Purpose

Previous investigators have reported widespread overuse of imaging tests for staging clinically localized prostate cancer. In this study imaging test utilization rates were analyzed in a contemporary group of patients, and clinical and demographic predictors of testing were identified.

Materials and methods

Data were abstracted from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a longitudinal registry of men with various stages of prostate cancer. A total of 4,966 men met study inclusion criteria of available treatment and staging data. The rates of computerized tomography, magnetic resonance imaging and bone scans performed between the dates of diagnosis and primary treatment were analyzed in patients at 3 levels of clinical risk based on serum prostate specific antigen, Gleason sum and T stage. Time trends in test utilization were analyzed by linear regression. Contemporary rates were compared with those identified in a previous analysis of an earlier CaPSURE cohort. Demographic and clinical predictors of utilization were identified using generalized linear model analysis.

Results

Since June 1997, the overall use of staging tests has decreased 63%, 25.9% and 11.4% in patients at low, intermediate and high risk, respectively. The most precipitous decrease was noted for bone scan but the use of cross-sectional imaging also decreased in all groups. Utilization rates were lower in 2001 than in any other year studied in CaPSURE.

Conclusions

The rates of testing decreased significantly in all risk groups. However, in the absence of established clinical practice guidelines many patients at low and intermediate risk continue to undergo unnecessary testing, while a growing number of those at high risk are proceeding to treatment without previous imaging.

Background

Recent reports have suggested that growing numbers of patients with localized prostate cancer are receiving androgen deprivation therapy as primary or neoadjuvant treatment, yet sparse clinical evidence supports the use of such treatment except among patients with high-risk or locally advanced disease receiving external beam radiotherapy. We describe national trends in the use of androgen deprivation therapy for localized disease.

Methods

CaPSURE is an observational database of 7195 patients with prostate cancer. This study included 3439 of these patients who were diagnosed since 1989, had clinical staging information available, and were treated with radical prostatectomy, radiation therapy, or primary androgen deprivation therapy (PADT). High-, intermediate-, and low-risk groups were defined by serum prostate-specific antigen level, Gleason score, and clinical tumor stage. Time trends in the use of PADT and neoadjuvant androgen deprivation therapy (NADT) were analyzed. All statistical tests were two-sided.

Results

Rates of PADT use rose sharply between 1989 and 2001, from 4.6% (95% confidence interval [CI] = 3.4% to 5.8%) to 14.2% (95% CI = 12.2% to 16.2%), from 8.9% (95% CI = 7.3% to 10.5%) to 19.7% (95% CI = 17.5% to 21.9%), and from 32.8% (95% CI = 29.9% to 35.7%) to 48.2% (95% CI = 45.1% to 51.3%) (all P<.001) in low-, intermediate-, and high-risk groups, respectively. NADT use also increased in association with radical prostatectomy (2.9% [95% CI = 2.1% to 3.7%] to 7.8% [95% CI = 6.5% to 9.1%] of patients, P =.003) and external beam radiotherapy (9.8% [95% CI = 7.5% to 12.1%] to 74.6% [95% CI = 70.8% to 78.4%], P<.001) across all risk levels combined. Rates of NADT use among patients treated with brachytherapy also increased but not statistically significantly (7.4% [95% CI = 3.5% to 11.3%] to 24.6% [95% CI = 18.2% to 31.0%], P =.100).

Conclusions

Rates of both PADT and NADT are increasing across risk groups and treatment types. Future clinical trials must define more clearly the appropriate role of hormonal therapy in localized prostate cancer, and their results should shape updated practice guidelines.

Purpose

Many instruments designed to predict prostate cancer risk use a combination of clinical T stage, biopsy Gleason score and serum prostate specific antigen (PSA). We designed a study to characterize time trends in these parameters and their impact on patient risk stratification.

Materials and methods

Data were abstracted from CaPSURE (Cancer of the Prostate Strategic Urological Research Endeavor), a disease registry of 8,685 men with prostate cancer. The 6,260 men diagnosed since 1989 who had complete clinical information reported were categorized into low, intermediate or high risk groups based on established parameters for T stage, Gleason score and PSA.

Results

Between 1989 to 1990 and 2001 to 2002 the proportion of patients presenting with high, intermediate and low risk disease changed from 40.9%, 28.0% and 31.2% to 14.8%, 37.5% and 47.7%, respectively (p <0.0001). The incidence of T1 tumors increased from 16.7% to 48.5% and that of T3-4 tumors decreased from 11.8% to 3.5%, respectively (p <0.0001). The incidence of Gleason 2 to 6 tumors decreased from 77.1% to 66.4%, while that of Gleason 7 tumors increased from 12.9% to 24.8%, respectively (p = 0.0030). PSA levels 10 ng/ml or less increased from 43.6% to 77.7%, respectively, while PSA 10 to 20 and greater than 20 ng/ml decreased accordingly (p <0.0001). These trends were mirrored in subset analysis of black patients.

Conclusions

A significant downward risk migration has occurred over time. Gleason score is now more likely and PSA less likely than previously to drive risk assignment. This shift is most likely attributable to changes in practice patterns with respect to screening and pathological grading. These changes should be considered when applying nomograms derived from earlier datasets to contemporary cases.

Purpose

Early intervention for prostate cancer is associated with excellent long-term survival, but many affected men, especially those with low-risk disease characteristics, might not experience adverse impact to survival or quality of life were treatment deferred. We sought to characterize temporal trends in clinical presentation and primary disease management among patients with low-risk prostate cancer.

Methods

Data were abstracted from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a disease registry of 8,685 men with various stages of prostate cancer. Included were 2,078 men who were diagnosed between 1989 and 2001 and had a serum prostate specific antigen ResultsThe proportion of patients with low-risk tumor characteristics rose from 29.8% in 1989 to 1992, to 45.3% in 1999 to 2001 (P <.0001). There have been sharp increases in the use of brachytherapy and androgen deprivation monotherapy, from 3.1% and 3.1%, to 12.0% and 21.7%, respectively. Utilization rates for prostatectomy, external-beam radiotherapy, and observation have fallen accordingly, from 63.8%, 16.1%, and 13.8%, to 51.6%, 6.8%, and 7.9% (P <.0001 for all except prostatectomy [P =.0019]). Age and socioeconomic status were significantly associated with treatment selection, but overall, the treatment trends were echoed on subgroup analysis of patients 75 years or older.

Conclusion

Low-risk features characterize a growing proportion of prostate cancer patients, and there have been significant shifts in the management of low-risk disease. Overtreatment may be a growing problem, especially among older patients.

Purpose

Veterans Affairs (VA) health care system investigators perform large clinical trials in prostate cancer treatment but potential differences between VA and other patient cohorts have not been explored systematically.

Materials and methods

Cancer of the Prostate Strategic Urologic Research Endeavor is an ongoing observational database of men with prostate cancer, comprising 7,202 patients treated at 35 sites across the United States. Three sites that together contribute 241 patients are VA medical centers. Demographic and clinical characteristics were compared between all VA and nonVA patients in the database and a multivariate model was used to explore the interactions between ethnicity and VA status for predicting clinical characteristics.

Results

VA patients were 4 times as likely as nonVA patients to be black. They had lower income, less education and more co-morbidity at presentation (all comparisons p <0.0001). VA patients had higher risk disease. Mean serum prostate specific antigen at diagnosis was 20.1 vs 15.3 ng/ml for nonVA patients (p = 0.003). Mean Gleason score was 6.4 for VA patients vs 6.0 for nonVA patients (p <0.0001). Differing ethnic distributions explained the differences in prostate specific antigen between VA and nonVA patients. However, VA status, socioeconomic level and ethnicity independently predicted Gleason score. VA patients were more likely to undergo watchful waiting or primary hormonal therapy and less likely to receive definitive local treatment (p <0.0001).

Conclusions

Significant sociodemographic and clinical differences exist between VA and nonVA patients, which should be borne in mind when extrapolating the results of VA clinical trials to the general population. These observations require validation in larger patient cohorts.

OBJECTIVES:To characterize the association between potency and comprehensive sexual function. The accurate assessment of sexual function is critical for the evaluation of outcomes after treatment of prostate cancer. The assessments of potency typically used in this context, however, may be oversimplified. METHODS:CaPSURE is a large, observational database of men with prostate cancer. Participants complete health-related quality-of-life questionnaires, including the University of California, Los Angeles Prostate Cancer Index, every 6 months after treatment. A total of 5135 men completed at least one questionnaire and did not use medications for erectile function. The men were categorized as potent or impotent based on their ability to have erections and/or intercourse in the prior 4 weeks. Using the remaining questions on the Prostate Cancer Index, sexual function and bother scores were calculated for each group. RESULTS:Of the 5135 men, 27.4% were potent. The mean sexual function scores were 56 and 13 for potent and impotent men, respectively (P <0.0001). The corresponding mean bother scores were 62 and 36 (P <0.0001). The function scores ranged from 0 to 100 and 0 to 92 among potent and impotent men, respectively, and bother scores from 0 to 100 in both groups. Function was inversely associated with age in both groups, but bother did not change among potent men and ameliorated among impotent men. Individual Prostate Cancer Index questions correlated with potency to a variable extent. CONCLUSIONS:Although potent and impotent men have divergent sexual function and bother scores after treatment, the wide range of these scores in both groups denotes a complex picture of sexual function. The simple documentation of potency after treatment provides an insufficient measure of sexual health-related quality of life and should be supplemented with more comprehensive measures.

Purpose

Two methods widely used to predict the risk of treatment failure after radical prostatectomy for localized prostate cancer are the 3 level D'Amico risk classification and the Kattan nomogram. Although they have been previously validated, to our knowledge they have not been compared in a community based cohort. We tested the 2 instruments in the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) database, a national registry of patients with prostate cancer, to assess their accuracy in a community based cohort.

Materials and methods

Men were invited to join CaPSURE from 33 American urology practices, of which 30 were community based. A total of 1,701 men with localized prostate cancer (T1-3a) were treated with radical prostatectomy between 1989 and 2000. Patients who received neoadjuvant or adjuvant therapy were excluded. Recurrence was defined as 2 or more consecutive prostate specific antigen measurements of 0.2 ng/ml or greater, or a second treatment greater than 6 months after surgery. Freedom from progression (FFP) was based on life table estimates and Kaplan-Meier curves. Risk groups were compared using a Cox proportional hazards model and ANOVA.

Results

Based on the D'Amico classification 671 cases (39%) were classified as low risk, 446 (26%) were intermediate risk and 584 (34%) were high risk. Five-year FFP was 78%, 63% and 60% in the low, intermediate and high risk groups (HR 1.00, 1.87 and 2.32 respectively, p <0.0001). Mean 5-year FFP predicted by the Kattan nomogram in the same risk groups was 91%, 74% and 69%, respectively. Outcomes in the low risk group were tightly grouped about the mean but there was considerable dispersion of outcomes in the intermediate (30% to 98% FFP) and high (17% to 98%) risk groups.

Conclusions

Stratifying patients in CaPSURE into low, intermediate and high risk categories for disease as described by D'Amico or applying the Kattan nomogram resulted in statistically significant differences in predicted 5-year FFP. However, there was considerable overlap of outcomes between the intermediate and high risk groups. This analysis suggests that simply estimating disease recurrence by stratifying patients into low, intermediate and high risk groups may not provide sufficient information for predicting outcomes among individuals.

Purpose

The epidemiology and treatment of prostate cancer have changed dramatically in the prostate specific antigen era. A large disease registry facilitates the longitudinal observation of trends in disease presentation, management and outcomes.

Materials and methods

The Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) is a national disease registry of more than 10000 men with prostate cancer accrued at 31 primarily community based sites across the United States. Demographic, clinical, quality of life and resource use variables are collected on each patient. We reviewed key findings from the data base in the last 8 years in the areas of disease management trends, and oncological and quality of life outcomes.

Results

Prostate cancer is increasingly diagnosed with low risk clinical characteristics. With time patients have become less likely to receive pretreatment imaging tests, less likely to pursue watchful waiting and more likely to receive brachytherapy or hormonal therapy. Relatively few patients treated with radical prostatectomy in the database are under graded or under staged before surgery, whereas the surgical margin rate is comparable to that in academic series. CaPSURE data confirm the usefulness of percent positive biopsies in risk assessment and they have further been used to validate multiple preoperative nomograms. CaPSURE results strongly affirm the necessity of patient reported quality of life assessment. Multiple studies have compared the quality of life impact of various treatment options, particularly in terms of urinary and sexual function, and bother.

Conclusions

The presentation and management of prostate cancer have changed substantially in the last decade. CaPSURE will continue to track these trends as well as oncological and quality of life outcomes, and will continue to be an invaluable resource for the study of prostate cancer at the national level.

Purpose

Watchful waiting (WW) is one option for men with clinically localized prostate cancer. We examined temporal trends in the use of WW, as well as sociodemographic and clinical profiles of men who choose this form of management.

Materials and methods

The Cancer of the Prostate Strategic Urologic Research Endeavor is a national registry of patients with various stages of prostate cancer. Between 1989 and 2000, 5,365 men in the database were diagnosed with localized disease and elected either WW or active treatment within 9 months of diagnosis. Of these men 402 elected WW as initial disease management. We analyzed time trends in WW use, and sociodemographic and clinical predictors of WW using chi-square tests and multivariate logistical regression.

Results

In examining 3-year intervals, use of WW increased from 7.5% in 1989 to 1991 to 9.5% in 1992 to 1994, and then decreased during the next 6 years to 5.5% in 1998 to 2000 (p = 0.001). With time there was a significant increase in the proportion of WW patients with T1 disease and prostate specific antigen of 10 ng/ml or less. Compared to patients choosing active treatment, patients opting for WW were more likely to have low risk disease. After controlling for clinical factors WW patients were also more likely to be 75 years old or older, to have Medicare insurance and to have greater comorbidity.

Conclusions

During the prostate specific antigen era rates of WW for the initial treatment of prostate cancer have been decreasing despite considerable downward stage migration. We expect that as prostate cancer risk assessment and surveillance strategies continue to improve, more patients may benefit from this approach to management.