<b><i>Background:</i></b> This prospective single-arm study is designed to compare in parallel ⁶⁸Ga-PSMA PET/TRUS (transrectal or transperineal) fusion biopsy (“experimental test”) with multiparametric MRI (mpMRI)/TRUS fusion prostate biopsy (“standard test”) in men with a high suspicion of prostate cancer (PCa) after at least one negative biopsy. The primary objective was to evaluate the diagnostic performance of ⁶⁸Ga-PSMA PET/TRUS fusion prostate biopsy in comparison to mpMRI/TRUS fusion prostate biopsy analyzed in parallel. Secondarily, we aimed to determine the relationship between the “experimental test” and the histopathological characteristics of the specimen, along with the clinical utility of the “experimental test” compared to the “standard test.” <b><i>Summary:</i></b> To test the superiority of ⁶⁸Ga-PSMA PET/CT compared to mpMRI, we will enroll a minimum cohort of 128 patients. Inclusion criteria comprise: age &#x3e;18 years; blood PSA level &#x3e;4.0 ng/mL; free-to-total PSA ratio &#x3c;20%; progressive rise of PSA levels in two consecutive blood samples despite antibiotics; serum blood tests suspicious for PCa; at least one previous negative biopsy; ASAP and/or high-grade PIN; negative digital rectal examination. All eligible patients will undergo ⁶⁸Ga-PSMA PET/CT and mpMRI scans within 1 month’s distance from each other, followed by biopsy session to be completed within 1 month’s distance. Targeted TRUS fusion needle biopsy will be performed for all lesions detected with PET and mpMRI. The total duration of the study is 36 months<b>.</b> <b><i>Key Messages:</i></b> By comparing the “experimental test” and the “standard test” in parallel, we will be able to determine the superior diagnostic performance of ⁶⁸Ga-PSMA PET/CT over mpMRI in detecting PCa, and in particular clinically significant PCa, in the specific cohort of patients with a high suspicion of PCa who are candidates to re-biopsy. The clinical impact of the “experimental test” will be subsequently analyzed in terms of the number of prostate biopsies that could be spared, time-consuming, patient friendliness, and cost-effectiveness.

BackgroundA surgical margin is the apparently healthy tissue around a tumor which has been removed. In oral cavity carcinoma, a negative margin is considered ≥ 5 mm, a close margin between 1 and 5 mm, and a positive margin ≤ 1 mm. Currently, the intraoperative surgical margin status is based on the visual inspection and tissue palpation by the surgeon and intraoperative histopathological assessment of the resection margins by frozen section analysis (FSA). FSA technique is limited and susceptible to sampling errors. Definitive information on the deep resection margins requires postoperative histopathological analysis.MethodsWe described a novel approach for the assessment of intraoperative surgical margins by examining a surgical specimen oriented through a 3D-printed specific patient tongue with real-time Magnetic Resonance Imaging (MRI). We reported the preliminary results of a case series of 10 patients, prospectively enrolled, with oral tongue carcinoma who underwent surgery between February 2020 and April 2021. Two radiologists with 5 and 10 years of experience, respectively, in Head and Neck radiology in consensus evaluated specimen MRI and measured the distance between the tumor and the specimen surface. We performed intraoperative bedside FSA. To compare the performance of bedside FSA and MRI in predicting definitive margin status we computed the weighted sensitivity (SE), specificity (SP), accuracy (ACC), area under the ROC curve (AUC), F1-score, Positive Predictive Value (PPV), and Negative Predictive Value (NPV). To express the concordance between FSA and ex-vivo MRI we reported the jaccard index.ResultsIntraoperative bedside FSA showed SE of 90%, SP of 100%, F1 of 95%, ACC of 0.9%, PPV of 100%, NPV (not a number), and jaccard of 90%, and ex-vivo MRI showed SE of 100%, SP of 100%, F1 of 100%, ACC of 100%, PPV of 100%, NPV of 100%, and jaccard of 100%. These results needed to be validated in a larger sample size of 21- 44 patients.ConclusionThe presented method allows a more accurate evaluation of surgical margin status, and the first clinical experiences underline the high potential of integrating FSA with ex-vivo MRI of the fresh surgical specimen.

No abstract

grade. The Cochran-Armitage test for trend was used to assess the relationship between SUV values and PCa stage and grade.RESULTS: Overall, 179 pts were included; mean age was 66 (IQR 60-71) and 38 (21.23%) pts had PCa family history. Mean PSA was 7. 07 (5.44-11.95) ng/ml. According to European Association of Urology risk groups, 109 (61%) pts were low/intermediate risk and 70 (39%) were high risk. LND was performed in 134 (74.86%) pts. Mean SUV max and SUV ratio significantly increased from 5.3 (4.2-10.8) and 12 (7-20) in pT2a to 9.9 (6.9-18.5) and 20 (12-53) in pT3b patients, respectively (all p<0.001); mean SUV max and SUV ratio increased from 5.9 (5.3-67) and 9 (4-14) in ISUP 1 PCa to 11.9 (5.5-19.3) and 33 (17-53) in ISUP 5 PCa, respectively (all p<0.001). Similarly mean SUV max and SUV ratio increased from 6. 82 (4.29-11.94) and 14 (10-30) in organ confined disease to 14.28 (7.1-22.88) and 29 (14-58) in nonorgan confined disease, respectively (all p<0.001).CONCLUSIONS: According to our results, both pT stage and ISUP grade appear to be significantly associated both with tumor stage and grade. In consequence, PSMA PET/CT could be useful for the pretreatment risk stratification of PCa individuals and may be adopted in the treatment decision-making process of these individuals.