 4%; P=.046), with no difference in grade ≥2 urinary toxicity (7% vs 7%; P=0.7). From 6 months onward, bowel QOL consistently favored the spacer group (P=.002), with the difference at 3 years (5.8 points; P<.05) meeting the threshold for a MID. The control group had a 3.9-point greater decline in urinary QOL compared with the spacer group at 3 years (P<.05), but the difference did not meet the MID threshold. At 3 years, more men in the control group than in the spacer group had experienced a MID decline in bowel QOL (41% vs 14%; P=.002) and urinary QOL (30% vs 17%; P=.04). Furthermore, the control group were also more likely to have experienced large declines (twice the MID) in bowel QOL (21% vs 5%; P=.02) and urinary QOL (23% vs 8%; P=.02).

Conclusions

The benefit of a hydrogel spacer in reducing the rectal dose, toxicity, and QOL declines after image guided intensity modulated radiation therapy for prostate cancer was maintained or increased with a longer follow-up period, providing stronger evidence for the benefit of hydrogel spacer use in prostate radiation therapy.

====================== end quote

MID means Minimally Important Differences; its medical jargon for a quality of life degradation severe enough for doctors to take note of it.

It will not help all men for the simple reason that not all men get rectal injuries from radiation. Not all people get in automobile accidents but the benefits of seat belts in preventing injuries are so dramatic that seat belt use is legally mandated in most states.

Bowel dysfunction has a major effect on quality of life. The spacer is designed to protect the bowel, while the study was commendably thorough in considering urinary and sexual toxicities, the bowel measurements are the most important.

So the spacer helped men; the difference was detectable at 6 months and grew stronger with time. Radiation is like that - as Snuffy Myers said "Radiation is the gift that keeps on giving." Sexual decline, bowel problems, secondary tumors, all of these show up months and years after radiation treatment.

After three years men who didn't get the spacer were 3 times as likely to have significant bowel issues compared to men who did (41% / 14%) and over 4 times as likely to have major problems with their bowels (21 % / 5%).

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Reply

To: FCoffey and Tall_Allen,

It's my humble (but valuable) opinion that both of you are without a doubt very competent and learned gentlemen on this forum. It just drives me nuts to see you two go after each other (like a pissing contest). It's like watching a great tennis match, my head moving side to side not knowing who to root for. So shake hands (and come out fighting LOL). All kidding aside we all appreciate your knowledge and posts, just dial it down a notch. Thanks.

🙈🙉🙊

Good Luck and Good Health.

j-o-h-n Thursday 05/03/2018 12:09 PM EDT

Reply

I had the spacer installed 4 months ago and had proton therapy at the Mayo Clinic.

I have had no side effects.

I was given a valium before the spacer install If I were to do it over I would choose mild sedation. Pain was about a 5 or 6 on a scale of 1 - 10.

I ate a lot of fruits, veggies, greens and fish. Minimal amounts of meat. I think this helped my bowel movements.

I drank a lot of water on a daily basis, at least half my body weight in ounces.

Minimal amounts of caffeine a day 1-2 cups of coffee a day and 2-3 cups of green tea a day. The rest was water.

Towards the end of the treatment I took one aleive in the AM and one at PM

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