Hope TA, Eiber M, Armstrong WR, et al. - ⁶⁸ Ga-PSMA-11 positron emission tomographic (PET) imaging in intermediate- to high-risk prostate cancer could miss small pelvic nodal metastases, thus, a prostate-specific membrane antigen (PSMA) PET scan negative for pelvic nodal metastasis does not imply that a pelvic nodal dissection is not needed. These observations were the foundation of a New Drug Application for ⁶⁸ Ga-PSMA-11.

• This is a prospective single-arm diagnostic imaging trial involving 764 men with intermediate- to high-risk prostate cancer who had a ⁶⁸ Ga-PSMA-11 PET scan, 277 of whom subsequently had radical prostatectomy.

• Presence of pelvic nodal metastasis in 75 of 277 patients (27%) was evident by pathology reports.

• For pelvic nodal, extrapelvic nodal, and bone metastatic disease, results of ⁶⁸ Ga-PSMA-11 PET were positive in 40 of 277 (14%), 2 of 277 (1%), and 7 of 277 (3%) of patients.

• For pelvic nodal metastases, ⁶⁸ Ga-PSMA-11 PET showed a sensitivity and specificity of 0.40 and 0.95, respectively, compared with histopathology.

• In addition, the positive and negative predictive values were 0.75 and 0.81, respectively.