A randomised trial of [ < sup > 18 < /sup > F]PSMA-1007-PET/CT versus NaF-PET/CT for staging primary prostate cancer: A trial protocol

BJUI Compass. 2023 May 12;4(5):513-522. doi: 10.1002/bco2.243. eCollection 2023 Sep.ABSTRACTBACKGROUND: 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 baseli...
Source: Cancer Control - Category: Cancer & Oncology Authors: Source Type: research