What are the evidence-based guidelines for prostate cancer screening?

Transcription

1 TITLE: Prostate Cancer Screening: A Review of the Guidelines DATE: 29 November 2013 CONTEXT AND POLICY ISSUES Prostate cancer is the third leading cause of cancer death in Canadian men. 1 The lifetime risk of developing prostate cancer is estimated around 14.2%, while the risk of dying from this cancer is 3.7%. 1 In most cases, prostate cancer grows slowly and most men die due to causes other than prostate cancer even before the cancer becomes clinically evident. 2 Survival from prostate cancer depends largely on the progression of tumor at the time of diagnosis. 2 The early detection of prostate cancer is believed to reduce the prostate cancer morbidity. 2 However, earlier detection may also result in over-diagnosis and over-treatment of mild forms of prostate cancer; 3 the treatment of such cancers might be more aggressive than the cancer itself. The debate over prostate cancer screening became more prominent by the introduction of the prostate-specific antigen (PSA) test for the detection of prostate cancer. The PSA testing was shown to be very sensitive, and has contributed the increase of prostate cancer incidence since Despite the wide adoption of PSA testing in prostate cancer screening, the evidence supporting its use still unclear. 3 Several clinical guidelines have been developed to organize and orient prostate cancer screening programs. The objective of this review is to evaluate the quality of the North American guidelines on prostate cancer screening. RESEARCH QUESTIONS What are the evidence-based guidelines for prostate cancer screening? KEY FINDINGS Ten North American guidelines on prostate cancer screening were included in the review. The ten guidelines agreed on recommending prostate cancer screening for men but the age at which screening was recommended differed between guidelines. Six guidelines gave positive for using PSA-based screening, while one guideline recommended against Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. Rapid responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material and may contain material in which a third party owns copyright. This report may be used for the purposes of research or private study only. It may not be copied, posted on a web site, redistributed by or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners own terms and conditions.

2 this practice. This disagreement was due to difference in the included primary evidence and the outcomes evaluated in each guideline. METHODS Literature Search Strategy A limited literature search was conducted on key resources including PubMed, The Cochrane Library (2013, Issue 10), University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, as well as a focused Internet search. Methodological filters were applied to limit retrieval to health technology assessments, systematic reviews, meta-analyses, and guidelines. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2008 and November 1, Selection Criteria and Methods One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed for relevance. Full texts of any relevant titles/abstracts were retrieved, and assessed for inclusion. The final article selection was based on the inclusion criteria presented in Table 1. Table 1: Selection Criteria Population Intervention Comparator Outcomes Study Designs Asymptomatic Adult Males Prostate Cancer Screening Not applicable Guidelines and North American guidelines Exclusion Criteria Guidelines were excluded if they were developed outside North America or if more recent updates to the guideline were available. Systematic reviews and meta-analyses used in the development of the included guidelines were not included in the main review; however, they were reviewed as supporting documents for methodological quality of the included guidelines. Guidelines on the diagnosis of prostate cancer (i.e. identification of prostate cancer in symptomatic males, not screening) were also excluded for this review. Critical Appraisal of Individual Studies The Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument was used to evaluate the quality of the included guidelines. 4 The instrument includes six domains; these include scope and purpose, stakeholder involvement, rigour of development, clarity and presentation, applicability, and editorial independence. Each domain is scored separately; Prostate Cancer Screening 2

3 theses scores range from 0% (lowest quality score) to 100% (highest quality score). The instrument allows the reviewer to give an overall score for the guidelines; the overall scores range from 1 to 7. Each guideline was evaluated by four independent reviewers, and the average scores from the four reviewers was used to evaluate the quality of the included guidelines. SUMMARY OF EVIDENCE Quantity of Research Available A total of 435 potential citations were identified by searching the bibliographic database, with 421 citations being excluded during the title and abstract screening based on their irrelevance to the questions of interest. The full text documents of the remaining 14 articles were retrieved. Thirteen additional articles were identified by grey literature and hand search. Of the 27 articles, 17 did not meet the inclusion criteria and were excluded; leaving 10 unique guidelines. A PRISMA diagram demonstrating the study selection process is presented in Appendix I. Summary of Study Characteristics Ten North American clinical guidelines were included in this review; 5-14 three guidelines were produced in Canada. 5,7,14 Details on studies characteristics are tabulated in Appendix II. Three guidelines produced specific for the use of prostate-specific antigen (PSA) in prostate screening programs; 8,9,11 five guidelines provided general guidance for prostate cancer screening, 6,7,10,12,13 and the remaining two guidelines provided overviews on the general management of prostate cancer. 5,14 Almost all the included guidelines reported that their were based on a balance between the benefits and harms of screening; however, the specific outcomes reviewed in each guideline and the weights given for each outcome varied from one guideline to another. For example, all-cause mortality and prostate-cancer-related mortality were specific outcomes used in four guidelines; 8,9,11,12 prostate-cancer-related mortality alone was the main outcome that derived the USPSTF. 9 Another example is quality of life which was considered in two guidelines in addition to the mortality outcomes; 8,12 four other guidelines did not provide details on specific outcomes used to support the recommednaiton. 5,7,10,14 Most of the included guidelines reported that evidence was collected from a systematic review of the literature; however, details on the methodologies used for the literature search varied between guidelines, and in two guidelines, this information was absent. 10,13 The included sources of evidence in each guideline varied depending on the range of outcomes considered in each one. For example, for guidelines that considered mortality and prostate-cancer-related mortality, the evidence was retrieved mainly from five trials; these are PLCO, ERSPC, Quebec prostate cancer study, Goteborg and Norrkoping trials. These five trials were reported in the four guidelines that specified mortality as part of their outcomes. 8,9,11,12 However, the five trials did not have the same weight in each of these guidelines; as reported in the USPSTF guideline, this was due to major methodological limitations in the Quebec prostate cancer study and Norrkoping trials, while the Goteborg study included high percentage of patients who were included in the ERSPC analysis. Prostate Cancer Screening 3

4 Summary of Critical Appraisal Details on the critical appraisal of individual studies are tabulated in Appendix III. Scope and purpose This domain includes three items about the clarity and completeness of the guideline objectives and the population for whom it will be applied. 4 Scores for this domain ranged from 43.1% 14 to 91.7%; 8 the median score was 72.9%. The main reason for score variability was due to the description of the clinical question of the guideline and the population for whom the guideline is intended to be used. Stakeholder involvement This domain contains three items that verify the involvement of professional experts in the field, patient groups, and the health care providers who will be using these guidelines. 4 The median score of this domain was 43.8%, and scores ranged from 22.2% 7 to 59.7%. 10 A frequent limitation of the included guidelines was that patients views and preferences were not considered except in three guidelines Rigour of development Eight items are included in this domain; this domain evaluates the process used to collect and synthesize the available evidence, the methods used to formulate the, and the guideline updating process. 4 The median score for this domain was 50.8%, the range of scores was from 13.0% 5 to 75.0%. 9 Reasons for the low scores seen for this domain include the limited or non-reporting of the strength and limitations of the evidence used to support the guidelines; another reason was that the guidelines were not reviewed or validated by external experts prior to publication. Clarity of presentation This domain evaluates the language, structure, and format of guidelines; this is done with three items. 4 The median score for the included guidelines was 75%; the minimum score was 48.6%, 10 and the highest score was 88.9%. 9 Applicability This domain assess whether the guidelines considered the challenges associated with implementation, strategies to improve uptake, and the resource implications of applying the guideline. 4 This domain had the lowest scores among the other domains; the median score is 26.0%, and the range varied from 0.0% 5 to 36.5%. 6 A general observation on the included guidelines was that they did not include a clear process on how they will be monitored in practice or how they will be updated. Editorial independence Two items are used in this domain that are concerned with the formulation of not being unduly biased by competing interests. 4 The median score is 57.3%, and scores ranged from 8.3% 5 to 81.3%. 11 Prostate Cancer Screening 4

5 Overall scores The overall score of the included guidelines ranged from to ,12 These values should be interpreted as relative quality measure for the included guidelines, rather than an absolute measure of quality. Summary of Findings Decision to Screen for Prostate Cancer A general recommendation was repeated throughout the included guidelines that screening should be based on an informed decision about the benefits and risks of screening. 5,6,10-14 None of the included guidelines provided against prostate cancer screening for the general population. However, some guidelines provided criteria on how the decision of screening for prostate cancer can be made, and in some situations these criteria excluded certain population subgroups based on their age and risk level. For average risk and healthy patients, risk assessment and information about the benefits and risks of screening was recommended for men between the ages 50 5,6,11 and 70 years. 5,11 One guideline added a condition that individual should have at least 10-year life expectancy to benefit from the screening. 6 This age range was relaxed in another guideline to include men from the age of 40 years to the age 74 years; after which the decision should be considered individually. 10 A tighter age range was proposed by another guideline to included only men from the age of 55 years up to the age of 69 years. 13 Screening for men above 74 years was specifically not recommended in this guideline. 13 One guideline provided for men at higher risk of developing prostate cancer; the guideline recommended screening starting at the age of 40 to 45 years, depending on the risk assessment. 6 Screening tests Three guidelines recommended that both DRE and PSA should be performed for prostate cancer screening. 5,7,14 Some guidelines provided age limitations for the provision of PSA; in three guidelines this was reported as a recommendation against PSA testing for men younger than 50 years or older than 70 years. 11,12,14 Life expectancy of at least 10 to 15 years was another prerequisite for providing PSA testing in three guidelines. 8,11,12 The guideline provided by the U.S. Preventive Services Task Force recommended against PSAbased screening for prostate cancer. 10 USPSTF reported evidence that screening prostate cancer with PSA can detect some cases of prostate cancer; however, they also reported that the evidence is not adequate to conclude that treatment for prostate cancer detected by screening improves health outcomes compared with treatment initiated for symptomatic disease. This recommendation was based mainly on the results of the PLCO and ERSPC trials. 9 The two trials compared the risk of prostate cancer death and all-cause death between a group of cohort who had prostate cancer screening with PSA and a control group. The guideline reported that the PLCO trial provided a statistically not significant risk ratio of prostate cancer death and all-cause death. 10 Regarding the ERSPC trial results for prostate cancer death, the risk ratio was statistically significant favoring the PSA screening group; however, this result was not consistent among the seven countries included in the trial, with two countries driving the overall result. 10 Based on the results of the ERSPC trial, the guideline argued that there is a Prostate Cancer Screening 5

6 considerable heterogeneity in the clinical and methodological aspects in the different countries included in this trial. 10 Therefore, guideline gave more weight to the PLCO trial than the ERSPC trial. Screening frequency Two guidelines provided about the frequency of screening. In one guideline the frequency of screening was related to the PSA values and the clinical risk factors. 10 In the other guideline, it was recommended that PSA testing every two years or more may be preferred over annual testing. 12 Limitations The current review evaluated the quality of the North American guidelines on the early detection of prostate cancer. Three Canadian guidelines were included in this review; however, guidelines with high overall quality scores were developed in USA. This is a potential limitation because American guidelines may not reflect the Canadian clinical practice, patients preferences, or the health system in general. The critical appraisal of the included guidelines was conducted by four reviewers working at the Canadian Agency for Drugs and Technologies in Health. Although having multiple reviewers will insure the reliability of the evaluation, the four reviewers share the same health technology assessment (HTA) perspective; in contrast to regulatory perspective, HTA reviews may have more quality requirements. CONCLUSIONS AND IMPLICATIONS FOR DECISION OR POLICY MAKING This report aimed to evaluate the North American guidelines about the prostate cancer screening. A total of ten guidelines were retrieved. With respect to the of the included guidelines, none of the included guidelines provided against prostate cancer screening for the general population. Most of the guidelines provided age criteria that limit screening for men between the ages of 40 or 50 up to the age of 70 or 75. Six guidelines recommended favorably on PSA-based screening for different age groups; on the other hand, one guideline by the USPSTF recommended against PSA testing for prostate cancer screening. This disagreement was mainly due to differences in the primary source of evidence included and the outcome priorities in each guideline. PREPARED BY: Canadian Agency for Drugs and Technologies in Health Tel: Prostate Cancer Screening 6

7 REFERENCES 1. Allard CB, Dason S, Lusis J, Kapoor A. Prostate cancer screening: Attitudes and practices of family physicians in Ontario. Can Urol Assoc J [Internet] Jun [cited 2013 Nov 6];6(3): Available from: 2. Hoffman RM, Fletcher RH, O'Leary MP, Rind DM. Screening for prostate cancer Oct 17 [cited 2013 Nov 27]. In: UpToDate [Internet]. Waltham (MA): UpToDate; Available from: Subscription required. 3. Gomella LG, Liu XS, Trabulsi EJ, Kelly WK, Myers R, Showalter T, et al. Screening for prostate cancer: the current evidence and guidelines controversy. Can J Urol [Internet] Oct [cited 2013 Nov 6];18(5): Available from: 4. The AGREE Next Steps Consortium. Appraisal of guidelines for research and evaluation II [Internet]. London (UK): The AGREE Research Trust; 2009 May. [cited 2013 Nov 11]. Available from: 5. Saskatchewan Cancer Agency. SCA clinical practice guideline for prostate cancer [Internet]. Regina: The Agency; [cited 2013 Nov 6]. Available from: MediaID=1560&Filename=SCA_Prostate_Guidelines_Dec31_2008.pdf 6. Wolf AM, Wender RC, Etzioni RB, Thompson IM, D'Amico AV, Volk RJ, et al. American Cancer Society guideline for the early detection of prostate cancer: update CA Cancer J Clin Mar;60(2): Izawa JI, Klotz L, Siemens DR, Kassouf W, So A, Jordan J, et al. Prostate cancer screening: Canadian guidelines Can Urol Assoc J [Internet] Aug [cited 2013 Nov 6];5(4): Available from: 8. Basch E, Oliver TK, Vickers A, Thompson I, Kantoff P, Parnes H, et al. Screening for prostate cancer with prostate-specific antigen testing: American Society of Clinical Oncology Provisional Clinical Opinion. J Clin Oncol [Internet] Aug 20 [cited 2013 Nov 27];30(24): Available from: 9. Moyer VA, U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med Jul 17;157(2): National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN Guidelines ): prostate cancer early detection. Version Fort Washington (PA): National Comprehensive Cancer Network, Inc.; Qaseem A, Barry MJ, Denberg TD, Owens DK, Shekelle P, Clinical Guidelines Committee of the American College of Physicians. Screening for prostate cancer: a guidance Prostate Cancer Screening 7

8 statement from the Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med May 21;158(10): Early detection of prostate cancer: AUA guideline [Internet]. Linthicum (MD): American Urological Association; [cited 2013 Nov 6]. Available from: Wilkinson J, Bass C, Diem S, Gravley A, Harvey L, Maciosek M, et al. Preventive services for adults [Internet]. Bloomington (MN): Institute for Clinical Systems Improvement; [cited 2013 Nov 6]. (Health care guideline). Available from: Prostate cancer. Version 4. Edmonton: Alberta Health Services; (Clinical practice guideline GU-004). 15. Chou R, Croswell JM, Dana T, Bougatsos C, Blazina I, Fu R, et al. Screening for prostate cancer: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med Dec 6;155(11): Prostate Cancer Screening 8

9 APPENDIX I: SELECTION OF INCLUDED STUDIES 435 citations identified from electronic literature search and screened 421 citations excluded 14 potentially relevant articles retrieved for scrutiny (full text, if available) 13 potentially relevant reports retrieved from other sources (grey literature, hand search) 27 potentially relevant reports 17 reports excluded: - Not clinical practice guideline (7) - Earlier versions of included guidelines (10) 10 unique guidelines included in the review Prostate Cancer Screening 9

10 APPENDIX II. CHARACTERISTICS OF THE INCLUDED GUIDELINES Table 2. Characteristics of the Included Guidelines Objectives Intervention and Intended users/ Major Outcomes Practice Target population SaskCancer, Saskatchewan Cancer Agency, Canada Health care professionals in Saskatchewan no further information was provided Management of prostate cancer Health benefits, side effects and risks for the provided were not reported. Wolf et al American Cancer Society (ASC), USA Health care providers and patients - Early detection of prostate cancer Impact of prostate cancer screening, impact of informed decision making, harms from prostate cancer early detection, adverse effects of prostate cancer therapies, and efficacy of PSA and DRE Evidence collection, Selection and Synthesis Systematic literature search, expert opinion, and inclusion of guidelines from other jurisdictions. The methodology of the systematic literature search and the evidence sources were not reported. Systematic literature search and expert opinion. The literature search included studies published before June The guideline was based on the PLCO and ERSPC studies; Quebec prostate cancer study and Norrkoping trials were reviewed, but they did not influence the because of methodological limitations. Evidence Quality and Strength The evidence quality and strength of was not reported The guideline summarized the different evidence sources and provided high-level assessment of the evidence. The strength of was reported Methodology Recommendations development and Evaluation Consensus from the physicians who attended a symposium held to develop this clinical guideline Consensus among the ACS Prostate Cancer Advisory Committee. The consensus was reached through deliberation process during the committee meetings Guideline Validation There was not a formal validation process for this guideline. It was reported that the guideline will be circulated, for feedback, among health care providers managing prostate cancer. There was not a formal validation process for this guideline. However, it was reported that the guideline was reviewed by the Mission Outcomes Committee and the ACS board, and it was modified accordingly Izawa et al Canadian Urological Association (CUA), Canada The intended users Prostate cancer Health benefits, Systematic literature The evidence Methods for the The guideline did Prostate Cancer Screening 10

11 Table 2. Characteristics of the Included Guidelines Objectives Intervention and Intended users/ Major Outcomes Practice Target population and target population were not explicitly reported screening side effects and risks for the provided were not reported Basch et al American Society of Clinical Oncology (ASCO), USA ASCO members/ asymptomatic men in the general population PSA testing versus no PSA test Moyer et al USPSTF, USA Intended users were not specified/ men in the general U.S. population, regardless of age PSA testing for prostate cancer screening Mortality; adverse events, including psychologic effects, and surgical complications; and quality of life Mortality, benefits and harms of PSAbased screening Evidence collection, Selection and Synthesis search that included studies published up to Evidence was retrieved mainly from three trials: PLCO, ERSPC and Goteborg studies Systematic literature search that included studies published until March Evidence was retrieved mainly from three trials: PLCO, ERSPC and Goteborg studies Systematic literature review that was published separately from the guideline document by Chow et al. 15 Evidence on mortality (prostate specific)was retrieved mainly from two trials: PLCO and ERSPC studies; Goteborg study was considered as a secondary source of information for the ERSPC study because the Evidence Quality and Strength quality and strength of were reported. However, the methodology used for this assessment was not clarified. The evidence quality and strength of were reported. The evidence quality and strength of were reported. Methodology Recommendations development and Evaluation development of were not provided Methods for the development of were not provided Methods for the development of were not provided in the reviewed document. However, the USPSTF website includes a detailed structure for the recommendation process Guideline Validation not provide any information on the validation process The guideline did not provide any information on the validation process The guideline document did not provide explicit information on the validation process. It was reported that there were comments from public audience, and the guideline addressed these comments Prostate Cancer Screening 11

12 Table 2. Characteristics of the Included Guidelines Objectives Intervention and Intended users/ Major Outcomes Practice Target population Evidence collection, Selection and Synthesis Goteborg center was participating in the ERSPC study National Comprehensive Cancer Network (NCCN), USA Intended users were not specified/ men opting to participate in an early detection program Prostate cancer screening Not specified Qaseem et al American College of Physicians (ACP), USA Internists, family physicians and other clinicians/ all men Strategies to manage prostate cancer; early detection using PSA and DRE Mortality and morbidity Carter et al American Urological Association (AUA), USA Urologists/ asymptomatic average risk men Early detection of prostate cancer Mortality, healthrelated quality of life, diagnostic accuracy and harms of testing Not specified in the reviewed document Review of published guideline prior to August The guidance was based on four published guidelines; these are the ACS, AUA, USPSTF and the ACPM guidelines Systematic literature search that included studies published between 1995 and Evidence was retrieved mainly from two trials: PLCO and ERSPC studies; Evidence Quality and Strength The evidence quality and strength of were not reported The AGREE II tool was used to evaluate the quality of the included guidelines. The strength of was not reported however. The evidence quality and strength of were not reported Methodology Recommendations development and Evaluation Methods for the development of were not provided in the reviewed document. However, the NCCN website includes a detailed structure for the recommendation process The methods used for the development of were published in separate methods paper by Qaseem et al. in The methods for developing the were not specified Guideline Validation The guideline did not provide any information on the validation process The guideline did not provide any information on the validation process The guideline was reviewed by 52 peer reviewers; 25 of which provided comments on the guideline Prostate Cancer Screening 12

13 Table 2. Characteristics of the Included Guidelines Objectives Intervention and Intended users/ Major Outcomes Practice Target population Evidence collection, Selection and Synthesis Goteborg, Stockholm, Norrkoping and Quebec studies were also considered, but to lesser extent. The relation between the Goteborg and ERSPC studies was made clear in the guideline. Wilkinson et al Institute for Clinical Systems Improvement (ICSI), USA The intended users were not specified/ average risk asymptomatic adults age 18 or older The guideline included various interventions included prostate cancer screening Alberta Health Services Canada The intended users and the target population were not specified General management of prostate cancer Harms and benefits of screening Health benefits, side effects and risks for the provided were not reported. The methods used for evidence collection were not reported in the reviewed document Systematic literature search that included studies published until August The source of evidence for the screening was not specified. Evidence Quality and Strength The evidence was assessed using the GRADE system The evidence quality and strength of were not reported Methodology Recommendations development and Evaluation Methods for the development of were not provided in the reviewed document. However, the ICSI website includes a detailed structure for the recommendation process Methods for the development of were not provided in the reviewed document. However, Alberta Health Services developed a handbook that detailed the methodology for the Guideline Validation The guideline did not provide any information on the validation process The guideline did not provide any information on the validation process, however, it was reported that the guideline were reviewed and endorsed by Alberta Provincial Genitourinary Tumour Team, but Prostate Cancer Screening 13

14 Table 2. Characteristics of the Included Guidelines Objectives Intervention and Intended users/ Major Outcomes Practice Target population DRE = digital rectal examination; PSA = prostate-specific antigen Evidence collection, Selection and Synthesis Evidence Quality and Strength Methodology Recommendations development and Evaluation guideline development Guideline Validation it was not clear if this was a formal validation process Prostate Cancer Screening 14

15 APPENDIX III. CRITICAL APPRAISAL OF THE INCLUDED GUIDELINES Mean Guidelines Scores and Scales Domain Scores Across Domains of AGREE II Instrument Guideline SaskCacner, Saskatchewan Cancer Agency, Canada Wolf et al American Cancer Society (ASC), USA Izawa et al Canadian Urological Association (CUA), Canada Basch et al American Society of Clinical Oncology (ASCO), USA Moyer et al USPSTF, USA National Comprehensive Cancer Network (NCCN), USA Qaseem et al American College of Physicians (ACP), USA Carter et al American Urological Association (AUA), USA Wilkinson et al Institute for Clinical Systems Improvement (ICSI), USA Alberta Health Services Canada Scope and purpose Stakeholder involvement Rigour of development Clarity of presentation Applicability Editorial independence 62.5% 37.5% 13.0% 65.3% 0.0% 8.3% % 45.8% 58.9% 76.4% 36.5% 41.7% % 22.2% 40.6% 80.6% 1.0% 52.1% % 36.1% 54.2% 73.6% 26.0% 60.4% % 55.6% 75.0% 88.9% 34.4% 77.1% % 59.7% 24.5% 48.6% 17.7% 54.2% % 56.9% 51.0% 79.2% 26.0% 81.3% % 52.8% 57.3% 84.7% 32.3% 68.8% % 41.7% 50.5% 63.9% 27.1% 62.5% % 31.9% 42.7% 70.8% 10.4% 54.2% 4 Overall Score Prostate Cancer Screening 15

16 APPENDIX IV. MAIN RECOMMENDATIONS OF THE INCLUDED GUIDELINES Main Recommendations a SaskCacner, Saskatchewan Cancer Agency, Canada If screening is provided, both DRE and PSA should be performed. Screening may be justified for patients with high risk of developing prostate cancer. Healthy men between 50 and 70 years should be informed about benefits and risks of prostate cancer screening. Screening should be provided based on patients informed decision. Wolf et al American Cancer Society (ASC), USA The guideline was based on the PLCO and ERSPC studies; Quebec prostate cancer study and Norrkoping trials were reviewed, but they did not influence the because of methodological limitations. Strength of Strength of recommendation was not reported for any of the reported. Screening should not occur without an informed decision-making process. Asymptomatic men who have at least a 10-year life expectancy should have an opportunity to make an informed decision to be screened for prostate cancer. o Asymptomatic men who have less than a 10-year life expectancy based on age and health status should not be offered prostate cancer screening. Provision of screening information depends mainly on the age and risk status of the individual: o Men at average risk should receive information about screening beginning at age 50 years. o Men at higher risk, including African American men and men who have a first-degree relative diagnosed with prostate cancer before age 65 years, should receive this information beginning at age 45 years. o Men at higher risk (multiple family members diagnosed with prostate cancer before age 65 years) should receive this information beginning at age 40 years. Strength of recommendation was not provided for any of the reported. Izawa et al Canadian Urological Association (CUA), Canada Evidence was retrieved mainly from three trials: PLCO, ERSPC and Goteborg studies DRE and PSA are the first line prostate cancer screening tests Grade A recommendation b Basch et al American Society of Clinical Oncology (ASCO), USA Evidence was retrieved mainly from three trials: PLCO, ERSPC and Goteborg studies In men with a life expectancy<10 years, it is recommended that general Strong recommendation c screening for prostate cancer with total PSA be discouraged, because harms seem to outweigh potential benefits (page 1) In men with a life expectancy>10 years,* it is recommended that Strong recommendation c physicians discuss with their patients whether PSA testing for prostate cancer screening is appropriate for them. (page 1) It is recommended that information written in lay language be available to Strong recommendation c clinicians and their patients to facilitate the discussion of the benefits and harms associated with PSA testing before the routine ordering of a PSA test. (page 1) a only about screening and early detection were reported in this section b The guideline did not define the different levels of c Strong recommendation indicates high confidence that the recommendation reflects best practice based on: strong evidence for true net effect, consistent results, with no or minor and/or no concerns about study quality. DRE = digital rectal examination; PSA = prostate-specific antigen, PSAD = prostate-specific antigen density; PSAV = prostate-specific antigen velocity Prostate Cancer Screening 16

17 Main Recommendations a Strength of Moyer et al USPSTF, USA Evidence on mortality (prostate specific)was retrieved mainly from two trials: PLCO and ERSPC studies; Goteborg study was considered as a secondary source of information for the ERSPC study because the Goteborg center was participating in the ERSPC study The USPSTF does not recommend the use of PSA-based screening for prostate cancer Grade D recommendation (moderate or high certainty that the service has no net benefits or the harms outweigh the benefits) National Comprehensive Cancer Network (NCCN), USA Evidence on mortality (prostate specific)was retrieved mainly from two trials: PLCO and ERSPC studies; Goteborg study was also considered, and the guideline clarified its relation with the ERSPC study. Risk assessment and discussion about the benefits and risks of prostate screening should start at age of 40; both DRE and PSA may be offered The decision of offering screening for patients >75 years should be considered individually The frequency of repeating the screening tests depends on the PSA values and the clinical risk factors (e.g. family history, African American). Qaseem et al American College of Physicians (ACP), USA The guidance was based on four published guidelines; these are the ACS, AUA, USPSTF and the ACPM guidelines Clinicians should inform men between the age of 50 and 69 years about the limited potential benefits and substantial harms of screening for prostate cancer. The decision of PSA-based screening should be determined according to the individual s risk for prostate cancer, a discussion of the benefits and harms of screening, the patient s general health and life expectancy, and patient preferences. It is not recommended to screen for prostate cancer using the PSA test in patients who do not express a clear preference for screening. It is not recommended to screen for prostate cancer using the PSA test in average-risk men under the age of 50 years, men over the age of 69 years, or men with a life expectancy of less than 10 to 15 years. Strength of recommendation was not provided for any of the reported. Strength of recommendation was not provided for any of the reported guidance statements. a only about screening and early detection were reported in this section DRE = digital rectal examination; PSA = prostate-specific antigen, PSAD = prostate-specific antigen density; PSAV = prostate-specific antigen velocity Prostate Cancer Screening 17

18 Main Recommendations a Strength of Carter et al American Urological Association (AUA), USA Evidence was retrieved mainly from two trials: PLCO and ERSPC studies; Goteborg, Stockholm, Norrkoping and Quebec studies were also considered, but to lesser extent. The relation between the Goteborg and ERSPC studies was made clear in the guideline. PSA-based screening: o Not recommended for men under 40 years old o Not recommended for men between 40 and 54 years who are at average risk o It is strongly recommended, after shared decision-making, for men between the age of 55 and 69 years o Routine screening intervals of two years or more may be preferred over annual screening. The baseline PSA values can be used to determine the frequency of screening o Not recommended for men over 70 years or any man with less than a 10 to 15 years life expectancy Recommendation b Recommendation b Standard b Option b (optional) Recommendation b Wilkinson et al Institute for Clinical Systems Improvement (ICSI), USA Screening can be offered for men who wish to undergo prostate cancer Weak recommendation (there screening by clinicians who wish to offer the screening after considering the following points: is significant uncertainty about the best estimates of benefits o PSA and DRE should not be automatically ordered or performed; individuals should be offered comprehensive information about the benefits and risks of screening and harms) o Any benefits of prostate screening are likely to be limited to men 55 to 69 years of age. o For men above 74 years, screening is not recommended o Frequency of screening has not been determined Alberta Health Services Canada Both DRE and PSA are standard methods for prostate cancer screening The strength of o PSA should be checked in fit men between 50 and 75 years, where clinically indicated. All information necessary to make an informed decision should be provided for those patients recommendation was not provided for any of the reported a only about screening and early detection were reported in this section b Standard indicates a directive statement that an action should or should not be taken based on high level evidence; Recommendation indicates a directive statement that an action should or should not be taken based on low level evidence; Option indicates non-directive statement that leaves the decision regarding an action up to the individual clinician and patient because the balance between benefits and risks appears equal or appears uncertain. DRE = digital rectal examination; PSA = prostate-specific antigen, PSAD = prostate-specific antigen density; PSAV = prostate-specific antigen velocity Prostate Cancer Screening 18