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Purpose: Radiation Protection Apparel (RPA) is used during diagnostic imaging and interventional procedures to minimise incidental radiation exposure. The majority of RPA in use are lead-containing, which has until now been considered safe. A recent single-centre study has demonstrated that the external surface of 63 % of RPA was contaminated with lead dust. The purpose of this study was to reproduce this investigation with a larger sample size across Europe and assess whether decontamination procedures were possible., Method: The routine RPA Quality Control (QC) process was adapted to include lead dust contamination tests and decontamination if present. The presence of lead dust was determined using a commercially available colorimetric method. RPA that failed initial QC or could not be decontaminated were removed from use., Results: From June to October 2019, 728 RPA from 85 imaging centres from five countries underwent initial QC. Of these, 712 were tested for lead dust contamination which was present on 162 (23 %). Following cleaning, 85 (12 %) remained contaminated and were removed from use. Linear regression analysis shows a significant correlation between type of RPA and contamination, (p = 0.0015). There was no correlation between contamination and imaging department, year of manufacture, country and RPA condition (p-values 0.98, 0.90, 0.94 and 0.14 respectively)., Conclusions: Lead dust contamination is present on 23 % of RPA that would pass routine QC procedures. Approximately half were not amenable to decontamination and were removed from use. Procedures were introduced for the routine handling of RPA, and updated QC steps for assessment and cleaning. Lead-free RPA should be considered., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Purpose: The aim of our study was to perform the final analysis of acute toxicity and quality of life data obtained from 221 consecutive patients who suffered from intermediate-to-high risk prostate cancer., Methods: In this trial, 221 patients were randomized to receive either hypofractionated (63 Gy in 20 fractions, 4 fractions/week) or conventionally fractionated (76 Gy in 38 fractions, 5 fractions/week) radiotherapy to the prostate and seminal vesicles. Elective pelvic lymph node irradiation with 46 Gy in 23 fractions sequentially and 44 Gy in 20 fractions simultaneously was also applied., Results: There was no statistically significant difference in acute GU and GI toxicity in men treated with hypofractionated (SIB) (Arm 2) in comparison with patients who had conventional fractionation (Arm 1) radiation therapy. Multivariate analysis using logistic regression showed statistical significant association between acute GU ≥ 1 and PTV(LN) ( p  = 0.008) only. We found out that clinically relevant decrease (CRD) was significantly higher only in the urinary domain of Arm 1 at month 3 ( p  = 0.02)., Conclusion: Our study demonstrated that hypofractionated radiotherapy was associated with a small but insignificant increase of acute toxicity. The reduction of overall treatment time has no significant influence on patients' QOL in any domain.

Background: The α/β ratio for prostate cancer is postulated being in the range of 0.8 to 2.2 Gy, giving rise to the hypothesis that there may be a therapeutic advantage to hypofractionation. To do so, we carried out a randomized trial comparing hypofractionated and conventionally fractionated image-guided intensity modulated radiotherapy (IG-IMRT) in high-risk prostate cancer. Here, we report on acute toxicity and quality of life (QOL) for the first 124 randomized patients., Methods: The trial compares 76 Gy in 38 fractions (5 fractions/week) (Arm 1) to 63 Gy in 20 fractions (4 fractions/week) (Arm 2) (IG-IMRT). Prophylactic pelvic lymph node irradiation with 46 Gy in 23 fractions sequentially (Arm 1) and 44 Gy in 20 fractions simultaneously (Arm 2) was applied. All patients had long term androgen deprivation therapy (ADT) started before RT. Both physician-rated acute toxicity and patient-reported QOL using EPIC questionnaire are described., Results: There were no differences in overall maximum acute gastrointestinal (GI) or genitourinary (GU) toxicity. Compared to conventional fractionation (Arm 1), GI and GU toxicity both developed significantly earlier but also disappeared earlier in the Arm 2, reaching significant differences from Arm 1 at week 8 and 9. In multivariate analyses, only parameter shown to be related to increased acute Grade ≥1 GU toxicity was the study Arm 2 (p = 0.049). There were no statistically significant differences of mean EPIC scores in any domain and sub-scales. The clinically relevant decrease (CRD) in EPIC urinary domain was significantly higher in Arm 2 at month 1 with a faster recovery at month 3 as compared to Arm 1., Conclusions: Hypofractionation at 3.15 Gy per fraction to 63 Gy within 5 weeks was well tolerated. The GI and GU physician-rated acute toxicity both developed earlier but recovered faster using hypofractionation. There was a correlation between acute toxicity and bowel and urinary QOL outcomes. Longer follow-up is needed to determine the significance of these associations with late toxicity.