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

Autor: Igor Latorzeff, Eric Bruguière, Emilie Bogart, Marie-Cécile Le Deley, Eric Lartigau, Delphine Marre, David Pasquier
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Frontiers in Oncology, Vol 11 (2021)
Druh dokumentu: article
ISSN: 2234-943X
DOI: 10.3389/fonc.2021.701998
Popis: Background/purposeDose-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/methodsPatients 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.ResultsAfter 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
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