You can do same with a 50% avoidance structure 1cm posterior to ptv in rectum. This is abt the physical fall off limit that can work on almost all prostate volumes for hot spot less than 10% (5% fall off per mm).
That's what I have typically done, put a large posterior avoid on the rectum, rapid plans still come out with sharper fall off posteriorly that what I have typically asked for. That plan I posted has 50% IDL at .5 cm and 30% line at 1 cm from the PTV.
You can do better depending on prostate volume but 50% at 1 cm and 30% at 2 cm should always work and will be better than 90% plans out there. 10%/mm is a stereotactic like fall off, which is great but can’t expect something like that for a mid to large prostate.
Agree.
No doubt.. but hey, you gotta give credit to the vipers at the gel factory. They sure did a heckuva job pushing that gel out to the docs.These MRI Dicoms should be sent to this group below and see how they read the MRI's.
Like any other procedure, some are better than others, be it reading the MRI or actually inserting the spaceOAR correctly.
AUA 2023: Real World Assessment of MRI Predictors of Rectal Complications Following Transperineal SpaceOAR® Hydrogel Insertion
AUA 2023 real-world assessment of MRI predictors of rectal complications following transperineal SpaceOAR® hydrogel insertion, SpaceOAR® hydrogel insertion, MAUDE database, SpaceOAR® PIVOTAL trial.urldefense.com
getyarn.io
Nope. Exents, elective colostomies, fistulas etc... just say no!
have a patient on w 70/28 and 70 Gy dose to rectum is about 2%. Sans spacer. Yes, the anatomy was pretty good, but gotta push the planner (not plan your own, you animals)
What's the absolute volume getting 70? You could just have them eat a big bowl of beans the night before sim if you really want to bring down the % getting 70. Looking at 2 patients under treatment right now, one of whom is my second patient with spaceoar ever, it's 70 Gy to 3.5% and 1.5 cc without vs 70 Gy to 0% with, and overall the rectal DVH looks way better with. That said, 1 in 100 patients I treat has it, and I don't push it. But I haven't really heard of these nightmares happening beyond anecdotally, and that's with and without.
I agree, anecdotally, of course. The only people in my neck of the woods getting spacers placed are having them done by urologists who do them all the time. No problems I'm aware of.
That’s why I look at the isodose percentage at 1cm posterior to the ptv.
I have em eat beans and call a little sigmoid rectum. I dominate constraints. In looking at these 2 patients, the whole curve looks way better with spaceoar. That said, I don't use it much or advocate for it.
Since the only benefit is less g1 toxicity, it needs to translate universally well into the community
I've put 2 patients on this trial... rather difficult contouring rules. Not surprised
| Patient Problems Fistula (1862); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Urinary Retention (2119) |
| Event Date 07/24/2023 |
| Event Type Injury |
| Event Description |
| It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue implant procedure on an unknown date. The procedure was performed under anesthesia. The patient received external beam radiation treatment, then seed and spaceoar placement was performed. The hydrogel was reported to be small and near the seminal vesicles and partially into the venous plexus, surrounding the prostate lower down. On (b)(6), 2023, the patient had a post procedure computed tomography, at that time the patient was having a lot of urinary frequency. One month after the hydrogel placement, on (b)(6), the patient began experiencing rectal pain around the anus. The patient was put in lithotomy position, no pain to palpitation on the testicles and perineum but had point tenderness right inside the anus on the rectum, it was thought the patient had a small fissure. The patient was sent to gastroenterologist physician (gi) but was unable to be seen. The patient was prescribed with lidocaine cream to put at the anal area for the presumed fissure. The next couple of days around (b)(6), the affected area and the pain worsened. The patient went to the urologist complaining of scrotal and perineal pain, the urologist did not examine the patient. The patient's pain was so severe that he went to emergency department (ed) and ended up in the intensive care unit (icu) with gangrene in scrotum and debridement of the entire perineal. It was noted some seeds were lost in the procedure. The patient was put on a ventilator and a wound vacuum to address the problem. The patient did not lose a testicle due to this event and it was reported that he will get a skin graft. The patient was discharged from the hospital at the time of this event. The patient condition was reported as "expected fully recovered. ". |
| Patient Problems Abscess (1690); Purulent Discharge (1812); Fistula (1862); Pain (1994) |
| Event Date 02/24/2022 |
| Event Type Injury |
| Manufacturer Narrative |
| Blocks d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown. Block h6: imdrf patient code e2314 captures the reportable event of fistula. Imdrf patient code e172001 captures the reportable event of abscess. |
| Event Description |
| It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue implant procedure on (b)(6) 2022. The procedure was performed with local anesthesia. Fiducial markers were placed transperineally. This patient received treatment 1. 5 years ago. He was diagnosed with prostate cancer in 2015, later in 2016 he was diagnosed with colon cancer, the magnetic resonance imaging (mri) showed that he had an obstructing lesion in the ascending colon, the lesion in the right lateral peripheral. His psa went from 5 to 10. In (b)(6) 2021, a fusion biopsy showed gleason. 3+4 = 7 in the mr fusion index lesion and so he went for treatment. The patient's physician gave him androgen deprivation therapy (adt) and wanted to do external beam radiation treatment (ebrt) therefore the patient did spaceoar vue and finished his treatment in april 2022. The radiation treatment was changed to moderate hypofractionation and received 70gy/28 fractions. (b)(6) 2022 the patient was doing fine. Was in (b)(6) 2022 that the patient reported having pain with bowel movements in the rectum, he was prescribed with proctofoam and was ok, the symptoms resolved 2-3 weeks later. Later in (b)(6) 2022 the symptoms in the rectum recured. He restarted proctofoam and had a computed tomography (ct) scan in the clinic and there was not abnormally on the scan nor rectal exam therefore the patient's physician decided to be watched on proctofoam watch soft stools. This was enough for a few months. In (b)(6) 2023, symptoms worsened he was referred to colorectal surgery who did a flex sig which found a punctate pinpoint fistula along the anterior rectal wall with some pus. The magnetic resonance imaging (mri) was performed and showed a rectoprostatic fistula that wasn't involving the urethra. The fistula was located to the posterior surface of the prostate. There were also a series of abscessed on the right abductor muscle. The patient went to the operating room (or) for pelvic exploration, there it was noted some fibrosis around the prostate, they drain into the muscle to drain the abscesses and then had a colostomy with hartman paunch. The patient had antibiotics for six weeks. The patient's physician looked at the spaceoar reps at the prior images and didn't see anything that would explain what had happened. The images were reviewed but there is not certain that a rectal wall infiltration that could have cause the fistula. The relationship between the device and the adverse events of fistula and abscess was unknown. The patient condition at the time of this report was as unknown. |
| Patient Problems Fistula (1862); Pain (1994); Ulcer (2274); Discomfort (2330); Dysuria (2684); Fluid Discharge (2686) |
| Event Date 07/01/2023 |
| Event Type Injury |
| Manufacturer Narrative |
| Blocks d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown. Block h6: imdrf device code a1502 captures the reportable event gel misplaced - non-vascular. Imdrf patient code e2314 captures the reportable event of fistula. Imdrf patient code e2339 captures the reportable event of ulcer. |
| Event Description |
| It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue implant procedure on an unknown date. The patient received transrectal fiducials a week prior to the procedure to the hydrogel placement procedure. The placement procedure was successful. The patient started radiation treatment that was switched to 180 per fraction to reduce the rectal risk. The patient was doing well until fraction 25 when he developed discomfort and rectal pain with bowel movements and dysuria. The patient was ruled out for urinary infection (uti). Two weeks into the patient's treatment, he experienced mucus discharge. On cone beam computed tomography (cbct) the hydrogel appears that there is a wisp of hydrogel that is placed posterior than what was noted previously. The patient treatment was paused, and magnetic resonance imaging (mri) was performed. The imaging showed an ulceration is superior, and the fistula extends into the hydrogel less than one centimeter. The radiation treatment was put on hold for six weeks. The patient condition was unknown at the time of this report. No further information has been obtained despite good faith efforts. |
They should have applied the diagnosis of Fournier’s Gangrene here. It is horrible horror movie stuff, often fatal. That there is any association of Fournier’s with SpaceOAR should get SpaceOAR totally recalled or demarketed or canceled or whatever.
rarediseases.org
Spaceoar placed after ebrt? You're asking for it if you're doing that.They should have applied the diagnosis of Fournier’s Gangrene here. It is horrible horror movie stuff, often fatal. That there is any association of Fournier’s with SpaceOAR should get SpaceOAR totally recalled or demarketed or canceled or whatever.
Fournier Gangrene - Symptoms, Causes, Treatment | NORD
Learn about Fournier Gangrene, including symptoms, causes, and treatments. If you or a loved one is affected by this condition, visit NORD to find resources
That "expert" is going to get rich when these gel fistulas start making it to litigation...
Agreed.
“Expert” sounded like a total pos.
Whenever I see this I am reminded that this is the failure to contour as specified in the protocol.
There is never really a "win" in litigation.
Only refer to experienced GI docs who know what they are doing.
I would say there’s a zero percent chance of Fournier’s gangrene from prostate RT tho
