National Prostate Cancer Registries: Contemporary Trends of Prostate Cancer in the United States

National Prostate Cancer Registries: Contemporary Trends of Prostate Cancer in the United States

the Specialty urologypracticejournal.com Review Article: National Prostate Cancer Registries: Contemporary Trends of Prostate Cancer in the United St...

135KB Sizes 0 Downloads 71 Views

the Specialty urologypracticejournal.com

Review Article: National Prostate Cancer Registries: Contemporary Trends of Prostate Cancer in the United States Ahmed A. Hussein,* Christopher J. Welty,* Jeanette Broering,* Matthew R. Cooperbergy,z and Peter R. Carrollx From the Department of Urology and Helen Diller Family Comprehensive Cancer Center (AAH, CJW, JB, PRC) and Department of Epidemiology and Biostatistics, University of California-San Francisco (MRC), San Francisco, California, and Department of Urology, Cairo University (AAH), Egypt

Abstract

Abbreviations and Acronyms

Introduction: Randomized clinical trials are considered the gold standard for evidence-based practices but strict inclusion and exclusion criteria, costs to perform them and the time required to design and complete them may limit generalizability, followup and timeliness. Observational studies based on well designed, large volume patient registries may be more flexible in that scope. Such registries can be modified with time to incorporate new treatments as they emerge. Methods: We describe the design, objectives, funding mechanisms and results to date of the major prostate cancer registries in the United States, highlighting as examples PCOS, CaPSUREÔ, PROST-QA, CEASAR, MUSIC and AQUA. Results: Registries and collaborations have provided valuable knowledge for prostate cancer regarding oncologic and health related quality of life outcomes among treatments, changes in disease prevalence, staging, national practice trends and health service utilization. Conclusions: While there are important limitations to observational data, registries will continue to have an important and growing role in advancing prostate cancer care as a complement to data from clinical trials and traditional cohort studies.

ADT = androgen deprivation therapy

Key Words: prostatic neoplasms, registries, epidemiologic research design, observational study as topic, data collection

EPIC = Expanded Prostate Cancer Index Composite

AQUA = AUA Quality Registry AUA = American Urological Association CAPRA = Cancer of the Prostate Risk Assessment CaPSURE = Cancer of the Prostate Strategic Urologic Research Endeavor CEASAR = Comparative Effectiveness Analysis of Surgery and Radiation EBRT = external beam radiotherapy

HRQOL = health related quality of life

Randomized clinical trials are still considered the gold standard for examining the safety and efficacy of new drugs or devices. However, their usefulness for generalizability may be limited due to strict constraints of inclusion and exclusion criteria. RCTs are also costly to perform. A recent study showed that approximately 1 of 4 genitourinary clinical

Submitted for publication May 8, 2014. * No direct or indirect commercial incentive associated with publishing this article. y Correspondence: Department of Urology, University of California-San Francisco, 1600 Divisadero St., Box 1695, San Francisco, California 94143 (telephone: 415-885-3660; FAX: 415-353-7093; e-mail address: mcooperberg@ urology.ucsf.edu). 2352-0779/14/14-198/0 Ó 2014 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION Published by Elsevier

trials terminate prematurely, mainly due to poor accrual.1 This was the case in the SPIRIT (Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial)2 and Observation or Radical Treatment in Patients With Prostate Cancer trials.3 The failure of these and other trials has led to the use by necessity of claims based databases such as Medicare, and national z

Financial interest and/or other relationship with Myriad, Genomic Health, GenomeDx, Dendreon, Astellas, Janssen and Abbott. x Financial interest and/or other relationship with Myriad Genetics, Genomic Health International, Takeda, GHI and Medivation/Astellas.

MUSIC = Michigan Urological Surgery Improvement Collaborative PADT = primary ADT PCa = prostate cancer PCOS = Prostate Cancer Outcomes Study PROST-QA = Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment study PSA = prostate specific antigen RCT = randomized clinical trial RP = radical prostatectomy RT = radiation therapy SEER = Surveillance, Epidemiology and End Results WW = watchful waiting

AND

RESEARCH, INC.

http://dx.doi.org/10.1016/j.urpr.2014.07.005 Urology Practice Vol. 1, 198-204, November 2014

National Prostate Cancer Registries

199

databases such as SEER and NCDB (National Cancer Database) for comparative effectiveness and health services research. While such data sources offer ready access to population based data, the depth of their clinical data is limited. In addition, although they are population based, they may only represent a specific subgroup of the entire population. Medicare in particular includes only individuals older than 65 years and it excludes those enrolled in Medicare managed care plans, who may differ in important and nonrandom ways from those in Medicare Fee-for-Service.4 Finally, because data are reported by billing/coding specialists and/or cancer registrars rather than clinicians, data accuracy is not always assured. A well designed, prospective patient registry offers a third path, one that is more labor intensive and costly than a claims based database but much less so than a RCT and with excellent data accuracy and depth. A registry can be more flexible in scope and be modified with time to incorporate new treatments as they emerge. A registry can also accomplish long-term followup more easily than a RCT. The result is that different stakeholders may perceive value and benefits from patient registries in different ways, such as clinicians (ie real world perspectives of disease and current treatment practices), physician organizations (ie assessment of the degree to which evidence-based guidelines are implemented) and payer perspectives (ie assessment of the usefulness of procedures or devices at the population level). In addition, other study designs that focus on more limited patient populations and focused research questions, such cohort, case-control and even RCTs, can come from within and be facilitated by registries.5 AHRQ (Agency for Healthcare Research and Quality) has sponsored the RoPR (Registries of Patient Registries) initiative since 2005. This suggests that well designed patient registries can be powerful tools to observe the course of disease with time, understand variations in treatments and outcomes, examine factors that influence prognosis and quality of life, describe patterns of care such as disparities in care delivery, and assess care effectiveness.5 Some of the largest registries and cohorts have been used to track and report PCa outcomes. Key examples (not all) are summarized in this review.

Patients reported baseline urinary incontinence but not irritative or obstructive symptoms, and bowel and sexual function 6 months after the initial diagnosis and during the last month. HRQOL questionnaires were collected at 12 and 24 months.6 The PCOS questionnaire was based on the previously validated SF-36Ò for general HRQOL and the UCLA-PCI (University of California-Los Angeles Prostate Cancer Index). The survey instrument was also translated and validated in Spanish.6 PCOS data showed that in 1994 to 1995, 47.6% of patients with localized PCa underwent RP, 23.4% received RT, 10.5% received PADT and 18.5% were treated with WW.7 Age 75 years or greater was associated with more conservative treatment, defined as PADT or WW. Another PCOS study showed that black men who had higher risk tumors were less likely to undergo RP than white men (35.2% vs 52.0%) and more likely to receive conservative treatment (38.9% vs 16.3%).8 A recent PCOS study revealed that in contrast to RT, RP was associated with a significant decrease in overall as well as cancer specific mortality in men diagnosed with localized PCa.9 This benefit was particularly noted in younger patients (age 65 years or less), healthier patients with a lower Charlson comorbidity index score and those with higher risk cancer. However, these findings should be interpreted cautiously since they may have been the result of residual selection bias rather than a true survival benefit. Several groups examined comparative posttreatment HRQOL using PCOS. Penson et al noted no statistical difference in general HRQOL domains in patients who received different treatments for localized PCa at 2 years.10 Another study demonstrated that men who elected RP were more likely to have incontinence and erectile dysfunction than patients who received RT, although each therapy showed decreased rates.11 Patients who received RT reported more bowel dysfunction. Resnick et al found that at 15 years men who elected RP and those who received RT experienced decreased outcomes in all functional domains.12 Notably that study did not include an untreated, age matched control group. Therefore, it was not possible to account for the effect of an age related decrease in these domains with time rather than the effect of PCa treatment.

PCOS

CaPSURE

PCOS is a population based outcomes study developed at NCI (National Cancer Institute) in 1994 to study variations in treatment strategies in men newly diagnosed with biopsy proven PCa as well as HRQOL outcomes, especially urinary, bowel and sexual function.6 A total of 11,137 men diagnosed with PCa between 1994 and 1995 from 6 of the 10 SEER cancer registries were eligible for PCOS. Patients were sampled according to a prespecified design to ensure a representative sample of all patients, including different ethnic groups and patients younger than 60 years. Nevertheless, PCOS is a crosssectional database with a fixed number of patients, which limits the reproducibility of outcomes. Bias may be introduced by the high rate of nonresponders, which may reflect a certain sociodemographic pattern.

CaPSURE was initiated on May 10, 1995 as a longitudinal, disease specific, observational registry of men with PCa.13 As of April 2014, almost 15,000 men have participated in CaPSURE from a total of 43 mostly community based urology practices around the United States. Since each PCa treatment can have a different impact on clinical, economic and HRQOL outcomes, an observational registry such as CaPSURE allows men to be followed in a naturalistic setting to determine treatment effects in the real world. CaPSURE collects clinician reported outcomes as well as patient reported outcomes using validated instruments to assess survival status, duration of disease-free survival, HRQOL, satisfaction with care and the economic burden of treatment. The secure CaPSURE website enables treating urologists to graphically display trends in

200

National Prostate Cancer Registries

outcomes at the participant level. Additionally, urologists can benchmark their practices against the national aggregate sample stratified by treatment type and by a number of patient reported outcomes. CaPSURE was funded for many years through a successful partnership between academia and industry. From its inception until 2007 it was funded by TAP Pharmaceutical Products, Lake Forest, Illinois. From 2007 to 2013 it was funded by a smaller educational grant from Abbott Laboratories, Chicago, Illinois, along with federal grants. CaPSURE is currently funded entirely though federal grants. Importantly data integrity, data analysis and publications are constantly supervised and monitored by academic investigators without influence from industry. Informed consent was obtained from each patient under central institutional review board supervision.13 CaPSURE collects approximately 1,000 urologist and patient reported variables, including history, biopsy details, pathology findings, staging tests, primary and subsequent treatments (RP, EBRT, brachytherapy, PADT, neoadjuvant ADT, cryosurgery, active surveillance and WW), Karnofsky performance status scores and medications. Data are collected at entry and every 6 months thereafter with regular monitoring to ensure completeness and validity. At each followup visit the urologist documents current disease status and any change in the mentioned data. Starting in 1999 only men with newly diagnosed PCa have been enrolled in CaPSURE.13 At enrollment each patient completes a questionnaire, including baseline HRQOL using SF-36 and UCLA-PCI as well as EPIC-26 since 2011.14 Patients are mailed followup questionnaires every 6 months. In 2011 assessment of the fear of disease recurrence and satisfaction with care were added. Aspects of health care utilization, including hospitalizations, outpatient services and emergency department use, are also captured. Patients are followed to death or study withdrawal.15 CaPSURE data have formed the basis of 170 published scientific studies of clinical outcomes, HRQOL, economic costs of treatment, practice patterns and health services, risk stratification, and the impact of diet and lifestyle on PCa progression.16,17 In the last 15 years CaPSURE has helped identify and describe changes in PCa disease patterns. Cooperberg et al found that disease trends were consistent with downward stage migration.18 The incidence of patients who presented with low risk disease, defined as PSA less than 10 ng/ml, Gleason score less than 7 without pattern 4 or 5 disease and clinical stage T2 or greater, increased from 31% in 1990 to 47% in 2002 and then remained relatively stable. These findings are currently challenged by those of Glass et al, who used CaPSURE data on men newly diagnosed with PCa.19 During 2008 to 2011 the proportion of men diagnosed with Gleason score 7 or greater was 50% compared to 34% in 1999 to 2001. However, these findings may reflect changes in grading and sampling standards rather than actual disease up-staging. CaPSURE data were used to compare the oncologic outcomes of different treatments for localized PCa. RP was associated with a significant decrease in mortality compared to

RT and ADT, especially in men with intermediate and higher risk disease.20 CaPSURE data also suggested that there is overtreatment of low risk disease. Barocas et al found underuse of active surveillance in the United States, where only 9% of men eligible for active surveillance elect it.21 The inclusion of practices in large urban areas, smaller cities and retirement communities has allowed investigators to describe treatment patterns and variability in PCa. Kindrick et al reported overuse of imaging modalities, namely bone scan, computerized tomography and magnetic resonance imaging, in patients with low risk disease, who are less likely to have extraprostatic disease.22 Followup studies showed that use of the mentioned imaging modalities dramatically decreased thereafter, especially in patients at low risk.19,23 This highlights the value of registries in not only developing evidence-based practices and guidelines but also monitoring adherence to them. CaPSURE has been used to improve disease risk stratification before and after PCa treatment. CAPRA was initially developed to predict pathological status, disease recurrence and mortality after RP based on preoperative parameters.24,25 The CAPRA score was successfully validated in other disease registries in the United States and Europe after RP, radiation therapy and PADT.26,27 CAPRA-S (CAPRA Post-Surgical) was developed by incorporating pathological information.25 In addition, it provides an accurate postoperative prediction model. CaPSURE data have also been used to validate the performance of other nomograms. The Kattan nomogram was found to be a valid, valuable tool for counseling patients on treatment options, although it overestimated recurrence-free survival, especially in men at low risk.28 Mitchell et al noted that while the Kattan and D’Amico nomograms predicted differences in 5-year disease-free survival, the mentioned tools may not provide sufficient information to accurately predict patient outcomes, highlighting the need for new pretreatment assessment tools.29 Collaboration of CaPSURE with the J-CaP (Japan Study Group of Prostate Cancer) database, a national Japanese registry of men receiving ADT, yielded the novel tool J-CAPRA (Japan CAPRA).27 It was the first risk instrument developed and validated for patients receiving PADT whether they have localized or advanced disease. Collaboration with the Department of Defense CPDR (Center for Prostate Disease Research) database was done to study PSA doubling time as a surrogate outcome for PCa clinical trials. D’Amico et al analyzed posttreatment PSA kinetics in patients treated with RP and EBRT in the 2 databases between 1988 and 2002.30 PSA doubling time 3 months or less after treatment and biochemical recurrence were significantly associated with disease specific and overall mortality, providing a valid short-term end point for comparisons among different therapeutic strategies for PCa. In the realm of HRQOL research CaPSURE has provided data on comparative outcomes among treatments as well as differences between physician and patient perceptions of quality of life. Litwin et al found that physician reported HRQOL generally underestimated the degree of decrease in

National Prostate Cancer Registries

HRQOL compared to patient reports, highlighting the importance of the patient reported survey.31 This finding persisted more than 10 years later.32 A separate CaPSURE HRQOL study compared outcomes of RP, EBRT, WW and PADT for the first 2 years after treatment.33 Patients who underwent RP had low immediate postoperative scores but remarkable improvement in all domains 1 year postoperatively. At 2 years sexual function continued to improve. On the other hand, patients treated with EBRT, WW and PADT had relatively stable scores except for sexual function, which decreased in all treatment groups with time.34 More recently Wu et al addressed the possible effects of multimodal therapy on HRQOL.35 Combining ADT with RP or RT resulted in temporary loss of sexual function but this improved 9 months postoperatively. However, combining EBRT and brachytherapy resulted in a decrease in urinary function and bother that continued for 21 months. These findings may enable better patient counseling before the initiation of a multimodal therapeutic approach. Finally, CaPSURE is one of the few PCa registries that includes a wide range of ethnic groups, particularly black patients. CaPSURE data were used to compare the baseline demographic, clinical and HRQOL characteristics of black and white men.36 Black patients in CaPSURE were younger, had lower levels of income and education, and presented with higher risk disease. Black men had lower HRQOL scores in many aspects, such as general health, self-esteem, health distress and bowel function but they showed higher sexual function scores. In a unique study focused specifically on Latino men Latini et al found that Latino men were generally similar to nonLatino white men in baseline clinical presentation but more likely to present with worse disease.37 Latino and nonLatino white men had lower PSA and Gleason scores at diagnosis than black men. Latino men were treated with brachytherapy more often while ADT was administered in black and nonLatino white men. The ongoing productivity of CaPSURE demonstrates the potential of a prospectively identified patient cohort incorporating a wide range of practice settings. Efforts are ongoing to improve this data set by incorporating more information on men with advanced disease. A new Department of Defense grant allows accession of the first CaPSURE biospecimens. Collating paraffin embedded biopsy and prostatectomy specimens is a high priority going forward. With almost 1,000 cancer specific mortality events and long-term followup on thousands of men CaPSURE has become truly a unique resource with value and potential that continue to grow yearly. Additionally, CaPSURE has facilitated the development of new PCa researchers through the support of the CaPSURE Scholars Program. CaPSURE researchers continue to participate in national and international collaborations with researchers in the United States,38 Japan,39 Australia and Korea.40 PROST-QA PROST-QA is a National Institutes of Health funded, prospectively collected, multi-institutional cohort of 1,204 patients

201

and 625 spouses recruited from 2003 to 2006. It was designed to compare quality of life after treatment of localized PCa with RP, EBRT or brachytherapy,41 primarily at academic medical centers. Urinary, bowel and sexual symptoms were assessed using EPIC-26 and treatment satisfaction was assessed using SCA (Service Satisfaction Scale for Cancer Care) at regular intervals for 2 years after treatment. The partner modules of the EPIC and SCA questionnaires were used for enrolled partners. PROST-QA results showed that all 3 treatment modalities have unique side effect profiles.41 Patients who underwent surgery experienced the greatest initial decreases in sexual and urinary function at 2 months with continued improvement at 2 years, especially in those treated with nerve sparing, while they had no change in bowel symptoms. Patients administered radiation experienced a gradual decrease in sexual function with EBRT and brachytherapy during 2 years. Those who received EBRT plus neoadjuvant hormone therapy had a sexual health score similar to that of men treated with nonnerve sparing surgery at 1 and 2 years. Each type of radiation was associated with significant decreases in urinary irritation scores followed by recovery at 6 and 12 months. They were also associated with decreased bowel related quality of life at 2 years. For all 3 treatments partners reported the greatest amount of treatment related distress related to sexual function at 1 year. All domains were associated with satisfaction after treatment, although the association was strongest for sexual function. The PROST-QA cohort was also used to develop EPIC-CP (EPIC for Clinical Practice), a modified, abbreviated form of EPIC-26.42 A more recent PROST-QA cohort was established to compare the outcomes of open vs robot-assisted RP. Results from this cohort are due to be reported in the near future.43 CEASAR CEASAR for localized PCa is an ongoing prospective cohort designed to compare quality of life after treatment with open and robotic surgery, various forms of RT, active surveillance and cryoablation.26 It is funded by AHRQ. Patients were identified through 5 registries in the SEER database and CaPSURE from January 2011 to February 2012. The primary end point of CEASAR is disease specific HRQOL as assessed by the EPIC questionnaire. Comorbidity is assessed using TIBI-CaP (Total Illness Burden Index for Prostate Cancer). After enrollment general HRQOL using the SF-12Ò questionnaire and cancer-free survival were assessed. Resnick et al recently reported baseline characteristics in CEASAR.44 A total of 3,072 men were included in the cohort, of whom 52% completed pretreatment baseline surveys. The remaining patients recalled their baseline symptoms retrospectively. Median age was 65 years and the mean TIBI-CaP score was 3 on a scale with a maximum of 10. There was a surprisingly high rate of erectile dysfunction (45%) and urinary incontinence symptoms (17%). CEASAR holds the promise of being able to report population based practice patterns, and

202

National Prostate Cancer Registries

prospective comparative quality of life and cancer specific outcomes of multiple contemporary treatment modalities for PCa. With additional funding it will be able to provide valuable intermediate and long-term data. MUSIC MUSIC is a collaboration of 32 Michigan urology practices, representing almost 200 urologists. It is led by University of Michigan and funded by Blue Cross BlueShield of Michigan. Practices participating in MUSIC voluntarily submit to an online repository a wide range of demographic and clinical data on all patients who have newly diagnosed PCa or are undergoing prostate biopsy. To date MUSIC data have been used to report biopsy related infections, variations in PCa detection and improvements in clinical staging documentation. Womble et al found a 0.89% rate of hospital admission for infection after prostate biopsy.45 Of these patients 79% were infected with fluoroquinolone resistant bacteria while only 3.7% received nonAUA compliant antibiotic prophylaxis. This group had a fourfold higher risk of post-biopsy infection (3.8% vs 0.89%, p ¼ 0.0026). Filson et al assessed the rate of documenting clinical TNM stage before and after comparative feedback and educational intervention among the initial MUSIC practices.46 Documentation of TNM stage improved from 58% to 79% of cases after intervention. Reidinger et al found a relatively high rate of PCa detection among 17 MUSIC practices (52%) but significant variability among practices (43% to 70%).47 This difference persisted after adjusting for age, family history, PSA value, digital rectal examination and prostate size. As MUSIC continues to grow, it holds the promise of not only describing the current practice patterns in PCa care but also assessing the effect of further interventions on variability and efficiency of care. Other Databases Other local registries and databases also provide useful information about the treatment patterns and risk factors associated with biochemical recurrence. For instance, Kaiser PermanenteÒ data confirmed that there is no survival benefit for PADT in patients with localized PCa.48 Data from the SEARCH (Shared Equal Access Regional Cancer Hospital) database showed that delaying RP in patients with intermediate risk PCa may be associated with worse outcomes.49 Others have studied the impact of factors such as obesity, smoking, infertility and the use of certain medications. Looking to the Future: The AQUA Registry Briefly, disease registries have provided valuable and unique information on PCa care and outcomes to date. Ongoing registries and collaborations aim to compare oncologic and HRQOL outcomes among treatments, describe and improve treatment variability and track patterns of disease prevalence, staging and treatment. For PCa in particular consistent funding

is critical for collecting data during a sufficient followup for meaningful end points. Despite this, registries require substantially less money to track more patients for a longer period than RCTs. CaPSURE and other registries demonstrate that it is feasible to obtain this funding through industry collaboration while maintaining the academic integrity of the registry. While they do not replace RCTs, registries will continue to have an important role in describing and improving PCa care. Longitudinal registries such as CaPSURE and MUSIC will only continue to grow in value as patient numbers and followup accrue. However, no registry discussed provides what is truly needed at the national level, that is a prospective registry that incorporates clinical and patient reported data that is scalable across the entire spectrum of American urology practices. Late in 2013 the AUA announced the launch of the AQUA registry (http://www.auanet.org/aqua). AQUA will eventually enroll patients with a range of urological conditions but initially it will focus on PCa. Recognizing that the greatest long-term cost of a registry and, therefore, the greatest barrier to sustainability is the need for labor-intensive data reported by participating practices, the AUA has partnered with FIGMD (http://www.figmd.com). This registry software provider has already developed successful registries with national cardiology and ophthalmology professional associations. The software that the company will deploy will allow automated collection of rich clinical data directly from electronic medical records with minimal to no effort from physicians or other care providers after the system is initially validated. HRQOL data will ultimately be gathered directly from patients in what to our knowledge will be the first truly national patient reported outcomes collection effort in any specialty. AQUA will report clinical site practice patterns, outcomes and quality metric performance directly to the site, benchmarked against aggregated data from the broader registry. AQUA will be a novel, uniquely powerful framework for quality assessment and quality improvement efforts locally and nationally. As AQUA develops and expands, it is also expected to evolve a data trove that will surpass any existing claims based database for health services, outcomes and comparative effectiveness research. Through AQUA urologists will have the means to reestablish control over high quality data and, therefore, over the terms of many perennial health policy debates with high relevance to urologists and patients with urological conditions. References 1. Stensland KD, Russell M, Wisnivesky JP et al: Premature termination of genitourinary cancer clinical trials. J Clin Oncol 2014; 32: abstract 288. 2. Crook JM, Gomez-Iturriaga A, Wallace K et al: Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial. J Clin Oncol 2011; 29: 362. 3. Observation or Radical Treatment in Patients With Prostate Cancer. Available at https://clinicaltrials.gov/ct2/show/record/NCT00499174? term¼ObservationþorþRadicalþTreatmentþinþPatientsþWithþProstateþ Cancer&rank¼1. Accessed June 10, 2014.

National Prostate Cancer Registries

4. National Cancer Institute: SEER Cancer Statistics FactsheetsdProstate Cancer. Available at http://seer.cancer.gov/statfacts/html/prost.html. Accessed June 10, 2014. 5. Gliklich R, Dreyer N and Leavy M: Registries for Evaluating Patient Outcomes: A User’s Guide, 3rd ed. Rockville: Agency for Healthcare Research and Quality 2014. Available at http://www.effectivehealthcare. ahrq.gov/registries-guide-3.cfm. Accessed April 2014. 6. Potosky AL, Harlan LC, Stanford JL et al: Prostate cancer practice patterns and quality of life: the Prostate Cancer Outcomes Study. J Natl Cancer Inst 1999; 91: 1719. 7. Harlan LC, Potosky A, Gilliland FD et al: Factors associated with initial therapy for clinically localized prostate cancer: prostate cancer outcomes study. J Natl Cancer Inst 2001; 93: 1864. 8. Hoffman RM, Harlan LC, Klabunde CN et al: Racial differences in initial treatment for clinically localized prostate cancer. Results from the prostate cancer outcomes study. J Gen Intern Med 2003; 18: 845. 9. Hoffman RM, Koyama T, Fan KH et al: Mortality after radical prostatectomy or external beam radiotherapy for localized prostate cancer. J Natl Cancer Inst 2013; 105: 711. 10. Penson DF, Feng Z, Kuniyuki A et al: General quality of life 2 years following treatment for prostate cancer: what influences outcomes? Results from the prostate cancer outcomes study. J Clin Oncol 2003; 21: 1147. 11. Potosky AL, Legler J, Albertsen PC et al: Health outcomes after prostatectomy or radiotherapy for prostate cancer: results from the Prostate Cancer Outcomes Study. J Natl Cancer Inst 2000; 92: 1582. 12. Resnick MJ, Koyama T, Fan KH et al: Long-term functional outcomes after treatment for localized prostate cancer. N Engl J Med 2013; 368: 436. 13. Lubeck DP, Litwin MS, Henning JM et al: The CaPSURE database: a methodology for clinical practice and research in prostate cancer. CaPSURE Research Panel. Cancer of the Prostate Strategic Urologic Research Endeavor. Urology 1996; 48: 773. 14. Wei JT, Dunn RL, Litwin MS et al: Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology 2000; 56: 899. 15. Cooperberg MR, Broering JM, Litwin MS et al: The contemporary management of prostate cancer in the United States: lessons from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a national disease registry. J Urol 2004; 171: 1393. 16. Richman EL, Carroll PR and Chan JM: Vegetable and fruit intake after diagnosis and risk of prostate cancer progression. Int J Cancer 2012; 131: 201. 17. Tomaszewski JJ, Richman EL, Sadetsky N et al: Impact of folate intake on prostate cancer recurrence following definitive therapy: data from CaPSURE. J Urol 2014; 191: 971. 18. Cooperberg MR, Broering JM, Kantoff PW et al: Contemporary trends in low risk prostate cancer: risk assessment and treatment. J Urol, suppl., 2007; 178: S14. 19. Glass AS, Cowan JE, Fuldeore MJ et al: Patient demographics, quality of life, and disease features of men with newly diagnosed prostate cancer: trends in the PSA era. Urology 2013; 82: 60. 20. Cooperberg MR, Vickers AJ, Broering JM et al: Comparative riskadjusted mortality outcomes after primary surgery, radiotherapy, or androgen-deprivation therapy for localized prostate cancer. Cancer 2010; 116: 5226. 21. Barocas DA, Cowan JE, Smith JA Jr et al: What percentage of patients with newly diagnosed carcinoma of the prostate are candidates for surveillance? An analysis of the CaPSURE database. J Urol 2008; 180: 1330. 22. Kindrick AV, Grossfeld GD, Stier DM et al: Use of imaging tests for staging newly diagnosed prostate cancer: trends from the CaPSURE database. J Urol 1998; 160: 2102. 23. Cooperberg MR, Lubeck DP, Grossfeld GD et al: Contemporary trends in imaging test utilization for prostate cancer staging: data from the Cancer of the Prostate Strategic Urologic Research Endeavor. J Urol 2002; 168: 491.

203

24. Cooperberg MR, Pasta DJ, Elkin EP et al: The University of California, San Francisco Cancer of the Prostate Risk Assessment score: a straightforward and reliable preoperative predictor of disease recurrence after radical prostatectomy. J Urol 2005; 173: 1938. 25. Cooperberg MR, Hilton JF and Carroll PR: The CAPRA-S score: a straightforward tool for improved prediction of outcomes after radical prostatectomy. Cancer 2011; 117: 5039. 26. May M, Knoll N, Siegsmund M et al: Validity of the CAPRA score to predict biochemical recurrence-free survival after radical prostatectomy. Results from a European multicenter survey of 1,296 patients. J Urol 2007; 178: 1957. 27. Cooperberg MR, Broering JM and Carroll PR: Risk assessment for prostate cancer metastasis and mortality at the time of diagnosis. J Natl Cancer Inst 2009; 101: 878. 28. Greene KL, Meng MV, Elkin EP et al: Validation of the Kattan preoperative nomogram for prostate cancer recurrence using a community based cohort: results from Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE). J Urol 2004; 171: 2255. 29. Mitchell JA, Cooperberg MR, Elkin EP et al: Ability of 2 pretreatment risk assessment methods to predict prostate cancer recurrence after radical prostatectomy: data from CaPSURE. J Urol 2005; 173: 1126. 30. D’Amico AV, Moul JW, Carroll PR et al: Surrogate end point for prostate cancer-specific mortality after radical prostatectomy or radiation therapy. J Natl Cancer Inst 2003; 95: 1376. 31. Litwin MS, Lubeck DP, Henning JM et al: Differences in urologist and patient assessments of health related quality of life in men with prostate cancer: results of the CaPSURE database. J Urol 1998; 159: 1988. 32. Sonn GA, Sadetsky N, Presti JC et al: Differing perceptions of quality of life in patients with prostate cancer and their doctors. J Urol, suppl., 2013; 189: S59. 33. Lim AJ, Brandon AH, Fiedler J et al: Quality of life: radical prostatectomy versus radiation therapy for prostate cancer. J Urol 1995; 154: 1420. 34. Lubeck DP, Litwin MS, Henning JM et al: Changes in health-related quality of life in the first year after treatment for prostate cancer: results from CaPSURE. Urology 1999; 53: 180. 35. Wu AK, Cooperberg MR, Sadetsky N et al: Health related quality of life in patients treated with multimodal therapy for prostate cancer. J Urol 2008; 180: 2415. 36. Lubeck DP, Kim H, Grossfeld G et al: Health related quality of life differences between black and white men with prostate cancer: data from the Cancer of the Prostate Strategic Urologic Research Endeavor. J Urol 2001; 166: 2281. 37. Latini DM, Elkin EP, Cooperberg MR et al: Differences in clinical characteristics and disease-free survival for Latino, African American, and non-Latino white men with localized prostate cancer: data from CaPSURE. Cancer 2006; 106: 789. 38. Barocas DA, Chen V, Cooperberg M et al: Using a populationbased observational cohort study to address difficult comparative effectiveness research questions: the CEASAR study. J Comp Eff Res 2013; 2: 445. 39. Cooperberg MR, Hinotsu S, Namiki M et al: Risk assessment among prostate cancer patients receiving primary androgen deprivation therapy. J Clin Oncol 2009; 27: 4306. 40. Akaza H, Hinotsu S, Cooperberg MR et al: Sixth joint meeting of J-CaP and CaPSUREda multinational perspective on prostate cancer management and patient outcomes. Jpn J Clin Oncol 2013; 43: 756. 41. Sanda MG, Dunn RL, Michalski J et al: Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med 2008; 358: 1250. 42. Chipman JJ, Sanda MG, Dunn RL et al: Measuring and predicting prostate cancer related quality of life changes using EPIC for clinical practice. J Urol 2014; 191: 638. 43. Effectiveness of Open and Robotic Prostatectomy (PROSTQA-RP2). Available at http://clinicaltrials.gov/show/NCT01325506 pp. Accessed May 8, 2014.

204

National Prostate Cancer Registries

44. Resnick MJ, Barocas DA, Morgans AK et al: Contemporary prevalence of pretreatment urinary, sexual, hormonal, and bowel dysfunction: defining the population at risk for harms of prostate cancer treatment. Cancer 2014; 120: 1263. 45. Womble PR, Dixon MW, Linsell SM et al: Infection related hospitalizations after prostate biopsy in a statewide quality improvement collaborative. J Urol 2014; 191: 1787. 46. Filson CP, Boer B, Curry J et al: Improvement in clinical TNM staging documentation within a prostate cancer quality improvement collaborative. Urology 2014; 83: 781.

47. Riedinger CB, Womble PR, Linsell SM et al: Variation in prostate cancer detection rates in a statewide quality improvement collaborative. J Urol 2014; 192: 373. 48. Potosky AL, Haque R, Cassidy-Bushrow AE et al: Effectiveness of primary androgen-deprivation therapy for clinically localized prostate cancer. J Clin Oncol 2014; 32: 1324. 49. Abern MR, Aronson WJ, Terris MK et al: Delayed radical prostatectomy for intermediate-risk prostate cancer is associated with biochemical recurrence: possible implications for active surveillance from the SEARCH database. Prostate 2013; 73: 409.