Once-weekly versus every-other-day stereotactic body radiotherapy in patients with prostate cancer (PATRIOT): A phase 2 randomized trial

Prostate stereotactic body radiotherapy (SBRT) regimens differ in time, dose, and fractionation. We completed a multicentre, randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL). Men with low and intermediate-risk prostate cancer were randomly assign...

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Veröffentlicht in:Radiotherapy and oncology 2018-05, Vol.127 (2), p.206-212
Hauptverfasser: Quon, Harvey C., Ong, Aldrich, Cheung, Patrick, Chu, William, Chung, Hans T., Vesprini, Danny, Chowdhury, Amit, Panjwani, Dilip, Pang, Geordi, Korol, Renee, Davidson, Melanie, Ravi, Ananth, McCurdy, Boyd, Zhang, Liying, Mamedov, Alexandre, Deabreu, Andrea, Loblaw, Andrew
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container_end_page 212
container_issue 2
container_start_page 206
container_title Radiotherapy and oncology
container_volume 127
creator Quon, Harvey C.
Ong, Aldrich
Cheung, Patrick
Chu, William
Chung, Hans T.
Vesprini, Danny
Chowdhury, Amit
Panjwani, Dilip
Pang, Geordi
Korol, Renee
Davidson, Melanie
Ravi, Ananth
McCurdy, Boyd
Zhang, Liying
Mamedov, Alexandre
Deabreu, Andrea
Loblaw, Andrew
description Prostate stereotactic body radiotherapy (SBRT) regimens differ in time, dose, and fractionation. We completed a multicentre, randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL). Men with low and intermediate-risk prostate cancer were randomly assigned to 40 Gy in 5 fractions delivered once per week (QW) vs. every other day (EOD). QOL was assessed using the Expanded Prostate Cancer Index Composite. The primary endpoint was the proportion with a minimum clinically important change (MCIC) in bowel QOL during the acute (≤12 week) period, and analysis was by intention-to-treat. ClinicalTrials.gov NCT01423474. 152 men from 3 centres were randomized with median follow-up of 47 months. Patients treated QW had superior acute bowel QOL with 47/69 (68%) reporting a MCIC compared to 63/70 (90%) treated EOD (p = 0.002). Fewer patients treated QW reported moderate–severe problems with bowel QOL during the acute period compared with EOD (14/70 [20%] vs. 40/70 [57%], p 
doi_str_mv 10.1016/j.radonc.2018.02.029
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We completed a multicentre, randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL). Men with low and intermediate-risk prostate cancer were randomly assigned to 40 Gy in 5 fractions delivered once per week (QW) vs. every other day (EOD). QOL was assessed using the Expanded Prostate Cancer Index Composite. The primary endpoint was the proportion with a minimum clinically important change (MCIC) in bowel QOL during the acute (≤12 week) period, and analysis was by intention-to-treat. ClinicalTrials.gov NCT01423474. 152 men from 3 centres were randomized with median follow-up of 47 months. Patients treated QW had superior acute bowel QOL with 47/69 (68%) reporting a MCIC compared to 63/70 (90%) treated EOD (p = 0.002). Fewer patients treated QW reported moderate–severe problems with bowel QOL during the acute period compared with EOD (14/70 [20%] vs. 40/70 [57%], p &lt; 0.001). Acute urinary QOL was also better in the QW arm, with 52/67 (78%) vs 65/69 (94%) experiencing a MCIC (p = 0.006). There were no significant differences in late urinary or bowel QOL at 2 years or last follow-up. Prostate SBRT delivered QW improved acute bowel and urinary QOL compared to EOD. 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subjects Aged
Dose Fractionation, Radiation
Gastrointestinal Diseases - etiology
Humans
Male
Patient Reported Outcome Measures
Prostatic neoplasms
Prostatic Neoplasms - radiotherapy
Quality of Life
Radiation Injuries - etiology
Radiosurgery
Radiosurgery - adverse effects
Radiosurgery - methods
Randomized controlled trial
Stereotactic body radiotherapy
Time Factors
Toxicity
Urination Disorders - etiology
title Once-weekly versus every-other-day stereotactic body radiotherapy in patients with prostate cancer (PATRIOT): A phase 2 randomized trial
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