No abstract

BackgroundProstate‐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 DesignThis is a prospective randomised controlled multicentre trial carried out at three centres in the Region of Southern Denmark.EndpointsThe primary endpoint is PFS. Secondary endpoints are residual disease, stage migration, impact on treatment strategies, stage distribution, QoL and diagnostic accuracy measures.Patients and MethodsPatients 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 RegistrationThe 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).

How do patients, newly diagnosed with prostate cancer, experience their healthrelated quality of life? There are numerous treatment options, all affecting healthrelated quality of life in different ways. How each treatment method affects patients is used when guiding these patients in the choice of treatment. However, we are missing knowledge about how the newly diagnosed patient specifically experiences the first year of treatment, supporting the decision making. Therefore, this review aimed to provide evidence on how newly diagnosed prostate cancer patients experience their health-related quality of life during the first year after their diagnosis, regardless of treatment choice. This review was performed in 2021 (renewed in 2022) in medline, cinahl, and embase. Studies showing the results for newly diagnosed patients with PC were included. A total of 12 studies were included. Across treatment types, sexual function was the most negatively affected domain, and emotional function was the domain with the most improvement from baseline to 12 months. Active surveillance seems to have similar to no impact on health-related quality of life, radical proctectomy negatively impacts urinary function, external beam radiotherapy mostly has a negative impact on bowel function, and brachytherapy negatively impacts urinary function. Across treatment types, sexual function was the most negatively affected domain, and emotional function was the domain with the most improvement from baseline to 12 months. This knowledge can be used by urologists and nurses when guiding newly diagnosed patients in how the early part of treatment for prostate cancer is experienced.