ONE SHOT - single shot radiotherapy for localized prostate cancer: study protocol of a single arm, multicenter phase I/II trial

Thomas Zilli, Marta Scorsetti, Daniel Zwahlen, Ciro Franzese, Robert Förster, Niccolò Giaj-Levra, Nikolaos Koutsouvelis, Aurelie Bertaut, Michel Zimmermann, Giuseppe Roberto D'Agostino, Filippo Alongi, Matthias Guckenberger, Raymond Miralbell

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)166
JournalRadiation Oncology
Volume13
Issue number1
DOIs
Publication statusPublished - Sep 4 2018

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Radiosurgery
Prostatic Neoplasms
Radiotherapy
Safety
Personal Autonomy
Survival
Electromagnetic Phenomena
Brachytherapy
Urethra
Therapeutics
Disease-Free Survival
Prostate
Quality of Life
Recurrence
Research
Neoplasms

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ONE SHOT - single shot radiotherapy for localized prostate cancer : study protocol of a single arm, multicenter phase I/II trial. / Zilli, Thomas; Scorsetti, Marta; Zwahlen, Daniel; Franzese, Ciro; Förster, Robert; Giaj-Levra, Niccolò; Koutsouvelis, Nikolaos; Bertaut, Aurelie; Zimmermann, Michel; D'Agostino, Giuseppe Roberto; Alongi, Filippo; Guckenberger, Matthias; Miralbell, Raymond.

In: Radiation Oncology, Vol. 13, No. 1, 04.09.2018, p. 166.

Research output: Contribution to journalArticle

Zilli, T, Scorsetti, M, Zwahlen, D, Franzese, C, Förster, R, Giaj-Levra, N, Koutsouvelis, N, Bertaut, A, Zimmermann, M, D'Agostino, GR, Alongi, F, Guckenberger, M & Miralbell, R 2018, 'ONE SHOT - single shot radiotherapy for localized prostate cancer: study protocol of a single arm, multicenter phase I/II trial', Radiation Oncology, vol. 13, no. 1, pp. 166. https://doi.org/10.1186/s13014-018-1112-0
Zilli, Thomas ; Scorsetti, Marta ; Zwahlen, Daniel ; Franzese, Ciro ; Förster, Robert ; Giaj-Levra, Niccolò ; Koutsouvelis, Nikolaos ; Bertaut, Aurelie ; Zimmermann, Michel ; D'Agostino, Giuseppe Roberto ; Alongi, Filippo ; Guckenberger, Matthias ; Miralbell, Raymond. / ONE SHOT - single shot radiotherapy for localized prostate cancer : study protocol of a single arm, multicenter phase I/II trial. In: Radiation Oncology. 2018 ; Vol. 13, No. 1. pp. 166.
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T2 - study protocol of a single arm, multicenter phase I/II trial

AU - Zilli, Thomas

AU - Scorsetti, Marta

AU - Zwahlen, Daniel

AU - Franzese, Ciro

AU - Förster, Robert

AU - Giaj-Levra, Niccolò

AU - Koutsouvelis, Nikolaos

AU - Bertaut, Aurelie

AU - Zimmermann, Michel

AU - D'Agostino, Giuseppe Roberto

AU - Alongi, Filippo

AU - Guckenberger, Matthias

AU - Miralbell, Raymond

PY - 2018/9/4

Y1 - 2018/9/4

N2 - 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.

AB - 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.

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JO - Radiation Oncology

JF - Radiation Oncology

SN - 1748-717X

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