A Phase II, Open-label study to assess safety and management change using ⁶⁸Ga-THP PSMA PET/CT in patients with high risk primary prostate cancer or biochemical recurrence after radical treatment: The PRONOUNCED study.

ABSTRACT: Objectives: To assess the safety and clinical impact of a novel, kit-based formulation of ⁶⁸Ga-THP PSMA positron emission tomography/computed tomography (PET/CT) when used to guide the management of patients with prostate cancer (PCa). Methods: Patients were prospectively recruited in to one of: Group A: high-risk untreated prostate cancer; Gleason score >4+3, or PSA >20 ng/mL or clinical stage >T2c. Group B: biochemical recurrence (BCR) and eligible for salvage treatment after radical prostatectomy with two consecutive rises in prostate specific antigen (PSA) with a three month interval in between reads and final PSA >0.1 ng/mL or a PSA level >0.5 ng/mL. Group C: BCR with radical curative radiotherapy or brachytherapy at least three months prior to enrolment, and

SUBMITTER: Afaq A 

PROVIDER: S-EPMC8612191 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature