Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial

Hamstra, D.A.; Mariados, Neil; Shah, Dhiren; Kurtzman, Steven; Sylvester, John; Zimberg, S.H.; Hudes, Richard; Karsh, Lawrence I.; Logsdon, Mark D.; Beyer, D.C.; Kos, Michael; Hsi, R.A.; Forsythe, Kevin; Soffen, Edward M.; Francke, Patrick; Zhang, H.; DeWeese, Theodore L.; Ellis, Rodney J.; Mantz, C.A.; Bosch, Walter; Michalski, Jeff M.

doi:10.1016/j.ijrobp.2016.09.050

Cited by 10 publications

(19 citation statements)

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“…The characteristics of the clinical trial and results have been reported previously. 3,4 For this analysis, clinical and dosimetric data were assessed for the 222 patients who 36 30 42 105 103 103 68 68 37 68 12 66 65 63 38 38 24 38 7 46 46 43 28 28 14 28 3 Failure Probability enrolled on either arm, whereas analysis of changes in bowel QOL was limited to those with baseline and follow-up QOL assessments at 15 or 36 months. Hydrogel spacer has previously been demonstrated to reduce rectal volume exposed to radiation over the entire range of rectal dose-volume histogram (DVH) assessed.…”

Section: Resultsmentioning

confidence: 99%

“…3e5 Briefly, men with low-or intermediate-risk prostate cancer, as defined by the National Comprehensive Cancer Network, and Zubrod performance 0 to 1 were enrolled in a multi-institutional, institutional review boardeapproved, single-blinded, phase III trial. Men with prostate glands !80 cm 3 , extraprostatic extension, >50% positive core biopsies, previous or planned use of androgen deprivation therapy, or prior treatment of prostate cancer were excluded. Randomization was 2:1 to the hydrogel spacer or control group, with all patients having fiducial markers for image guided radiation therapy.…”

Section: Patients and Treatmentmentioning

confidence: 99%

“…At a median follow-up of 37 months, spacer reduced rectal dose and toxicity while improving quality of life compared with control. 3 The present study is a secondary analysis of the phase III trial with the objective to identify, based on clinical, anatomic, and dosimetric factors, a subgroup of men who may not benefit from spacer placement.…”

Section: Introductionmentioning

confidence: 99%

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Who Benefits From a Prostate Rectal Spacer? Secondary Analysis of a Phase III Trial

Quinn

Daignault‐Newton

Bosch

et al. 2020

Practical Radiation Oncology

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Previously a phase III trial of a hydrogel rectal spacer during prostate radiation therapy found decreased toxicity and a clinically significant improvement in bowel quality of life (QOL) at 3 years by the Expanded Prostate Cancer Index. We performed a secondary analysis to identify men less likely to benefit. Sources of support: This work was supported by research funding from Augmenix, Inc, which is now a wholly owned subsidiary of Boston Scientific. Disclosures: N. Mariados and D. Shah have each made small investments in Augmenix. D.A. Hamstra, J. Michalski, and S. Daignault-Newton have provided paid consulting services for Augmenix and Boston Scientific. J. Michalski, H.A. Gay, and W. Bosch have provided core laboratory services for Augmenix.

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Section: Resultsmentioning

confidence: 99%

Section: Patients and Treatmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Who Benefits From a Prostate Rectal Spacer? Secondary Analysis of a Phase III Trial

Quinn

Daignault‐Newton

Bosch

et al. 2020

Practical Radiation Oncology

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“…Whether this reduction is of clinical significance is yet to be determined for the Rectafix, although the recently reported results of a randomised trial of over 200 men exploring the utility of the SpaceOAR verified that the dosimetric benefits seen at planning did indeed translate into clinical benefit at later follow-up. 10 All plans were assessed retrospectively from the PROMETHEUS trial data. Plans were optimised to the strict trial constraints which in itself required meticulous sparing of the rectal structures.…”

Section: Discussionmentioning

confidence: 99%

“…8,9 For the SpaceOAR, a randomised trial has shown that this dosimetric benefit translates to subsequent reductions in late rectal toxicity and improvements in patient-related quality of life. 10 The PROMETHEUS (PROstate Multicentre External beam radioTHErapy Using Stereotactic boost) clinical trial is a phase 2 multicentre study where men receive 'Virtual High Dose Rate Brachytherapy' with two SBRT fractions prior to a 46 Gy in 23 fraction course of conventionally fractionated radiotherapy. For the SBRT component, a RDD is mandated for study participants, with subsets having use of either the Rectafix or SpaceOAR.…”

Section: Introductionmentioning

confidence: 99%

Rectal protection in prostate stereotactic radiotherapy: a retrospective exploratory analysis of two rectal displacement devices

Wilton

Richardson

Keats³

et al. 2017

J of Medical Radiation Sci

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IntroductionHigh rectal doses are associated with increased toxicity. A rectal displacement device (RDD) reduces rectal dose in prostate stereotactic body radiation therapy (SBRT). This study investigates any dosimetric difference between two methods of rectal displacement (Rectafix and SpaceOAR) for prostate SBRT.MethodsRectal dosimetry of 45 men who received SBRT within the PROMETHEUS trial was retrospectively examined, across two radiation therapy centres using the two RDD's. Men received a total dose (TD) of 19 or 20 Gy in two fractions followed by 46 Gy in 23 fractions. Centre 1 contributed 16 Rectafix and 10 SpaceOAR patients. Centre 2 contributed 19 Rectafix patients. Rectal dose volume histogram (DVH) data were recorded as a TD percentage at the following volume intervals; V1%, V2%, V5%, V10% and then 10% increments to V80%. As only one centre employed both RDD's, three sequential rectal dosimetry comparisons were performed; (1) centre 1 Rectafix versus centre 1 SpaceOAR; (2) centre 1 Rectafix versus centre 2 Rectafix and (3) centre 1+ centre 2 Rectafix versus centre 1 SpaceOAR.ResultsIn comparison (1) Rectafix demonstrated lower mean doses at 9 out of 11 measured intervals (P = 0.0012). Comparison (2) demonstrated a moderate difference with centre 2 plans producing slightly lower rectal doses (P = 0.013). Comparison (3) further demonstrated that Rectafix returned lower mean doses than SpaceOAR (P < 0.001). Although all dose levels were in favour of Rectafix, in absolute terms differences were small (2.6–9.0%).ConclusionsIn well‐selected prostate SBRT patients, Rectafix and SpaceOAR RDD's provide approximately equivalent rectal sparing.

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EUS‐guided hydrogel microparticle injection in a cadaveric model

Kim

Ding

Rao

et al. 2021

J Applied Clin Med Phys

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Background and Aims A potential method to reduce gastrointestinal toxicity during radiation therapy in pancreatic head cancer is to create a physical space between the head of the pancreas (HOP) and the duodenum. To date, there have been early reports on the feasibility of endoscopic ultrasound (EUS)‐guided hydrogel injection into the interface between the HOP and the duodenum to increase the peri‐pancreatic space for radiotherapy. We aimed to evaluate the technical feasibility of EUS‐guided hydrogel injection for the creation of space at the peri‐pancreatic interface in a cadaveric model. Methods Baseline abdominal computerized tomography (CT) was performed on three unfixed cadaveric specimens. The hydrogel was injected transduodenally into the interface between the HOP and duodenum using linear‐array EUS and a 19G needle for fine needle aspiration (FNA). This procedure was repeated along the length of the HOP. CT imaging and gross dissection were performed after the procedure to confirm the localization of the hydrogel and to measure the distance between the HOP and the duodenum. Results All cadavers underwent successful EUS‐guided injection of the hydrogel. Cadavers 1, 2, and 3 were injected with 9.5, 27, and 10 cc of hydrogel, respectively; along the HOP, the formation of the peri‐pancreatic space was a maximum size of 11.77, 13.20, and 12.89 mm, respectively. The hydrogel injections were clearly visualized as hyperechoic bullae during EUS and on post‐procedure CT images without any artifacts in all cases. Conclusions We demonstrated that EUS‐guided delivery of hydrogel is feasible, and that it increases the peri‐pancreatic space in a cadaveric model. The polyethylene glycol (PEG) hydrogel was clearly visible on EUS and CT, without significant artifacts. This may lead to new treatment approaches for pancreatic carcinomas.

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Continued Benefit to Rectal Separation for Prostate RT: Final Results of a Phase III Trial

Cited by 10 publications

References 0 publications

Who Benefits From a Prostate Rectal Spacer? Secondary Analysis of a Phase III Trial

Who Benefits From a Prostate Rectal Spacer? Secondary Analysis of a Phase III Trial

Rectal protection in prostate stereotactic radiotherapy: a retrospective exploratory analysis of two rectal displacement devices

EUS‐guided hydrogel microparticle injection in a cadaveric model

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