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.
This is a prospective randomised controlled multicentre trial carried out at three centres in the Region of Southern Denmark.
The primary endpoint is PFS. Secondary endpoints are residual disease, stage migration, impact on treatment strategies, stage distribution, QoL and diagnostic accuracy measures.
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.
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).
BJUI compass. 2023 May 12*** epublish ***
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
Department of Nuclear Medicine Odense University Hospital Odense C Denmark., Department of Clinical Research University of Southern Denmark Odense Denmark., Department of Oncology OUH Odense Odense C Denmark., Department of Radiology and Nuclear Medicine The Hospital of South West Jutland Esbjerg Denmark., Department of Nuclear Medicine Lillebaelt University Hospital of Southern Denmark Vejle Denmark., Department of Urology Lillebaelt University Hospital of Southern Denmark Vejle Denmark., Department of Urology The Hospital of South West Jutland Esbjerg Denmark., Department of Radiology OUH Odense Odense C Denmark., Department of Clinical Engineering Region of Southern Denmark Vejle Denmark., Department of Public Health University of Southern Denmark Odense C Denmark., Department of Nuclear Medicine Technical University of Munich Munich Germany.