RT Journal Article SR Electronic T1 A Comprehensive Assessment of 68Ga-PSMA-11 PET in Biochemically Recurrent Prostate Cancer: Results from a Prospective Multicenter Study on 2,005 Patients JF Journal of Nuclear Medicine JO J Nucl Med FD Society of Nuclear Medicine SP 567 OP 572 DO 10.2967/jnumed.121.262412 VO 63 IS 4 A1 Abghari-Gerst, Monica A1 Armstrong, Wesley R. A1 Nguyen, Kathleen A1 Calais, Jeremie A1 Czernin, Johannes A1 Lin, David A1 Jariwala, Namasvi A1 Rodnick, Melissa A1 Hope, Thomas A. A1 Hearn, Jason A1 Montgomery, Jeffrey S. A1 Alva, Ajjai A1 Reichert, Zachery R. A1 Spratt, Daniel E. A1 Johnson, Timothy D. A1 Scott, Peter J.H. A1 Piert, Morand YR 2022 UL http://jnm.snmjournals.org/content/63/4/567.abstract AB We prospectively investigated the performance of the prostate-specific membrane antigen (PSMA) ligand 68Ga-PSMA-11 for detecting prostate adenocarcinoma in patients with elevated levels of prostate-specific antigen (PSA) after initial therapy. Methods: 68Ga-PSMA-11 hybrid PET was performed on 2,005 patients at the time of biochemically recurrent prostate cancer after radical prostatectomy (RP) (50.8%), definitive radiation therapy (RT) (19.7%), or RP with postoperative RT (PORT) (29.6%). The presence of prostate cancer was assessed qualitatively (detection rate = positivity rate) and quantitatively on a per-patient and per-region basis, creating a disease burden estimate from the presence or absence of local (prostate/prostate bed), nodal (N1: pelvis), and distant metastatic (M1: distant soft tissue and bone) disease. The primary study endpoint was the positive predictive value (PPV) of 68Ga-PSMA-11 PET/CT confirmed by histopathology. Results: After RP, the scan detection rate increased significantly with rising PSA level (44.8% at PSA < 0.25%–96.2% at PSA > 10 ng/mL; P < 0.001). The detection rate significantly increased with rising PSA level in each individual region, overall disease burden, prior androgen deprivation, clinical T-stage, and Gleason grading from the RP specimen (P < 0.001). After RT, the detection rate for in-gland prostate recurrence was 64.0%, compared with 20.6% prostate bed recurrence after RP and 13.3% after PORT. PSMA-positive pelvic nodal disease was detected in 42.7% after RP, 40.8% after PORT, and 38.8% after RT. In patients with histopathologic validation, the PPV per patient was 0.82 (146/179). The SUVmax of histologically proven true-positive lesions was significantly higher than that of false-positive lesions (median, 11.0 [interquartile range, 6.3–22.2] vs. 5.1 [interquartile range, 2.2–7.4]; P < 0.001). Conclusion: We confirmed a high PPV for 68Ga-PSMA-11 PET in biochemical recurrence and the PSA level as the main predictor of scan positivity.