Recommendations to address respondent burden associated with patient-reported outcome assessment.

Patient-reported outcomes (PROs) are increasingly used in healthcare research to provide evidence of the benefits and risks of interventions from the patient perspective and to inform regulatory decisions and health policy. The use of PROs in clinical practice can facilitate symptom monitoring, tailor care to individual needs, aid clinical decision-making and inform value-based healthcare initiatives. Despite their benefits, there are concerns that the potential burden on respondents may reduce their willingness to complete PROs, with potential impact on the completeness and quality of the data for decision-making. We therefore conducted an initial literature review to generate a list of candidate recommendations aimed at reducing respondent burden. This was followed by a two-stage Delphi survey by an international multi-stakeholder group. A consensus meeting was held to finalize the recommendations. The final consensus statement includes 19 recommendations to address PRO respondent burden in healthcare research and clinical practice. If implemented, these recommendations may reduce PRO respondent burden.

The management of stage I Non-Small cell lung cancer (NSCLC) in Ontario: A Population-Based study of patterns of care and Stereotactic Ablative Body radiotherapy (SABR) utilization from 2010 to 2019.

BACKGROUND: Stereotactic Ablative Body Radiotherapy (SABR) is the standard of care for medically inoperable patients with Stage I NSCLC. The adoption of SABR and its association with cancer outcomes requires characterization. AIM: We described the management of biopsy-proven Stage I NSCLC with SABR, surgery, non-SABR curative radiotherapy (RT) and observation in Ontario, Canada, between 2010 and 2019. Temporal and geographic trends in practice and survival outcomes were analyzed. METHODS: This was a retrospective population-based cohort study conducted by linking electronic radiotherapy (RT) records to a population-based cancer registry. RESULTS: A total of 12,065 patients were identified, 61.7 % underwent surgery, 17.9 % received SABR, 8.6 % received non-SABR curative RT and 11.7 % were observed. Between 2010 and 2019, the utilization of surgery decreased (63.8 % to 49.9 %, p < 0.0001), while SABR use increased (7.5 % to 24.4 %, p < 0.0001), non-SABR curative RT use increased (6.7 % to 9.6 %, p < 0.0014) and patients observed decreased (14.4 % to 12.0 %, p < 0.0001). Substantial variation in practice exists across Ontario. Two- yr CSS improved for the entire cohort (81.9 % to 85.0 %, p < 0.0001). While there was improvement in 2 yr CSS for surgical patients (92.1 %% to 95.7 %, p < 0.001), survival for patients who received SABR, Non-SABR curative RT and observation remained stable. CONCLUSION: There has been an increase in SABR utilization and a reduction in surgical utilization with a corresponding increased survival of stage I patients in Ontario between 2010 and 2019. Substantial differences in practice patterns exist across health regions, suggesting the need for strategies to improve access to SABR in many jurisdictions.

An Economic Analysis of SC24 in Canada: A Randomized Study of SBRT Compared With Conventional Palliative RT for Spinal Metastases.

PURPOSE: The Canadian Cancer Trials Group (CCTG) Symptom Control 24 protocol (SC.24) was a multicenter randomized controlled phase 2/3 trial conducted in Canada and Australia. Patients with painful spinal metastases were randomized to either 24 Gy/2 stereotactic body radiation therapy (SBRT) or 20 Gy/5 conventional external beam radiation therapy (CRT). The study met its primary endpoint and demonstrated superior complete pain response rates at 3 months following SBRT (35%) versus CRT (14%). SBRT planning and delivery is resource intensive. Given its benefits in SC.24, we performed an economic analysis to determine the incremental cost-effectiveness of SBRT compared with CRT. METHODS AND MATERIALS: The trial recruited 229 patients. Cost-effectiveness was assessed using a Markov model taking into account observed survival, treatments costs, retreatment, and quality of life over the lifetime of the patient. The EORTC-QLU-C10D was used to determine quality of life values. Transition probabilities for outcomes were from available patient data. Health system costs were from the Canadian health care perspective and were based on 2021 Canadian dollars (CAD). The incremental cost-effectiveness ratio (ICER) was expressed as the ratio of incremental cost to quality-adjusted life years (QALY). The impact of parameter uncertainty was investigated using deterministic and probabilistic sensitivity analyses. RESULTS: The base case for SBRT compared with CRT had an ICER of $9,040CAD per QALY gained. Sensitivity analyses demonstrated that the ICER was most sensitive to variations in the utility assigned to "No local failure" ($5,457CAD to $241,051CAD per QALY), adopting low and high estimates of utility and the cost of the SBRT (ICERs ranging from $7345-$123,361CAD per QALY). It was more robust to variations in assumptions around survival and response rate. CONCLUSIONS: SBRT is associated with higher upfront costs than CRT. The ICER shows that, within the Canadian health care system, SBRT with 2 fractions is likely to be more cost-effective than CRT.

Measuring prognostic awareness in patients with advanced cancer: a scoping review and interpretive synthesis of the impact of hope.

BACKGROUND: Assessment of prognostic awareness (PA) in patients with advanced cancer is challenging because patient responses often indicate their hopes. The objectives of this scoping review were to summarize studies that measured PA in patients with advanced cancer and to synthesize data about how PA was measured and whether hope was incorporated into the measurement. METHODS: MEDLINE and Embase databases were searched from inception to December 14, 2021. Data regarding the impact of hope on assessment of PA were extracted when studies reported on patients' beliefs about prognosis and patients' beliefs about their doctor's opinion about prognosis. An interpretive synthesis approach was used to analyze the data and to generate a theory regarding the incorporation of hope into the assessment of PA. RESULTS: In total, 52 studies representing 23 766 patients were included. Most were conducted in high-income countries and measured PA based on the goal of treatment (curable vs incurable). Five studies incorporated hope into the assessment of PA and reported that among patients who responded that their treatment goal was a cure, an average of 30% also acknowledged that their doctors were treating them with palliative intent. Interpretive synthesis of the evidence generated a trinary conceptualization of PA patients who are aware and accepting of their prognosis; aware and not accepting; and truly unaware. Each of these groups will benefit from different types of interventions to support their evolving PA. CONCLUSION: The trinary conceptualization of PA may promote understanding of the impact of hope in the assessment of PA and guide future research.

Supply and Demand for Radiation Oncologists in Canada: Workforce Planning Projections From 2020 to 2040.

PURPOSE: The number of Canadians diagnosed with cancer, and subsequent demand for radiation therapy, are expected to increase over time. This study aimed to update our needs-based workforce planning model to ensure appropriate staffing levels in the future. METHODS AND MATERIALS: The supply of radiation oncologists, by age group, sex, and full-time equivalent status, was projected from 2020 to 2040 using a recursive-aging, input-output model developed with seeding parameters derived from national sources. The demand for radiation oncologists until 2040 was estimated using referral patterns for radiation therapy and consultation workload metrics applied to projected annual cancer incident cases to calculate required full-time equivalent positions. Baseline model parameters were also applied to the 2005-2019 workforce and incident case data to evaluate preprojection supply and demand trends. RESULTS: Preprojection trends for 2005 to 2019 revealed accelerated staffing growth that transitioned from a workforce shortage to a surplus state in 2014 followed by substantial growth slowdown in 2016. The model predicts a transient surplus of radiation oncologists until 2026 followed by a projected deficit in subsequent years. Sensitivity analyses using the plausible range for each parameter continued to favor an undersupply, suggesting a trainee shortage unable to meet workforce expansion needs. Considering possible future declining trends in radiotherapy utilization and workload, calculations to inform corrective efforts in resident numbers resulted in 25 entry positions per year, up from 21 per year currently. Geographic distribution of trainees, relative to workforce and cancer incidence distributions, could be improved with more residency positions in Canadian regions outside Ontario. CONCLUSIONS: Demand for radiation therapy and radiation oncologists in Canada are expected to grow more quickly than future expansion in staffing levels. Our workforce planning model provides evidence for more trainee requirements to inform stakeholders of possible corrective actions to training programs and recruitment. Further research is needed to explore additional strategies to expand capacity and high-quality delivery of radiation therapy to meet the foreseeable increase in Canadian patients with cancer.

A Clinical Consensus Approach to Developing a New Funding Model for Radiation Services in Ontario.

In 2021, Ontario Health (Cancer Care Ontario) introduced a quality-based procedure model for the funding of radiation treatment (RT) in Ontario. This model ties reimbursement to patient care activities, ensuring equity and transparency in funding. Over 200 RT interprofessionals (oncologists, therapists and physicists) participated on 22 expert panels to establish or identify 288 evidence-based RT protocols and 672 quality expectations (QEs) to optimally deliver RT, which eventually led to the micro-costing of all protocols. Iterative review is required to ensure updated techniques and identify evolving standards of care, thereby providing the highest quality of RT care to Ontarians.

Patients' attitudes and preferences toward delayed disease progression in the absence of improved survival.

BACKGROUND: Cancer patients' attitudes toward progression-free survival (PFS) gains offered by treatment are not well understood, particularly in the absence of overall survival (OS) gains. The objectives were to describe patients' willingness to accept treatment that offers PFS gains without OS gains, to compare these findings with treatments offering OS gains, and to qualitatively summarize patients' reasons for their preferences. METHODS: A multicenter, cross-sectional, convergent mixed-methods study design recruited patients who had received at least 3 months of systemic therapy for incurable solid tumors. A treatment trade-off exercise determined the gains in imaging PFS that patients require to prefer additional systemic treatment for a scenario of a newly diagnosed, asymptomatic, incurable abdominal tumor. A qualitative, descriptive, thematic analysis explored factors influencing patients' decisions, and a narrative method integrated the quantitative and qualitative findings. RESULTS: In total, 100 patients participated (63% were older than 60 years of age). If additional treatment with added toxicity offered no OS advantage, 17% would prefer it for no PFS benefit; 26% for some PFS benefit (range, 3-9 months), whereas 51% would decline it regardless of PFS benefit. Similarly, 71% preferred additional treatment offering a 6-month OS advantage dependent on described toxicity levels (P = .03). A spectrum of reasons for these preferences reflected the complexity of participants' attitudes and values. CONCLUSIONS: Prolongation of time to progression was not universally valued. Most patients did not prefer treatments that negatively affect quality of life for PFS gains alone. Implications for individual decision making, policy, and trials research are discussed.

Characterizing Variability in Lung Cancer Outcomes and Influence of a Lung Diagnostic Assessment Program in Southeastern Ontario, Canada.

INTRODUCTION: Regional variability in lung cancer (LC) outcomes exists across Canada, including in the province of Ontario. The Lung Diagnostic Assessment Program (LDAP) in southeastern (SE) Ontario is a rapid-assessment clinic that expedites the management of patients with suspected LC. We evaluated the association of LDAP management with LC outcomes, including survival, and characterized the variability in LC outcomes across SE Ontario. METHODS: We conducted a population-based retrospective cohort study by identifying patients with newly diagnosed LC through the Ontario Cancer Registry (January 2017-December 2019) and linked to the LDAP database to identify LDAP-managed patients. Descriptive data were collected. Using a Cox model approach, we compared 2-year survival for patients managed through LDAP vs. non-LDAP. RESULTS: We identified 1832 patients, 1742 of whom met the inclusion criteria (47% LDAP-managed and 53% non-LDAP). LDAP management was associated with a lower probability of dying at 2 years (HR 0.76 vs. non-LDAP, p < 0.0001). Increasing distance from the LDAP was associated with a lower likelihood of LDAP management (OR 0.78 for every 20 km increase, p < 0.0001). LDAP-managed patients were more likely to receive specialist assessment and undergo treatments. CONCLUSIONS: In SE Ontario, initial diagnostic care provided via LDAP was independently associated with improved survival in patients with LC.

Radiation Therapy and Indigenous Peoples in Canada and Australia: Building Paths Toward Reconciliation in Cancer Care Delivery.

Indigenous peoples represent approximately 5% of the world's population and reside in over 90 countries worldwide. They embody a rich diversity of cultures, traditions, languages and relationships with the land that are shared through many generations and that are distinct from those of the settler societies within which they now live. Many Indigenous peoples have a shared experience of discrimination, trauma, and violation of rights, rooted in complex sociopolitical relationships with settler societies that are still ongoing. This results in continuing social injustices and pronounced disparities in health for many Indigenous peoples around the globe. Indigenous peoples exhibit a significantly higher cancer incidence, mortality, and poorer survival compared to non-Indigenous peoples. Cancer services, including radiotherapy, have not been designed to support the specific values and needs of Indigenous populations, resulting in poorer access to cancer services for Indigenous peoples globally across the entire cancer care spectrum. Specific to radiotherapy, available evidence demonstrates disparities in radiotherapy uptake between Indigenous and non-Indigenous patients. Radiotherapy centres are also located disparately further away from Indigenous communities. Studies are limited by a lack of Indigenous-specific data to help inform effective radiotherapy delivery. Recent Indigenous-led partnerships and initiatives have helped to address existing gaps in cancer care, and radiation oncologists play an important role in supporting such efforts. In this article, we present an overview of access to radiotherapy for Indigenous peoples in Canada and Australia, with a focus on strengthening cancer care delivery through education, partnerships, and research.

Characterizing Regional Variability in Lung Cancer Outcomes across Ontario-A Population-Based Analysis.

Background: Lung cancer (LC) is the leading cause of cancer-related mortality. In Ontario, Canada, there are significant survival differences for patients with newly diagnosed LC across the 14 provincial regions. Methods: A population-based retrospective cohort study using ICES databases from 01/2007-12/2017 identified patients with newly diagnosed LC through the Ontario Cancer Registry and those with LC as the cause of death. Descriptive data included patient, disease, and system characteristics. The primary outcome was 5-year survival by region. Results: 178,202 patient records were identified; 101,263 met inclusion criteria. LC incidence varied by region (5.6-14.6/10,000), as did histologic subtype (adenocarcinoma: 27.3-46.1%). Five-year cancer-specific survival was impacted by age, rurality, pathologic subtype, stage at diagnosis, and income quintile. Timely care was inversely related to survival (fastest quintile: HR 3.22, p < 0.0001). Adjusted 5-year cancer-specific survival varied across regions (24.1%, HR 1.12; 34.0%, HR 0.89, p < 0.001). Conclusions: When adjusting for confounders, differences in survival by health region persisted, suggesting a complex interplay between patient, disease, and system factors. A single approach to improving patient care is likely to be ineffective across different systems. Quality improvement initiatives to improve patient outcomes require different approaches amongst health regions to address local disparities in care.

Explaining regional variations in colon cancer survival in Ontario, Canada: a population-based retrospective cohort study.

OBJECTIVES: Regional variation in cancer survival is an important health system performance measurement. We evaluated if regional variation in colon cancer survival may be driven by differences in the patient population, their health and healthcare utilisation, and/or cancer care delivery. DESIGN: Population-based retrospective cohort study using routinely collected linked health administrative data. SETTING: Ontario, Canada. PARTICIPANTS: Patients with colon cancer diagnosed between 1 January 2009 and 31 December 2012. OUTCOME: Cancer-specific survival was compared across the province's 14 health regions. Using accelerated failure time models, we assessed whether regional survival variations were mediated through differences in case mix, including age, sex, comorbidities, stage at diagnosis and colon subsite, potential marginalisation and/or prediagnosis healthcare. RESULTS: The study population included 16 895 patients with colon cancer. There was statistically significant regional variation in cancer-specific survival. Three regions had cancer-specific survival that was between 30% (95% CI 1.03 to 1.65) and 39% (95% CI 1.13 to 1.71) longer and one region had cancer-specific survival that was 26% shorter (95% CI 0.58 to 0.93) than the reference region. For three of these regions, case mix explained between 26% and 56% of the survival variation. Further adjustment for rurality explained 22% of the remaining survival variation in one region. Adjustment for continuity of primary care and the diagnostic interval length explained 10% and 11% of the remaining survival variation in two other regions. Socioeconomic marginalisation, recent immigration and colonoscopy history did not explain colon cancer survival variation. CONCLUSIONS: Case mix accounted for much of the regional variation in colon cancer survival, indicating that efforts to monitor the quality of cancer care through survival metrics should consider case mix when reporting regional survival differences. Future work should repeat this approach in other settings and other cancer sites considering a broad range of potential mediators.

Listening to the Patient Voice Adds Value to Cancer Clinical Trials.

Randomized clinical trials are critical for evaluating the safety and efficacy of interventions in oncology and informing regulatory decisions, practice guidelines, and health policy. Patient-reported outcomes (PROs) are increasingly used in randomized trials to reflect the impact of receiving cancer therapies from the patient perspective and can inform evaluations of interventions by providing evidence that cannot be obtained or deduced from clinicians' reports or from other biomedical measures. This commentary focuses on how PROs add value to clinical trials by representing the patient voice. We employed 2 previously published descriptive frameworks (addressing how PROs are used in clinical trials and how PROs have an impact, respectively) and selected 9 clinical trial publications that illustrate the value of PROs according to the framework categories. These include 3 trials where PROs were a primary trial endpoint, 3 trials where PROs as secondary endpoints supported the primary endpoint, and 3 trials where PROs as secondary endpoints contrast the primary endpoint findings in clinically important ways. The 9 examples illustrate that PROs add valuable data to the care and treatment context by informing future patients about how they may feel and function on different treatments and by providing clinicians with evidence to support changes to clinical practice and shared decision making. Beyond the patient and clinician, PROs can enable administrators to consider the cost-effectiveness of implementing new interventions and contribute vital information to policy makers, health technology assessors, and regulators. These examples provide a strong case for the wider implementation of PROs in cancer trials.

Striving to Fill in Gaps between Clinical Practice and Standards: The Evolution of a Pan-Canadian Approach to Patient-Reported Outcomes Use.

Despite the known importance and necessity of the standardized collection and use of patient-reported outcomes (PROs), there remain challenges to successful clinical implementation. Facilitated through a quality improvement initiative spearheaded by the Canadian Partnership for Quality Radiotherapy (CPQR), and now guided by the Canadian Association of Radiation Oncology (CARO)'s Quality and Standards Committee, patient representatives and early-adopter radiation treatment programs continue to champion the expansion of PROs initiatives across the country. The current review discusses the evolution of a pan-Canadian approach to PROs use, striving to fill in gaps between clinical practice and guideline recommendations through multi-centre and multidisciplinary collaboration.

Employment Outcomes for Canadian Radiation Oncology Graduates: 2020 Assessment and Longitudinal Trends.

Purpose: Canadian radiation oncology (RO) trainees have experienced employment challenges after residency training. The present study was conducted to evaluate current employment trends and perform comparisons to prior reported assessments. Methods and Materials: A survey was administered to all 13 Canadian RO program directors requesting the employment status and location of their graduates during the past 3 years, and their perceptions on graduates' employment challenges. Visa trainees were excluded. Findings were compared with surveys performed in 2014, 2016, and 2018. Results: The response rate from RO program directors was 100%. There were 77 graduates identified who completed their residency training between 2017 and 2020. All had known employment status and location. Two (17%) 2020 graduates, 16 (84%) 2019 graduates, 17 (81%) 2018 graduates, and 24 (100%) 2017 graduates had staff employment. Of the 59 graduates with staff positions, 86% were in Canada. Some graduates (28%) obtained staff or locum employment in a province other than their training program. The proportion of graduates obtaining staff positions 1 year after residency increased to 84% from 46%-48% in prior assessments. Most program directors (62%) did not perceive any difficulties with their graduates finding staff employment or trainees transferring to training programs in other disciplines owing to perceived workforce challenges. Conclusions: Compared with 3 prior employment outcome assessments, this study observed a higher proportion of graduates with staff positions in Canada, fewer total graduates, fewer graduates seeking staff employment or in fellowship positions, and a trend for fewer graduates seeking employment or fellowships abroad. These findings support the view that the Canadian RO job market continues to improve. Although employment challenges for newly certified, Canadian-trained radiation oncologists still exist, national corrective measures to regulate resident intake in 2011 appear to have had a positive effect on the employment outcomes of recent Canadian RO graduates.

Association of Quality-of-Life Outcomes in Cancer Drug Trials With Survival Outcomes and Drug Class.

Importance: Although quality of life (QOL) is an important clinical end point, cancer drugs are often approved based on overall survival (OS) or putative surrogate end points such as progression-free survival (PFS) without QOL data. Objective: To ascertain whether cancer drug trials that show improvement in OS or PFS also improve global QOL of patients with cancer compared with the control treatment, as well as to assess how unchanged or detrimental QOL outcomes are reported in trial publications. Design, Setting, and Participants: This retrospective cohort study included all patients with cancer in the advanced setting who were enrolled into phase 3 randomized clinical trials (RCTs) of cancer drugs reporting QOL data and published in English language in a PubMed-indexed journal in the calendar year 2019. The systematic search of PubMed was conducted in July 2020. Main Outcomes and Measures: Association of QOL outcomes with OS and PFS, framing of unchanged QOL outcomes in trial publications, and the association of favorable framing with industry funding of the trials. Results: A total of 45 phase 3 RCTs enrolling 24 806 participants (13 368 in the experimental arm and 11 438 in the control arm) met the inclusion criteria and were included in the study analyses. Improvement in global QOL with the experimental agent was reported in 11 (24%) RCTs. The RCTs with improved QOL were more likely to also show improved OS vs trials with unimproved QOL (7 of 11 [64%] trials vs 10 of 34 [29%] trials; χ2 = 4.13; P = .04); there was no such association observed for PFS (6 of 11 [55%] trials vs 17 of 34 [50%] trials, χ2 = 0.03; P = .87). Six trials reported worsening QOL, of which 3 (50%) were trials of targeted drugs, and 11 trials reported improvement in QOL, of which 6 (55%) were trials of immunotherapy drugs. Of the 34 trials in which QOL was not improved compared with controls, 16 (47%) reported these results in a positive frame, an observation statistically significantly associated with industry funding (χ2 = 6.35; P = .01). Conclusions and Relevance: In this cohort study, a small proportion of RCTs of cancer drugs showed benefit in global QOL with the experimental agent. These results showed an association between QOL benefit and OS benefit but no such association with PFS benefit. Trials that failed to show improved QOL often reported their QOL outcomes more favorably. Non-immunotherapy-targeted drugs led to worse QOL more often than did cytotoxic agents.

Knowledge translation concerns for the CONSORT-PRO extension reporting guidance: a review of reviews.

This review of reviews aimed to appraise the use of the CONSORT-PRO Extension as an evaluation tool for assessing the reporting of patient-reported outcome (PROs) in publications, and to describe the reporting of PRO research across reviews. We also outlined how variation in such evaluations impacts knowledge translation and may lead to potential misuse of the CONSORT-PRO Extension. We systematically searched Medline, Pubmed and CINAHL from 2013 to 2025 March 2021 for reviews of the completeness of reporting of PRO endpoints according to CONSORT-PRO criteria. Two reviewers extracted details of each review, the percentage of included studies that addressed each CONSORT-PRO item, and key recommendations from each review. Fourteen reviews met inclusion criteria, and only six of these used the full CONSORT-PRO checklist with minimal justified modifications. The remaining eight studies made significant or unjustified adjustments to the CONSORT-PRO Extension. Review studies also varied in how they scored multi-component CONSORT-PRO items. CONSORT-PRO items were often unreported in trial reports, and certain CONSORT-PRO items were reported less often than others. The reporting of statistical approaches to dealing with missing PRO data were poor in RCTs included in all 14 review articles. Studies reviewing PRO publications often omitted recommended CONSORT-PRO items from their evaluations, which may cause confusion among readers regarding how best to report their PRO research according to the CONSORT-PRO extension. Many trials published since CONSORT-PRO's release did not report recommended CONSORT-PRO items, which may lead to misinterpretation and consequently to research waste.

PSMA PET/CT guided intensification of therapy in patients at risk of advanced prostate cancer (PATRON): a pragmatic phase III randomized controlled trial.

BACKGROUND: Positron emission tomography targeting the prostate specific membrane antigen (PSMA PET/CT) has demonstrated unparalleled performance as a staging examination for prostate cancer resulting in substantial changes in management. However, the impact of altered management on patient outcomes is largely unknown. This study aims to assess the impact of intensified radiotherapy or surgery guided by PSMA PET/CT in patients at risk of advanced prostate cancer. METHODS: This pan-Canadian phase III randomized controlled trial will enroll 776 men with either untreated high risk prostate cancer (CAPRA score 6-10 or stage cN1) or biochemically recurrent prostate cancer post radical prostatectomy (PSA > 0.1 ng/mL). Patients will be randomized 1:1 to either receive conventional imaging or conventional plus PSMA PET imaging, with intensification of radiotherapy or surgery to newly identified disease sites. The primary endpoint is failure free survival at 5 years. Secondary endpoints include rates of adverse events, time to next-line therapy, as well as impact on health-related quality of life and cost effectiveness as measured by incremental cost per Quality Adjusted Life Years gained. DISCUSSION: This study will help create level 1 evidence needed to demonstrate whether or not intensification of radiotherapy or surgery based on PSMA PET findings improves outcomes of patients at risk of advanced prostate cancer in a manner that is cost-effective. TRIAL REGISTRATION: This trial was prospectively registered in ClinicalTrials.gov as NCT04557501 on September 21, 2020.