The capsure database: a methodology for clinical practice and research in prostate cancer

doi:10.1016/S0090-4295(96)00226-9

Urology

Volume 48, Issue 5, November 1996, Pages 773-777

https://doi.org/10.1016/S0090-4295(96)00226-9 Get rights and content

Abstract

Objectives

Implicit in the modern concept of patient outcome assessment is a shift from primary reliance on clinical indicators to a broader definition that includes physical, psychological, and social well-being. This is especially true of prostate cancer, where treatment can profoundly alter patient well-being. We have initiated a longitudinal observational database, CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) to document the impact of prostate cancer on resource utilization, clinical outcomes, health-related quality of life, and survival in typical practice settings.

Methods

Observational databases have been used in the treatment of other conditions. We have incorporated many well-tested elements in our study. Data are collected from two sources: the physician and the patient. The urologist enrolls eligible patients into the study, completes a medical history, and records current status, treatment, and laboratory results at each office visit. Patients complete quarterly questionnaires on health-related quality of life, resource utilization, work loss, and satisfaction with care.

Results

Currently 21 sites participate in CaPSURE with 1419 patients enrolled by April 1996. Twenty percent of patients are newly diagnosed with prostate cancer. Time since diagnosis averages 3.0 years (SD = 3.1); mean age at diagnosis is 68.9 years (SD = 7.9, range = 39.6 to 90.7). The majority of patients (72%) are diagnosed with Stage B cancer. Patients receive a variety of treatments including surgery, irradiation, hormonal therapy, and watchful waiting.

Conclusions

Information available from CaPSURE will assist practicing urologists who must make clinical decisions on the basis of data such as the results of treatment in typical care settings, the effect of prostate cancer and its treatment methods on patient quality of life, and the effect on health care costs of the early detection of prostate cancer.

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Cited by (255)

Impact of Stress Urinary Incontinence After Radical Prostatectomy on Time to Intervention, Quality of Life and Work Status
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To characterize the incidence of stress urinary incontinence (SUI) after radical prostatectomy (RP), its treatment, and impact on quality of life (QoL) and work status 1 year after RP.
Prostate cancer patients treated by RP (1998-2016) were selected from CaPSURE. SUI was defined as any pads per day (ppd) 1 year after RP. SUI procedures were tracked by CPT codes (sling and artificial sphincter). Patients reported work status (full-time, part-time, unpaid), UCLA PCa Index urinary function (UF) and bother (UB) and SF36 Index physical function (PF). Associations of incontinence with UF, UB, and PF and work status changes were assessed (ANOVA). Lifetable estimates and Cox proportional hazards regression evaluated risk of undergoing SUI procedures.
664/2989 (22%) men treated with RP reported SUI at 1 year. More men with SUI had ≥GG2, intermediate to high-risk disease and non-nerve-sparing surgery (all P < .01).
Cumulative incidence of SUI procedures was 1.4% at 10 years after RP. Age (HR 2.68 per 10 years, 95% CI 1.41-5.08) and number of ppd at 1 year (HR 3.20, 95% CI 2.27-4.50) were associated with undergoing SUI procedures.
UF declined at 1 year after RP, while UB and PF remained stable. UF, UB, and PF were inversely associated with number of ppd (all P < .01). Change in work status was not associated with incontinence or QoL scores.
Incontinence affected QoL without impacting work status, suggesting that men with SUI after RP may continue working and go under-treated despite impact on QoL.
Long-term Prostate Cancer–specific Mortality After Prostatectomy, Brachytherapy, External Beam Radiation Therapy, Hormonal Therapy, or Monitoring for Localized Prostate Cancer
2023, European Urology
The optimal treatment of localized prostate cancer (PCa) remains controversial.
To compare long-term survival among men who underwent radical prostatectomy (RP), brachytherapy (BT), external beam radiation therapy (EBRT), primary androgen deprivation therapy (PADT), or monitoring (active surveillance [AS]/watchful waiting [WW]) for PCa.
This is a cohort study with long-term follow-up from the multicenter, prospective, largely community-based Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) registry. Men with biopsy-proven, clinical T1–3aN0M0, localized PCa were consecutively accrued within 6 mo of diagnosis and had clinical risk data and at least 12 mo of follow-up after diagnosis available.
PCa risk was assessed, and multivariable analyses were performed to compare PCa-specific mortality (PCSM) and all-cause mortality by primary treatment, with extensive adjustment for age and case mix using the Cancer of the Prostate Risk Assessment (CAPRA) score and a well-validated nomogram.
Among 11 864 men, 6227 (53%) underwent RP, 1645 (14%) received BT, 1462 (12%) received EBRT, 1510 (13%) received PADT, and 1020 (9%) were managed with AS/WW. At a median of 9.4 yr (interquartile range 5.8–13.7) after treatment, 764 men had died from PCa. After adjusting for CAPRA score, the hazard ratios for PCSM with RP as the reference were 1.57 (95% confidence interval [CI] 1.24–1.98; p < 0.001) for BT, 1.55 (95% CI 1.26–1.91; p < 0.001) for EBRT, 2.36 (95% CI 1.94–2.87; p < 0.001) for PADT, and 1.76 (95% CI 1.30–2.40; p < 0.001) for AS/WW. In models for long-term outcomes, PCSM differences were negligible for low-risk disease and increased progressively with risk. Limitations include the evolution of diagnostic and therapeutic strategies for PCa over time. In this nonrandomized study, the possibility of residual confounding remains salient.
In a large, prospective cohort of men with localized PCa, after adjustment for age and comorbidity, PCSM was lower after local therapy for those with higher-risk disease, and in particular after RP. Confirmation of these results via long-term follow-up of ongoing trials is awaited.
We evaluated different treatment options for localized prostate cancer in a large group of patients who were treated mostly in nonacademic medical centers. Results from nonrandomized trials should be interpret with caution, but even after careful risk adjustment, survival rates for men with higher-risk cancer appeared to be highest for patients whose first treatment was surgery rather than radiotherapy, hormones, or monitoring.
A 25-year perspective on advances in the study of the epidemiology, disparities, and outcomes of urologic cancers
2021, Urologic Oncology: Seminars and Original Investigations
In this narrative review, key developments in epidemiologic and clinical outcomes-based research from eminent historical data sources over the past quarter century are summarized. We then describe the rise of secondary and administrative datasets (AD), summarizing the predominant types of available secondary datasets for contemporary research and describe the benefits and inherent limitations in working with secondary data. We review the methodological advances that permit researchers to capitalize on the full capability of secondary data while also addressing the limitations inherent in utilizing these data for the purposes of epidemiologic and outcomes research. Finally, we present candidate strategies to perpetuate this momentum towards optimizing the development of clinical research infrastructure that harnesses the full potential of the ADs to further clinical and epidemiological research, advancing data analysis, and address the many unanswered questions that remain.
The multiple effects of aspirin in prostate cancer patients
2021, Cancer Treatment and Research Communications
Aspirin is a commonly used medication with anti-inflammatory and analgesic properties, and it is widely used to reduce the risk of ischaemic heart disease-related events and/or cerebrovascular accidents. However, there is also evidence from epidemiological and interventional studies to suggest that regular aspirin use can reduce the risk of prostate cancer development and progression, and can reduce the risk of disease recurrence following anti-prostate cancer therapy. Aspirin use in African-American men is associated with a reduced incidence of advanced PCa and reduced disease recurrence, and there is evidence from other studies of an association between regular aspirin use and decreased PCa-related mortality. The cyclooxygenase-2 enzyme inhibited by Aspirin and other NSAIDs, and which catalyses prostaglandin synthesis and mediates inflammation, is overexpressed in prostate cancer, therefore inhibition of cyclooxygenase-2 may have direct, and indirect, therapeutic effects. This review explores the evidence suggesting that aspirin use can modify prostate cancer biology and disease characteristics, and explores the potential mechanisms underpinning the observed associations between aspirin use and modification of prostate cancer risk. It also summarises the potential for adjuvant aspirin use to combine with other therapeutic approaches such as radical surgery and radiotherapy.
Radiotherapy after radical prostatectomy: Effect of timing of postprostatectomy radiation on functional outcomes
2020, Urologic Oncology: Seminars and Original Investigations
The timing of radiotherapy (RT) after prostatectomy is controversial, and its effect on sexual, urinary, and bowel function is unknown. This study seeks to compare patient-reported functional outcomes after radical prostatectomy (RP) and postprostatectomy radiation as well as elucidate the timing of radiation to allow optimal recovery of function.
The Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study is a prospective, population-based, observational study of men with localized prostate cancer. Patient-reported sexual, urinary, and bowel functional outcomes were measured using the 26-item Expanded Prostate Index Composite at baseline and at 6, 12, 36, and 60 months after enrollment. Functional outcomes were compared among men undergoing RP alone, post-RP adjuvant radiation (RP + aRT), and post-RP salvage radiation (RP + sRT) using multivariable models controlling for baseline clinical, demographic, and functional characteristics.
Among 1,482 CEASAR participants initially treated with RP for clinically localized prostate cancer, 11.5% (N = 170) received adjuvant (aRT, N = 57) or salvage (sRT, N = 113) radiation. Men who received post-RP RT had worse scores in all domains (sexual function [−9.0, 95% confidence interval {−14.5, −3.6}, P < 0.001], incontinence [−8.8, {−14.0, −3.6}, P < 0.001], irritative voiding [−5.9, {−9.0, −2.8}, P < 0.001], bowel irritative [−3.5, {-5.8, −1.2}, P = 0.002], and hormonal function [−4.5, {−7.2, −1.7}, P = 0.001]) compared to RP alone at 5 years of follow-up. Compared to men treated with RP alone in an adjusted linear model, sRT was associated with significantly worse scores in all functional domains. aRT was associated with significantly worse incontinence, urinary irritation, and hormonal function domain scores compared to RP alone at 5 years of follow-up. On multivariable modeling, RT administered approximately 24 months after RP was associated with the smallest decline in sexual domain score, with an adjusted mean decrease of 8.85 points (95% confidence interval [−19.8, 2.1]) from post-RP, pre-RT baseline.
In men with localized prostate cancer, post-RP RT was associated with significantly worse sexual, urinary, and bowel function domain scores at 5 years compared to RP alone. Radiation delayed for approximately 24 months after RP may be optimal for preserving erectile function compared to radiation administered closer to the time of RP.
Examining initial treatment and survival among men with metastatic prostate cancer: An analysis from the CaPSURE registry
2020, Urologic Oncology: Seminars and Original Investigations
New data is emerging to guide initial treatment of patients with metastatic prostate cancer (CaP). This study utilizes the Cancer of the Prostate Strategic Urologic Research Endeavor registry to evaluate variations in survival based on initial treatment received by men with metastatic disease at diagnosis or after progression.
Cancer of the Prostate Strategic Urologic Research Endeavor is a national registry of men diagnosed with CaP and managed at 43 community, academic, and Veteran's centers. We examined socio-demographic factors, disease biology, initial and subsequent therapy received, and survival among patients who presented with de novo or recurrent metastatic disease stratified by receipt of initial local therapy vs. combined local and hormonal therapy. The outcome was prostate cancer specific mortality (PCSM). We performed Fine and Gray competing risks regression analysis to evaluate the association between timing of metastasis and PCSM, adjusted for age, initial treatment, and subsequent therapy.
Of the 14,753 patients diagnosed with CaP from 1990 to 2016, 669 (5%) had metastatic disease. Among the examined patients, 303 (45%) had metastatic disease at diagnosis and 366 (55%) progressed to metastatic disease. Overall, 461 (69%) were ≥65 years old, 582 (87%) had Medicare, and 227 (34%) had an annual income < $30,000. Prostate-specific antigen at diagnosis was >20 ng/ml for 342 (51%) patients and biopsy Gleason grade was ≥4 + 3 for 386 (58%) patients. Among patients with metastatic disease at diagnosis, 31 (10%) received initial local therapy and 272 (90%) received initial hormonal therapy. Among patients who progressed to metastatic disease, 239 (65%) received initial local therapy and 127 (35%) received initial systemic hormonal therapy. Among patients with metastatic disease, the multivariate competing risks model, after adjusting for sociodemographics, marital status, diagnosis year, and comorbidities, revealed a significantly lower risk of PCSM among patients with de novo vs. recurrent metastatic disease (Hazard Ratio 0.66 (95% Confidence Interval 0.51, 0.85) P = 0.002). In the stratified analysis, no difference was seen for patients treated with initial hormonal vs. combined local and hormonal therapy.
In this analysis of a nationwide cohort of men treated for CaP with all types of therapy over 25 years, we observed that among men with metastatic CaP, the risk of PCSM was lower for de novo vs. recurrent metastatic disease. Additionally, no difference was observed based on initial treatment with combined local and hormonal therapy vs. hormonal therapy alone.

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^*: This research is supported by funding from TAP Holdings Inc., Deerfield, Illinois.

^†: The CaPSURE Research Panel also includes James Cochran, Donald Finnerty, Eugene Kramalowsky, Robert Segaul, and Jay Young.

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Adult urologyThe capsure database: a methodology for clinical practice and research in prostate cancer*

Objectives

Methods

Results

Conclusions

Comput Biomed Res

Quality-of-life outcomes in men treated for localized prostate cancer

JAMA

Cancer statistics, 1995

CA Cancer J Clin

Tong T and Montgomery S

Cancer statistics, 1994. CA Cancer J Clin

Clinical data bases: accomplishments and unrealized potential

Med Care

The dimensions of health outcomes: the Health Assessment Questionnaire disability, and pain scales

J Rheumatol

A multicenter study of hospitalization in rheumatoid arthritis: effect of health care system severity, and regional difference

J Rheumatol

The clinical value of the Stanford Health Assessment Questionnaire Functional Disability Index in patients with rheumatoid arthritis

J Rheumatol

A multicenter study of annual health service utilization and costs in rheumatoid arthritis

Arthritis Rheum

The economic impact of rheumatoid arthritis

The economic impact of arthritis

Arth Care Res

A question of value: measuring the impact of chronic disease

Milbank Q

Adult urology
The capsure database: a methodology for clinical practice and research in prostate cancer*