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The PRIMARY Scoring System on PSMA PET for Clinically Significant Prostate Cancer Detection: A Systematic Review and

Felipe A Mourato1, Luiza G Schmitt2, Miriana Mariussi3

  • 1Unidade de Diagnóstico por Imagem, Empresa Brasileira de Serviços Hospitalares (EBSERH), Hospital das Clínicas da Universidade Federal de Pernambuco (UFPE), Recife, PE, Brazil.

Clinical Nuclear Medicine
|February 3, 2026
PubMed
Summary
This summary is machine-generated.

The PRIMARY score shows high accuracy for detecting clinically significant prostate cancer (csPCa) using PSMA PET scans. Its performance is comparable to PI-RADS, especially in biopsy-naïve men.

Keywords:
PRIMARYPSMAclinically significant prostate cancerprostate cancer

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Area of Science:

  • Radiology and Nuclear Medicine
  • Oncology
  • Urology

Background:

  • Prostate-specific membrane antigen (PSMA) PET imaging is crucial for assessing prostate cancer.
  • Standardized interpretation of PSMA PET for intraprostatic lesions is needed.
  • The PRIMARY score offers a standardized approach for PSMA PET interpretation.

Purpose of the Study:

  • To systematically evaluate the diagnostic accuracy of the PRIMARY score for clinically significant prostate cancer (csPCa).
  • To compare the performance of the PRIMARY score against the PI-RADS classification.
  • To assess the PRIMARY score's utility in biopsy-naïve patients.

Main Methods:

  • A systematic review and meta-analysis adhering to PRISMA-DTA guidelines.
  • Inclusion of 13 studies (n=1974) evaluating the PRIMARY score on PSMA PET/CT or PET/MRI.
  • Bivariate random-effects modeling to estimate pooled sensitivity and specificity.

Main Results:

  • In biopsy-naïve patients, PRIMARY ≥3 achieved 90% sensitivity and 63% specificity.
  • Across all included studies, PRIMARY showed 87% sensitivity and 56% specificity.
  • Head-to-head comparisons indicated comparable accuracy between the PRIMARY score and PI-RADS.

Conclusions:

  • The PRIMARY score demonstrates high sensitivity and moderate specificity for csPCa detection.
  • Its performance is comparable to PI-RADS, particularly in biopsy-naïve individuals.
  • The PRIMARY score is a valuable tool for pre-biopsy risk stratification and integrated diagnostic workflows.