Diagnostic accuracy of 18F-Prostate Specific Membrane Antigen (PSMA) PET/CT in staging of patients with high-risk prostate cancer or biochemical recurrence

Article type
Authors
Dullea A1, O'Sullivan L2, O'Brien K3, McGarry M3, Carrigan M3, Ahern S3, Harrington P3, Walsh K4, Smith S1, Ryan M5
1Discipline of Public Health & Primary Care, School of Medicine, Trinity College Dublin, The University of Dublin, Dublin, Ireland
2Health Technology Assessment Directorate, Health Information and Quality Authority, Cork, Ireland; Health Research Board-Trials Methodology Research Network, College of Medicine, Nursing and Health Sciences, National University of Galway, , Galway, Ireland
3Health Technology Assessment Directorate, Health Information and Quality Authority, Cork, Ireland
4Health Technology Assessment Directorate, Health Information and Quality Authority, Cork, Ireland; School of Pharmacy, University College Cork, Cork, Ireland
5Health Technology Assessment Directorate, Health Information and Quality Authority, Cork, Ireland; Department of Pharmacology and Therapeutics, Trinity College Dublin, The University of Dublin, , Dublin, Ireland
Abstract
Background:
Prostate-specific membrane antigen (PSMA)-targeted radiotracers are increasingly being applied in clinical practice in an attempt to improve the diagnostic accuracy of staging and restaging; however recommendations on their use (and the strength of those recommendations) vary.
Objectives: To consolidate existing evidence syntheses and provide a comprehensive overview of the evidence for 18F-PSMA PET/CT in the staging of high-risk prostate cancer, intermediate/high-risk prostate cancer and re-staging after biochemical recurrence.

Methods:
An overview of reviews was performed and reported in line with the preferred reporting items for overview of reviews (PRIOR) statement and synthesis without meta-analysis (SWiM) reporting guidelines. A comprehensive database and grey literature search was conducted up to 18 July 2023. Systematic reviews were assessed using the risk of bias in systematic reviews (ROBIS) tool. The certainty of the evidence was assessed using grading of recommendations, assessment, development and evaluations (GRADE). Data on intermediate/high-risk groups which could not be disaggregated were extracted, and considered relative to the data from solely high-risk groups.

Results:
Eleven systematic reviews were identified, 10 of which were at high or unclear risk of bias. Sensitivity, specificity and overall accuracy were reported on a per-patient, per-lymph node and per-lesion basis. There was a lack of data on dose, adverse events and evidence comparing 18F-PSMA PET/CT to other imaging modalities. Evidence with moderate to very low certainty indicated high sensitivity, specificity and accuracy of 18F-PSMA PET/CT in patients with high-risk prostate cancer and biochemical recurrence. For the combined intermediate/high-risk cohort, there was greater variability in effect estimates and evidence for the outcomes was of lower certainty.

Conclusion:
While evidence gaps remain for some outcomes, and most systematic reviews were at high or unclear risk of bias, the current evidence base is broadly supportive of 18F-PSMA PET/CT imaging in the staging and restaging of patients with high-risk prostate cancer and biochemical recurrence.

Statement on the relevance and importance:
Although evidence gaps remain, 18F-PSMA PET/CT is generally associated with high diagnostic accuracy when staging patients with high-risk prostate cancer or biochemical recurrence. However, effect estimates vary greatly and are of lower certainty in patients with intermediate/high-risk prostate cancer.