학술논문
A randomised trial of [18F]PSMA‐1007‐PET/CT versus NaF‐PET/CT for staging primary prostate cancer: A trial protocol
Document Type
article
Author
Karen Middelbo Buch‐Olsen; Mads Hvid Poulsen; Steinbjørn Hansen; Mie Holm Vilstrup; Jorun Holm; Søren Hess; Paw Christian Holdgaard; Karsten Egbert Arnold Zieger; Søren Sørensen Madsen; Oke Gerke; Kasper Tholstrup Pedersen; Johan Hygum Dam; Niels Langkjær; Louise Dorner Østergaard; Jon Thor Asmussen; Poul Erik Braad; Birgitte Nørgaard; Matthias Eiber; Malene Grubbe Hildebrandt
Source
BJUI Compass, Vol 4, Iss 5, Pp 513-522 (2023)
Subject
Language
English
ISSN
2688-4526
Abstract
Abstract Background Prostate‐specific membrane antigen (PSMA)‐positron emission tomography/contrast‐enhanced computed tomography (PET/CT) is a sensitive imaging modality for prostate cancer (PCa). Due to lack of knowledge of the patient benefit, PSMA‐PET/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‐free survival (PFS) and quality of life (QoL) of using PSMA‐PET/CT versus sodium fluoride (NaF)‐PET/CT for staging and treatment planning in patients with newly diagnosed PCa. Study Design This is a prospective randomised controlled multicentre trial carried out at three centres in the Region of Southern Denmark. Endpoints The primary endpoint is PFS. Secondary endpoints are residual disease, stage migration, impact on treatment strategies, stage distribution, QoL and diagnostic accuracy measures. Patients and Methods Patients eligible for the study have newly diagnosed unfavourable intermediate‐ or high‐risk PCa. A total of 448 patients will be randomised 1:1 into two groups: (A) a control group staged with Na[18F]F‐PET/CT and (B) an intervention group staged with [18F]PSMA‐1007‐PET/CT. A subgroup in the intervention group will have a supplementary blinded Na[18F]F‐PET/CT performed for the purpose of performing accuracy analyses. QoL will be assessed at baseline and with regular intervals (3–12 months) 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. Trial Registration The Regional Committees on Health Research Ethics for Southern Denmark (S‐20190161) and the Danish Medicines Agency (EudraCT Number 2021‐000123‐12) approved the study, and it has been registered on clinicaltrials.gov (Record 2020110469).