Grant Number:	1R01CA318433-01 Interpret this number
Primary Investigator:	Mitchell, Aaron
Organization:	Sloan-Kettering Inst Can Research
Project Title:	Access and Outcomes of Radioligand Therapy for Us Veterans with Prostate Cancer
Fiscal Year:	2026

PROJECT SUMMARY Prostate cancer is the most prevalent cancer among US veterans, and the Veterans Affairs Health System (VA) cares for 15,000 new cases each year. Castration-resistant prostate cancer (CRPC) is difficult to treat, typically requiring toxic chemotherapies which achieve only modest benefit. Unfortunately, progress has been slow, and there has been a drought of new treatments for CRPC. Radioligand therapy (therapeutic radioactive isotopes targeted to malignant cells) is a new, effective class of treatments for CRPC. In 2022 Lutetium Lu-177 vipivotide tetraxetan (Lu-177) became the first FDA-approved radioligand for CRPC after demonstrating improved overall survival and reduced toxicity in clinical trials. Due to these promising results, Lu-177’s approval was met with great excitement from both providers and patients. However, access to Lu-177 therapy within the Veterans Affairs Health System (VA) is unknown. The high infrastructure requirements necessary to administer Lu-177 may cause access barriers; the VA has far fewer sites capable of administering Lu-177 compared to non-VA providers. The VA Community Care program (VACC) – in which the VA pays for veterans to receive care from non-VA providers – may help mitigate access barriers, but the VACC has faced prolonged wait times and quality-of-care concerns. In addition, the clinical outcomes of Lu-177 within the veteran population have not been evaluated; clinical trial results often fail to generalize to real-world patient populations that are typically older and more comorbid than those enrolled on trials, resulting in diminished survival benefit and increased toxicity. To address these knowledge gaps, we propose to describe access to and outcomes of Lu-177 therapy among US veterans. We will apply national, Medicare-linked VA data to identify veterans diagnosed with prostate cancer and measure care delivered by both VA and non-VA providers to achieve a comprehensive understanding of veteran access and outcomes. Aim 1: Measure adoption and access to Lu-177 therapy for US veterans. Using national VA data linked to Medicare claims, we will compare Lu-177 adoption within the VA to non-veteran patients treated in community settings (Flatiron Health) (Aim 1A), and assess geographic and income-based access barriers within the VA (Aim 1B). Aim 2: Measure clinical outcomes of Lu-177 therapy among US veterans. We will measure overall survival (Aim 2A) and treatment toxicity (Aim 2B) among veterans treated with Lu-177, compared to clinical trial participants and to non-veteran patients treated in community settings. Aim 3: Evaluate the role of VA Community Care in providing access to Lu-177 therapy. We will measure access to (Aim 3A) and outcomes of (Aim 3B) Lu-177 therapy for veterans receiving treatment within VA facilities vs. via VACC.





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