BACKGROUND: Many @entity1 with Gleason 3 + 3 and 3 + 4 early @entity5 receive invasive treatment but likely derive little or no benefit. A novel 8-protein prognostic assay generates a risk score at time of biopsy that is predictive of @entity263 @entity146 and can inform treatment decisions. The objective of this study was to evaluate the cost-effectiveness of using the assay to inform treatment decisions compared with usual care. @entity1 AND METHODS: We developed a simulation model to estimate quality-adjusted life-year (QALY) and cost outcomes for the 8-protein assay and usual care strategies. Risk classification outcomes, treatment distributions, costs, health state utilities, and mortality rates were derived from the assay's validation study and the peer-reviewed literature. Outcomes included incremental QALYs, costs, and cost-effectiveness ratios. We conducted one-way and probabilistic sensitivity analyses to evaluate the most influential inputs and to explore joint uncertainty in outcomes, respectively. RESULTS: The 8-protein assay strategy resulted in 0.04 more QALY and  700 less in costs compared with usual care (and thus was "dominant"). The cost-effectiveness of the assay strategy was most sensitive to the assay cost, the active surveillance health state utility, and the proportion of low-risk @entity1 receiving active surveillance (vs. treatment) in usual care. In the probabilistic sensitivity analyses, the assay strategy decreased cost and increased QALYs in 86.9% and 58.3% of simulations, respectively. CONCLUSION: Assuming that ongoing prospective studies support the results of retrospective validation studies, the 8-protein prognostic assay strategy for @entity263 is likely to be a cost-effective alternative to usual guideline-based care in biopsy Gleason 3 + 3 and 3 + 4 early @entity5 . IMPLICATIONS FOR PRACTICE: @entity263 prognostic assays such as the 8-protein assay can provide information about disease @entity146 that may improve decisions about use of active surveillance versus invasive treatment in Gleason 3 + 3 and 3 + 4 disease. This study, the first cost-effectiveness evaluation of this type of assay reported in the peer-reviewed literature, found that the assay strategy is expected to result in increased quality-adjusted survival and decreased cost compared with usual care. The findings demonstrate the potential for prognostic assays to be dominant strategies in this clinical setting, in which many @entity1 currently receive invasive treatment but derive limited clinical benefit.

Cost-Effectiveness of a Biopsy-Based 8-Protein @entity263 Prognostic Assay to Optimize Treatment Decision Making in Gleason 3 + 3 and 3 + 4 Early Stage XXXX .

@entity1 :: ('9606', 'Species') :: ['patients', 'PATIENTS'] @entity263 :: ('MESH:D011471', 'Disease') :: ['prostate cancer', 'Prostate cancer'] @entity5 :: ('MESH:D009369', 'Disease') :: ['stage prostate cancer'] @entity146 :: ('MESH:D001523', 'Disease') :: ['aggressiveness']
@entity263 :: (MESH:D011471,Disease) :: ['Prostate Cancer']
