1. Impact of 68Ga-PSMA-11 PET on the management of biochemically recurrent prostate cancer in a prospective single-arm clinical trial
- Author
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Ken Herrmann, Thomas A. Hope, Wolfgang P. Fendler, Johannes Czernin, Ashley Mishoe, Peter R. Carroll, Eric J. Small, Felix Y. Feng, Roger Slavik, Jeannine Gartmann, Matthew Rettig, Hao Gia Nguyen, Justin Ferdinandus, Jeremie Calais, Raven Smith, Matthias Eiber, Robert R. Flavell, and Robert E. Reiter
- Subjects
Oncology ,Cancer Research ,medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Urology ,lcsh:Diseases of the genitourinary system. Urology ,lcsh:RC870-923 ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Ligand (biochemistry) ,lcsh:RC254-282 ,68Ga-PSMA-11 ,Clinical trial ,03 medical and health sciences ,0302 clinical medicine ,Positron emission tomography ,030220 oncology & carcinogenesis ,Psma pet ,Internal medicine ,Medicine ,Recurrent prostate cancer ,business ,030215 immunology ,Membrane antigen - Abstract
292 Background: Prostate-specific membrane antigen ligand positron emission tomography (PSMA PET) induced management changes in up to every second patient in smaller clinical trials. We aim to determine the impact of 68Ga-PSMA-11 PET/CT on management of biochemically 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 (NCT02940262 and NCT03353740). Pre-PET, Post-PET and Post-Treatment Questionnaires were sent to referring physicians recording working clinical summaries, intended and implemented therapeutic and diagnostic management. Results: Intended management change occurred in 260/382 (68%) patients. Intended change was considered major in 176/382 (46%) patients. Management pathway aligned with PET findings, i.e. change towards local/focal therapy for locoregional disease (54/126 patients, 44%) and towards systemic therapy or combination approaches for metastatic disease (106/153 patients, 69%). Intended management was implemented in 160/206 (78%) patients. Perceived site of disease was unknown in 259/382 (68%) patients before and 111/382 (29%) patients after PSMA PET. 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. A total of 73 tests, mostly biopsies (n=44, 60%) requested by the study protocol, were triggered. Conclusions: Disease localization by PSMA PET translated into management changes in more than half of patients with biochemical recurrence of prostate cancer. More than twice as many diagnostic tests were prevented than triggered following PET. Clinical trial information: NCT02940262 and NCT03353740.
- Published
- 2020