Palliative radiotherapy to dominant symptomatic lesion in patients with hormone refractory prostate cancer (PRADO)

Jesper Carl; Dirk Rades; Claudia Doemer; Cornelia Setter; Jürgen Dunst; Niels Henrik Holländer

doi:10.1186/s13014-019-1209-0

Palliative radiotherapy to dominant symptomatic lesion in patients with hormone refractory prostate cancer (PRADO)

Jesper Carl, Dirk Rades^*, Claudia Doemer, Cornelia Setter, Jürgen Dunst, Niels Henrik Holländer

^*Corresponding author for this work

Department of Radiotherapy

3 Citations (Scopus)

Abstract

Background: This study was conducted to investigate a new short-course radiotherapy regimen for patients with metastatic hormone refractory prostate cancer (HRPC) presenting with a dominant debilitating symptom. Methods / design: This is an international, multi-center single arm prospective feasibility study that aims to include 34 patients with HRPC and a dominant debilitating symptom. The dominant symptomatic lesion will receive 4 × 5 Gy of high-precision radiotherapy, and the most aggressive part of the lesion 4 × 7 Gy using a simultaneous integrated boost technique. Based on advanced magnetic resonance imaging (MRI), an apparent diffusion coefficient (ADC) map will be calculated for the lesion using diffusion weighted imaging sequences. The dominant symptomatic lesion (GTV1) is drawn manually using the information from T2w-MRI and computed tomography scans. The most aggressive part of the dominant lesion (GTV2) is defined by using the ADC map. An auxiliary volume is created including only voxels in the GTV1 that presents with ADC values below 1200 × 10 ^{- 6} mm ² /s. The most aggressive part is defined as voxels with an ADC value below the median ADC value. Primary endpoint is feasibility, i.e. proportion of patients who complete radiotherapy with ≥90% of the prescribed dose. Secondary endpoints include dominant symptom score, progression-free survival (freedom from symptoms), overall survival, acute toxicity, quality of life, change in ADC from baseline to end of treatment and 6 months following treatment. Discussion: If this new radiotherapy regimen proves to be feasible, a prospective randomized phase II/III dose escalation study will be designed in order to improve the outcomes of palliative radiotherapy of symptomatic metastatic HRPC. Study status: The study is ongoing and will be recruiting patients soon. Trial registration: clinicaltrials.gov NCT03658434. Initially registered on 30th of July, 2018

Original language	English
Article number	3
Journal	Radiation Oncology
Volume	14
Issue number	1
DOIs	https://doi.org/10.1186/s13014-019-1209-0
Publication status	Published - 10.01.2019

Funding

The study is part of the INTERREG-project InnoCan, which is funded by the European Union (reference: Innoc 11–1.0-15). The funding body has no role in the design of the study, in collection, analysis and interpretation of the data and in writing of the manuscript.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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10.1186/s13014-019-1209-0

Cite this

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title = "Palliative radiotherapy to dominant symptomatic lesion in patients with hormone refractory prostate cancer (PRADO)",

abstract = " Background: This study was conducted to investigate a new short-course radiotherapy regimen for patients with metastatic hormone refractory prostate cancer (HRPC) presenting with a dominant debilitating symptom. Methods / design: This is an international, multi-center single arm prospective feasibility study that aims to include 34 patients with HRPC and a dominant debilitating symptom. The dominant symptomatic lesion will receive 4 × 5 Gy of high-precision radiotherapy, and the most aggressive part of the lesion 4 × 7 Gy using a simultaneous integrated boost technique. Based on advanced magnetic resonance imaging (MRI), an apparent diffusion coefficient (ADC) map will be calculated for the lesion using diffusion weighted imaging sequences. The dominant symptomatic lesion (GTV1) is drawn manually using the information from T2w-MRI and computed tomography scans. The most aggressive part of the dominant lesion (GTV2) is defined by using the ADC map. An auxiliary volume is created including only voxels in the GTV1 that presents with ADC values below 1200 × 10 - 6 mm 2 /s. The most aggressive part is defined as voxels with an ADC value below the median ADC value. Primary endpoint is feasibility, i.e. proportion of patients who complete radiotherapy with ≥90\% of the prescribed dose. Secondary endpoints include dominant symptom score, progression-free survival (freedom from symptoms), overall survival, acute toxicity, quality of life, change in ADC from baseline to end of treatment and 6 months following treatment. Discussion: If this new radiotherapy regimen proves to be feasible, a prospective randomized phase II/III dose escalation study will be designed in order to improve the outcomes of palliative radiotherapy of symptomatic metastatic HRPC. Study status: The study is ongoing and will be recruiting patients soon. Trial registration: clinicaltrials.gov NCT03658434. Initially registered on 30th of July, 2018 ",

author = "Jesper Carl and Dirk Rades and Claudia Doemer and Cornelia Setter and J{\"u}rgen Dunst and Holl{\"a}nder, \{Niels Henrik\}",

note = "Funding Information: The study is part of the INTERREG-project InnoCan, which is funded by the European Union (reference: Innoc 11–1.0-15). The funding body has no role in the design of the study, in collection, analysis and interpretation of the data and in writing of the manuscript. Publisher Copyright: {\textcopyright} 2019 The Author(s). Copyright: Copyright 2019 Elsevier B.V., All rights reserved.",

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doi = "10.1186/s13014-019-1209-0",

language = "English",

volume = "14",

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T1 - Palliative radiotherapy to dominant symptomatic lesion in patients with hormone refractory prostate cancer (PRADO)

AU - Carl, Jesper

AU - Rades, Dirk

AU - Doemer, Claudia

AU - Setter, Cornelia

AU - Dunst, Jürgen

AU - Holländer, Niels Henrik

N1 - Funding Information: The study is part of the INTERREG-project InnoCan, which is funded by the European Union (reference: Innoc 11–1.0-15). The funding body has no role in the design of the study, in collection, analysis and interpretation of the data and in writing of the manuscript. Publisher Copyright: © 2019 The Author(s). Copyright: Copyright 2019 Elsevier B.V., All rights reserved.

PY - 2019/1/10

Y1 - 2019/1/10

N2 - Background: This study was conducted to investigate a new short-course radiotherapy regimen for patients with metastatic hormone refractory prostate cancer (HRPC) presenting with a dominant debilitating symptom. Methods / design: This is an international, multi-center single arm prospective feasibility study that aims to include 34 patients with HRPC and a dominant debilitating symptom. The dominant symptomatic lesion will receive 4 × 5 Gy of high-precision radiotherapy, and the most aggressive part of the lesion 4 × 7 Gy using a simultaneous integrated boost technique. Based on advanced magnetic resonance imaging (MRI), an apparent diffusion coefficient (ADC) map will be calculated for the lesion using diffusion weighted imaging sequences. The dominant symptomatic lesion (GTV1) is drawn manually using the information from T2w-MRI and computed tomography scans. The most aggressive part of the dominant lesion (GTV2) is defined by using the ADC map. An auxiliary volume is created including only voxels in the GTV1 that presents with ADC values below 1200 × 10 - 6 mm 2 /s. The most aggressive part is defined as voxels with an ADC value below the median ADC value. Primary endpoint is feasibility, i.e. proportion of patients who complete radiotherapy with ≥90% of the prescribed dose. Secondary endpoints include dominant symptom score, progression-free survival (freedom from symptoms), overall survival, acute toxicity, quality of life, change in ADC from baseline to end of treatment and 6 months following treatment. Discussion: If this new radiotherapy regimen proves to be feasible, a prospective randomized phase II/III dose escalation study will be designed in order to improve the outcomes of palliative radiotherapy of symptomatic metastatic HRPC. Study status: The study is ongoing and will be recruiting patients soon. Trial registration: clinicaltrials.gov NCT03658434. Initially registered on 30th of July, 2018

AB - Background: This study was conducted to investigate a new short-course radiotherapy regimen for patients with metastatic hormone refractory prostate cancer (HRPC) presenting with a dominant debilitating symptom. Methods / design: This is an international, multi-center single arm prospective feasibility study that aims to include 34 patients with HRPC and a dominant debilitating symptom. The dominant symptomatic lesion will receive 4 × 5 Gy of high-precision radiotherapy, and the most aggressive part of the lesion 4 × 7 Gy using a simultaneous integrated boost technique. Based on advanced magnetic resonance imaging (MRI), an apparent diffusion coefficient (ADC) map will be calculated for the lesion using diffusion weighted imaging sequences. The dominant symptomatic lesion (GTV1) is drawn manually using the information from T2w-MRI and computed tomography scans. The most aggressive part of the dominant lesion (GTV2) is defined by using the ADC map. An auxiliary volume is created including only voxels in the GTV1 that presents with ADC values below 1200 × 10 - 6 mm 2 /s. The most aggressive part is defined as voxels with an ADC value below the median ADC value. Primary endpoint is feasibility, i.e. proportion of patients who complete radiotherapy with ≥90% of the prescribed dose. Secondary endpoints include dominant symptom score, progression-free survival (freedom from symptoms), overall survival, acute toxicity, quality of life, change in ADC from baseline to end of treatment and 6 months following treatment. Discussion: If this new radiotherapy regimen proves to be feasible, a prospective randomized phase II/III dose escalation study will be designed in order to improve the outcomes of palliative radiotherapy of symptomatic metastatic HRPC. Study status: The study is ongoing and will be recruiting patients soon. Trial registration: clinicaltrials.gov NCT03658434. Initially registered on 30th of July, 2018

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U2 - 10.1186/s13014-019-1209-0

DO - 10.1186/s13014-019-1209-0

M3 - Journal articles

C2 - 30630502

AN - SCOPUS:85059828228

SN - 1748-717X

VL - 14

JO - Radiation Oncology

JF - Radiation Oncology

IS - 1

M1 - 3

ER -

Palliative radiotherapy to dominant symptomatic lesion in patients with hormone refractory prostate cancer (PRADO)

Abstract

Funding

UN SDGs

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