{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T05:55:14Z","timestamp":1780379714504,"version":"3.54.1"},"reference-count":30,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,5,12]],"date-time":"2023-05-12T00:00:00Z","timestamp":1683849600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100010357","name":"Ingeni\u00f8r K. A. Rohde og hustrus Legat","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100010357","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004196","name":"Odense Universitetshospital","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004196","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJUI Compass"],"published-print":{"date-parts":[[2023,9]]},"abstract":"Abstract<\/jats:title>Background<\/jats:title>Prostate\u2010specific membrane antigen (PSMA)\u2010positron emission tomography\/contrast\u2010enhanced computed tomography (PET\/CT) is a sensitive imaging modality for prostate cancer (PCa). Due to lack of knowledge of the patient benefit, PSMA\u2010PET\/CT is not yet recommended in the European guidelines for staging and treatment planning of patients with newly diagnosed PCa. We will investigate the potential difference in progression\u2010free survival (PFS) and quality of life (QoL) of using PSMA\u2010PET\/CT versus sodium fluoride (NaF)\u2010PET\/CT for staging and treatment planning in patients with newly diagnosed PCa.<\/jats:p><\/jats:sec>Study Design<\/jats:title>This is a prospective randomised controlled multicentre trial carried out at three centres in the Region of Southern Denmark.<\/jats:p><\/jats:sec>Endpoints<\/jats:title>The primary endpoint is PFS. Secondary endpoints are residual disease, stage migration, impact on treatment strategies, stage distribution, QoL and diagnostic accuracy measures.<\/jats:p><\/jats:sec>Patients and Methods<\/jats:title>Patients eligible for the study have newly diagnosed unfavourable intermediate\u2010 or high\u2010risk PCa. A total of 448 patients will be randomised 1:1 into two groups: (A) a control group staged with Na[18<\/jats:sup>F]F\u2010PET\/CT and (B) an intervention group staged with [18<\/jats:sup>F]PSMA\u20101007\u2010PET\/CT. A subgroup in the intervention group will have a supplementary blinded Na[18<\/jats:sup>F]F\u2010PET\/CT performed for the purpose of performing accuracy analyses. QoL will be assessed at baseline and with regular intervals (3\u201312\u2009months) during the study period. Treatment decisions are achieved at multidisciplinary team conferences based on the results of the respective scans and according to current Danish guidelines.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>The Regional Committees on Health Research Ethics for Southern Denmark (S\u201020190161) and the Danish Medicines Agency (EudraCT Number 2021\u2010000123\u201012) approved the study, and it has been registered on clinicaltrials.gov<\/jats:ext-link> (Record 2020110469).<\/jats:p><\/jats:sec>","DOI":"10.1002\/bco2.243","type":"journal-article","created":{"date-parts":[[2023,5,13]],"date-time":"2023-05-13T02:39:45Z","timestamp":1683945585000},"page":"513-522","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A randomised trial of [18<\/sup>F]PSMA\u20101007\u2010PET\/CT versus NaF<\/scp>\u2010PET\/CT for staging primary prostate cancer: A trial protocol"],"prefix":"10.1002","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6456-2593","authenticated-orcid":false,"given":"Karen Middelbo","family":"Buch\u2010Olsen","sequence":"first","affiliation":[{"name":"Department of Nuclear Medicine Odense University Hospital Odense C Denmark"},{"name":"MANTRA \u2010 Centre for MagNetic resonance Technology for Response Adapted radiotherapy Odense University Hospital Odense Denmark"},{"name":"Department of Clinical Research University of Southern Denmark Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7622-8402","authenticated-orcid":false,"given":"Mads Hvid","family":"Poulsen","sequence":"additional","affiliation":[{"name":"Department of Clinical Research University of Southern Denmark Odense Denmark"},{"name":"Department of Urology OUH Odense Odense C Denmark"},{"name":"Department of Urology The Hospital of South West Jutland Esbjerg 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\u2010 Centre for Personalized Response Monitoring in Oncology Odense University Hospital Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1249-133X","authenticated-orcid":false,"given":"S\u00f8ren","family":"Hess","sequence":"additional","affiliation":[{"name":"Department of Radiology and Nuclear Medicine The Hospital of South West Jutland Esbjerg Denmark"},{"name":"IRIS \u2010 Imaging Research Initiative Southwest Hospital South West Denmark Esbjerg Denmark"},{"name":"Department of Regional Health Research, Faculty of Health Sciences University of Southern Denmark Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0122-0916","authenticated-orcid":false,"given":"Paw Christian","family":"Holdgaard","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine Lillebaelt University Hospital of Southern Denmark Vejle 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