A Randomized Controlled Diagnostic Trial comparing
[¹⁸F]PSMA-1007-PET/CT with Conventional Imaging
in Primary Staging of Prostate Cancer

PSMA-PET/CT is a sensitive imaging method, but not yet introduced in the European Guidelines for staging primary prostate cancer because of lack of evidence of the clinical impact of it.

We hypothesize that more sensitive imaging such as PSMA-PET/CT will lead to more correct staging, hence enabling a more targeted/individualized treatment.

We plan to include 448 patients from the region of Southern Denmark with intermediate or high risk prostate cancer where imaging is indicated, and randomize them in two groups 1:1 to conventional imaging vs. PSMA-PET/CT. Patients will be asked to fill in Quality of Life questionnaires during the study period. Treatment strategies will be planned based on the results of the scans and according to current guidelines. The endpoints will be compared for group A vs. B with primary endpoints being treatment strategies, progression-free survival and quality of life (EudraCT number 2021-000123-12).

Progression free survival is expected to be longer and Quality of Life expected to be higher in the interventional group because of more accurate staging enabling an even more specific therapy than possible when using the less sensitive conventional imaging.

There is a knowledge gap regarding the benefit for patients of using PSMA-PET/CT for staging primary prostate cancer patients. This study intends to provide this knowledge to improve evidence based clinical decision making.