Assessing the accuracy of [¹⁸F]PSMA-1007 PET/CT for primary staging of lymph node metastases in intermediate- and high-risk prostate cancer patients

Background: [¹⁸F]PSMA-1007 is a promising tracer for integrated positron emission tomography and computed tomography (PET/CT). Objective: Our aim was to assess the diagnostic accuracy of [¹⁸F]PSMA-1007 PET/CT for primary staging of lymph node metastasis before robotic-assisted laparoscopy (RALP) with extended lymph node dissection (ePLND). Design, Setting and Participants: The study was a retrospective cohort in a tertiary referral center. Men with prostate cancer that underwent surgical treatment for intermediate- or high-risk prostate cancer between May 2019 and August 2021 were included. Interventions: [¹⁸F]PSMA-1007 PET/CT for initial staging followed by RALP and ePLND. Outcome measurements and statistical analyses: Sensitivity and specificity were calculated both for the entire cohort and for patients with lymph node metastasis ≥ 3 mm. Positive (PPV) and negative (NPV) predictive values were calculated. Results and limitations: Among 104 patients included in the analyses, 26 patients had lymph node metastasis based on pathology reporting and metastases were ≥ 3 mm in size in 13 of the cases (50%). In the entire cohort, the sensitivity and specificity of [¹⁸F]PSMA-1007 were 26.9% (95% confidence interval (CI); 11.6–47.8) and 96.2% (95% CI; 89.2–99.2), respectively. The sensitivity and specificity of [¹⁸F]PSMA-1007 to detect a lymph node metastasis ≥ 3 mm on PET/CT were 53.8% (95% CI; 25.1–80.8) and 96.7% (95% CI; 90.7–99.3), respectively. PPV was 70% and NPV 93.6%. Conclusions: In primary staging of intermediate- and high-risk prostate cancer, [¹⁸F]PSMA-1007 PET/CT is highly specific for prediction of lymph node metastases, but the sensitivity for detection of metastases smaller than 3 mm is limited. Based on our results, [¹⁸F]PSMA-1007 PET/CT cannot completely replace ePLND. Patient summary: This study investigated the use of an imaging method based on a prostate antigen-specific radiopharmaceutical tracer to detect lymph node prostate cancer metastasis. We found that it is unreliable to discover small metastasis.