Grant Number:	1R01CA307404-01 Interpret this number
Primary Investigator:	Radhakrishnan, Archana
Organization:	University Of Michigan At Ann Arbor
Project Title:	Transitioning From Active Surveillance to Observation in Prostate Cancer
Fiscal Year:	2026

Over 500,000 US men with prostate cancer are managed with active surveillance. Due to its indolent natural history, guidelines for low-risk prostate cancer evolved over the past decade from recommending treatment with surgery or radiation therapy to managing with active surveillance. Indeed, this approach spares men the adverse effects of treatment (e.g., incontinence, erectile dysfunction) without compromising survival through routine monitoring with clinician visits, prostate-specific antigen (PSA) blood tests, magnetic resonance imaging (MRI) scans, and prostate biopsy every 1 to 3 years. The goal is to identify and treat cancer progression only if it occurs allowing most men to safely age despite living with prostate cancer. While there is extensive guidance around the initial decision to manage men on active surveillance, how and when men who are too old or too sick with other serious medical illnesses to benefit from cancer treatment, are transitioning to observation is largely unknown. Active surveillance is an appropriate initial management option, but at some point, in an increasingly aging, comorbid population, it becomes overtreatment. In fact, guidelines recommend transitioning to observation which entails clinician visits and patient self-monitoring for symptom changes among men with limited life expectancy. Whether large-scale shifts from the routine monitoring involved in active surveillance to observation are actually occurring and the implications are unknown. Moreover, little is known about drivers of clinician decision-making related to transitioning to observation. Lastly, consequence of these decisions, i.e., the impact on long-term outcomes such as progression, treatment, and costs, must be understood. For these reasons, we propose the following: in Aim 1, we will examine patient factors associated with transitions to observation among older men (65+) managed on active surveillance for low-risk prostate cancer. We will characterize levels of transition to observation (full/moderate/low/none) and examine association of key patient clinical, sociodemographic, and geographic factors with each level; in Aim 2, we will identify clinician factors associated with propensity to recommend transition to observation, surveying urologists and radiation oncologists to assess attitudinal and organizational barriers and facilitators that influence clinician decisions around recommending transition to observation; and in Aim 3, we will use simulation modeling to estimate long-term outcomes (e.g., cancer progression, mortality, cost) associated with various levels of transition to observation. This population-based study will generate rigorous scientific understanding about levels of and factors associated with transitioning men with low-risk prostate cancer from active surveillance to observation. Our study will provide targeted, actionable information for personalized transitions informing clinical guidelines and multilevel interventions to support safe and appropriate cancer care. Importantly, this study aligns with the NCI priority to de-implement low-value care across the cancer continuum.





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