***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    Input: Study Type – Therapy ( prospect i ve cohort ) Level of Evidence 2b The Early Prostate Cancer ( EPC ) Program consists of three r and omised , double blind , placebo-controlled trials that assess bicalutamide either as adjuvant to treatment of curative intent or alone ( radical prostatectomy , radiotherapy or watchful waiting ) in patients with non-metastatic prostate cancer . In total , 8113 men have been enrolled in a 1/1 ratio to receive bicalutamide 150 mg/day orally or a matching placebo . We present the results at a median follow-up . No significant results are yet observed on overall survival in the localised , low-risk disease groups . For patients with locally advanced disease , adjuvant hormonal therapy significantly improves objective progression-free survival over placebo . Moreover , adjuvant bicalutamide offers a significant benefit in terms of overall survival in radiotherapy treated patients for locally advanced prostate cancer 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 cl aims data from a national 5 % r and om 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 eluci date the mechanism of the volume- outcome effect A fifteen-year follow-up of a prospect i ve , r and omized study comparing placebo with radical prostatectomy as the primary treatment of early prostatic cancer is presented . A total of 111 patients with clinical Stage I or II prostatic cancer , normal acid phosphatase levels , and negative findings on skeletal x-ray film were evaluable . Thirty Stage I patients and 20 Stage II patients received placebo only ; 31 Stage I and 30 Stage II patients underwent radical prostatectomy . The survival status for 95 patients ( 86 % ) was established at the fifteen-year follow-up . No significant differences in crude survival occurred in either stage or in both stages combined . Moreover , the survival curves closely followed reference curves based on expected U.S. mortality for men of comparable ages and races . A statistically significant association between a high Gleason histologic score and poor survival was established . In this study , initial treatment with radical prostatectomy did not yield longer survival than initial placebo treatment alone . However , the findings should be interpreted with caution , since sample size was small and staging procedure was simplified The objective was to investigate how prostate cancer and its treatment affects sexual , urinary and bowel functions and to what extent eventual complications cause distress . A question naire was sent to 431 men aged 50 - 80 years with prostate cancer diagnosed in 1992 in the Stockholm area ( Sweden ) and 435 r and omly selected men with a similar age distribution .  Sexual function , as compared with their youth , was diminished in a majority of all men . The prostate cancer patients were , however , more likely to report low frequency and /or intensity in all aspects of sexual function . A majority of the men were distressed by a waning sexual capacity . The proportion of men with prostate cancer who were severely distressed owing to a decline in sexual function was larger than in the reference group . The willingness to trade off an intact sexual function for long-term survival varied considerably among the men in the reference group . Urinary and bowel symptoms were less common than a waning sexual function in both groups , and few appeared to be severely distressed by urinary or bowel symptoms . A decline in sexual functions was the most common cause of disease-specific distress in men with prostate cancer Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men . In the United States , 90 % of men with prostate cancer are more than age 60 years , diagnosed by early detection with the prostate-specific antigen ( PSA ) blood test , and have disease believed confined to the prostate gl and ( clinical ly localized ) . Common treatments for clinical ly localized prostate cancer include watchful waiting ( WW ) , surgery to remove the prostate gl and ( radical prostatectomy ) , external-beam radiation therapy and interstitial radiation therapy ( brachytherapy ) , and and rogen deprivation . Little is known about the relative effectiveness and harms of treatments because of the paucity of r and omized controlled trials . The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study # 407:Prostate Cancer Intervention Versus Observation Trial ( PIVOT ) , initiated in 1994 , is a multicenter r and omized controlled trial comparing radical prostatectomy with WW in men with clinical ly localized prostate cancer . We describe the study rationale , design , recruitment methods , and baseline characteristics of PIVOT enrollees . We provide comparisons with eligible men declining enrollment and men participating in another recently reported r and omized trial of radical prostatectomy vs WW conducted in Sc and inavia . We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment . From these , 5023 met initial age , comorbidity , and disease eligibility criteria , and a total of 731 men agreed to participate and were r and omized . The mean age of enrollees was 67 years . Nearly one-third were African American . Approximately 85 % reported that they were fully active . The median PSA was 7.8ng/mL ( mean 10.2ng/mL ) . In three-fourths of men , the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise . Using previously developed tumor risk categorizations incorporating PSA levels , Gleason histologic grade , and tumor stage , it was found that approximately 40 % had low-risk , 34 % had medium-risk , and 21 % had high-risk prostate cancer based on local histopathology . Comparison to our national sample of eligible men declining PIVOT participation as well as to men enrolled in the Sc and inavian trial indicated that PIVOT enrollees are representative of men being diagnosed and treated in the United States and quite different from men in the Sc and inavian trial . PIVOT enrolled an ethnically diverse population representative of men diagnosed with prostate cancer in the United States . Results will yield important information regarding the relative effectiveness and harms of  surgery  compared with WW for men with predominately PSA-detected clinical ly localized prostate cancer PURPOSE This article review s the data supporting an approach of active surveillance with selective delayed intervention for good risk localized prostate cancer . The challenge is to identify those patients who are not likely to experience significant progression , while offering radical therapy to those who are at risk . MATERIAL S AND METHODS A prospect i ve phase 2 study of active surveillance with selective delayed intervention was initiated in 1995 . Patients were treated initially with surveillance , while those who had a prostate specific antigen ( PSA ) doubling time ( DT ) of 2 years or less , or grade progression on re-biopsy were offered radical intervention . The remainder were closely monitored . RESULTS The cohort consisted of 299 patients with good risk prostate cancer or intermediate risk prostate cancer in men older than 70 years .  Median PSA DT was 7.0 years and 35 % of the men had a PSA DT of greater than 10 years . The majority of patients remain on surveillance . At 8 years overall actuarial survival was 85 % and disease specific survival was 99 % . CONCLUSIONS Most men with favorable risk prostate cancer will die of unrelated causes . The approach of active surveillance with selective delayed intervention based on PSA DT represents a practical compromise between radical therapy in all , which results in overtreatment in patients with indolent disease , and watchful waiting with palliative therapy only , which results in under treatment in those with aggressive disease . Results at 8 years are favorable . Longer followup will be required to confirm the safety of this approach in men with long ( greater than 15-year ) life expectancy [ Radical prostatectomy reduces the risk of death in prostatic cancer . The effect on total mortality can not be established yet as shown in ar and omized controlled trial Recruitment to trials is known to be difficult . Previous research suggests that a crucial factor may be participants ' difficulty with the concept of r and omization . This study explored patients ' perceptions of r and omization  and reasons for consent or refusal to participate in the ProtecT study ( a r and omized trial of surgery , radiotherapy , and monitoring for localized prostate cancer ) . In-depth interviews were conducted with 21 men diagnosed with localized prostate cancer who were invited to participate in the ProtecT treatment trial . Interviewees were selected purpose fully from three U.K. clinical centers to ensure the inclusion of similar proportions of those agreeing or refusing r and om treatment allocation in each of the treatment groups . Interviews explored men 's recall and underst and ing of chance , comparison , and equipoise , and reasons for consent/refusal of r and omization  and acceptance/rejection of treatment allocation . Data were analyzed method ically using the techniques of constant comparison . Checking of coding and interpretation was assured by four experienced qualitative research ers . Recall and underst and ing of the major principles of the r and omized design were good and were similar for " chance " and " comparison " between those who consented to and refused r and omization . Clinical equipoise , however , caused difficulty . Almost all recalled and understood it , but those who found it acceptable tended to consent to r and omization and those who could not accept it tended to refuse to participate . Belief in clinical equipoise was key to participants ' consent to r and omization . Ensuring patients underst and and accept equipoise may thus increase their readiness to consent to participate in trials . A priority for future research is to focus on the provision and presentation of suitable and effective trial information , concentrating in particular on the neglected concept of clinical equipoise Background . Currently , no r and omized trials of the various treatment options for localized prostate cancer have been reported . Therefore , radical prostatectomy and external irradiation are offered as the primary management options and are thought by many to be curative PURPOSE The goal of this study was to determine the relationship between primary treatment , urinary dysfunction , sexual dysfunction , and general health-related quality of life ( HRQOL ) in prostate cancer . METHODS A sample of men with newly diagnosed prostate cancer between 1994 and 1995 was r and omly selected from six population -based Surveillance , Epidemiology , and End Results registries . A baseline survey was completed by 2,306 men within 6 to 12 months of diagnosis , and these men also completed a follow-up HRQOL survey  2 years after diagnosis . Logistic regression models were used to determine whether primary treatment , urinary dysfunction , and sexual dysfunction were independently associated with general HRQOL outcomes approximately 2 years after diagnosis as measured by the  Medical Outcomes Study 36-item Short Form Health Survey .  The magnitude of this effect was estimated using least square means models . RESULTS After adjustment for potential confounders , primary treatment was not associated with 2-year general HRQOL outcomes in men with prostate cancer .  Urinary function and bother were independently associated with worse general HRQOL in all domains . Sexual function and bother were also independently associated with worse general HRQOL , although the relationship was not as strong as in the urinary domains . CONCLUSION Primary treatment is not associated with 2-year general HRQOL outcomes in prostate cancer . Although both sexual and urinary function and bother are associated with quality of life , men who are more bothered by their urination or impotence are more likely to report worse quality of life . This implies that future research should be directed toward finding ways to improve treatment-related outcomes or help patients better cope with their posttreatment urinary or sexual dysfunction BACKGROUND The effect of screening with prostate-specific-antigen ( PSA ) testing and digital rectal examination on the rate of death from prostate cancer is unknown . This is the first report from the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial on prostate-cancer mortality . METHODS From 1993 through 2001 
    Output:
    
The existing trials provide insufficient evidence to allow confident statements to be made about the relative beneficial and harmful effects of RP and WW for patients with localised prostate cancer .