TY - JOUR
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
UR - http://www.scopus.com/inward/record.url?scp=85059828228&partnerID=8YFLogxK
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 -
