OBJECTIVES: Transrectal Ultrasound-Guided Biopsies (TRUSGB) are today the main approach of diagnosing prostate cancer but overdiagnosis and sampling errors are major limitations. Magnetic Resonance Imaging-Guided Biopsies (MRGB) have been researched and previously published as an alternative approach. In this study, five tests for use after an initial negative biopsy for better patient stratification were assessed: PCA3, ConfirmMDx, Prostate Core Mitomic Test (PCMT), Prostate Health Index (PHI) and the 4Kscore. The resulting costs and QALY were compared to the use of TRUSGB and MRGB.

METHODS: A Markov model was used over 5, 10, 15 and 20 years. All tests were performed on patients referred to a second biopsy due to a remaining suspicion of prostate cancer after an initial negative biopsy. The Markov model considers the probability of harboring prostate cancer, diagnostic accuracy of the tests, the stratification of patients after performing the tests and probabilities of being assigned to different treatments. The included costs were direct cost in the Quebec health care system perspective.

RESULTS: Introducing PCA3 resulted in cumulative effects at 7,24, 9,12 and 10,21 QALY after 10, 15 and 20 years. The corresponding values for ConfirmMDx were 7,24, 9,13 and 10,21. PCMT, PHI and 4Kscore were excluded during the systematic literature review due to lack of data. The cumulative costs using PCA3 after 10, 15 and 20 years were $11525, $14951 and $17480. The corresponding costs for ConfirmMDx were $11706, $15092 and $17598. The costs and QALY were compared to the approach used today, TRUSGB, and the incorporation of MRGB. Both strategies, PCA3 and ConfirmMDx, demonstrated similar costs and QALYs as the standard strategy TRUSGB.

CONCLUSIONS: Introducing the new tests showed potential of use in clinical practice, demonstrating similar clinical and economic outcomes when compared to TRUSGB.