Ability of 2 pretreatment risk assessment methods to predict prostate cancer recurrence after radical prostatectomy: data from CaPSURE.

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.

The changing face of low-risk prostate cancer: trends in clinical presentation and primary management.

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

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.

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.

Patterns of secondary cancer treatment for biochemical failure following radical prostatectomy: data from CaPSURE.

PURPOSE: Biochemical failure after definitive treatment for localized prostate cancer may occur in a substantial number of patients. The pattern and type of treatment offered to such patients have been poorly documented. We determined second treatment patterns in patients with biochemical failure following radical prostatectomy (RP). MATERIALS AND METHODS: A total of 303 patients treated with RP who had biochemical failure were identified from CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor, Tap Pharmaceutical Products, Inc., Lake Forest, Illinois), a national longitudinal registry of men with prostate cancer. Failure was defined as 2 or more prostate specific antigen (PSA) values 0.2 or greater following RP. The timing and type of secondary cancer treatment were determined. Cox proportional hazards regression analysis was conducted to determine significant predictors of time to secondary treatment, and logistic regression was used to determine predictors of the type of secondary treatment (androgen deprivation versus radiation). RESULTS: Of the 303 patients with biochemical failure 102 (33.7%) received second treatment a mean of 12 months after failure was documented. Second treatments were divided between androgen deprivation (57%) and radiation (43%). On multivariate analysis predictors of second treatment were clinical stage, biopsy Gleason score and PSA at failure. Patients with higher PSA at diagnosis and seminal vesicle invasion were more likely to receive androgen deprivation than radiation as second treatment. CONCLUSIONS: Second treatment timing and type after biochemical failure for patients initially treated with RP were documented. Clinical characteristics, such as PSA, Gleason score and clinical stage, can be used to determine which patients are at highest risk for second treatment after RP and can help guide subsequent treatment decisions.

Impact of patient educational level on treatment for patients with prostate cancer: data from CaPSURE.

OBJECTIVES: To examine the effect of a patient's educational level on treatment selection for patients with newly diagnosed prostate cancer. A patient's educational level may impact a patient's understanding and perception of the risks and benefits of the treatment options for prostate cancer. METHODS: We examined 3484 patients in CaPSURE with prostate cancer between 1992 and 2001. Chi-square and multinomial logistic regression analyses were performed to determine the role of education level in primary treatment received relative to other pretreatment predictors (age, race, insurance status, prostate cancer risk, comorbidity). Prostate cancer risk stratification was determined by serum prostate-specific antigen level and tumor stage and grade. RESULTS: The mean patient age was 67.7 +/- 8.3 years, and the mean prostate-specific antigen level was 13.0 +/- 18.7 ng/mL. Of the 3484 patients, 16.7% had less than a high school education, 27.0% had completed high school or technical school, 19.5% had had some college, 18.0% had graduated from college, and 18.6% had had some graduate education. In bivariate analysis, the factors predictive of treatment selection were patient age, race, education, insurance status, risk group, and patient comorbidity (all P <0.001). In multinomial regression analysis, the factors predicting treatment received were age, race, cancer risk group, and comorbidity. For patients older than 75 years, those with a higher education level received more aggressive treatment (radiotherapy versus hormonal therapy) than did those with less education. CONCLUSIONS: Patient age, race, cancer risk group, comorbidity, and, for men older than 75 years, education level are the factors predictive of the primary treatment received by men with newly diagnosed prostate cancer.

Predictors of treatment after initial surveillance in men with prostate cancer: results from CaPSURE.

PURPOSE: Expectant management of prostate cancer or watchful waiting (WW) is a reasonable option for some men with clinically localized prostate cancer. We identified predictors of eventual prostate cancer treatment in a cohort of men initially choosing WW. MATERIALS AND METHODS: We identified 457 men in the Cancer of the Prostate Strategic Urologic Research Endeavor data base selecting WW as initial management without subsequent treatment for at least 6 months. A subset of these men eventually received active treatment for prostate cancer. These groups were compared with respect to baseline clinical, sociodemographic characteristics and followup prostate specific antigen (PSA) characteristics using Kaplan-Meier life tables and Cox proportional hazards models to determine predictors of active treatment after WW. RESULTS: Of the 457 men initially on WW 188 (41%) went on to active treatment at a median of 1.7 years after diagnosis. Baseline characteristics associated with progression to active treatment included younger age, higher level of formal education, higher PSA and higher Gleason grade. Actuarial freedom from treatment (that is continued WW) was 74% at 2, 63% at 3 and 49% at 5 years with androgen deprivation the most common form of therapy (72%). Men progressing to treatment had higher baseline and followup PSA as well as a significantly greater PSA change that those remaining on WW (7.2 vs -0.4 ng/ml). Other measures of PSA dynamics also predicted eventual active treatment. These observations persisted in multivariate models. CONCLUSIONS: WW is an appropriate and common form of treatment in many men with prostate cancer and about half remain on WW at 5 years. Our analysis of national practice patterns identified demographic, clinical and PSA characteristics associated with men who continue with this modality. Conversely these factors may help determine which men (for example higher risk/PSA) ultimately receive active treatment despite initial treatment preference and allow investigation of the effects of these interventions on cancer outcomes and quality of life.

Time trends in clinical risk stratification for prostate cancer: implications for outcomes (data from CaPSURE).

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.

Time trends and characteristics of men choosing watchful waiting for initial treatment of localized prostate cancer: results from CaPSURE.

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.

Health related quality of life patterns in patients treated with interstitial prostate brachytherapy for localized prostate cancer--data from CaPSURE.

PURPOSE: We measured the impact brachytherapy monotherapy (BMT) has on general and disease specific health related quality of life (HRQOL) compared to patients treated with radical prostatectomy (RP). MATERIALS AND METHODS: We studied 419 men with newly diagnosed prostate cancer who enrolled in CaPSURE (Cancer of the Prostate Strategic Urological Research Endeavor) data base whose primary treatment was brachytherapy monotherapy (92) or radical prostatectomy (327). The validated RAND 36-Item Health Survey and the UCLA Prostate Cancer Index were used to measure HRQOL before treatment and at 6-month intervals during the first 2 years after treatment. RESULTS: Patients treated with BMT or RP did not differ greatly in general HRQOL after treatment. Both treatment groups showed early functional impairment in most general domains with scores returning to or approaching baseline in most domains 18 to 24 months after treatment. Patients treated with BMT had significantly higher urinary function scores at 0 to 6 months after treatment (84.5, SD 18.7) than patients treated with RP (63.3, SD 26.6). Urinary bother scores at 0 to 6 months after treatment were not significantly different between patients treated with BMT (67.7, SD 31.2) and those treated with RP (67.4, SD 29.1). Both treatment groups had decreases in sexual function that did not return to pretreatment levels. CONCLUSIONS: Overall BMT and RP are well tolerated procedures that cause mild changes in general HRQOL. Disease specific HRQOL patterns are different in patients treated with BMT or RP. Baseline and serial HRQOL measurements after treatment can provide valuable information regarding expected quality of life outcome after treatment for localized prostate cancer.

Fear of cancer recurrence in patients undergoing definitive treatment for prostate cancer: results from CaPSURE.

PURPOSE: Contemporary cancer treatments have resulted in patients living longer but with the risk of disease recurrence. Studies suggest that fear of recurrence is a significant burden. We described fear of cancer recurrence in patients with prostate cancer undergoing treatment with radical prostatectomy (RP), radiation (XRT) or brachytherapy (BT). MATERIALS AND METHODS: A total of 519 patients (326 RP, 53 XRT, 140 BT) were identified from CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor), a national longitudinal registry of men with prostate cancer. To be included in the study patients had to complete at least 1 pretreatment and 2 posttreatment health related quality of life questionnaires and have complete clinical information. Fear of cancer recurrence was assessed with a validated 5-item scale, and was described at baseline and up to 2 years after treatment. Multivariate linear regression was performed to determine significant predictors of fear of cancer recurrence. RESULTS: Men receiving XRT were older and had worse clinical disease characteristics than patients treated with RP or BT. For all groups fear of cancer recurrence was more severe before treatment and improved after treatment but did not change substantially in the 2 years thereafter. Regression revealed that only general health and mental health were important predictors of fear of cancer recurrence. No other general or disease specific health related quality of life domains or clinical characteristics contributed appreciable explanatory power. CONCLUSIONS: Fear of prostate cancer recurrence imposes a substantial burden in patients before and after treatment. Understanding the fear of cancer recurrence associated with different treatments can help physicians better counsel patients and promote psychological well-being.

Sociodemographic and clinical risk characteristics of patients with prostate cancer within the Veterans Affairs health care system: data from CaPSURE.

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.

Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged.

UNLABELLED: Postoperative pain can have a significant effect on patient recovery. An understanding of patient attitudes and concerns about postoperative pain is important for identifying ways health care professionals can improve postoperative care. To assess patients' postoperative pain experience and the status of acute pain management, we conducted a national study by using telephone questionnaires. A random sample of 250 adults who had undergone surgical procedures recently in the United States was obtained from National Family Opinion. Patients were asked about the severity of postsurgical pain, treatment, satisfaction with pain medication, patient education, and perceptions about postoperative pain and pain medications. Approximately 80% of patients experienced acute pain after surgery. Of these patients, 86% had moderate, severe, or extreme pain, with more patients experiencing pain after discharge than before discharge. Experiencing postoperative pain was the most common concern (59%) of patients. Almost 25% of patients who received pain medications experienced adverse effects; however, almost 90% of them were satisfied with their pain medications. Approximately two thirds of patients reported that a health care professional talked with them about their pain. Despite an increased focus on pain management programs and the development of new standards for pain management, many patients continue to experience intense pain after surgery. Additional efforts are required to improve patients' postoperative pain experience. IMPLICATIONS: A survey of 250 US adults who had undergone a recent surgical procedure asked about their postoperative pain experience. Approximately 80% of patients experienced pain after surgery. Of these patients, 86% had moderate, severe, or extreme pain. Additional efforts are required to improve patients' postoperative pain experience.

Temporal trends in radical prostatectomy complications from 1991 to 1998.

PURPOSE: We performed a retrospective, longitudinal, population based study to ascertain whether radical prostatectomy outcomes improved after the diffusion of surgical innovations during the last decade. MATERIALS AND METHODS: Using a 5% national random sample of Medicare beneficiaries we identified 12,079 men who underwent radical prostatectomy from 1991 to 1998. We analyzed relevant Medicare data to establish length of stay and the rate of in hospital complications (cardiac, respiratory, vascular, wound and genitourinary conditions) as well as the rate of anastomotic stricture, incontinence and impotence through 36 months after surgery. We performed multivariate logistic regression to control for age, race and geographic region when assessing the association of surgery year with outcomes of interest. RESULTS: Between 1991 and 1998 the in hospital complication rate decreased from 38% to 30% and mean length of stay decreased from 8.1 to 5.1 days. Each value had significant regional variation throughout the United States. The 3-year incontinence rate decreased from 20% in 1991 to 4% in 1995. However, no meaningful trends were observed in the rate of impotence, anastomotic stricture, or placement of artificial urinary sphincters or penile prostheses. On multivariate analysis, older age (75 years or older, OR 1.68, p <0.01) and nonwhite race (OR 1.35, p <0.01) were associated with more in hospital complications. Nonwhite patients were also more likely to be diagnosed with impotence (OR 1.25, p <0.01) and undergo penile prosthesis placement (OR 1.5, p <0.01). CONCLUSIONS: As urologists reach consensus on the ideal clinical characteristics for radical prostatectomy candidates, surgery in fewer elderly patients and the dissemination of surgical advances have been associated with shorter length of stay, fewer in hospital complications and a lower long-term incontinence rate. However, there is capacity for improvement, as evidenced by the unchanging rate of anastomotic stricture and impotence.

How potent is potent? Evaluation of sexual function and bother in men who report potency after treatment for prostate cancer: data from CaPSURE.

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.

Role of surgeon volume in radical prostatectomy outcomes.

PURPOSE: To examine the effect of hospital and surgeon volume on postoperative outcomes and to determine whether hospital or surgeon volume is the stronger predictor. PATIENTS AND METHODS: Using 1997 to 1998 claims data from a national 5% random sample of Medicare beneficiaries, we identified 2,292 men who underwent radical prostatectomy at 1,210 hospitals by 1,788 surgeons. Hospitals were classified as high (> or = 60 per year) or low (< 60 per year) volume according to radical prostatectomy experience over the 2-year period. Surgeons were classified as high (> or = 40 per year) or low (< 40 per year) volume. Multivariate logistic regression was performed to control for patient demographics and comorbidities when assessing the association of hospital and surgeon volume with in-hospital complications, length of stay, and anastomotic stricture rates. In-hospital complications included cardiac, respiratory, vascular, wound, genitourinary, and miscellaneous surgical and medical conditions. RESULTS: High-volume surgeons had half the complication risk (odds ratio [OR] = 0.53; 95% confidence interval [CI], 0.32 to 0.89) and shorter lengths of stay (4.1 v 5.2 days, P =.03) compared with low-volume surgeons. High-volume hospital patients tended to have fewer anastomotic strictures (OR = 0.72; 95% CI, 0.49 to 1.04). Patient age (> or = 75 years) was associated with more complications (OR = 1.9; 95% CI, 1.39 to 2.70), more anastomotic strictures (OR = 2.2; 95% CI, 1.54 to 3.15), and longer hospital stays (parameter estimate = 2.26; 95% CI, 1.75 to 2.77). CONCLUSION: Surgeon volume is inversely related to in-hospital complications and length of stay in men undergoing radical prostatectomy. Hospital volume is not significantly associated with outcomes after adjusting for physician volume. Further study is necessary to elucidate the mechanism of the volume-outcome effect.

Predicting recurrence after radical prostatectomy for patients with high risk prostate cancer.

PURPOSE: Previous studies have shown that patients with clinical stage T2c-T3 prostate cancer, serum prostate specific antigen (PSA) at diagnosis greater than 20 ng./ml. or a biopsy Gleason score of 8 to 10 are at high risk for disease recurrence after radical prostatectomy. We determined the most important pretreatment predictors of disease recurrence in this high risk population. MATERIALS AND METHODS: We identified 547 patients with high risk prostate cancer who underwent radical prostatectomy at University of California, San Francisco or as part of the Cancer of the Prostate Strategic Urological Research Endeavor data base, a longitudinal disease registry of patients with prostate cancer. High risk disease was defined as 1992 American Joint Committee on Cancer clinical stage T2c-T3 disease in 411 patients, serum PSA at diagnosis greater than 20 ng./ml. in 124 and/or biopsy Gleason score 8 to 10 in 114. Disease recurrence was defined as PSA 0.2 ng./ml. or greater on 2 consecutive occasions after radical prostatectomy or second cancer treatment more than 6 months after surgery. The Cox proportional hazards analysis was performed to determine significant independent predictors of disease recurrence. The likelihood of disease recurrence for clinically relevant patient groups was determined using the Kaplan-Meier method and compared using the log rank test. RESULTS: Median followup after surgery was 3.1 years. Disease recurred in 177 patients (32%). Multivariate analysis demonstrated that serum PSA at diagnosis, biopsy Gleason score, ethnicity and the percent of positive prostate biopsies were significant independent predictors of disease recurrence, while patient age and clinical tumor stage were not. Patients with a Gleason score 8 to 10 tumor and a serum PSA of 10 ng./ml. or less had a significantly higher likelihood of remaining disease-free 5 years after surgery than those with PSA greater than 10 ng./ml. (47% versus 19%, p <0.05). Patients with a serum PSA at diagnosis of greater than 20 ng./ml. and a Gleason score of less than 8 had a significantly higher likelihood of remaining disease-free 5 years after surgery than similar patients with a Gleason score of 8 or greater (45% versus 0%, p <0.05). CONCLUSIONS: PSA, Gleason score, ethnicity and the percent of positive prostate biopsies appear to be the most important pretreatment predictors of disease recurrence in men with high risk prostate cancer. Patients with high grade disease may continue to be appropriate candidates for local therapy if PSA is less than 10 ng./ml. at diagnosis or there are fewer than 66% positive prostate biopsies.

Is ethnicity an independent predictor of prostate cancer recurrence after radical prostatectomy?

PURPOSE: Prostate cancer incidence and mortality are higher in black than in white American men. We determined whether ethnicity is an independent predictor of disease recurrence in men undergoing radical prostatectomy. MATERIALS AND METHODS: We studied 1,468 patients who underwent radical prostatectomy at the University of California, San Francisco or as part of the Cancer of the Prostate Strategic Urological Research Endeavor database, a longitudinal disease registry of patients with prostate cancer. Preoperative characteristics, including age, race, prostate specific antigen (PSA) at diagnosis, clinical T stage, biopsy Gleason score and percent positive prostate biopsies at diagnosis were determined in each patient. Disease recurrence was defined as PSA 0.2 ng./ml. or greater on 2 consecutive occasions after radical prostatectomy or second cancer treatment at least 6 months after surgery. Cox proportional hazards analysis was performed to determine independent predictors of time to disease recurrence. To control for pretreatment disease characteristics simultaneously patients were assigned to previously described risk groups based on clinical tumor stage, PSA at diagnosis and biopsy Gleason score. The likelihood of disease recurrence per risk group stratified according to ethnicity was determined using the Kaplan-Meier method and compared using the log rank test. Additional multivariate analysis was performed in the subset of patients enrolled in Cancer of the Prostate Strategic Urological Research Endeavor on whom education and income information was available. RESULTS: Disease recurred in 304 of the 1,468 patients (21%). Black ethnicity, serum PSA at diagnosis, biopsy Gleason score and percent positive prostate biopsies were independent predictors of recurrence on multivariate analysis. Black ethnicity remained an independent predictor of disease recurrence in the multivariate model after stratifying patients into risk groups (p = 0.0007). Ethnicity was most important in patients at high risk, in whom estimated 5-year disease-free survival was 65% and 28% in white and black men, respectively. Education, income and ethnicity correlated highly. When education and income were entered into the multivariate model, ethnicity was no longer an independent predictor of outcome after prostatectomy. CONCLUSIONS: Ethnicity appears to be an independent predictor of disease recurrence after adjusting for pretreatment measures of disease extent in patients undergoing radical prostatectomy. It appears to be particularly important in those with high risk disease characteristics. However, black ethnicity, education and income are highly correlated variables, suggesting that sociodemographic factors may contribute to the poorer outcomes in black patients even after adjusting for differences in pretreatment disease characteristics.

Psychological impact of erectile dysfunction: validation of a new health related quality of life measure for patients with erectile dysfunction.

PURPOSE: Male erectile dysfunction has a substantial impact on health related quality of life. We examined the psychometric properties of 2 new scales created to measure the psychological impact of erectile dysfunction. MATERIALS AND METHODS: Patients enrolled in a long-term study of men with erectile dysfunction completed clinical and health related quality of life information at baseline and at 3 followup points. The questionnaire incorporated a number of standard scales of psychosocial characteristics as well as questions developed from comments made during focus groups of men with erectile dysfunction and of their female partners. Principal components analysis was used to identify underlying constructs in response to the new questions. RESULTS: A total of 168 men completed the baseline quality of life questionnaire. The principal components analysis of the psychological impact of erectile dysfunction questions resulted in 2 new scales. Reliability was good with an internal consistency reliability of 0.91 for scale 1 and 0.72 for scale 2. Test-retest reliability was 0.76 and 0.66, respectively. Men reporting a greater psychological impact of erectile dysfunction also reported greater impairment in functional status, lower sexual self-efficacy, greater depression and anxiety at the last intercourse. Each new scale significantly differentiated men with mild/moderate versus severe erectile dysfunction. CONCLUSIONS: We developed 2 new scales to measure the psychological impact of erectile dysfunction and they showed good reliability and validity. These new scales, named the Psychological Impact of Erectile Dysfunction instrument, comprehensively capture the psychological effect of erectile dysfunction on health related quality of life, which is not adequately assessed by existing patient centered measures of erectile function.

Contemporary patterns of androgen deprivation therapy use for newly diagnosed prostate cancer.

Although once reserved for the management of metastatic prostate cancer, androgen deprivation therapy (ADT) is being used increasingly to treat lower stages of disease. We sought to assess patterns of ADT use in a contemporary cohort of men newly diagnosed with prostate cancer. Men with newly diagnosed prostate cancer who had > or =12 months of follow-up evaluation were identified in a national disease registry of patients with prostate cancer. The patterns of ADT use, both primary and secondary, were characterized and stratified by risk according to prostate-specific antigen levels, clinical stage, and Gleason score. In a cohort of 1485 men, 46% underwent ADT at some point during their treatment: 41% as primary therapy (either sole therapy or neoadjuvant therapy), and 5% as secondary therapy. In all, 50% of men receiving initial ADT had low- or intermediate-risk disease characteristics. Among patients treated with radical prostatectomy and radiation therapy, neoadjuvant ADT was administered in 20% and 48% of patients, respectively. Secondary hormonal manipulation was observed in 5% and 7% of patients treated initially with surgery or radiation, respectively. ADT is commonly used to treat men with prostate cancer. Much of the use of ADT is in men with low- and intermediate-risk disease characteristics. The appropriateness of such therapy requires further study, including its effect, not only on disease endpoints, but also on resource utilization and health-related quality of life.

Contemporary trends in imaging test utilization for prostate cancer staging: data from the cancer of the prostate strategic urologic research endeavor.

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.