Five-year results of post-prostatectomy patients administered a hydrogel rectal spacer implant in conjunction with dose escalated external beam radiation therapy

Lehrich, Brandon M.; Moyses, Helen; Ravera, John; Yoshida, Jeffrey; Torrey, Robert; Baghdassarian, Ruben; Gazzaniga, Michael S.; Weinberg, Alan C.; Phan, Cu; Chalfin, Stuart; Barnes, Lucy; Mesa, Albert; Tokita, Kenneth

doi:10.1007/s13566-018-0369-0

Cited by 7 publications

(4 citation statements)

References 32 publications

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“…A recent study has shown that using a hydrogel rectal spacer is well tolerated by patients in postprostatectomy RT. This single‐arm study has reported that a minimal improvement in 5 years late GI and GU toxicities were achieved by using a hydrogel spacer . However, there were several limitations in that study such as single arm, retrospective investigation, using physician scoring to measure adverse events, and heterogeneous cohort.…”

Section: Discussionmentioning

confidence: 99%

Application of rectal retractor for postprostatectomy salvage radiotherapy of prostate cancer: A case report and literature review

Ghaffari

Ardekani

Molana

et al. 2019

Clinical Case Reports

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Section: Discussionmentioning

confidence: 99%

Application of rectal retractor for postprostatectomy salvage radiotherapy of prostate cancer: A case report and literature review

Ghaffari

Ardekani

Molana

et al. 2019

Clinical Case Reports

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“…Although V65 to V50 remains significantly improved in the intact setting after excluding patients who received pelvic RT, the dosimetry advantage at lower doses is likely not due to hydrogel spacer alone, and the use of pelvic RT may be a significant confounder. Lastly, although there are case reports and a small retrospective series evaluating hydrogel spacers in the postprostatectomy setting, 22 , 23 there remain unanswered clinical questions, including concern about potential tumor cell dissemination (possibly with disruption of Denonvilliers’ fascia), which warrant further prospective investigation. Postprostatectomy placement is not currently a widely accepted indication.…”

Section: Discussionmentioning

confidence: 99%

Radiation Dose to the Rectum With Definitive Radiation Therapy and Hydrogel Spacer Versus Postprostatectomy Radiation Therapy

Yang

Verma

et al. 2020

Advances in Radiation Oncology

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Purpose Management options for localized prostate cancer include definitive radiation therapy (RT) or radical prostatectomy, with a subset of surgical patients requiring adjuvant or salvage RT after prostatectomy. The use of a peri-rectal hydrogel spacer in patients receiving definitive RT has been shown to reduce rectal doses and toxicity. However, in the postprostatectomy setting, a hydrogel spacer cannot be routinely placed. Therefore, we sought to compare rectal dosimetry between definitive RT with a hydrogel spacer versus postoperative RT. Methods and Materials We identified patients with prostate cancer who underwent conventionally fractionated RT. Rectal dosimetry was evaluated between 2 groups: definitive RT with a hydrogel spacer (79.2 Gy, group 1) and postoperative RT (70.2 Gy, group 2). Rectal dosimetry values were tabulated and compared using Mann-Whitney U test. We implemented a Bonferroni correction to account for multiple comparisons (threshold P < .005). Linear regression analysis evaluated predictors of candidate rectal dose-volume parameters. Results We identified 51 patients treated during years 2017 to 2018; 16 (31%) and 35 (69%) patients were included in groups 1 and 2, respectively. The rectal volume receiving ≥65 Gy (V65) was significantly lower in group 1 (median, 2.1%; interquartile range, 0.9%-3.1%) than in group 2 (10.7%, 6.6%-14.5%) ( P < .001). Use of a hydrogel spacer in the definitive setting was independently associated with lower V65 ( P < .001). Similar results were found for V60, V55, V50, and V45 ( P < .005 for all). Conclusions Rectal dosimetry is more favorable for definitive RT (79.2 Gy) with a hydrogel spacer compared with postoperative RT (70.2 or 66.6 Gy). This may inform shared decision-making regarding primary management of prostate cancer, especially among patients at high risk of needing postoperative RT after prostatectomy.

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“…Фактически Описан опыт применения БДС для оптимизации спасительной лучевой терапии на область ложа удаленной предстательной железы [11,12]. Такой подход осуществим, однако его реализация сопряжена с повышенными рисками травматизации прямой кишки из-за рубцовых изменений в зоне введения спейсера, особенно при использовании для имплантации классической острой иглы-интродьюсера.…”

Section: показания к имплантации спейсераunclassified

Methodological aspects of implantation of a Russian prostate-rectum spacer based on stabilized hyaluronic acid of non-animal origin

Novikov,

Zhivulina,

Sysoeva

et al. 2024

Onkourologiâ

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Over the past few years, the use of spacers to optimize radiation treatment of prostate cancer has become increasingly popular in radiotherapy practice. In Russia, the experience of clinical application of this technology is small and limited to few trials at federal centers. The technique of perineal implantation of a biodegradable spacer is invasive and requires the participation of specialists with appropriate manual skills. Therefore, informing urologists, urologic oncologists, and interventional radiologists on the methodological aspects of this procedure has significant practical importance.The purpose of this work is to describe the methodology of using a new Russian medical device as a biodegradable spacer – a monophasic implantable gel (hydrogel) based on stabilized (cross-linked) hyaluronic acid of non-animal origin (EsteFILL intim), which makes it possible to reduce radiation exposure to the anterior wall of the rectum and has other positive effects (increased accuracy of radiation delivery, reduced risks of radiation-induced erectile dysfunction) in different radiotherapy methods of prostate cancer treatment. The described procedure was developed and approved at the Department of Radiotherapy of the N.N. Petrov National Medical Research Center of Oncology. The design of the study implying implantation of the stabilized non-animal hyaluronic acid (EsteFILL intim) was approved by the local ethics committee (protocol No. 16 dated 21.09.2023) and approved as a promising research work at the meetings of the Problem Commission (protocol No. 125 dated 25.09.2023) and the Academic Council of the N.N. Petrov National Medical Research Center of Oncology (protocol No. 8 dated 26.09.2023).

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Five-year results of post-prostatectomy patients administered a hydrogel rectal spacer implant in conjunction with dose escalated external beam radiation therapy

Cited by 7 publications

References 32 publications

Application of rectal retractor for postprostatectomy salvage radiotherapy of prostate cancer: A case report and literature review

Application of rectal retractor for postprostatectomy salvage radiotherapy of prostate cancer: A case report and literature review

Radiation Dose to the Rectum With Definitive Radiation Therapy and Hydrogel Spacer Versus Postprostatectomy Radiation Therapy

Methodological aspects of implantation of a Russian prostate-rectum spacer based on stabilized hyaluronic acid of non-animal origin

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