PT  - JOURNAL ARTICLE
AU  - Wolfgang P. Fendler
AU  - Justin Ferdinandus
AU  - Johannes Czernin
AU  - Matthias Eiber
AU  - Robert R. Flavell
AU  - Spencer C. Behr
AU  - I-Wei K. Wu
AU  - Courtney Lawhn-Heath
AU  - Miguel H. Pampaloni
AU  - Robert E. Reiter
AU  - Matthew B. Rettig
AU  - Jeannine Gartmann
AU  - Vishnu Murthy
AU  - Roger Slavik
AU  - Peter R. Carroll
AU  - Ken Herrmann
AU  - Jeremie Calais
AU  - Thomas A. Hope
TI  - Impact of <sup>68</sup>Ga-PSMA-11 PET on the Management of Recurrent Prostate Cancer in a Prospective Single-Arm Clinical Trial
AID  - 10.2967/jnumed.120.242180
DP  - 2020 Dec 01
TA  - Journal of Nuclear Medicine
PG  - 1793--1799
VI  - 61
IP  - 12
4099  - http://jnm.snmjournals.org/content/61/12/1793.short
4100  - http://jnm.snmjournals.org/content/61/12/1793.full
SO  - J Nucl Med2020 Dec 01; 61
AB  - Prostate-specific membrane antigen (PSMA) ligand PET induces management changes in patients with prostate cancer. We aim to better characterize the impact of 68Ga-PSMA-11 PET (68Ga-PSMA PET) on management of recurrent prostate cancer in a large prospective cohort. Methods: We report management changes after 68Ga-PSMA PET, a secondary endpoint of a prospective multicenter trial in men with biochemical recurrence of prostate cancer. Pre-PET (Q1), post-PET (Q2), and posttreatment (Q3) questionnaires were sent to referring physicians recording site of recurrence and intended (Q1 to Q2 change) and implemented (Q3) therapeutic and diagnostic management. Results: Q1 and Q2 response was collected for 382 of 635 patients (60%, intended cohort), and Q1, Q2, and Q3 response was collected for 206 patients (32%, implemented cohort). An intended management change occurred in 260 of 382 (68%) patients. The intended change was considered major in 176 of 382 (46%) patients. Major changes occurred most often for patients with prostate-specific antigen of 0.5 to less than 2.0 ng/mL (81/147, 55%). By analysis of stage groups, management change was consistent with PET disease location, that is, a majority of major changes toward active surveillance (47%) for unknown disease site (103/382, 27%), toward local or focal therapy (56%) for locoregional disease (126/382, 33%), and toward systemic therapy (69% M1a; 43% M1b/c) for metastatic disease (153/382, 40%). According to Q3 responses, the intended management was implemented in 160 of 206 (78%) patients. In total, 150 intended diagnostic tests, mostly CT (n = 43, 29%) and bone scans or 18F-NaF PET (n = 52, 35%), were prevented by 68Ga-PSMA PET; 73 tests, mostly biopsies (n = 44, 60%) as requested by the study protocol, were triggered. Conclusion: According to referring physicians, sites of recurrence were clarified by 68Ga-PSMA PET, and disease localization translated into management changes in more than half of patients with biochemical recurrence of prostate cancer.