PSMA Ligand PET/MRI for Primary Prostate Cancer: Staging Performance and Clinical Impact.

Abstract

Primary staging of prostate cancer relies on modalities, which are limited. We evaluate simultaneous [⁶⁸Ga]Ga-PSMA-11 PET (PSMA-PET)/MRI as a new diagnostic method for primary tumor-node-metastasis staging compared with histology and its impact on therapeutic decisions. We investigated 122 patients with PSMA-PET/MRI prior to planned radical prostatectomy (RP). Primary endpoint was the accuracy of PSMA-PET/MRI in tumor staging as compared with staging-relevant histology. In addition, a multidisciplinary team reassessed the initial therapeutic approach to evaluate its impact on the therapeutic management. PSMA-PET/MRI correctly identified prostate cancer in 119 of 122 patients (97.5%). Eighty-one patients were treated with RP and pelvic lymphadenectomy. The accuracy for T staging was 82.5% [95% confidence interval (CI), 73-90; <i>P</i> < 0.001], for T2 stage was 85% (95% CI, 71-94; <i>P</i> < 0.001), for T3a stage was 79% (95% CI, 43-85; <i>P</i> < 0.001), for T3b stage was 94% (95% CI, 73-100; <i>P</i> < 0.001), and for N1 stage was 93% (95% CI, 84-98; <i>P</i> < 0.001). PSMA-PET/MRI changed the therapeutic strategy in 28.7% of the patients with either the onset of systemic therapy/radiotherapy (<i>n</i> = 16) or active surveillance (<i>n</i> = 19). PSMA-PET/MRI can provide an accurate staging of newly diagnosed prostate cancer. In addition, treatment strategies were changed in almost a third of the patients due to the information of this hybrid imaging technique.