@article {Afaqjnumed.120.257527, author = {Asim Afaq and Heather Payne and Reena Davda and John Hines and Gary J.R. Cook and Marie Meagher and Dimitrios Priftakis and Victoria S. Warbey and Anand Kelkar and Clement Orczyk and Anita Mitra and Sarah Needleman and Michael Ferris and Greg Mullen and Jamshed Bomanji}, title = {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.}, elocation-id = {jnumed.120.257527}, year = {2021}, doi = {10.2967/jnumed.120.257527}, publisher = {Society of Nuclear Medicine}, 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 an increase in PSA level \>2.0 ng/mL above the nadir level after radiotherapy or brachytherapy. Patients underwent evaluation with PET/CT 60 minutes following intravenous administration of 160{\textpm}30 MBq of 68Ga-THP PSMA. Safety was assessed by means including vital signs, cardiovascular profile, serum haematology, biochemistry, urinalysis, PSA, and Adverse Events (AEs). A change in management was reported when the predefined clinical management of the patient altered as a result of 68Ga-THP PSMA PET/CT findings. Results: Forty-nine patients were evaluated with PET/CT; 20 in Group A, 21 in Group B and 8 in Group C. No patients experienced serious AEs discontinued the study due to AEs, or died during the study. Two patients had Treatment Emergent AEs attributed to 68Ga-THP-PSMA (pruritus in one patient and intravenous catheter site rash in another). Management change secondary to PET/CT occurred in 42.9\% of all patients; 30\% in Group A, 42.9\% in Group B and 75\% in Group C. Conclusion: 68Ga-THP PSMA was safe to use with no serious AE and no AE resulting in withdrawal from the study. 68Ga-THP PSMA PET/CT changed the management of patients in 42.9\% of the study population, comparable to studies using other PSMA tracers. These data form the basis of a planned Phase III study of 68Ga-THP PSMA in patients with prostate cancer.}, issn = {0161-5505}, URL = {https://jnm.snmjournals.org/content/early/2021/03/19/jnumed.120.257527}, eprint = {https://jnm.snmjournals.org/content/early/2021/03/19/jnumed.120.257527.full.pdf}, journal = {Journal of Nuclear Medicine} }