Hypofractionated Radiation Therapy for Localized Prostate Cancer: Executive Summary of an ASTRO, ASCO, and AUA Evidence-Based Guideline. Update on AUA guideline on the management of benign prostatic hyperplasia. Presenting treatment options to men with clinically localized prostate cancer: the acceptability of active surveillance/monitoring. Management of Depression in Patients With Cancer: A Clinical Practice Guideline. EAU guidelines on prostate cancer. part 1: screening, diagnosis, and local treatment with curative intent-update 2013. Individualizing quality-of-life outcomes reporting: how localized prostate cancer treatments affect patients with different levels of baseline urinary, bowel, and sexual function. A Decision Aid to Support Informed Choices for Patients Recently Diagnosed With Prostate Cancer: A Randomized Controlled Trial The Personal Patient Profile-Prostate decision support for men with localized prostate cancer: a multi-center randomized trial. Trends in Management for Patients With Localized Prostate Cancer, 1990-2013. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer. EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and treatment of clinically localised disease. Decision Support with the Personal Patient Profile‐Prostate: A Multicenter Randomized Trial Patient Education Materials about the Treatment of Early-Stage Prostate Cancer: A Critical Review Patient‐reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life The importance of local control in high-risk locally advanced prostate cancer. Commentary: controversies in NICE guidance on prostate cancer
PURPOSE The aim of this guideline is to present recommendations regarding moderately hypofractionated ( 240 - 340 cGy per fraction ) and ultrahypofractionated ( 500 cGy or more per fraction ) radiation therapy for localized prostate cancer . METHODS AND MATERIAL S The American Society for Radiation Oncology convened a task force to address 8 key questions on appropriate indications and dose-fractionation for moderately and ultrahypofractionated radiation therapy , as well as technical issues , including normal tissue dose constraints , treatment volumes , and use of image guided and intensity modulated radiation therapy . Recommendations were based on a systematic literature review and created using a predefined consensus-building methodology and Society-approved tools for grading evidence quality and recommendation strength . RESULTS Based on high- quality evidence , strong consensus was reached for offering moderate hypofractionation across risk groups to patients choosing external beam radiation therapy . The task force conditionally recommends ultrahypofractionated radiation may be offered for low- and intermediate-risk prostate cancer but strongly encourages treatment of intermediate-risk patients on a clinical trial or multi-institutional registry . For high-risk patients , the task force conditionally recommends against routine use of ultrahypofractionated external beam radiation therapy . With any hypofractionated approach , the task force strongly recommends image guided radiation therapy and avoidance of nonmodulated 3-dimensional conformal techniques . CONCLUSIONS Hypofractionated radiation therapy provides important potential advantages in cost and convenience for patients , and these recommendations are intended to provide guidance on moderate hypofractionation and ultrahypofractionation for localized prostate cancer . The limits in the current evidentiary base-especially for ultrahypofractionation-highlight the imperative to support large-scale r and omized clinical trials and underscore the importance of shared decision making between clinicians and patients PURPOSE To revise the 2003 version of the American Urological Association 's ( AUA ) Guideline on the management of benign prostatic hyperplasia ( BPH ) . MATERIAL S AND METHODS From MEDLINE ® search es of English language publications ( January 1999 through February 2008 ) using relevant MeSH terms , articles concerning the management of the index patient , a male ≥45 years of age who is consulting a healthcare provider for lower urinary tract symptoms ( LUTS ) were identified . Qualitative analysis of the evidence was performed . Selected studies were stratified by design , comparator , follow-up interval , and intensity of intervention , and meta-analyses ( quantitative synthesis ) of outcomes of r and omized controlled trials were planned . Guideline statements were drafted by an appointed expert Panel based on the evidence . RESULTS The studies varied as to patient selection ; r and omization ; blinding mechanism ; run-in periods ; patient demographics , comorbidities , prostate characteristics and symptoms ; drug doses ; other intervention characteristics ; comparators ; rigor and intervals of follow-up ; trial duration and timing ; suspected lack of applicability to current US practice ; and techniques of outcomes measurement . These variations affected the quality of the evidence review ed making formal meta- analysis impractical or futile . Instead , the Panel and extractors review ed the data in a systematic fashion and without statistical rigor . Diagnosis and treatment algorithms were adopted from the 2005 International Consultation of Urologic Diseases . Guideline statements concerning pharmacotherapies , watchful waiting , surgical options and minimally invasive procedures were either up date d or newly drafted , peer review ed and approved by AUA Board of Directors . CONCLUSIONS New pharmacotherapies and technologies have emerged which have impacted treatment algorithms . The management of LUTS/BPH continues to evolve Presenting treatment options to men with localized prostate cancer is difficult because of the lack of definitive evidence and the range of treatment options available . Active surveillance and monitoring programs are now a recognized treatment option for men with low-risk localized prostate cancer , but many patients are not fully aware of the details of such programs , and most still opt for immediate radical ( surgery or radiotherapy ) treatment . The provision of high- quality information with decision aids has been shown to increase the acceptability of active surveillance/monitoring programs . This chapter outlines techniques for providing high- quality information about active surveillance/monitoring , based on the findings of a r and omized controlled trial of treatments for localized prostate cancer . The ProtecT ( Prostate testing for cancer and Treatment ) trial has r and omized over 1500 men between active monitoring , radical surgery , and radical radiotherapy by ensuring that information was tailored to men 's existing knowledge and views . Care was taken with the content , order , and enthusiasm of the presentation of treatments by recruitment staff , and clinicians and other health professionals were supported to feel comfortable with being open about the uncertainties in the evidence and helped to rephrase terminology likely to be misinterpreted by patients . These techniques of information provision should be added to the use of decision aids to enable patients diagnosed with clinical ly localized prostate cancer in routine practice to reach well-informed and reasoned decisions about their treatment , including full consideration of active surveillance and monitoring programs PURPOSE This report up date s the Cancer Care Ontario Program in Evidence -Based Care guideline for the management of  depression in adult patients with cancer . This guideline covers pharmacologic , psychological , and collaborative care interventions , with a focus on integrating practical management tools to assist clinicians in delivering appropriate treatments for depression in patients with cancer . METHODS Recommendations were developed by synthesizing information from extant guidelines and review s and search ing for r and omized controlled trials from the date of data base inception ( 1964 for MEDLINE and 1974 for EMBASE ) to January 2015 . Quality assessment of guidelines and systematic review s were conducted by using the Appraisal of Guidelines for Research and Evaluation II ( AGREE II ) , Assessment of Multiple Systematic Review s ( AMSTAR ) , and Cochrane Risk of Bias tools . Final recommendations were developed through a st and ardized Program in Evidence -Based Care multidisciplinary expert and knowledge user review process . RESULTS Two high- quality relevant clinical practice guidelines , eight pharmacologic trials , nine psychological trials , and eight collaborative care intervention trials composed the evidence base upon which the recommendations were developed . Eight specific recommendations were made to establish a st and ard of care for the management of depression in patients with cancer . The recommendations and practical management tools were review ed as being well organized and helpful , although systemic barriers to implementation were identified . CONCLUSION This up date d guideline supports the previous general recommendation that patients with cancer who have depression may benefit from psychological and /or pharmacologic interventions , without evidence for the superiority of any specific treatment over another . New recommendations for a collaborative care model that incorporates a stepped care approach suggest that multidisciplinary mental health care restructuring may be required for optimal management of depression CONTEXT The most recent summary of the European Association of Urology ( EAU ) guidelines on prostate cancer ( PCa ) was published in 2011 . OBJECTIVE To present a summary of the 2013 version of the EAU guidelines on screening , diagnosis , and local treatment with curative intent of clinical ly organ-confined PCa . EVIDENCE ACQUISITION A literature review of the new data emerging from 2011 to 2013 has been performed by the EAU PCa guideline group . The guidelines have been up date d , and levels of evidence and grade s of recommendation have been added to the text based on a systematic review of the literature , which included a search of online data bases and bibliographic review s. EVIDENCE SYNTHESIS A full version of the guidelines is available at the EAU office or online ( www.uroweb.org ) . Current evidence is insufficient to warrant widespread population -based screening by prostate-specific antigen ( PSA ) for PCa . Systematic prostate biopsies under ultrasound guidance and local anesthesia are the preferred diagnostic method . Active surveillance represents a viable option in men with low-risk PCa and a long life expectancy . A biopsy progression indicates the need for active intervention , whereas the role of PSA doubling time is controversial . In men with locally advanced PCa for whom local therapy is not m and atory , watchful waiting ( WW ) is a treatment alternative to and rogen-deprivation therapy ( ADT ) , with equivalent oncologic efficacy . Active treatment is recommended mostly for patients with localized disease and a long life expectancy , with radical prostatectomy ( RP ) shown to be superior to WW in prospect i ve r and omized trials . Nerve-sparing RP is the approach of choice in organ-confined disease , while neoadjuvant ADT provides no improvement in outcome variables . Radiation therapy should be performed with ≥ 74 Gy in low-risk PCa and 78 Gy in intermediate- or high-risk PCa . For locally advanced disease , adjuvant ADT for 3 yr results in superior rates for disease-specific and overall survival and is the treatment of choice . Follow-up after local therapy is largely based on PSA and a disease-specific history , with imaging indicated only when symptoms occur . CONCLUSIONS Knowledge in the field of PCa is rapidly changing . These EAU guidelines on PCa summarize the most recent findings and put them into clinical practice . PATIENT SUMMARY A summary is presented of the 2013 EAU guidelines on screening , diagnosis , and local treatment with curative intent of clinical ly organ-confined prostate cancer ( PCa ) . Screening continues to be done on an individual basis , in consultation with a physician . Diagnosis is by prostate biopsy . Active surveillance is an option in low-risk PCa and watchful waiting is an alternative to and rogen-deprivation therapy in locally advanced PCa not requiring immediate local treatment . Radical prostatectomy is the only surgical option . Radiation therapy can be external or delivered by way of prostate implants . Treatment follow-up is based on the PSA level PURPOSE Although it is the most powerful predictor of early prostate cancer treatment-related complications and quality -of-life ( QOL ) outcomes , most studies do not stratify results by baseline function . Further , reporting functional outcomes as averaged numerical results may obscure informatively disparate courses . Using levels of treatment-related dysfunction , we address these problems and present the final QOL outcomes of our prospect i ve cohort study of patients with early prostate cancer . METHODS We created categories for sexual , bowel , and urinary function , measured using numerical scores of the vali date d Prostate Cancer Symptom Indices and stratified into " normal , " " intermediate " and " poor " levels of function by incorporating patient-reported symptom and distress information . We present QOL outcomes for 409 patients 36 months after radical prostatectomy , external-beam radiation therapy , and brachytherapy .  RESULTS Different levels of baseline sexual , bowel , and urinary function produced distinctive treatment-related changes from baseline to 36 months . In general , the average scale increases in dysfunction were greatest among patients with normal baseline function , although patients with normal and intermediate baseline function had similar increases in sexual dysfunction . For patients whose baseline urinary obstruction/irritation was poor , both average scale scores and most patients ' level of function improved after treatment , particularly after surgery . CONCLUSION The use of functional levels to stratify treatment-related outcomes by pretreatment functional status and to display the proportions of patients with improved , stable , or worsened function after treatment provides information that more specifically conveys the expected impact of treatment to patients choosing among localized prostate cancer treatments Background : Decision aids provide balanced information about the benefits and risks of treatment options and improve the match between patient preferences and the treatment received . Objective : To assess the impact of a decision aid regarding the treatment options for patients with localized prostate cancer . Methods : A 2-arm r and omized controlled trial was used to compare booklet patient decision aid ( intervention group n = 61 ) with st and ard information for localized prostate cancer ( control group  n = 61 ) . The study was conducted at 3 hospitals between 2011 and 2013 . The main outcome measures were knowledge , decisional conflict , satisfaction with the decision-making process , and coping . Results : The respective mean Decisional Conflict Scale scores before and after the intervention were 53.0 ± 16.9 and 31.2 ± 10.2 in the intervention group and 49.1 ± 13.7 and 51.7 ± 13.3 in the control group ( P < .001 ) . Mean Knowledge scores were 38.6 ± 16.5 and 75.7 ± 19.0 in the intervention group and 42.0 ± 17.6 and 49.9 ± 16.0 in the control group ( P < .001 ) . Mean Satisfaction With Decision Scale scores were 81.1 ± 8.92 and 95.7 ± 6.89 in the intervention group and 82.5 ± 12.0 and 79.3 ± 10.3 in the control group ( P < .001 ) . Conclusions : Decision aid not only improved patient knowledge about localized prostate cancer and its treatment and their satisfaction with decision making but also decreased their decisional conflict . Implication s for Practice : Decision aid represents a rather innovative approach for a health insurance fund to develop and offer this format of information and decision support . This opens a new field of study for nurses to empower patients in the decision-making process and develop new roles in this area OBJECTIVE The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate , vs. usual education alone , on conflict associated with decision making , plus explore time-to-treatment , and treatment choice . METHODS A r and omized , multi-center clinical trial was conducted with measures at baseline , 1- , and 6 months . Men with newly diagnosed localized prostate cancer ( CaP ) who sought consultation at urology , radiation oncology , or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited . Intervention group participants used the Personal Patient Profile-Prostate , a decision support system comprised of customized text and video coaching regarding potential outcomes , influential factors , and communication with care providers . The primary outcome , patient-reported decisional conflict , was evaluated over time using generalized estimating equations to fit generalized linear models . Additional outcomes , time-to-treatment , treatment choice , and program acceptability/usefulness , were explored . RESULTS A total of 494 eligible men were r and omized ( 266 intervention ; 228 control ) . The intervention reduced adjusted decisional conflict over time compared with the control group , for the uncertainty score ( estimate -3.61 ; ( confidence interval , -7.01 , 0.22 ) , and values clarity ( estimate -3.57 ; confidence interval ( -5.85,-1.30 ) . Borderline effect was seen for the total decisional conflict score ( estimate -1.75 ; confidence interval ( -3.61,0.11 ) . Time-to-treatment was comparable between groups , while undecided men in the intervention group chose brachytherapy more often than in the control group . Acceptability and usefulness were highly rated . CONCLUSION The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences Letters RESEARCH LETTER Trends in Management for Patients With Localized Prostate Cancer , 1990 - 2013 A growing literature supports the safety and efficacy of active surveillance  for patients with low-risk prostate cancer . How- ever , the experience behind this literature is based almost en- tirely in academic centers , and prior reports have consis- tently found surveillance generally underused in most other setting s. 1,2 Conversely , high-risk tumors have been under- treated with and rogen deprivation treatment alone . 2,3 Re- cent trends in community-based practice patterns have not been well documented . Methods | Cancer of the Prostate Strategic Urologic Research En- deavor ( CaPSURE ) is a national registry accruing men with pros- tate cancer diagnosed at 45 urology practice s across the United States since 1995 . A mix of large and small practice s are in- cluded . All but 3 are community-based practice s and 28 states across all regions are represented . Both prospect i ve enroll- ment of newly diagnosed men and retrospective enrollment of previously diagnosed men were permitted before 1998 ; how- ever , since 1998 all enrollment has been prospect i ve . Approximately 90 % of eligible patients are accrued . Urologists report clinical data ; patients provide written consent under central institutional review board supervi- sion . Other method ological details have been reported . 4 We analyzed men with tumors classified as stage cT3aN0M0 or lower managed with prostatectomy , radiation , and rogen deprivation monotherapy , or active surveillance/watchful waiting between 1990 and 2013 . Only recently have these 2 terms been clearly separated , 1 and CaPSURE has histori- cally recorded them as a single category . There were 656 men ( 5.9 % ) with missing treatment data who were excluded .  Cancer risk was stratified using the vali date d Cancer of the Prostate Risk Assessment ( CAPRA ) score . 5 We analyzed treatment trends over 5-year intervals in the full cohort and in a subset of men aged 75 years or older . We calculated Mantel-Haenszel tests for trends over time . There have been changes in the CaPSURE sites over time ( eg , some have closed or withdrawn and others have been added ) . A subset analysis including only practice s steadily contributing patients found substantially similar results . Analyses were performed with Stata version 12.1 ( StataCorp ) . Statistical tests were 2-tailed with α = .05 . Figure 1 . Treatment Trends for the Overall Cohort in the Cancer of the Prostate Strategic Urologic Research Endeavor ( CaPSURE ) Registry Type of treatment Active surveillance/watchful waiting Radical prostatectomy CAPRA score range , 3 - 5 CAPRA score range , 6 - 10 Patients With Prostate Cancer , % Patients With Prostate Cancer , % Patients With Prostate Cancer , % CAPRA score range , 0 - 2 Year of Diagnosis Radiation therapy Primary and rogen deprivation therapy Year of Diagnosis Year of Diagnosis Error bars indicate 95 % confidence intervals ; CAPRA , Cancer of the Prostate Risk Assessment . JAMA July 7 , 2015 Volume 314 , Number 1 ( Reprinted ) Copyright 2015 American Medical Association . All rights reserved . Downloaded From : http://jama.jamanetwork.com/ by a UCSF LIBRARY User on 07/28/2016 PURPOSE To up date eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone . METHODS A committee of investigators experienced in conducting trials for prostate cancer defined new consensus criteria by review ing previous criteria , Response Evaluation Criteria in Solid Tumors ( RECIST ) , and emerging trial data . RESULTS The Prostate Cancer Clinical Trials Working Group ( PCWG2 ) recommends a two- objective paradigm : ( 1 ) controlling , relieving , or eliminating disease manifestations that are present when treatment is initiated and ( 2 ) preventing or delaying disease manifestations expected to occur . Prostate cancers progressing despite castrate levels of testosterone are considered castration resistant and not hormone refractory . Eligibility is defined using st and ard disease assessment s to authenticate disease progression , prior treatment , distinct clinical subtypes , and predictive models . Outcomes are reported independently for prostate-specific antigen ( PSA ) , imaging , and clinical measures , avoiding grouped categorizations such as complete or partial response . In most trials , early changes in PSA and /or pain are not acted on without other evidence of disease progression , and treatment should be continued for at least 12 weeks to ensure adequate drug exposure . Bone scans are reported as " new lesions " or " no new lesions , " changes in soft-tissue disease assessed by RECIST , and pain using vali date d scales . Defining eligibility for prevent/delay end points requires attention to estimated event frequency and /or r and om assignment to a control group . CONCLUSION PCWG2 recommends increasing emphasis on time-to-event end points ( ie , failure to progress ) as decision aids in proceeding from phase II to phase III trials . Recommendations will evolve as data are generated on the utility of intermediate end points to predict clinical benefit PURPOSE To assess the long-term quality of life ( QoL ) outcomes from a phase 3 trial comparing 2 modes of intensity modulated radiation therapy ( IMRT ) : conventional IMRT ( CIMRT ) versus hypofractionated IMRT ( HIMRT ) in patients with localized prostate cancer . METHODS AND MATERIAL S Between 2002 and 2006 , 303 men with low-risk to high-risk prostate cancer were r and omized to 76 Gy in 38 fractions ( CIMRT ) versus 70.2 Gy  in 26 fractions ( HIMRT ) . QoL was compared by use of the Exp and ed Prostate Cancer Index Composite ( EPIC ) , the International Prostate Symptom Score ( IPSS ) , and EuroQoL ( EQ5D ) question naires . The primary outcome of the QoL analysis was a minimum clinical ly important difference defined as a 0.5 st and ard deviation change from baseline for each respective QoL parameter . Treatment effects were evaluated with the use of logistic mixed effects regression models . RESULTS A total of 286 , 299 , and 218 patients had baseline EPIC , IPSS , or EQ5D data available and were included in the analysis . Overall , there was no statistically significant difference between the 2 treatment arms in terms of EPIC , IPSS , or EQ5D scores over time , although there was a trend toward lower EPIC urinary incontinence scores in the HIMRT arm . More patients in the HIMRT arm had a lower EPIC urinary incontinence score relative to baseline versus patients in the CIMRT arm with long-term follow-up . On multivariable analysis , there was no association between radiation fractionation scheme and any QoL parameter . When other clinical factors were examined , lymph node radiation was associated with worse EPIC hormonal scores versus patients receiving no lymph node radiation . In general , QoL outcomes were generally stable over time , with the exception of EPIC hormonal and EQ5D scores . CONCLUSIONS In this r and omized prospect i ve study , there were stable QoL changes in patients receiving HIMRT or CIMRT . Our results add to the growing body of literature suggesting that HIMRT may be an acceptable treatment modality in clinical ly localized prostate cancer OBJECTIVE Our aim was to present a summary of the 2010 version of the European Association of Urology ( EAU ) guidelines on the screening , diagnosis , and treatment of clinical ly localised cancer of the prostate ( PCa ) . METHODS The working panel performed a literature review of the new data emerging from 2007 to 2010 . The guidelines were up date d , and level of evidence and grade of recommendation were added to the text based on a systematic review of the literature , which included a search of online data bases and bibliographic review s. RESULTS A full version is available at the EAU office or Web site ( www.uroweb.org ) . Current evidence is insufficient to warrant widespread population -based screening by prostate-specific antigen ( PSA ) for PCa . A systematic prostate biopsy under ultrasound guidance and local anaesthesia is the preferred diagnostic method . Active surveillance represents a viable option in men with low-risk PCa and a long life expectancy .  PSA doubling time in <3 yr or a biopsy progression indicates the need for active intervention . In men with locally advanced PCa in whom local therapy is not m and atory , watchful waiting ( WW ) is a treatment alternative to and rogen-deprivation therapy ( ADT ) with equivalent oncologic efficacy . Active treatment is mostly recommended for patients with localised disease and a long life expectancy with radical prostatectomy ( RP ) shown to be superior to WW in a prospect i ve r and omised trial . Nerve-sparing RP represents the approach of choice in organ-confined disease ; neoadjuvant and rogen deprivation demonstrates no improvement of outcome variables . Radiation therapy should be performed with at least 74 Gy and 78 Gy in low-risk and intermediate/high-risk PCa , respectively . For locally advanced disease , adjuvant ADT for 3 yr results in superior disease-specific and overall survival rates and represents the treatment of choice . Follow-up after local therapy is largely based on PSA , and a disease-specific history with imaging is indicated only when symptoms occur . CONCLUSIONS The knowledge in the field of PCa is rapidly changing . These EAU guidelines on PCa summarise the most recent findings and put them into clinical practice Purpose We evaluated the efficacy of the web based P3P ( Personal Patient Profile‐Prostate ) decision aid vs usual care with regard to decisional conflict in men with localized prostate cancer . Material s and Methods A r and omized ( 1:1 ) , controlled , parallel group , nonblinded trial was performed in 4 regions of the United States . Eligible men had clinical ly localized prostate cancer and an upcoming consultation , and they spoke and read English or Spanish . Participants answered question naires to report decision making stage , personal characteristics , concerns and preferences plus baseline symptoms and decisional conflict . A r and omization algorithm allocated participants to receive tailored education and communication coaching , generic teaching sheets and external websites plus a 1‐page summary to clinicians ( intervention ) or the links plus material s provided in clinic ( usual care ) . Conflict outcomes and the number of consultations were measured at 1 month . Univariate and multivariable models were used to analyze outcomes . Results A total of 392 men were r and omized , including 198 to intervention and 194 to usual care , of whom 152 and 153 , respectively , returned 1‐month outcomes .  The mean ± SD 1‐month decisional conflict scale ( score range 0 to 100 ) was 10.9 ± 16.7 for intervention and 9.9 ± 18.0 for usual care . The multivariable model revealed significantly reduced conflict in the intervention group ( –5.00 , 95 % CI –9.40––0.59 ) . Other predictors of conflict included income , marital or partner status , decision status , number of consultations , clinical site and D’Amico risk classification . Conclusions In this multicenter trial the decision aid significantly reduced decisional conflict . Other variables impacted conflict and modified the effect of the decision aid , notably risk classification , consultations and re sources . P3P is an effective adjunct for shared decision making in men with localized prostate cancer Prostate cancer is the most prevalent noncutaneous malignant condition and , after lung cancer , the second leading cause of cancer deaths among U.S. men ( 1 ) . Localized prostate cancer is typically treated with watchful waiting , radical prostatectomy , radiation therapy ( external and brachytherapy ) , and , more rarely , hormone therapy .  Men receiving a diagnosis of localized prostate cancer face a difficult treatment decision because most r and omized , controlled trials are still in progress . However , a recent Swedish r and omized , controlled trial found that while radical prostatectomy reduced mortality from prostate cancer more than did watchful waiting , men who had surgery lived no longer than those who were treated with watchful waiting ( 2 ) . Because specialists disagree and the literature is inconclusive , patients are increasingly expected to participate in treatment decisions . Patients must learn the risks and benefits of each treatment and choose which risks they can tolerate and which benefits they prefer . Decision aids have become the evidence -based medicine information source for patients who face choices that 1 ) have clinical ly important differences in the balance between outcomes and complication rates , 2 ) require tradeoffs between near-term and long-term outcomes , 3 ) include treatments that may result in a grave outcome , or 4 ) have only marginal differences in outcomes . Decision aids are one form of patient education material s. A recent Cochrane review of r and omized trials of decision aids showed that compared with usual care , decision aids improve patient knowledge and realistic expectations and reduce decisional conflict . Exposure to decision aids also seemed to increase patient participation in decisions and improve decision quality ( 3 ) . We sought to determine the adequacy of publicly available patient education material s to offer these identified advantages to patients . More particularly , we first evaluated whether the needed information was presented ( content review ) and then evaluated how well the information was presented ( quality review ) . Methods Development of Review Criteria We developed the criteria for evaluating the content of patient education material s by first examining the empirical and theoretical literature on informed consent and decision aids . For a primary -level analysis , we adopted the Cochrane definition of balanced presentation : 1 ) Are all options presented ( including , if appropriate , watchful waiting ) ? and 2 ) Are potential harms as well as potential benefits presented ( 4 ) ? We used the Cochrane criteria to eliminate all patient education material s that 1 ) did not discuss the 4 st and ard prostate cancer treatments ( watchful waiting , radical prostatectomy , radiation therapy , and hormone therapy ) , 2 ) discussed only cancer in general , or 3 ) discussed only  prostate cancer screening . In a second-level detailed analysis , we applied previously developed generic criteria specific to prostate cancer ( 5 ) . Additional items to reflect patient needs were obtained through a literature review and through review of our criteria from a local prostate cancer support group and from prostate cancer experts ( urologists , oncologists , nurses , research ers , and activists ) from the Michigan Cancer Consortium Prostate Cancer Action Committee . Four of the authors independently developed common definitions and coded test documents . An initial list of 85 criteria was reduced to 54 criteria by consensus and was operationalized ( Tables 1 , 2 , and 3 ) . A weighting system was considered but was not implemented because no gold st and ard could be identified from the literature on decision aids or risk communication . Similarly , the Cochrane criteria provide an empirically vali date d set of criteria for the second-level detailed analysis . Table 1 . Frequency of Clinical Condition Content Table 2 . Frequency of Treatment Option Content Table 3 . Frequency of Quantitative Elements and Other Factors In previous work , we have shown that decision aids can produce decisions that better reflect patient preferences ( 6 , 7 ) . The parallel criteria selected for prostate cancer are the categories of treatment outcomes and side effects . Traditional patient education elements of description of the anatomy and disease progression were also included . Identification of Patient Education Material s Print Material s , Videotapes , and CD-ROMs To identify these material s ( identified between September and December 2001 ) , we asked national organizations ( including patient advocacy groups , government organizations , pharmaceutical companies , insurance companies , health maintenance organizations , universities , and comprehensive cancer centers ) for their material s. To be included , all material s must be widely available to the public at no cost . Internet Search Strategy We first review ed Web sites of prominent organizations ( including all of those identified during the print material , videotape , and CD-ROM search ) . Second , we review ed Web sites of pharmaceutical companies that had received approval from the U.S. Food and Drug Administration to produce prostate cancer drugs . Third , a naive patient with prostate cancer strategy used an open ( broad-based ) search strategy with Google and Yahoo , which located more than 300 000 Web sites . We review ed at least the first 100 links provided and discontinued our search when relevance decreased . We did not evaluate Web sites composed of links to other Web sites or duplicated print material s previously review ed ( for example , the Web site of the National Cancer Institute ) . The initial review set of 546 material s was reduced by 502 material s after applying the Cochrane criteria for all st and ard treatment options to be presented ( see the Appendix Table , for list of print material s not eligible for review ) . The remaining 44 material s ( 19 print material s , 19 Web sites , 4 videotapes , and 2 CD-ROMs ) underwent a formal content and quality review ( Table 4 ) . Table 4 . Full Review Documents Appendix Table . Print Material s Rejected for Formal Analysis Content Review Three coding teams composed of 2 coders were each responsible for review ing one third of the material s. Thus , each material was independently scored by 2 coders . Criteria were rated as present if they were mentioned in the text , even if briefly ( 8) . Paired ratings were compared , and differences were resolved by a second review and , in rare occasions , by a third review er . Percentage agreement achieved by the teams ranged from 91 % to 94 % . Quality Review The quality review evaluated 1 ) the accuracy of the information contained in the patient education material , 2 ) whether presentation of treatment options was balanced , and 3 ) whether the information was comprehensible to the average reader . An experienced clinician with previous prostate cancer research experience performed the accuracy and balance review . The clinician did not participate in the content review and was blind to content scores . Accuracy criteria were developed from the prostate cancer literature on the natural history of the disease and the efficacy and side effects of treatments . The estimates of balance were subjective , grade d from minimal to marked bias toward any particular treatment method . To further evaluate the best material s identified through the simple content inclusion criteria , a health literacy expert performed an extensive plain- language review on the top 5 print material s and top 5 Web sites . To determine these top-rated material s , we developed a scoring system that identified how many of the 54 essential criteria each piece of patient education material contained but did not prioritize further . Those material s that contained inaccurate information or were strongly biased toward a particular treatment were excluded from consideration . Only 1 of the print material s was eliminated from the top rating because of presence of bias . The review assessed characteristics of text and design that affect reading ease and comprehension , incorporating the widely used Suitability Assessment of Material s system ( 9 ) . Criteria include 1 ) readability ; 2 ) amount and organization of content ; 3 ) writing style as it affects literacy dem and s ; 4 ) graphics , layout , and typography ; 5 ) evidence of learning stimulation ; and 6 ) cultural appropriateness . Each criterion was evaluated according to specific subcharacteristics rated on a 0- to 2-point scale ( 0 = unsuitable ; 1 = adequate ; 2 = superior ; or not applicable ) . Final scores were calculated as percentages based on a denominator of 44 possible points . The 0- to 2-point scale was then translated into grade level . Web sites were evaluated by using similar criteria . Updating the Material s Several Web sites changed during the 4-month review period . The review described later in this paper reflects assessment of Web sites between 1 September 2001 and 14 December 2001 . In April 2003 , we rescored the top 5 and bottom 5 Web sites and brochures to determine whether they had changed substantially since our review . Role of the Funding Source The funding source was not involved in the design , conduct , or reporting of the study or in the decision to su bmi t the manuscript for publication . Results Tables 1 , 2 , and 3 show the proportion of criteria ( in consoli date d form ) scored as present in the 44 patient education material s. Although videotape and the CD-ROM material s are reported in Tables 1 , 2 , and 3 , discussion in the paper is restricted to print material s and Web sites because these are the tools most available to public audiences . We found some differences while rescoring the top 5 and bottom 5 print material s and Web sites , but they were small and did not change the rankings of the material s. Content Review Disease Process Most patient education material s included basic information on prostate anatomy and physiology ( 95 % and 80 % of print material s and Web sites , respectively ) . Most print material s and Web sites also discussed prostate cancer staging ( 100 % and 95 % , respectively To present the baseline patient‐reported outcome measures ( PROMs ) in the Prostate Testing for Cancer and Treatment ( ProtecT ) r and omized trial comparing active monitoring , radical prostatectomy and external‐beam conformal radiotherapy for localized prostate cancer and to compare results with other population Prostate cancer is a common malignancy worldwide , and in Canada , it is the most frequently diagnosed cancer in men . The stratification of prostate cancer into risk categories has allowed for improved counselling of patients and provides guidance for treatment selection . However , the exact definition of high-risk prostate cancer remains controversial , and that lack of consensus remains a barrier to assessing available data from various institutions and from clinical trials . The proportion of patients with locally advanced high-risk disease has fallen in the last 20 years largely because of screening for prostate-specific antigen , but management in this population continues to be an important clinical problem . A factor that has emerged in recent years is the importance of local disease control , with data from multiple r and omized trials suggesting that local therapy improves progression-free survival , disease-free survival , and overall survival . Further research in this population is necessary to improve outcomes The NICE guidelines on prostate cancer provide comprehensive advice on best practice for diagnosis and treatment of  prostate cancer .  They are based on systematic review s of the evidence , incorporate multidisciplinary opinions , and try to balance the values of healthcare providers and patients for various outcomes while emphasising a patient centred approach . Their conclusions are generally consistent with other review s and guidelines evaluating similar evidence .1 2 3 4 5 If followed , these recommendations will likely improve prostate cancer outcomes while reducing unnecessary , ineffective , harmful , and costly care . Although NICE ’s recommendations are generally appropriate , any guidelines on prostate cancer are going to be hampered by the lack of high quality information available . The paucity of r and omised trials limits the quality of data used for informed decision making , particularly regarding detection and treatment of localised disease . Even where r and omised trials have shown benefits , the absolute magnitude of benefit is generally small , requires many years to accrue , and must be weighed against accompanying harms and costs . Few studies enrolled men with disease that had been detected as a result of measuring the level of prostate specific antigen ( PSA ) or were adequately powered to assess  survival outcomes . Individual patients and providers may place different values on a particular outcome or have clinical and tumour characteristics that have not been adequately assessed by the trials providing the evidence used for drafting
Results The AUA ( American Urological Association ) , ASTRO , and SUO ( Society of Urologic Oncology ) formulated an evidence ‐based guideline based on a risk stratified clinical framework for the management of localized prostate cancer .
Purpose This guideline is structured to provide a clinical framework stratified by cancer severity to facilitate care decisions and guide the specifics of implementing the selected management options .
The summary presented represents Part I of the two‐part series dedicated to Clinical ly Localized Prostate Cancer : AUA/ASTRO/SUO Guideline discussing risk stratification and care options by cancer severity .