Prophylactic Radiotherapy Of MInimally Symptomatic Spinal Disease (PROMISSeD): study protocol for a randomized controlled trial.

"Declarations Ethics approval and consent to participateThe study protocol (2021-KOT-002) was approved by the WCG institutional review board (Study Number 1337188, IRB tracking number 20223735) on 07/25/2022. Prior to study participation, written and informed consent for participation is obtained from all participants after risks and benefits have been explained. Consent for publicationAll authors provide consent for publication of this manuscript. The investigators will provide a model consent form and other study documents upon reasonable request. Competing interestsR. J. Rothrock: None. A. Ozair: None. M. C. Avendano: None. S. Herrera: None. H. R. Appel: Personal fees from Novocure Inc, and GT Medical Technologies. S. Ramos: None. A. K. Starosciak: Consulting for Viz.ai. D. Leon-Ariza: None. M. Rubens: None. M. W. McDermott: Consulting for Stryker, Zap surgical, Deinde Medical, Light Helmets. M. S. Ahluwalia: Grants from AstraZeneca, BMS, Bayer, Incyte, Pharmacyclics, Novocure, MimiVax, Merck. Consulting for Bayer, Novocure, Kiyatec, Insightec, GSK, Xoft, Nuvation, Cellularity, SDP Oncology, Apollomics, Prelude, Janssen, Tocagen, Voyager Therapeutics, Viewray, Caris Lifesciences, Pyramid Biosciences, Varian Medical Systems, Cairn Therapeutics, Anheart Therapeutics, Theraguix. Scientific advisory board member for Cairn Therapeutics, Pyramid Biosciences, Modifi Biosciences. Stock shareholding in Mimivax, Cytodyn, MedInnovate Advisors LLC. M. P. Mehta: Consulting for Karyopharm, Tocagen, Astrazeneca, Blue Earth Diagnostics, Celgene, Abbvie; board of directors: Oncoceutics. R. R. Kotecha: Personal fees from Accuray Inc., Elekta AB, ViewRay Inc., Novocure Inc., Elsevier Inc., Brainlab, Kazia Therapeutics, Castle Biosciences, and institutional research funding from Medtronic Inc., Blue Earth Diagnostics Ltd., Novocure Inc., GT Medical Technologies, AstraZeneca, Exelixis, ViewRay Inc., Brainlab, Cantex Pharmaceuticals, and Kazia Therapeutics. Competing interests R. J. Rothrock: None. A. Ozair: None. M. C. Avendano: None. S. Herrera: None. H. R. Appel: Personal fees from Novocure Inc, and GT Medical Technologies. S. Ramos: None. A. K. Starosciak: Consulting for Viz.ai. D. Leon-Ariza: None. M. Rubens: None. M. W. McDermott: Consulting for Stryker, Zap surgical, Deinde Medical, Light Helmets. M. S. Ahluwalia: Grants from AstraZeneca, BMS, Bayer, Incyte, Pharmacyclics, Novocure, MimiVax, Merck. Consulting for Bayer, Novocure, Kiyatec, Insightec, GSK, Xoft, Nuvation, Cellularity, SDP Oncology, Apollomics, Prelude, Janssen, Tocagen, Voyager Therapeutics, Viewray, Caris Lifesciences, Pyramid Biosciences, Varian Medical Systems, Cairn Therapeutics, Anheart Therapeutics, Theraguix. Scientific advisory board member for Cairn Therapeutics, Pyramid Biosciences, Modifi Biosciences. Stock shareholding in Mimivax, Cytodyn, MedInnovate Advisors LLC. M. P. Mehta: Consulting for Karyopharm, Tocagen, Astrazeneca, Blue Earth Diagnostics, Celgene, Abbvie; board of directors: Oncoceutics. R. R. Kotecha: Personal fees from Accuray Inc., Elekta AB, ViewRay Inc., Novocure Inc., Elsevier Inc., Brainlab, Kazia Therapeutics, Castle Biosciences, and institutional research funding from Medtronic Inc., Blue Earth Diagnostics Ltd., Novocure Inc., GT Medical Technologies, AstraZeneca, Exelixis, ViewRay Inc., Brainlab, Cantex Pharmaceuticals, and Kazia Therapeutics."

"Funding This investigator-initiated randomized controlled trial is supported by institutional funding alone, through the Miami Neuroscience Institute General Support Fund (Study Number # 2021-KOT-002, Reference Number: BHM Restricted Fund #2219). The funder has no influence on the design, conduct, and analysis of the trial. Further information regarding may be obtained from Deborah T. Suarez, Director of Research Administration at deborahtv@baptisthealth.net."

"Trial registration ClinicalTrials.Gov NCT05534321. Registered September 9, 2022."