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

Purpose: 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. Experimental Design: 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. Results: 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; P < 0.001], for T2 stage was 85% (95% CI, 71–94; P < 0.001), for T3a stage was 79% (95% CI, 43–85; P < 0.001), for T3b stage was 94% (95% CI, 73–100; P < 0.001), and for N1 stage was 93% (95% CI, 84–98; P < 0.001). PSMA-PET/MRI changed the therapeutic strategy in 28.7% of the patients with either the onset of systemic therapy/radiotherapy (n = 16) or active surveillance (n = 19). Conclusions: 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.