| Objective1.To investigate the efficacy of 68Ga-PSMA PET/CT in the detection of clinically significant prostate cancer in newly diagnosed prostate cancer patients.2.Cost-effectiveness of 68Ga-PSMA PET/CT and transrectal ultrasound-guided needle biopsy versus transrectal ultrasound-guided needle biopsy alone in diagnosing clinically significant prostate cancer.Methods1.Retrospective analysis was performed on 168 consecutive cases of suspicious prostate cancer(PCa)patients admitted to Xijing hospital from April 2017 to January2019.Data of the patients were collected including prostate-specific antigen(PSA),age,digital rectal examination(DRE),the Prostate Imaging-Reporting and Data System(PI-RADS)score,prostate volume(PV),maximum standardized uptake value(SUVmax)and biopsy results.According to the exclusion criteria and inclusion criteria,a total of 95 patients were enrolled.Spearman rank correlation method was used to evaluate the correlation of grade data,and histological findings were used as the gold standard to compare 68Ga-PSMA PET/CT with the PI-RADS score of multiparametric magnetic resonance imaging(mp MRI).The receiver operator characteristic curve(ROC)was used to analyze the diagnostic performance of PET/CT and calculate its corresponding sensitivity and specificity.Decision Curve Analysis(DCA)was used for clinical usefulness and risk tradeoffs.2.According to the clinical diagnosis process,establish a decision tree combined with Markov model that includes two strategies for the diagnosis of clinically significant prostate cancer(cs PC),and simulate the diagnosis process of patients with PSA>4 ng/m L.The two decisions are the diagnostic method with or without 68Ga-PSMA PET/CT examination.Relevant parameters in the model were determined based on literature retrieval,systematic review and expert opinion.Quality adjusted life years(QALYs)were used to assess the benefits of both strategies.The cost-effectiveness,single factor sensitivity analysis and probability sensitivity analysis were carried out.Results1.The SUVmax of 68Ga-PSMA PET/CT was moderately correlated with the International Society of Urological Pathology(ISUP)2014 group,ρ= 0.445,95%confidence interval(95%CI: 0.224-0.623),P = 0.0002.The area under the curve(AUC)of SUVmax in the diagnosis of cs PC was 0.943(95%CI: 0.876-0.980),the threshold value was 5.6,the sensitivity and specificity were 80.00%(95%CI: 67.0-89.6)and 95.00%(95%CI: 83.1-99.4),respectively,which was better than the PI-RADS scores of mp MRI(P< 0.001).SUVmax was better than mp MRI in the PSA group of 4-10ng/m L and 10-20ng/m L.When PSA > 20 ng/m L,there was no statistical difference between the AUC of SUVmax and mp MRI,which were 0.894(95%CI: 0.751-0.970)and 0.752(95%CI:0.585-0.877),P=0.1037.The DCA shows that the net benefit(NB)of SUVmax is higher than other strategies when the risk threshold(i.e.the risk when biopsy is considered to be needed)is greater than 10%.2.The cost expectation of 68Ga-PSMA PET/CT is higher than that of transrectal ultrasound-guided biopsy(TRUSGB)(￥16059.61 vs ￥15376.17),the incremental cost is￥662.45,the incremental benefit is 0.37,and the incremental Cost-effectiveness(ICER)is￥1852.25 per QALY gained.The probabilistic sensitivity analysis of all the uncertain parameters in the model shows that the 68Ga-PSMA PET/CT strategy has full incremental benefits,of which 41.25% have low cost and high benefit,and 58.15% have high benefit and high cost.When willingness to pay(WTP)= ￥10,000,86.2% possibility of the68Ga-PSMA PET/CT strategy was cost-effective.conclusion1.68Ga-PSMA PET/CT has good diagnostic efficacy for cs PC.2.68Ga-PSMA PET/CT is cost-effective to detect cs PC. |
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