Implementation of a Telehealth Genetic Testing Station to Deliver Germline Testing for Men With Prostate Cancer.

PURPOSE: Germline testing for men with prostate cancer (PCa) poses numerous implementation barriers. Alternative models of care delivery are emerging, but implementation outcomes are understudied. We evaluated implementation outcomes of a hybrid oncologist- and genetic counselor-delivered model called the genetic testing station (GTS) created to streamline testing and increase access. METHODS: A prospective, single-institution, cohort study of men with PCa referred to the GTS from October 14, 2019, to October 14, 2021, was conducted. Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, we described patients referred to GTS (Reach), the association of GTS with germline testing completion rates within 60 days of a new oncology appointment in a pre- versus post-GTS multivariable logistic regression (Effectiveness), Adoption, Implementation, and Maintenance. Because GTS transitioned from an on-site to remote service during the COVID-19 pandemic, we also compared outcomes for embedded versus remote GTS. RESULTS: Overall, 713 patients were referred to and eligible for GTS, and 592 (83%) patients completed germline testing. Seventy-six (13%) patients had ≥ 1 pathogenic variant. Post-GTS was independently associated with higher odds of completing testing within 60 days than pre-GTS (odds ratio, 8.97; 95% CI, 2.71 to 29.75; P < .001). Black race was independently associated with lower odds of testing completion compared with White race (odds ratio, 0.35; 95% CI, 0.13 to 0.96; P = .042). There was no difference in test completion rates or patient-reported decisional conflict for embedded versus remote GTS. GTS has been adopted by 31 oncology providers across four clinics, and implementation fidelity was high with low patient loss to follow-up, but staffing costs are a sustainability concern. CONCLUSION: GTS is a feasible, effective model for high-volume germline testing in men with PCa, both in person and using telehealth. GTS does not eliminate racial disparities in germline testing access.

ICD-11 adjustment disorder following diagnostic procedures of prostate cancer: A 12-month follow-up study.

OBJECTIVE: The medical procedures in diagnosing or treating prostate cancer may impair adjustment and quality of life. The current prospective study aimed to evaluate the trajectories of symptoms of ICD-11 adjustment disorder in patients diagnosed vs. non-diagnosed with prostate cancer before (T1), after diagnostic procedures (T2), and at 12-month follow-up (3). METHODS: In total, 96 male patients were recruited before prostate cancer diagnostic procedures. The mean age of the study participants at baseline was 63.5 (SD = 8.4), ranging from 47 to 80 years; 64% were diagnosed with prostate cancer. Adjustment disorder symptoms were measured using the Brief Adjustment Disorder Measure (ADNM-8). RESULTS: The prevalence of ICD-11 adjustment disorder was 15% at T1, 13% at T2, and 3% at T3. The effect of cancer diagnosis was not significant on adjustment disorder. A medium main effect for time was detected on adjustment symptom severity, F(2, 134) = 19.26, p < .001, partial η2 = 0.223, with symptoms significantly lower at 12-month follow-up, compared to T1 and T2, p < .001. CONCLUSIONS: The study's findings reveal the increased levels of adjustment difficulties in males undergoing the diagnostic process of prostate cancer.

Changes in use of low-value services during the COVID-19 pandemic.

The COVID-19 pandemic led to a significant disruption, then recovery, of health care services use. Prior research has not examined the relative rates of resumption of high-value and low-value care. We examined the use of 6 common low-value services that received a D grade from the US Preventive Services Task Force compared with clinically comparable high-value services in a large commercially insured population nationwide from before the pandemic to April 1, 2021. We found that, overall, low-value services and high-value services were disrupted similarly. In aggregate, low-value care declined to 56.2% and high-value care to 53.2% in the initial month of the pandemic (April 2020) relative to baseline (number of visits in 2019 normalized by relevant enrolled population), then rebounded to 83.1% of baseline for low-value services and 95.0% of baseline for high-value services by January 2021. Substantial heterogeneity appeared across clinical contexts, such as prostate cancer screening for men 70 years and older rebounding to 111.8% of baseline and asymptomatic chronic obstructive pulmonary disease screening remaining at 38.5% of baseline in January 2021. This suggests that although, on average, resuming lower-value services may have been perceived to be a lesser priority by providers and patients, the pandemic may have had heterogeneous effects on consumer and provider decision-making along the dimension of clinical value. This enhances our understanding of how disruptions affect the relationship between clinical value and usage of different services and suggests the need for more targeted interventions to reduce low-value care.

How I Use It: The Exosome Diagnostics (EPI) prostate cancer biomarker utility in urology and primary care.

Prostate-specific antigen (PSA) screening remains the mainstay for early detection of prostate cancer. Although PSA is a nonspecific prostate cancer biomarker, its specificity for high grade prostate cancer can be enhanced by pre-biopsy liquid biomarkers including the Exosome Dx Prostate IntelliScore (EPI) test. EPI is a stand-alone urine genomic test that measures 3 exosome-derived gene expression signatures without the need for digital rectal examination (DRE) or inclusion of standard of care parameters in the test algorithm. EPI has broad clinical utility as a risk stratification tool for clinically significant high grade prostate cancer in men considering diagnostic prostate biopsy (MRI-targeted and systematic biopsy). During the COVID-19 pandemic, the EPI At-Home Collection Kit was introduced and quickly became an important component of tele-urology. The EPI test has emerged as a prioritization tool for primary care referral to urologists and for prostate biopsy scheduling. EPI provides an objective and actionable genomic risk assessment tool for high grade prostate cancer and is a critical part of the informed decision-making regarding biopsy (targeted, systematic or both) in both urology and primary care practices.

Trends in breast and prostate cancer screening and diagnostic procedures during the COVID-19 pandemic in central Massachusetts.

PURPOSE: We calculated rates of breast and prostate cancer screening and diagnostic procedures performed during the COVID-19 pandemic through December 2021 compared to the same months in 2019 in a large healthcare provider group in central Massachusetts. METHODS: We included active patients of the provider group between January 2019 and December 2021 aged 30-85 years. Monthly rates of screening mammography and digital breast tomosynthesis, breast MRI, total prostate specific antigen (PSA), and breast or prostate biopsy per 1,000 people were compared by year overall, by age, and race/ethnicity. Completed procedures were identified by relevant codes in electronic health record data. RESULTS: Rates of screening mammography, tomosynthesis, and PSA testing reached the lowest levels in April-May 2020. Breast cancer screening rates decreased 43% in March and 99% in April and May 2020, compared to 2019. Breast cancer screening rates increased gradually beginning in June 2020 through 2021, although more slowly in Black and Hispanic women and in women aged 75-85. PSA testing rates decreased 34% in March, 78% in April, and 53% in May 2020, but rebounded to pre-pandemic levels by June 2020; trends were similar across groups defined by age and race/ethnicity. CONCLUSION: The observed decline in two common screening procedures during the COVID-19 pandemic reflects the impact of the pandemic on cancer early detection and signals potential downstream effects on the prognosis of delayed cancer diagnoses. The slower rate of return for breast cancer screening procedures in certain subgroups should be investigated to ensure all women return for routine screenings.

The effect of COVID-19 on prostate cancer testing in Australia.

AIM: The effects of the COVID-19 pandemic on healthcare in Australia have yet to be fully determined. There are well documented decreases in the rates of screening and diagnostic testing for many cancers in 2020, with commensurate stage migration of cancers when they are eventually detected. We aimed to determine whether there was a decrease in the rate of prostate cancer (PC) screening and testing in Australia in 2020. METHOD: Data was extracted from the Department of Human Services (DHS) website for Medicare Benefits Schedule (MBS) item numbers for tests pertinent to detection of Prostate Cancer. This data is de-identified and publicly available. Data was analysed at both a national, and a state level. RESULTS: For 2020 nationwide the percentage change for prostate cancer testing was minor with 97% as many PSA tests, 99% as many prostate MRIs, and 105% as many prostate biopsies as the average for the preceding years. The differences were not significant (PSA tests p = 0.059 and prostate biopsies p = 0.109). The predicted values are fairly similar to both the average values for the preceding 5 years and the actual number of tests done in 2020. With exception of PSA tests in Victoria the actual number of tests performed was within the 95% Prediction Interval (performed: 167,426; predicted 171,194-196,699; p = 0.015). CONCLUSION: The current pandemic has had a widespread reach across Australia, with varying impact across each state and territory. Contrary to the trends across the world, our data suggest that during 2020 in Australia most areas remained unaffected in terms of prostate cancer testing excluding Victoria, which had statistically significant decrease in the number of PSA tests correlating with the extended lockdown that occurred in the state.

Strengthening Capacity for Prostate Cancer Early Diagnosis in West Africa Amidst the COVID-19 Pandemic: A Realist Approach to Rethinking and Operationalizing the World Health Organization 2017 Guide to Cancer Early Diagnosis.

Two years after SARS-CoV-2 (COVID-19) was declared a global public health emergency, the restoration, at least, to the pre-pandemic level of early diagnostic services for prostate cancer has remained enormously challenging for many health systems, worldwide. This is particularly true of West Africa as the region grapples also with the broader impacts of changing demographics and overly stretched healthcare systems. With the lingering COVID-19 crisis, it is likely that the current trend of late prostate cancer diagnosis in the region will worsen with a concomitant increase in the burden of the disease. There is, therefore, a compelling need for innovative and evidence-based solutions to de-escalate the current situation and forestall the collapse of existing structures supporting early prostate cancer diagnosis in the region. In this viewpoint, we make a case for the operationalization of the World Health Organization (WHO) guide to early cancer diagnosis to strengthen the capacity for early prostate cancer diagnosis in West Africa using a realist approach, drawing on participatory health research and evidence-based co-creation. Ultimately, we demonstrate the potential for developing COVID-19 responsive and context-specific models to optimize patient navigation/journey along the essential steps of the World Health Organization guide to early cancer diagnosis.

Lessons learned after one year of COVID-19 from a urologist and radiotherapist view: A German survey on prostate cancer diagnosis and treatment.

INTRODUCTION: Since the beginning of the pandemic in 2020, COVID-19 has changed the medical landscape. International recommendations for localized prostate cancer (PCa) include deferred treatment and adjusted therapeutic routines. MATERIALS AND METHODS: To longitudinally evaluate changes in PCa treatment strategies in urological and radiotherapy departments in Germany, a link to a survey was sent to 134 institutions covering two representative baseline weeks prior to the pandemic and 13 weeks from March 2020 to February 2021. The questionnaire captured the numbers of radical prostatectomies, prostate biopsies and case numbers for conventional and hypofractionation radiotherapy. The results were evaluated using descriptive analyses. RESULTS: A total of 35% of the questionnaires were completed. PCa therapy increased by 6% in 2020 compared to 2019. At baseline, a total of 69 radiotherapy series and 164 radical prostatectomies (RPs) were documented. The decrease to 60% during the first wave of COVID-19 particularly affected low-risk PCa. The recovery throughout the summer months was followed by a renewed reduction to 58% at the end of 2020. After a gradual decline to 61% until July 2020, the number of prostate biopsies remained stable (89% to 98%) during the second wave. The use of RP fluctuated after an initial decrease without apparent prioritization of risk groups. Conventional fractionation was used in 66% of patients, followed by moderate hypofractionation (30%) and ultrahypofractionation (4%). One limitation was a potential selection bias of the selected weeks and the low response rate. CONCLUSION: While the diagnosis and therapy of PCa were affected in both waves of the pandemic, the interim increase between the peaks led to a higher total number of patients in 2020 than in 2019. Recommendations regarding prioritization and fractionation routines were implemented heterogeneously, leaving unexplored potential for future pandemic challenges.

Association of the COVID-19 Pandemic With Rates of Prostate Cancer Biopsies and Diagnoses in Black vs White US Veterans.

Importance: Several studies have assessed the negative effect of the COVID-19 pandemic on cancer screening and diagnosis rates. However, this has not been evaluated for prostate biopsy and prostate cancer (PC) diagnosis in an equal-access health care system. Objective: To determine the association of the pandemic with prostate biopsy and PC diagnosis rates among Black vs White patients in the Veterans Affairs Health Care System (VAHCS). Design, Setting, and Participants: This cohort study included a retrospective analysis of all prostate biopsies performed on patients in the VAHCS without a preexisting PC diagnosis between January 2018 and March 2021. The base population included all living male patients who had at least 1 visit to the VAHCS during the 3 years prior to each month of the study. Exposure: The COVID-19 pandemic. Main Outcomes and Measures: The main outcomes were the number of prostate biopsies and PC diagnoses by month. The influence of the pandemic on prostate biopsy volume and the incidence of PC diagnoses was modeled using an interrupted time-series analysis. Poisson generalized linear models were fitted to project the expected number of prostate biopsies and PC diagnoses had there been no pandemic interruption. Additional models were used to test for differences by race. Results: Prior to the pandemic (January 2018 through February 2020), monthly biopsy numbers among 51 606 included men ranged between 1230 and 1695, of which 56% to 60% of results were positive for PC. The estimated number of missed PC diagnoses from March 2020 through March 2021 ranged from 97 cases (October 2020: 752 cases expected, 655 cases observed) to 573 cases (April 2020: 794 cases expected, 221 cases observed). Prior to the pandemic, biopsy rates were statistically significantly higher among Black vs White men (incidence rate ratio, 2.25; 95% CI, 2.06-2.46; P < .001). There was no change in biopsy rates associated with race at the onset of the pandemic nor during the recovery period from March 2020 to March 2021. Similar trends were observed for PC diagnosis rates. Conclusions and Relevance: Results of this cohort study demonstrate that during the COVID-19 pandemic, prostate biopsy and PC diagnosis rates decreased, particularly during the peak of the pandemic. However, there were no statistically significant changes in rates by race.

Change from transrectal to transperineal ultrasound-guided prostate biopsy under local anaesthetic eliminates sepsis as a complication.

Transrectal ultrasound-guided (TRUS) biopsy of the prostate is associated with increased risk of post-procedural sepsis with associated morbidity, mortality, re-admission to hospital, and increased healthcare costs. In the study institution, active surveillance of post-procedural infection complications is performed by clinical nurse specialists for prostate cancer under the guidance of the infection prevention and control team. To protect hospital services for acute medical admissions related to the coronavirus disease 2019 (COVID-19) pandemic, TRUS biopsy services were reduced nationally, with exceptions only for those patients at high risk of prostate cancer. In the study institution, this change prompted a complete move to transperineal (TP) prostate biopsy performed in outpatients under local anaesthetic. TP biopsies eliminated the risk of post-procedural sepsis and, consequently, sepsis-related admission while maintaining a service for prostate cancer diagnosis during the COVID-19 pandemic.

Increasing the uptake in a general practice prostate cancer screening programme.

BACKGROUND: Prostate cancer (PC) is the second most common cause of cancer deaths among males worldwide. Prostate-specific antigen (PSA) is a predictive indicator of prostate pathology. Men with elevated PSA levels are at increased risk of developing PC. There is currently no UK national PC screening programme, therefore patients often present to general practices (GPs) at later stages of pathology, worsening patient prognosis and outcomes. LOCAL PROBLEM: The location of the GP surgery had a large patient population at increased risk of PC, namely Afro-Caribbean/Asian males. METHODS: We conducted baseline measurements to identify male patients over the age of 65 and/or male patients who were at high risk of developing PC. These included previous referred patients or patients with a PSA over 10.0. We then implemented three plan-do-study-act (PDSA) cycles and measured their effect after 2 weeks of starting the respective intervention. INTERVENTIONS: PDSA1: Generating a list of target patients who have not had repeat/follow-up/referral and directly contacting by telephone to invite them for a blood test.PDSA2: Creating patient-specific electronic pop-up reminders on the electronic-patient-record system for PSA follow-up/referral/repeat test.Planned PDSA3: Patient education of prostate health and general self-checking, as well as benefits/risks of undergoing PSA screening in the form of patient focus groups and informative leaflets. RESULTS: We identified 220 male patients over 65 registered at a large South London GP surgery. 77.7% of eligible patients had a PSA measurement since 1 April 2019. Our results showed an overall increase in screening of 13.5% from baseline. CONCLUSIONS: Our project identified patients that may potentially have undiagnosed prostate pathology. However, a key factor for not reaching our goal was blood test refusal. This was further exacerbated by the COVID-19 pandemic, impacting the capacity to disseminate appropriate information to the local population on the importance of PSA screening.

Implications and effects of COVID-19 on diagnosis and management of prostate cancer.

PURPOSE OF REVIEW: The Coronavirus disease 2019 (COVID-19) pandemic has led to uncertainty on the optimal management for prostate cancer (PCa). This narrative review aims to shed light on the optimal diagnosis and management of patients with or suspected to have PCa. RECENT FINDINGS: Faecal-oral or aerosol transmission is possible during prostate procedures; caution must be in place when performing digital rectal examinations, transrectal ultrasound-guided prostate biopsies and prostate surgeries requiring general anaesthesia. Patients must also be triaged using preoperative polymerase chain reaction tests for COVID-19. COVID-19 has accelerated the adoption of multiparametric Magnetic Resonance Imaging (MRI), reducing the need for prostate biopsy unless when absolutely indicated, and the risk of COVID-19 spread can be reduced. Combined with prostate-specific antigen (PSA) density, amongst other factors, multiparametric MRI could reduce unnecessary biopsies in patients with little chance of clinically significant PCa. Treatment of PCa should be stratified by the risk level and preferences of the patient. COVID-19 has accelerated the development of telemedicine and clinicians should utilise safe and effective teleconsultations to protect themselves and their patients. SUMMARY: COVID-19 transmission during prostate procedures is possible. Patients with a Prostate Imaging-Reporting and Data System (PI-RADS) of <3 and PSA density <0.15 ng/ml/ml are deemed low-risk and are safe to undergo surveillance without MRI-targeted biopsy. Intermediate- or high-risk patients should be offered definitive treatment within four months or 30days of diagnosis to avoid compromising treatment outcomes; three-month courses of neoadjuvant androgen deprivation therapy can be considered when a delay of surgery is anticipated.

Impact of the COVID-19 pandemic on the diagnosis and treatment of men with prostate cancer.

OBJECTIVE: To determine the impact of the COVID-19 pandemic on diagnostic and treatment activity in 2020 across hospital providers of prostate cancer (PCa) care in the English National Health Service. METHODS: Diagnostic and treatment activity between 23 March (start of first national lockdown in England) and 31 December 2020 was compared with the same calendar period in 2019. Patients newly diagnosed with PCa were identified from national rapid cancer registration data linked to other electronic healthcare datasets. RESULTS: There was a 30.8% reduction (22 419 vs 32 409) in the number of men with newly diagnosed PCa in 2020 after the start of the first lockdown, compared with the corresponding period in 2019. Men diagnosed in 2020 were typically at a more advanced stage (Stage IV: 21.2% vs 17.4%) and slightly older (57.9% vs 55.9% ≥ 70 years; P < 0.001). Prostate biopsies in 2020 were more often performed using transperineal (TP) routes (64.0% vs 38.2%). The number of radical prostatectomies in 2020 was reduced by 26.9% (3896 vs 5331) and the number treated by external beam radiotherapy (EBRT) by 14.1% (9719 vs 11 309). Other changes included an increased use of EBRT with hypofractionation and reduced use of docetaxel chemotherapy in men with hormone-sensitive metastatic PCa (413 vs 1519) with related increase in the use of enzalutamide. CONCLUSION: We found substantial deficits in the number of diagnostic and treatment procedures for men with newly diagnosed PCa after the start of the first lockdown in 2020. The number of men diagnosed with PCa decreased by about one-third and those diagnosed had more advanced disease. Treatment patterns shifted towards those that limit the risk of COVID-19 exposure including increased use of TP biopsy, hypofractionated radiation, and enzalutamide. Urgent concerted action is required to address the COVID-19-related deficits in PCa services to mitigate their impact on long-term outcomes.

Androgen deprivation therapy, comorbidity, cancer stage and mortality from COVID-19 in men with prostate cancer.

BACKGROUND: Androgens facilitate entrance of the severe acute respiratory syndrome coronavirus 2 into respiratory epithelial cells, and male sex is associated with a higher risk of death from corona virus disease (COVID-19). Androgen deprivation therapy (ADT) could possibly improve COVID-19 outcomes. METHODS: In a case-control study nested in the Prostate Cancer data Base Sweden (PCBaSe) RAPID 2019, we evaluated the association between ADT and COVID-19 as registered cause of death in men with prostate cancer. Each case was matched to 50 controls by region. We used conditional logistic regression to adjust for confounders and also evaluated potential impact of residual confounding. RESULTS: We identified 474 men who died from COVID-19 in March-December 2020. In crude analyses, ADT exposure was associated with an increased risk of COVID-19 death (odds ratio [OR] 5.05, 95% CI: 4.18-6.10); however, the OR was substantially attenuated after adjustment for age, comorbidity, prostate cancer characteristics at diagnosis, recent healthcare use, and indicators of advanced cancer (adjusted OR 1.25, 95% CI: 0.95-1.65). If adjustment has accounted for at least 85% of confounding, then the true effect could be no more than a 5% reduction of the odds for COVID-19 death. CONCLUSIONS: The increased mortality from COVID-19 in men with prostate cancer treated with ADT was mainly related to high age, comorbidity, and more advanced prostate cancer. There was no evidence to support the hypothesis that ADT is associated with improved COVID-19 outcomes.