biostudies-literatureUnknownAfaq AEngineering and Physical Sciences Research Council<b>Objectives:</b> 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). <b>Methods:</b> 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 Journal of nuclear medicine : official publication, Society of Nuclear Medicinejnumed.120.257527https://www.ebi.ac.uk/biostudies/studies/S-EPMC8612191biostudies-literatureA 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.PMC8612191EP/S032789/1Afaq AKelkar ABomanji JCook GJRMitra AOrczyk CHines JPriftakis DMeagher MPayne HDavda RWarbey VSMullen GNeedleman SFerris MfalseA 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.<b>Objectives:</b> 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). <b>Methods:</b> 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 2021-01-01T00:00:00Z2021 Mar2025-04-05T08:59:08.606Z2024-11-08T17:59:18.427ZS-EPMC86121913374164810.2967/jnumed.120.257527