Palliative radiotherapy to dominant symptomatic lesion in patients with hormone refractory prostate cancer (PRADO).
Brachytherapy
Feasibility Studies
Follow-Up Studies
Humans
International Agencies
Male
Palliative Care
Prospective Studies
Prostatic Neoplasms, Castration-Resistant
/ pathology
Radiotherapy Dosage
Radiotherapy Planning, Computer-Assisted
/ methods
Radiotherapy, Intensity-Modulated
/ methods
Research Design
Dominant symptomatic lesion
Feasibility
High-precision radiotherapy
Hypo-fractionation
Metastatic disease
Prostate cancer
Journal
Radiation oncology (London, England)
ISSN: 1748-717X
Titre abrégé: Radiat Oncol
Pays: England
ID NLM: 101265111
Informations de publication
Date de publication:
10 Jan 2019
10 Jan 2019
Historique:
received:
23
10
2018
accepted:
02
01
2019
entrez:
12
1
2019
pubmed:
12
1
2019
medline:
2
2
2019
Statut:
epublish
Résumé
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. 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 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. The study is ongoing and will be recruiting patients soon. clinicaltrials.gov NCT03658434 . Initially registered on 30th of July, 2018.
Sections du résumé
BACKGROUND
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
METHODS
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
DISCUSSION
CONCLUSIONS
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
METHODS
The study is ongoing and will be recruiting patients soon.
TRIAL REGISTRATION
BACKGROUND
clinicaltrials.gov NCT03658434 . Initially registered on 30th of July, 2018.
Identifiants
pubmed: 30630502
doi: 10.1186/s13014-019-1209-0
pii: 10.1186/s13014-019-1209-0
pmc: PMC6327575
doi:
Banques de données
ClinicalTrials.gov
['NCT03658434']
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
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