# Cost Analysis of PSMA-PET in the PROSPET-BX Trial

## TL;DR

This study finds that combining MRI and PSMA-PET imaging is the most cost-effective way to detect significant prostate cancer after a negative biopsy.

## Contribution

This is the first cost analysis study to evaluate PSMA-PET in re-biopsy settings, showing its cost-effectiveness when combined with MRI.

## Key findings

- The combined 'mpMRI or PSMA-PET' strategy detected 22 out of 26 cases of clinically significant prostate cancer.
- This combined strategy had a low incremental cost-effectiveness ratio (~EUR 2900 per extra case) compared to MRI alone.
- The 'mpMRI or PSMA-PET' pathway showed a positive incremental net benefit across willingness-to-pay thresholds.

## Abstract

This first re-biopsy cost analysis study, derived from the PROSPET-BX trial (NCT05297162), highlights combined imaging as the optimal strategy for clinically significant prostate cancer (csPCa) detection. More specifically, analyses of six triage strategies showed that the combination of mpMRI or PSMA-PET positive was most cost-effective, detecting the majority of csPCa (22/26) with a low incremental cost-effectiveness ratio (ICER) (~EUR 2900/extra case) versus mpMRI alone, positive incremental net benefit (INB) across willingness-to-pay (WTP) thresholds, and balanced efficiency.

Background: The PROSPET-BX trial compared [68Ga]PSMA-11 PET/CT (PSMA-PET) with multiparametric MRI (mpMRI) in parallel in men with suspicion of prostate cancer (PCa) after at least one previously negative biopsy (ClinicalTrials.gov: NCT05297162; GR-2018-12366240). In this study, we performed the cost analysis of the two imaging modalities with respect to the detection of clinically significant PCa (csPCa). Methods: We analyzed the data from patients enrolled in the trial who met the inclusion criteria. For the cost analysis, we identified six competing triage strategies, each defined as a binary decision rule for referral to prostate biopsy: (1) biopsy-all; (2) elevated PSA-density (PSAD; biopsy if PSAD > 0.15 ng/mL/cc; (3) mpMRI positive (PIRADS 3–5); (4) PSMA-PET positive (PRIMARY 3–5); (5) mpMRI or PSMA-PET positive; (6) PSAD and mpMRI. For each strategy, we yielded sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy for csPCa. Direct hospital costs were modeled from a provider perspective, incorporating testing and procedural costs. Unit costs (in EUR) were sourced from our institutional accounting records. Pairwise cost-effectiveness comparisons were performed using incremental cost-effectiveness ratio (ICER) and incremental net benefit (INB). Results: Among the six triage strategies evaluated, the “biopsy-all” approach achieved perfect sensitivity, whereas the PSAD + mpMRI pathway was the most parsimonious strategy but missed 14 csPCa cases (53.8%). The combined “mpMRI or PSMA-PET” strategy maximized detection (22 cPCa, missing only 4) at an intermediate cost (EUR 81.991 total; EUR 3.727 per csPCa). The pairwise comparison of each strategy with mpMRI alone showed for the mpMRI or PSMA-PET pathway a low ICER (~EUR 2.900/extra csPCa), with consistently positive and increasing INB across higher WTP (willingness-to-pay). Therefore, this combination provided the most favorable cost-effectiveness profile, balancing detection, efficiency, and cost. Conclusions: To the best of our knowledge, this is the first cost analysis study to compare different strategies incorporating PSMA-PET in the re-biopsy setting, demonstrating that the combined “mpMRI or PSMA-PET” pathway is the most cost-effective diagnostic pathway for csPCa detection.