Impact of 68Ga-PSMA-11 PET on the Management of recurrent Prostate Cancer in a Prospective Single-Arm Clinical Trial.

Introduction: Prostate-specific membrane antigen ligand positron emission tomography (PSMA PET) induces management changes in patients with prostate cancer. We aim to better characterize the impact of PSMA PET on management of recurrent prostate cancer in a large prospective cohort. Methods: We report management changes following PSMA PET, a secondary endpoint of a prospective multicenter trial in men with prostate cancer biochemical recurrence. Pre-PET (Q1), Post-PET (Q2) and Post-Treatment (Q3) questionnaires were sent to referring physicians recording site of recurrence, intended (Q1 to Q2 change) and implemented (Q3) therapeutic and diagnostic management. Results: Q1/Q2 response was collected for 382/635 (60%, intended cohort), Q1/Q2/Q3 for 206 patients (32%, implemented cohort). Intended management change (Q1/2) occurred in 260/382 (68%) patients. Intended change (Q1/2) was considered major in 176/382 (46%) patients. Major changes occurred most often for patients with PSA of 0.5 to <2.0 ng/mL (81/147, 55%). By analysis of stage-groups, management change was consistent with PET disease location, i.e. majority of major changes towards active surveillance (47%) for unknown disease site (103/382, 27%), towards local/focal therapy (56%) for locoregional disease (126/382, 33%), and towards systemic therapy (69% M1a; 43% M1b/c) for metastatic disease (153/382, 40%). According to Q3 responses, intended management was implemented in 160/206 (78%) patients. A total of 150 intended diagnostic tests, mostly CT (n = 43, 29%) and bone Scans/NaF-PET (n = 52, 35%), were prevented by PSMA PET; 73 tests, mostly biopsies (n = 44, 60%) as requested by the study protocol, were triggered (Q1/2). Conclusion: According to referring physicians, sites of recurrence were clarified by PSMA PET and disease localization translated into management changes in more than half of patients with biochemical recurrence of prostate cancer.

Journal of nuclear medicine : official publication, Society of Nuclear Medicine. 2020 May 01 [Epub ahead of print]

Wolfgang P Fendler, Justin Ferdinandus, Johannes Czernin, Matthias Eiber, Robert R Flavell, Spencer C Behr, I-Wei K Wu, Courtney Lawhn-Heath, Miguel H Pampaloni, Robert E Reiter, Matthew B Rettig, Jeannine Gartmann, Vishnu Murthy, Roger Slavik, Peter R Carroll, Ken Herrmann, Jeremie Calais, Thomas A Hope

Department of Molecular and Medical Pharmacology, University of California Los Angeles, Germany., Department of Nuclear Medicine, University Hospital Essen, University of Duisburg-Essen, Germany., Departments of Radiology and Biomedical Imaging, University of California San Francisco, United States., Department of Urology, UCLA Medical Center, University of California Los Angeles, United States., Department of Urology, University of California San Francisco, United States.