Interstitial biodegradable balloon for reduced rectal dose during prostate radiotherapy: Results of a virtual planning investigation based on the pre- and post-implant imaging data of an international multicenter study

Melchert, Corinna; Gez, Eliahu; Bohlen, G.; Scarzello, Giovanni; Koziol, Isaac; Anscher, Mitchell S.; Cytron, Shmuel; Paz, Adrian; Torre, Taryn; Bassignani, Matthew J.; Moro, Fabrizio; Jocham, Dieter; Yosef, R. Ben; Corn, Benjamin W.; Kovács, György

doi:10.1016/j.radonc.2013.01.007

Cited by 56 publications

(56 citation statements)

References 19 publications

(37 reference statements)

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“…This pain could be reduced by optimizing the local anesthesia procedure and adding the administration of anxiolytic medication before the injection. After the injection, the HA was very well tolerated, confirming the data from Prada et al (12,13) and other teams (22)(23)(24).…”

Section: Tolerance Of Hyaluronic Acidsupporting

confidence: 86%

“…Units of measurement for prostate volume are in cubic centimeters literature (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24). An injection of 3 to 20 mL gave an average prostate-rectum separation of 8 to 20 mm.…”

Section: Tolerance Of Hyaluronic Acidmentioning

confidence: 99%

“…An injection of 3 to 20 mL gave an average prostate-rectum separation of 8 to 20 mm. In all these studies, normofractionated irradiation was used alone or was combined with a boost of high-dose-rate brachytherapy (12,(16)(17)(18)(19)(20)(21)(22)(23)(24).…”

Section: Tolerance Of Hyaluronic Acidmentioning

confidence: 99%

See 2 more Smart Citations

Prostate Hypofractionated Radiation Therapy With Injection of Hyaluronic Acid: Acute Toxicities in a Phase 2 Study

Chapet

Decullier

Bin

et al. 2015

International Journal of Radiation Oncology*Biology*Physics

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Section: Tolerance Of Hyaluronic Acidsupporting

confidence: 86%

Section: Tolerance Of Hyaluronic Acidmentioning

confidence: 99%

See 1 more Smart Citation

Prostate Hypofractionated Radiation Therapy With Injection of Hyaluronic Acid: Acute Toxicities in a Phase 2 Study

Chapet

Decullier

Bin

et al. 2015

International Journal of Radiation Oncology*Biology*Physics

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“…Clinical reports about the biodegradable balloon are limited so far (Kovacs et al 2010;Levy et al 2009;Melchert et al 2013). Levy et al (2009) reported about the proper functionality of the insertion-mounting device as well as the balloon capability to retain its inflated form.…”

Section: Reproducibility/stability and Radioprotection Of The Rectum/mentioning

confidence: 99%

“…Levy et al (2009) reported about the proper functionality of the insertion-mounting device as well as the balloon capability to retain its inflated form. Within a multicenter study Melchert et al were able to demonstrate a remarkable reduction of rectal volume exposed to higher radiation dose comparing dose-volume histograms prior and after insertion of the biodegradable balloon in 26 patients (Melchert et al 2013). Already in 2007 (Prada et al 2009) reported on 27 patients receiving external and HDR-brachytherapy boost.…”

Section: Reproducibility/stability and Radioprotection Of The Rectum/mentioning

confidence: 99%

Internal Immobilization: From Rectal Balloon to Hyaluronic Acid

Goldner

2013

Radiotherapy in Prostate Cancer

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Multicenter, dual fractionation scheme, single core lab comparison of rectal volume dose reduction following injection of two biodegradable perirectal spacers

Kos¹,

Nurani²,

Costa³

et al. 2023

J Applied Clin Med Phys

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PurposeA multicenter, double‐arm, central core lab, retrospective study was performed to compare the rectal dosimetry of patients implanted with two injectable, biodegradable perirectal spacers, in conventional fractionation (CF), as well as ultrahypofractionation (UH) treatment plans.Methods and materialsFifty‐nine patients were enrolled into the study in five centers: two centers in Europe, which implanted a biodegradable balloon spacer in a total of 24 subjects and three centers in the US, which implanted the SpaceOAR in 35 subjects. Anonymized CTs (pre and post‐implantation) were reviewed by the central core lab. For VMAT CF plans rectal V50, V60, V70, and V80 were calculated. For UH plans, a corresponding rectal V22.6, V27.1, V31.37, and V36.25 were established representing 62.5%, 75%, 87.5%, and 100% of the 36.25 Gy prescribed dose.ResultsFor CF VMAT, a comparison between the balloon spacer and the SpaceOAR revealed a significant difference of 33.4% decrease in mean rectal V50 (71.9% vs. 38.5%, p < 0.001), 27.7% in mean rectal V60 (79.6% vs. 51.9%, p < 0.001), 17.1% difference in mean rectal V70 (84.1% vs. 67.0%, p = 0.001), and a significant difference of 3.0% (p = 0.019) in mean rectal V80 (87.2% vs. 84.2%). With UH analysis, the mean rectal dose reduction for the balloon spacer compared to the SpaceOAR was 79.2% and 53.3% for V27.1 (p < 0.001), 84.1% and 68.1% for V31.71 (p = 0.001), and 89.7% and 84.8% for V36.25 (p = 0.012), respectively.ConclusionRectal dosimetry is more favorable for treatment with the balloon spacer compared with SpaceOAR. Further research, particularly in the context of a prospective randomized clinical trial design, is needed to assess the acute and late toxicity experience as well as physician satisfaction with achieving symmetrical implantation, and ease of use in light of increasing clinical use.

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Interstitial biodegradable balloon for reduced rectal dose during prostate radiotherapy: Results of a virtual planning investigation based on the pre- and post-implant imaging data of an international multicenter study

Cited by 56 publications

References 19 publications

Prostate Hypofractionated Radiation Therapy With Injection of Hyaluronic Acid: Acute Toxicities in a Phase 2 Study

Prostate Hypofractionated Radiation Therapy With Injection of Hyaluronic Acid: Acute Toxicities in a Phase 2 Study

Internal Immobilization: From Rectal Balloon to Hyaluronic Acid

Multicenter, dual fractionation scheme, single core lab comparison of rectal volume dose reduction following injection of two biodegradable perirectal spacers

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