ONE SHOT - single shot radiotherapy for localized prostate cancer: study protocol of a single arm, multicenter phase I/I
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STUDY PROTOCOL
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ONE SHOT - single shot radiotherapy for localized prostate cancer: study protocol of a single arm, multicenter phase I/II trial Thomas Zilli1,2* , Marta Scorsetti3,4, Daniel Zwahlen5, Ciro Franzese4, Robert Förster6, Niccolò Giaj-Levra7, Nikolaos Koustouvelis1, Aurelie Bertaut8, Michel Zimmermann5, Giuseppe Roberto D’Agostino4, Filippo Alongi7,9, Matthias Guckenberger6 and Raymond Miralbell1,2
Abstract Background: Stereotactic body radiotherapy (SBRT) is an emerging treatment alternative for patients with localized prostate cancer. Promising results in terms of disease control and toxicity have been reported with 4 to 5 SBRT fractions. However, question of how far can the number of fractions with SBRT be reduced is a challenging research matter. As already explored by some authors in the context of brachytherapy, monotherapy appears to be feasible with an acceptable toxicity profile and a promising outcome. The aim of this multicenter phase I/II prospective trialis to demonstrate early evidence of safety and efficacy of a single-fraction SBRT approach for the treatment of localized disease. Methods: Patients with low- and intermediate-risk localized prostate cancer without significant tumor in the transitional zone will be treated with a single SBRT fraction of 19 Gy to the whole prostate gland with urethra-sparing (17 Gy). Intrafractional motion will be monitored with intraprostatic electromagnetic transponders. The primary endpoint of the phase I part of the study will be safety as assessed by CTCAE 4.03 grading scale, while biochemical relapse-free survival will be the endpoint for the phase II. The secondary endpoints include acute and late toxicity, quality of life, progression-free survival, and prostate-cancer specific survival. Discussion: This is the first multicenter phase I/II trial assessing the efficacy and safety of a single-dose SBRT treatment for patients with localized prostate cancer. If positive, results of ONE SHOT may help to design subsequent phase III trials exploring the role of SBRT monotherapy in the exclusive radiotherapy treatment of localized disease. Trial registration: Clinicaltrials.gov identifier: NCT03294889; Registered 27 September 2017. Keywords: Prostate cancer, Stereotactic body radiotherapy, Urethra-sparing, Single fraction, Quality of life, Electromagnetic transponders
Background Total dose and dose per fraction play an important role in the curative treatment of prostate cancer with radiotherapy (RT). Modern image-guided external RT allows safe dose escalation for prostate cancer. Doses above 74 Gy with conventional fractionation (2 Gy/day) have been shown to be beneficial. There are strong * Correspondence: [email protected]; [email protected] 1 Radiation Oncology, Geneva University Hospital, CH-1211, 14 Geneva, Switzerland 2 Faculty of Medicine, Geneva University, Geneva, Switzerland Full list of author information is available at the end of the article
radiobiological considerations that suggest that treatment with a small number of
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