Use of a Biodegradable, Contrast-Filled Rectal Spacer Balloon in Intensity-Modulated Radiotherapy for Intermediate-Risk Prostate Cancer Patients: Dosimetric Gains in the BioPro-RCMI-1505 Study

Overview

Journal Front Oncol

Specialty Oncology

Date 2021 Sep 13

PMID 34513681

Citations 7

Authors

Igor Latorzeff

Eric Bruguiere

Emilie Bogart

Marie-Cecile Le Deley

Eric Lartigau

Delphine Marre

David Pasquier

Affiliations

Soon will be listed here.

Abstract

Background/purpose: Dose-escalated external beam radiotherapy (RT) is effective in the control of prostate cancer but is associated with a greater incidence of rectal adverse events. We assessed the dosimetric gain and safety profile associated with implantation of a new biodegradable rectal spacer balloon.

Materials/methods: Patients scheduled for image-guided, intensity-modulated RT for intermediate-risk prostate cancer were prospectively included in the French multicenter BioPro-RCMI-1505 study (NCT02478112). We evaluated the dosimetric gain, implantation feasibility, adverse events (AEs), and prostate-cancer-specific quality of life associated with use of the balloon spacer.

Results: After a scheduled review of the initial recruitment target of 50 patients by the study's independent data monitoring committee (IDMC), a total of 24 patients (including 22 with dosimetry data) were included by a single center between November 2016 and May 2018. The interventional radiologist who implanted the balloons considered that 86% of the procedures were easy. 20 of the 24 patients (83.3%) received IMRT and 4 (16.7%) received volumetric modulated arc therapy (78-80 Gy delivered in 39 fractions). The dosimetric gains associated with spacer implantation were highly significant (p<0.001) for most variables. For the rectum, the median (range) relative gain ranged from 15.4% (-9.2-47.5) for D20cc to 91.4% (36.8-100.0) for V70 Gy (%). 15 patients (62%) experienced an acute grade 1 AE, 8 (33%) experienced a late grade 1 AE, 1 (4.2%) experienced an acute grade 2 AE, and 3 experienced a late grade 2 AE. No grade 3 AEs were reported. Quality of life was good at baseline (except for sexual activity) and did not markedly worsen during RT and up to 24 months afterwards.

Conclusion: The use of a biodegradable rectal spacer balloon is safe, effective and associated with dosimetric gains in modern RT for intermediate-risk prostate cancer.

Citing Articles

Long-term evaluation of the safety of a rectal-prostate spacer, the ProSpace® balloon, in patients treated with radiotherapy for prostate cancer.

Janoray G, Bruguiere E, Mazurier J, Dudouet P, Guillotreau J, Tollon C BMC Cancer. 2024; 24(1):934.

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[Advances in research on organ-at-risk protection in pelvic tumor external beam radiotherapy].

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Use of rectal balloon spacer in patients with localized prostate cancer receiving external beam radiotherapy.

Costa P, Vale J, Fonseca G, Costa A, Kos M Tech Innov Patient Support Radiat Oncol. 2024; 29:100237.

PMID: 38322778 PMC: 10846399. DOI: 10.1016/j.tipsro.2024.100237.

Assessment of Bioprotect's Biodegradable Balloon System as a Rectal Spacer in Radiotherapy: An Animal Study on Tissue Response and Biocompatibility.

Ramot Y, Levin-Harrus T, Ezratty A, Steiner M, Ezov N, Domb A Pharmaceutics. 2023; 15(12).

PMID: 38140085 PMC: 10747072. DOI: 10.3390/pharmaceutics15122744.

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

Kos M, Nurani R, Costa P, Dabkowski M, da Silva J, Zimberg S J Appl Clin Med Phys. 2023; 24(10):e14086.

PMID: 37376868 PMC: 10562021. DOI: 10.1002/acm2.14086.

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