TY - JOUR
T1 - Magnetic Resonance-Guided Adaptive Radiation therapy for Prostate Cancer
T2 - The First Results from the MOMENTUM study-An International Registry for the Evidence-Based Introduction of Magnetic Resonance-Guided Adaptive Radiation Therapy
AU - Teunissen, Frederik R
AU - Willigenburg, Thomas
AU - Tree, Alison C
AU - Hall, William A
AU - Choi, Seungtaek L
AU - Choudhury, Ananya
AU - Christodouleas, John P
AU - de Boer, Johannes C J
AU - Groot-van Breugel, Eline N de
AU - Kerkmeijer, Linda G W
AU - Pos, Floris J
AU - Schytte, Tine
AU - Vesprini, Danny
AU - Verkooijen, Helena M
AU - Voort van Zyp, Jochem R N van der
N1 - Funding Information:
Sources of support: The MOMENTUM study receives funding from Elekta. Dr Choudhury is supported by the NIHR Manchester Biomedical Research Centre. Dr Tree acknowledges support from the Rosetrees Trust, CRUK grant C33589/A28284 and C7224/A28724, Elekta, and the Medical Research Council. This project represents independent research supported by the National Institute for Health research Biomedical Research Centre at The Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
Funding Information:
Sources of support: The MOMENTUM study receives funding from Elekta. Dr Choudhury is supported by the NIHR Manchester Biomedical Research Centre. Dr Tree acknowledges support from the Rosetrees Trust, CRUK grant C33589/A28284 and C7224/A28724, Elekta, and the Medical Research Council. This project represents independent research supported by the National Institute for Health research Biomedical Research Centre at The Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Disclosures: Dr Tree reports grants from Elekta during the conduct of the study; grants from Accuray, Varian, Cancer Research UK, Prostate Cancer UK, the JP Moulton Foundation and the Rosetrees Trust; personal fees from Janssen, Elekta, and Accuray, outside the submitted work. Dr Hall reports the project described was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, award number KL2TR001438. The content is solely the responsibility of the author(s) and does not necessarily represent the official views of the National Institutes of Health and that the Medical College of Wisconsin Department of Radiation Oncology receives research and travel support from Elekta. Dr Choudhury reports grants and nonfinancial support from Elekta, during the conduct of the study; grants from National Institute of Health Research Manchester Biomedical Research Centre, Cancer Research, UK, Medical Research Council, UK, Prostate Cancer, UK, and Bayer, UK; personal fees from Janssen Pharmaceutical and BMS; nonfinancial support from ASCO; grants and nonfinancial support from Elekta, outside the submitted work. Dr Christodouleas reports employee status at Elekta. Dr Vesprini reports travel reimbursement from Elekta, outside the submitted work. Dr Kerkmeijer reports grants from the Dutch Cancer Foundation, outside the submitted work. Dr Verkooijen reports grants from Elekta, Dutch Cancer Foundation, National Organisation for Health Research and Development, and the European Commission during the conduct of the study. Dr Voort van Zyp reports grants from ZonMW IMDI-LSH/TKI Foundation (The Netherlands, project number 104006004), outside the submitted work. All other authors have no disclosures to declare.
Funding Information:
Disclosures: Dr Tree reports grants from Elekta during the conduct of the study; grants from Accuray, Varian, Cancer Research UK, Prostate Cancer UK, the JP Moulton Foundation and the Rosetrees Trust; personal fees from Janssen, Elekta, and Accuray, outside the submitted work. Dr Hall reports the project described was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, award number KL2TR001438. The content is solely the responsibility of the author(s) and does not necessarily represent the official views of the National Institutes of Health and that the Medical College of Wisconsin Department of Radiation Oncology receives research and travel support from Elekta. Dr Choudhury reports grants and nonfinancial support from Elekta, during the conduct of the study; grants from National Institute of Health Research Manchester Biomedical Research Centre, Cancer Research, UK, Medical Research Council, UK, Prostate Cancer, UK, and Bayer, UK; personal fees from Janssen Pharmaceutical and BMS; nonfinancial support from ASCO; grants and nonfinancial support from Elekta, outside the submitted work. Dr Christodouleas reports employee status at Elekta. Dr Vesprini reports travel reimbursement from Elekta, outside the submitted work. Dr Kerkmeijer reports grants from the Dutch Cancer Foundation, outside the submitted work. Dr Verkooijen reports grants from Elekta, Dutch Cancer Foundation, National Organisation for Health Research and Development, and the European Commission during the conduct of the study. Dr Voort van Zyp reports grants from ZonMW IMDI-LSH/TKI Foundation (The Netherlands, project number 104006004), outside the submitted work. All other authors have no disclosures to declare.
Publisher Copyright:
© 2022 The Authors
PY - 2023
Y1 - 2023
N2 - PURPOSE: Magnetic resonance (MR)-guided radiation therapy (MRgRT) is a new technique for treatment of localized prostate cancer (PCa). We report the 12-month outcomes for the first PCa patients treated within an international consortium (the MOMENTUM study) on a 1.5T MR-Linac system with ultrahypofractionated radiation therapy.METHODS AND MATERIALS: Patients treated with 5 × 7.25 Gy were identified. Prostate specific antigen-level, physician-reported toxicity (Common Terminology Criteria for Adverse Events [CTCAE]), and patient-reported outcomes (Quality of Life Questionnaire PR25 and Quality of Life Questionnaire C30 questionnaires) were recorded at baseline and at 3, 6, and 12 months of follow-up (FU). Pairwise comparative statistics were conducted to compare outcomes between baseline and FU.RESULTS: The study included 425 patients with localized PCa (11.4% low, 82.0% intermediate, and 6.6% high-risk), and 365, 313, and 186 patients reached 3-, 6-, and 12-months FU, respectively. Median prostate specific antigen level declined significantly to 1.2 ng/mL and 0.1 ng/mL at 12 months FU for the nonandrogen deprivation therapy (ADT) and ADT group, respectively. The peak of genitourinary and gastrointestinal CTCAE toxicity was reported at 3 months FU, with 18.7% and 1.7% grade ≥2, respectively. The QLQ-PR25 questionnaire outcomes showed significant deterioration in urinary domain score at all FU moments, from 8.3 (interquartile range [IQR], 4.1-16.6) at baseline to 12.4 (IQR, 8.3-24.8; P = .005) at 3 months, 12.4 (IQR, 8.3-20.8; P = .018;) at 6 months, and 12.4 (IQR, 8.3-20.8; P = .001) at 12 months. For the non-ADT group, physician- and patient-reported erectile function worsened significantly between baseline and 12 months FU.CONCLUSIONS: Ultrahypofractionated MR-guided radiation therapy for localized PCa using a 1.5T MR-Linac is effective and safe. The peak of CTCAE genitourinary and gastrointestinal toxicity was reported at 3 months FU. Furthermore, for patients without ADT, a significant increase in CTCAE erectile dysfunction was reported at 12 months FU. These data are useful for educating patients on expected outcomes and informing study design of future comparative-effectiveness studies.
AB - PURPOSE: Magnetic resonance (MR)-guided radiation therapy (MRgRT) is a new technique for treatment of localized prostate cancer (PCa). We report the 12-month outcomes for the first PCa patients treated within an international consortium (the MOMENTUM study) on a 1.5T MR-Linac system with ultrahypofractionated radiation therapy.METHODS AND MATERIALS: Patients treated with 5 × 7.25 Gy were identified. Prostate specific antigen-level, physician-reported toxicity (Common Terminology Criteria for Adverse Events [CTCAE]), and patient-reported outcomes (Quality of Life Questionnaire PR25 and Quality of Life Questionnaire C30 questionnaires) were recorded at baseline and at 3, 6, and 12 months of follow-up (FU). Pairwise comparative statistics were conducted to compare outcomes between baseline and FU.RESULTS: The study included 425 patients with localized PCa (11.4% low, 82.0% intermediate, and 6.6% high-risk), and 365, 313, and 186 patients reached 3-, 6-, and 12-months FU, respectively. Median prostate specific antigen level declined significantly to 1.2 ng/mL and 0.1 ng/mL at 12 months FU for the nonandrogen deprivation therapy (ADT) and ADT group, respectively. The peak of genitourinary and gastrointestinal CTCAE toxicity was reported at 3 months FU, with 18.7% and 1.7% grade ≥2, respectively. The QLQ-PR25 questionnaire outcomes showed significant deterioration in urinary domain score at all FU moments, from 8.3 (interquartile range [IQR], 4.1-16.6) at baseline to 12.4 (IQR, 8.3-24.8; P = .005) at 3 months, 12.4 (IQR, 8.3-20.8; P = .018;) at 6 months, and 12.4 (IQR, 8.3-20.8; P = .001) at 12 months. For the non-ADT group, physician- and patient-reported erectile function worsened significantly between baseline and 12 months FU.CONCLUSIONS: Ultrahypofractionated MR-guided radiation therapy for localized PCa using a 1.5T MR-Linac is effective and safe. The peak of CTCAE genitourinary and gastrointestinal toxicity was reported at 3 months FU. Furthermore, for patients without ADT, a significant increase in CTCAE erectile dysfunction was reported at 12 months FU. These data are useful for educating patients on expected outcomes and informing study design of future comparative-effectiveness studies.
UR - https://www.scopus.com/pages/publications/85146453768
U2 - 10.1016/j.prro.2022.09.007
DO - 10.1016/j.prro.2022.09.007
M3 - Article
C2 - 36462619
SN - 1879-8500
VL - 13
SP - e261-e269
JO - Practical Radiation Oncology
JF - Practical Radiation Oncology
IS - 3
ER -