OBJECTIVES: The objective of the analysis is to determine the clinical, healthcare resource, and cost consequences of different diagnostic strategies, including multiparametric magnetic resonance imaging (mpMRI) and phi test for diagnosing prostate cancer (PCa) in Italy.

METHODS: A decision analytic model using a decision tree was developed and validated using 12 subject matter experts (SME) representing various disciplines like laboratory, radiology, urology, and oncology. The population included men with PSA >2 and <10 and suspicious or negative digital rectal examination. Four diagnostic strategies were considered: mpMRI alone (1), mpMRI followed by phi (2), phi followed by mpMRI (3), and phi alone (4). Two cut-offs for phi were considered (25 and 28). Positive results of mpMRI or phi were confirmed by prostate biopsy. Prevalence data and operational characteristics of diagnostic methods were obtained from clinical literature. Direct cost information was obtained from national Italian sources. Analysis was limited to the diagnostic phase of the patient pathway; further diagnostics and treatment of PCa were not considered. The analysis was performed from the perspective of Italian healthcare payers. Deterministic, probabilistic sensitivity, and scenario analyses were performed.

RESULTS: At phi cut-off 25, strategies 1–4 led to 36, 46, 32, and 42 PCa identified and the cost of €31,206, €42,338, €29,599, and €23,964 per 100 population respectively. At phi cut-off 28, strategies 1–4 led to 36, 45, 29, and 38 PCa identified and the cost of €31,206, €40,877, €26,639, and €21,538 per 100 population respectively. At both cut-off points, the strategy mpMRI followed by phi (2), unlike other strategies, did not miss any single case of clinically significant PCa per 100 population.

CONCLUSIONS: A diagnostic strategy of mpMRI followed by phi provides the largest clinical benefit but is associated with the highest cost in the Italian healthcare system.