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Preliminary results from the PEDAL trial: A prospective single arm paired comparison of ability to diagnose and locate prostate cancer between multiparametric MRI and 18F-PSMA-PET/CT

  • Tran V.,
  • Sutherland T.,
  • Taubman K.,
  • Lee S.F.,
  • Schlicht S.,
  • Corcoran N.,
  • Lawrentschuk N.,
  • Tarlinton L.,
  • Wong L.M.

Introduction & Objectives

To investigate the accuracy of 18F-DCFPyl-PSMA-PET/CT to detect and localize prostate lesions compared to multiparametric MRI (mpMRI) prostate in men with suspected prostate cancer.

Materials & Methods

This is a prospective single arm paired comparison trial of ability to diagnose prostate cancer between mpMRI and 18F-DCFPyL-PSMA PET/CT. Detection and localisation of suspicious prostate lesions were compared between mpMRI, PET/CT and fused PET/MR images. Radiological findings were correlated with histological findings following a targeted prostate biopsy.

Results

Fifty-four men who completed both imaging arms were analysed. The median age was 66 years and median prostate specific antigen (PSA) level 6.15ng/ml. Prostate mpMRI detected 35 lesions (PIRADS ≥3), compared to 40 lesions on PET/CT (SUVmax ≥7.0). Twenty-five lesions were detected on both mpMRI and PET/CT, with 15 lesions identified by PET/CT alone. Prostate cancer was detected in 25 of 34 men who underwent prostate biopsy. On a per-lesion analysis, 17 of 25 (73.8%) lesions with clinically significant prostate cancer (Grade group ≥2) were visualized on both imaging arms. All clinically significant lesions identified by mpMRI were visualised on PET/CT. PET/CT identified 3 (13%) further clinically significant lesions that were undetected by mpMRI, and diagnosed 11 patients with metastatic disease.

Conclusions

18F-DCFPyl PSMA-PET/CT is able to detect prostate lesions seen on mpMRI prostate, as well as identify additional clinically significant lesions. The ability of PSMA-PET/CT to diagnose metastatic disease also saves the need for further staging following diagnosis. These early results provide promising evidence for a fully-powered trial to follow.

Tags: EAU21