Economic Evaluation of a Novel MicroRNA-Based Assay to Determine Risk of Late Genitourinary Radiation Toxicity in Patients With Prostate Cancer.

Abstract

Background: Prostate cancer is one of the most common malignancies in men, and radiation therapy, most often stereotactic body radiation therapy or conventionally fractionated radiotherapy, is a standard curative treatment for advanced cases. Although genitourinary toxicity is a known side effect, with acute symptoms typically resolving and late toxicity causing lasting harm, individual risk varies substantially. However, no validated tool exists to predict patient-specific toxicity across radiation modalities, leaving treatment decisions to be made without personalized risk insights.

Objective: The goal of this analysis was to estimate changes in cost and quality of life associated with reductions in late genitourinary toxicity attributable to personalized radiation therapy in individuals with prostate cancer. Implementation of PROSTOX ultra, a novel microRNA-based assay for toxicity risk assessment with stereotactic body radiation therapy, is expected to enable the personalization of radiation therapy, helping patients avoid toxic effects from specific types of radiation therapy.

Methods: This study utilizes a hybrid decision-tree and Markov model approach to estimate the 5-year cost-impact and lifetime cost-effectiveness in prostate cancer patients of PROSTOX ultra vs current treatment standards that do not include toxicity risk assessment. High or low risk assessment influences whether patients receive stereotactic body radiation therapy, conventionally fractionated radiotherapy, or prostatectomy, impacting toxicity-related treatment costs and quality-of-life decrements.

Results: Over 5 years, PROSTOX ultra patients totaled $47\hspace{0.17em}683incostsvs$ 67 298 with standard-care risk assessment. Cumulative savings over 5 years were $19 615 per tested patient. Over a lifetime, PROSTOX ultra was expected to save about $24 777 per tested patient while adding 0.24 quality-adjusted life-years compared with patients tested using standard assessment.

Conclusions: Model results indicate that toxicity risk assessment with PROSTOX ultra would be cost saving over 5 years compared with standard risk assessment. Cost-effectiveness results show cost savings and quality-adjusted life-year gains over a lifetime, indicating that PROSTOX ultra would be a dominant strategy compared with treatment without risk assessment.