Background: Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) is currently under evaluation for detecting clinically significant prostate cancer. The PSMA-PET/CT may complement the current standard diagnostic pathway for prostate cancer, which includes prostate-specific antigen (PSA) testing and multiparametric magnetic resonance imaging (mpMRI). This study evaluated the cost-effectiveness and quality of life impact of incorporating PSMA-PET/CT into this diagnostic algorithm.

Methods: A life-time decision model compared the current standard of care of a MRI driven diagnostic pathway, where men undergo prostate biopsy in case of a Prostate Imaging Reporting and Data System (PI-RADS) scores 3-5, to a strategy incorporating PSMA-PET/CT to potentially avoid unnecessary biopsies. Long-term quality-adjusted life years (QALY) and healthcare costs were calculated for each approach.

Results: In PI-RADS 3 lesions, PSMA-PET/CT improved the per-patient QALY by 0.002 and was borderline cost-effective, with an increased cost of €170-€186 per patient and an incremental cost-effectiveness ratio (ICER) of €56,700-€93,212 per QALY. In PI-RADS 1-2, additional biopsies and over-detection of low-risk prostate cancers led to a per-patient QALY decrease of 0.001 points, a cost increase of €416-€429 per patient and was thus not cost-effective.

Conclusion: The addition of PSMA-PET/CT to MRI in patients with equivocal MRI findings appears to be borderline cost-effective due to biopsy avoidance and a reduced detection of indolent, low-risk tumors. In men with a negative MRI, adding a PSMA-PET/CT does not seem to be cost-effective due to a higher number of unnecessary biopsies and only minor improvement in the detection of clinically significant prostate cancer.

Keywords: Cost-effectiveness; PSA; PSMA; Prostate cancer; mpMRI.

© 2025. The Author(s).