PURPOSE: To evaluate the cost-effectiveness of 18F-choline PET/mpMRI vs. mpMRI alone for detection of primary Gleason ≥3+4 prostate cancer in men with elevated prostate specific antigen (PSA).
METHODS: A Markov model of prostate cancer onset and progression was used to estimate health and economic consequences of 18F-choline PET/mpMRI for primary detection of Gleason ≥3+4 prostate cancer in men with elevated PSA. Multiple 18F-choline PET/mpMRI strategies were evaluated: 1) simultaneous hybrid 18F-choline PET/mpMRI (biopsy high-risk mpMRI lesions, biopsy low- and intermediate-risk mpMRI lesions with 18F-choline tumor-to-background-ratio ≥1.583, no biopsy otherwise), 2) sequential 18F-choline PET/mpMRI (biopsy high-risk mpMRI lesions, perform 18F-choline PET if intermediate-risk mpMRI lesion, biopsy if 18F-choline tumor-to-background-ratio ≥1.583, no biopsy otherwise). These strategies were compared to universal standard biopsy and mpMRI alone. Deaths averted, quality-adjusted life years (QALYs), cost, and incremental cost-effectiveness ratios (ICER) were estimated for each strategy.
RESULTS: When 18F-choline PET/mpMRI was negative, standard biopsy was more expensive and had lower QALYs than performing no biopsy. The optimal screening strategy (ICER: $30,264/QALY relative to mpMRI alone) performed hybrid 18F-choline PET/mpMRI, recommended combined biopsy for men with positive imaging and no biopsy for men with negative imaging, and reduced the number of screening biopsies by 30.6% compared to mpMRI alone. In threshold analysis, this strategy remained cost-effective when sensitivity and specificity of PET/mpMRI and combined biopsy were simultaneously reduced by 19 percentage points.
CONCLUSION: 18F-choline PET/mpMRI for detection of Gleason ≥3+4 primary prostate cancer is cost-effective and can reduce the number of unneeded biopsies compared to mpMRI alone.
