A prospective single-arm clinical trial was conducted to determine whether ¹⁸F-choline PET/mpMRI can improve the specificity of multiparametric MRI (mpMRI) of the prostate for Gleason ≥ 3+4 prostate cancer. Methods: Before targeted and systematic prostate biopsy, mpMRI and ¹⁸F-choline PET/CT were performed on 56 evaluable subjects with 90 Likert score 3–5 mpMRI target lesions, using a ¹⁸F-choline target-to-background ratio of greater than 1.58 to indicate a positive ¹⁸F-choline result. Prostate biopsies were performed after registration of real-time transrectal ultrasound with T2-weighted MRI. A mixed-effects logistic regression was applied to measure the performance of mpMRI (based on prospective Likert and retrospective Prostate Imaging Reporting and Data System, version 2 [PI-RADS], scores) compared with ¹⁸F-choline PET/mpMRI to detect Gleason ≥ 3+4 cancer. Results: The per-lesion accuracy of systematic plus targeted biopsy for mpMRI alone was 67.8% (area under receiver-operating-characteristic curve [AUC], 0.73) for Likert 4–5 and 70.0% (AUC, 0.76) for PI-RADS 3–5. Several PET/MRI models incorporating ¹⁸F-choline with mpMRI data were investigated. The most promising model selected all high-risk disease on mpMRI (Likert 5 or PI-RADS 5) plus low- and intermediate-risk disease (Likert 4 or PI-RADS 3–4), with an elevated ¹⁸F-choline target-to-background ratio greater than 1.58 as positive for significant cancer. Using this approach, the accuracy on a per-lesion basis significantly improved to 88.9% for Likert (AUC, 0.90; P < 0.001) and 91.1% for PI-RADS (AUC, 0.92; P < 0.001). On a per-patient basis, the accuracy improved to 92.9% for Likert (AUC, 0.93; P < 0.001) and to 91.1% for PI-RADS (AUC, 0.91; P = 0.009). Conclusion: ¹⁸F-choline PET/mpMRI improved the identification of Gleason ≥ 3+4 prostate cancer compared with mpMRI, with the principal effect being improved risk stratification of intermediate-risk mpMRI lesions.

进行了一项前瞻性单臂临床试验，以确定¹⁸ F-胆碱PET / mpMRI是否可以提高前列腺多参数MRI（mpMRI）对Gleason≥3 + 4前列腺癌的特异性。方法：在进行有针对性的和系统的前列腺活检之前，对56位可评估受试者进行mpMRI和¹⁸ F-胆碱PET / CT，这些受试者具有90 Likert评分3-5 mpMRI目标病变，且¹⁸ F-胆碱目标与背景之比大于1.58表示积极的¹⁸F-胆碱结果。经T2加权MRI实时直肠超声检查后进行前列腺活检。与¹⁸ F-胆碱PET / mpMRI相比，采用混合效应逻辑回归来测量mpMRI的性能（基于前瞻性Likert和回顾性前列腺成像报告和数据系统，版本2 [PI-RADS]，得分），以检测Gleason ≥3 + 4癌症。结果：单独进行mpMRI的系统性和靶向活检的病灶准确度，李克特4-5分别为67.8％（在接受者操作特征曲线[AUC]下，0.73下）和PI-RADS为70.0％（AUC，0.76）上3–5。包含¹⁸种PET / MRI的几种模型用mpMRI数据检查F-胆碱。最有前途的模型选择了mpMRI上的所有高危疾病（Likert 5或PI-RADS 5）以及低危和中危疾病（Likert 4或PI-RADS 3-4），同时将¹⁸ F-胆碱靶标升高与背景的比率大于1.58，表示重大癌症为阳性。使用这种方法，李克特（AUC，0.90; P <0.001）和PI-RADS（AUC，0.92; P <0.001）的逐病灶精度显着提高到88.9％和91.1％。在每个病人的基础上，李克特（AUC，0.93; P <0.001）和PI-RADS（AUC，0.91; P = 0.009）的准确度提高到92.9％。结论： ¹⁸与mpMRI相比，F-胆碱PET / mpMRI改善了对Gleason≥3 + 4前列腺癌的识别，其主要作用是改善了中危mpMRI病变的危险分层。