The Prostate Cancer Survivorship Care Guidelines and Recommendations

Transcription

1 Published Ahead of Print on February 9, 2015 as /JCO The latest version is at JOURNAL OF CLINICAL ONCOLOGY A S C O S P E C I A L A R T I C L E Prostate Cancer Survivorship Care Guideline: American Society of Clinical Oncology Clinical Practice Guideline Endorsement Matthew J. Resnick, Christina Lacchetti, Jonathan Bergman, Ralph J. Hauke, Karen E. Hoffman, Terrence M. Kungel, Alicia K. Morgans, and David F. Penson Matthew J. Resnick and David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Affairs Health Care System; Alicia K. Morgans, Vanderbilt-Ingram Cancer Center, Nashville, TN; Christina Lacchetti, American Society of Clinical Oncology, Alexandria, VA; Jonathan Bergman, David Geffen School of Medicine, University of California, Los Angeles and Veterans Health Administration of Greater Los Angeles, Los Angeles, CA; Ralph J. Hauke, Nebraska Cancer Specialists, Omaha, NE; Karen E. Hoffman, University of Texas MD Anderson Cancer Center, Houston, TX; and Terrence M. Kungel, Maine Coalition to Fight Prostate Cancer, Augusta, ME. Published online ahead of print at on February 9, Clinical Practice Guideline Committee approval: November 14, Editor s note: This American Society of Clinical Oncology clinical practice guideline endorsement provides recommendations based on the review and analysis of the relevant literature in the American Cancer Society Prostate Cancer Survivorship Care Guidelines. Additional information, which may include methodology and data supplements, slide sets, patient versions, frequently asked questions, and other clinical tools and resources, is available at prostatesurvivorship. Authors disclosures of potential conflicts of interest are found in the article online at Author contributions are found at the end of this article. Corresponding author: American Society of Clinical Oncology, 2318 Mill Rd, Suite 800, Alexandria, VA 22314; guidelines@asco.org by American Society of Clinical Oncology X/15/3399-1/$20.00 DOI: /JCO A B S T R A C T Purpose The guideline aims to optimize health and quality of life for the post-treatment prostate cancer survivor by comprehensively addressing components of follow-up care, including health promotion, prostate cancer surveillance, screening for new cancers, long-term and late functional effects of the disease and its treatment, psychosocial issues, and coordination of care between the survivor s primary care physician and prostate cancer specialist. Methods The American Cancer Society (ACS) Prostate Cancer Survivorship Care Guidelines were reviewed for developmental rigor by methodologists. The American Society of Clinical Oncology (ASCO) Endorsement Panel reviewed the content and recommendations, offering modifications and/or qualifying statements when deemed necessary. Results The ASCO Endorsement Panel determined that the recommendations from the 2014 ACS Prostate Cancer Survivorship Care Guidelines are clear, thorough, and relevant, despite the limited availability of high-quality evidence to support many of the recommendations. ASCO endorses the ACS Prostate Cancer Survivorship Care Guidelines, with a number of qualifying statements and modifications. Recommendations Assess information needs related to prostate cancer, prostate cancer treatment, adverse effects, and other health concerns and provide or refer survivors to appropriate resources. Measure prostate-specific antigen (PSA) level every 6 to 12 months for the first 5 years and then annually, considering more frequent evaluation in men at high risk for recurrence and in candidates for salvage therapy. Refer survivors with elevated or increasing PSA levels back to their primary treating physician for evaluation and management. Adhere to ACS guidelines for the early detection of cancer. Assess and manage physical and psychosocial effects of prostate cancer and its treatment. Annually assess for the presence of long-term or late effects of prostate cancer and its treatment. J Clin Oncol by American Society of Clinical Oncology INTRODUCTION There are approximately 3 million men currently living with prostate cancer in the United States, and an additional 233,000 patients are expected to be diagnosed in Prostate cancer is the most common cancer among male survivors, accounting for 20% of all cancer survivors in the United States. 2,3 Although a number of guidelines exist that specifically address prostate cancer screening and treatment, few structured recommendations remain to optimize the survivorship experience of men who have been previously treated for prostate cancer. In 2014, the American Cancer Society (ACS) developed guideline recommendations on prostate cancer survivorship care for primary care clinicians. 4 This American Society of Clinical Oncology (ASCO) endorsement reinforces the recommendations offered in the ACS guidelines and acknowledges the effort put forth by the ACS to produce a combination of evidence and expert clinical practice based management recommendations to guide prostate cancer survivorship care across care delivery settings. The issues addressed in the original ACS guidelines as well as this ASCO endorsement are most 2015 by American Society of Clinical Oncology 1 Copyright 2015 by American Society of Clinical Oncology

2 Resnick et al THE BOTTOM LINE Prostate Cancer Survivorship Care Guideline: American Society of Clinical Oncology Clinical Practice Guideline Endorsement The American Society of Clinical Oncology (ASCO) endorses the American Cancer Society (ACS) Prostate Cancer Survivorship Care Guidelines, with minor modifications and qualifying statements (in bold italics). Target Population Prostate cancer survivors. Target Audience Primary care providers, medical oncologists, radiation oncologists, urologists, and other providers. Methods The ASCO Endorsement Panel was convened to evaluate the ACS Prostate Cancer Survivorship Care Guidelines recommendations that were based on a systematic review of the medical literature. The ASCO Endorsement Panel considered the methodology used in the ACS guidelines by considering the results from the Appraisal of Guidelines for Research and Evaluation II review instrument. The ASCO Endorsement Panel carefully reviewed the ACS guidelines content to determine appropriateness for ASCO endorsement. ASCO Key Recommendations for Prostate Cancer Survivorship Care ACS recommendations, with original language, are listed below, with modifications and qualifying statements added by the ASCO Expert Panel in bold italics. (See Table 1 in Data Supplement for reprint of all ACS recommendations.) Health Promotion 1. Assess information needs related to prostate cancer and its treatment, adverse effects, other health concerns, and available support services and provide or refer survivors to appropriate resources to meet these needs. 2. Counsel survivors to achieve and maintain a healthy weight by limiting consumption of high-calorie foods and beverages and promoting increased physical activity. 3. Counsel survivors to engage in at least 150 minutes per week of physical activity; this may include weight-bearing exercises. 4. Counsel survivors to achieve a dietary pattern that is high in fruits and vegetables and whole grains. a. Consume a diet emphasizing micronutrient-rich and phytochemical-rich vegetables and fruits, low amounts of saturated fat, intake of at least 600 IU of vitamin D per day, and consuming adequate, but not excessive, amounts of dietary sources of calcium (not to exceed 1,200 mg/d). b. Refer survivors with nutrition-related challenges (eg, bowel problems that impact nutrient absorption) to a registered dietitian. 5. Counsel survivors to avoid or limit alcohol consumption to no more than two drinks per day. 6. Assess for tobacco use and offer and/or refer survivors to cessation counseling and resources. Counsel survivors to avoid tobacco products. Surveillance for Prostate Cancer Recurrence 7. Measure serum PSA [prostate-specific antigen] level every 6 to 12 months for the first 5 years, then recheck annually thereafter. ASCO qualifying statement: Prostate cancer specialists may recommend more frequent PSA monitoring during the early survivorship experience for some men, particularly men with higher risk of prostate cancer recurrence and/or men who may be candidates for salvage therapy. The exact schedule for PSA measurement should be determined by both the prostate cancer specialist and primary care physician in collaboration. 8. Ensure that survivors with elevated or rising PSA level are evaluated by their primary treating specialist for further follow-up and treatment. 9. Perform an annual DRE [digital rectal examination] in coordination with cancer specialist to avoid duplication. (continued on following page) by American Society of Clinical Oncology JOURNAL OF CLINICAL ONCOLOGY

3 Prostate Cancer Survivorship Care Guideline THE BOTTOM LINE (CONTINUED) ASCO qualifying statement: Primary care physicians should discuss with the prostate cancer specialist the need for DRE, specifically as it relates to detection of disease recurrence in prostate cancer survivors. Screening for Second Primary Cancers 10. Adhere to American Cancer Society screening and early detection guidelines (cancer.org/professionals). Prostate cancer survivors having undergone radiation therapy may have slightly higher risk of bladder and colorectal cancers (based on level-2a evidence) and may need to follow screening guidelines for higher-risk individuals, if available. ASCO qualifying statement: Patients and physicians should be informed of the increased risk of bladder and colorectal cancer (CRC) after pelvic radiation therapy. Patients should undergo routine screening for CRC as suggested by existing evidence-based guidelines and should undergo appropriate evaluation for any signs or symptoms suggestive of either bladder cancer or CRC. 11. For survivors presenting with hematuria, perform a thorough evaluation to determine the cause of symptoms and to rule out bladder cancer, including urologist referral for cystoscopy and upper urinary tract evaluation. 12. Refer survivors presenting with persistent rectal bleeding, pain, or other symptoms of unknown origin to the appropriate specialist as well as the treating radiation oncologist to conduct a thorough evaluation for cause of symptoms and to evaluate for colorectal cancer. Assessment and Management of Physical and Psychosocial Effects of Prostate Cancer and Treatment Anemia: Specific Risk for Men Receiving ADT [androgen-deprivation therapy] 13. Consider [ASCO Endorsement Panel changed from perform ] annual CBC to monitor hemoglobin levels, particularly in men presenting with symptoms suggestive of anemia. Bowel Dysfunction 14. Discuss bowel function and symptoms (eg, rectal bleeding) with survivors. 15. For men with a negative colorectal cancer screening result, prescribe stool softeners, topical steroids, or antiinflammatories for survivors experiencing rectal bleeding. ASCO qualifying statement: For survivors experiencing rectal bleeding after radiation therapy, CRC should be ruled out, and appropriate management should be discussed with the treating radiation oncologist. Management may include corticosteroid suppositories to decrease inflammation, stool softeners, and dietary changes. 16. Refer survivors with persistent rectal symptoms (eg, bleeding, sphincter dysfunction, rectal urgency, and frequency) to the appropriate specialist. Cardiovascular and Metabolic Effects: Specific Risk for Men Receiving ADT 17. Follow USPSTF [US Preventive Services Task Force] guidelines for evaluation and screening for cardiovascular risk factors, blood pressure monitoring, lipid profiles, and serum glucose (uspreventiveservicestaskforce.org/uspstopics.htm). Distress/Depression/PSA Anxiety 18. Assess for distress/depression/psa anxiety at initial visit, at appropriate intervals, and as clinically indicated [ASCO Endorsement Panel removed wording that recommended assessment should occur periodically, at least annually and removed suggestion that simple screening tool be used such as the Distress Thermometer ]. ASCO qualifying statement: Physicians should refer to the ASCO Screening, Assessment, and Care of Anxiety and Depressive Symptoms in Adults With Cancer guideline ( for more information on management of this important problem. 19. Manage distress/depression using in-office counseling resources or pharmacotherapy as appropriate. 20. If office-based counseling and treatment are insufficient, refer survivors experiencing distress/depression for further evaluation and or treatment by appropriate specialists. (continued on following page) by American Society of Clinical Oncology 3

4 Resnick et al THE BOTTOM LINE (CONTINUED) Fracture Risk/Osteoporosis: Specific Risk for Men Receiving ADT 21. Assess risk of fracture for men treated with ADT or older radiation techniques through baseline DEXA [dual energy x-ray absorptiometry] scan and calculation of a FRAX [WHO fracture risk assessment] score. 22. For men determined to be high risk, prescribe weekly bisphosphonate therapy (oral alendronate at a dose of 70 mg) or annual intravenous zoledronic acid at a dose of 5 mg to increase bone density. Denosumab is also approved by the US Food and Drug Administration to treat men at increased risk of osteoporosis. ASCO qualifying statement: A collaborative strategy should be developed between the primary care physician and prostate cancer specialist to optimize bone health in men at risk for osteoporosis. This strategy should include a thorough discussion of the benefits and harms of bone-targeted agents. Sexual Dysfunction/Body Image 23. Discuss sexual function with survivors. 24. Use validated tools to monitor erectile function over time. [ASCO Endorsement Panel removed reference to SHIM tool.] 25. Erectile dysfunction may be addressed through a variety of options, including penile rehabilitation or prescription of phosphodiesterase type 5 inhibitors (eg, sildenafil, vardenafil, tadalafil 25 ). 26. Refer men with persistent sexual dysfunction to a urologist, sexual health specialist, or psychotherapist to review treatment and counseling options. Sexual Intimacy 27. Encourage couples to discuss their sexual intimacy and refer to counseling or support services as appropriate. 28. Prescribe medication as described above to address erectile dysfunction. 29. Instruct couples on use of sexual aids to improve erectile dysfunction for men/male partners as well as postmenopausal symptoms for women. Refer to mental health professional with expertise in sex therapy. Urinary Dysfunction 30. Discuss urinary function (eg, urinary stream, difficulty emptying the bladder) and incontinence with all survivors. 31. Consider timed voiding, prescribing anticholinergic medications (eg, oxybutynin) to address issues such as nocturia, frequency, or urgency. Consider alpha-blockers (eg, tamsulosin) for slow stream. 32. Refer survivors with postprostatectomy incontinence to a physical therapist for pelvic floor rehabilitation; at a minimum, instruct survivors about Kegel exercises. 33. Refer men with persistent, bothersome leakage or other urinary symptoms to a urologist for further evaluation (eg, urodynamic testing, cystoscopy) and discussion of treatment options including surgical placement of a male urethral sling or artificial urinary sphincter for incontinence. Vasomotor Symptoms (eg, hot flushes): Specific Risk for Men Receiving ADT 34. Although not approved by the US Food and Drug Administration for this indication, prescription of selective serotonin or noradrenergic reuptake inhibitors or gabapentin may offer symptom relief. ASCO qualifying statement: The ASCO Endorsement Panel believes further clinical investigation is required to validate this recommendation. Until that time, physicians should be aware of the development of vasomotor symptoms with ADT and should discuss with their patients the risks, benefits, and costs of available therapies for possible symptom relief. Care Coordination and Practice Implications 35. The primary treating specialist is encouraged to provide a treatment summary and survivorship care plan to the primary care clinician (PCC) when survivorship care is transferred to the PCC. PCCs and treating oncology specialists should confer regarding the survivorship care plan components and determine roles and responsibilities that are appropriate for the survivor s condition and the resources available in the primary care setting. (continued on following page) by American Society of Clinical Oncology JOURNAL OF CLINICAL ONCOLOGY

5 Prostate Cancer Survivorship Care Guideline THE BOTTOM LINE (CONTINUED) 36. PCCs should maintain their role as general medical care coordinator throughout the spectrum of prostate cancer detection, treatment, and aftercare, focusing on preventive care and the management of preexisting comorbid conditions, regularly addressing the patient s overall physical and psychosocial status, and those components of survivorship care that are mutually agreed on with the treating clinicians. 37. Annually assess for the presence of long-term or late effects of prostate cancer and its treatment, including potential urinary, bowel, sexual, and hormonal symptoms. [The ASCO Endorsement Panel removed the following: Use of a validated tool such as EPIC-CP may be helpful in this assessment. ] 38. Encourage the inclusion of caregivers, spouses, or partners in usual prostate cancer survivorship care. 39. Refer survivors to appropriate community-based and peer support resources. Additional Resources More information, including a Data Supplement, Methodology Supplement, slide sets, and clinical tools and resources, is available at Patient information is available at A link to the ACS Prostate Cancer Survivorship Care Guidelines can be found at ASCO believes that cancer clinical trials are vital to inform medical decisions and improve cancer care and that all patients should have the opportunity to participate. applicable to patients with early prostate cancer and are less pertinent to patients with metastatic disease. These issues include health promotion, detection of disease recurrence, screening and early detection of second primary cancers, assessment and management of physical and psychosocial long-term and late effects, and care coordination and practice implications. Qualifying statements were added to a number of the original recommendations, when deemed necessary for clarification, expansion, and/or transference into a collaborative clinical setting. OVERVIEW OF ASCO GUIDELINE ENDORSEMENT PROCESS ASCO has policies and procedures for endorsing practice guidelines that have been developed by other professional organizations. The goal of guideline endorsement is to increase the number of highquality, ASCO-vetted guidelines available to the ASCO membership. The ASCO endorsement process involves an assessment by ASCO staff of candidate guidelines for methodologic quality using the Rigour of Development subscale of the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument (see Methodology Supplement for more detail). Disclaimer The clinical practice guideline and other guidance published herein are provided by ASCO to assist providers in clinical decision making. The information herein should not be relied on as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time information is developed and when it is published or read. The information presented here is not continually updated and may not reflect the most recent evidence. The information discussed here addresses only the topics specifically identified herein and is not applicable to other interventions, diseases, or stages of disease. This information does not mandate any particular course of medical care. Furthermore, this information is not intended to substitute for the independent professional judgment of the treating provider, because the information does not account for individual variation among patients. Recommendations reflect high, moderate, or low confidence that the recommendation reflects the net effect of a given course of action. The use of words like must, must not, should, and should not indicate that a course of action is recommended or not recommended for either most or many patients, but there is latitude for the treating physician to select other courses of action in individual cases. In all cases, the selected course of action should be considered by the treating provider in the context of treating the individual patient. Use of this information is voluntary. ASCO provides this information on an as-is basis and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising from or related to any use of this information or for any errors or omissions. Guideline and Conflicts of Interest The ASCO Endorsement Panel (Appendix Table A1, online only) was assembled in accordance with the ASCO Conflict of Interest Management Procedures for Clinical Practice Guidelines (summarized at Members of the panel completed the ASCO disclosure form, which requires disclosure of financial and other interests that are relevant to the subject matter of the guideline, including relationships with commercial entities that are reasonably likely to experience direct regulatory or commercial impact as the result of promulgation of the guideline. Categories for disclosure include employment relationships, consulting arrangements, stock ownership, honoraria, research funding, and expert testimony. In accordance with these procedures, the majority of the members of the ASCO Endorsement Panel did not disclose any such relationships by American Society of Clinical Oncology 5

6 Resnick et al ACS PROSTATE CANCER SURVIVORSHIP CARE GUIDELINES Clinical Questions and Target Population The ACS guidelines address five key areas of prostate cancer survivorshiptoproviderecommendationsonbestpracticeinthemanagement of men after prostate cancer treatment, focusing on the role of primary care clinicians. The five areas covered include (1) health promotion, (2) surveillance for recurrence, (3) screening and early detection of second primarycancers,(4)assessmentandmanagementofphysicalandpsychosocial long-term and late effects, and (5) care coordination and practice implications. The complete set of ACS recommendations is provided in the Data Supplement. The target patient population for the ACS guidelines is post-treatment prostate cancer survivors. Summary of ACS Prostate Cancer Survivorship Care Guidelines Development Methodology The ACS guidelines were developed by an expert workgroup composed of 16 multidisciplinary experts specializing in the care of patients with prostate cancer and the treatment of long-term and late effects experienced by prostate cancer survivors. Representatives from the fields of urology, medical and radiation oncology, psychology, and nursing were included. The literature was initially searched using PubMed from 2004 through November During guideline development, an additional search of PubMed was conducted to identify any new evidence published from November 2012 through February Details of the searches and study inclusion criteria are available in the ACS guidelines. The initial search identified 468 publications, of which 222 were included as supporting evidence in the guidelines. The subsequent literature search identified additional studies that were added to the evidentiary base. However, the additional studies did not result in any material changes to the drafted recommendations. The panel relied on expert consensus opinion to formulate recommendations for 20 of the 27 recommendations, given that most of the studies were of varying quality and were largely observational in design. RESULTS OF ASCO METHODOLOGY REVIEW The methodology review of the ACS guidelines was completed independently by two ASCO guideline staff members using the Rigour of Development subscale from the AGREE II instrument. Detailed results of the scoring for this guideline are available on request to Overall, the ACS Prostate Cancer Survivorship Care Guidelines scored 77%. The preliminary ASCO content reviewers of the ACS Prostate Cancer Survivorship Care Guidelines, as well as the ASCO Endorsement Panel, found the recommendations clear and well referenced, when evidence was available on the topic. This is the most recent information as of the publication date. For updates and the most recent information and to submit new evidence, please visit and the ASCO Guidelines Wiki ( METHODS AND RESULTS OF ASCO UPDATED LITERATURE REVIEW ASCO guideline staff updated the ACS Prostate Cancer Survivorship Care Guidelines literature search, adapting the strategy described in Skolarus et al 4 (see Data Supplement). A PubMed search from February 2014 to July 9, 2014, yielded 70 new records that were not included in the ACS guidelines. A review of the 70 abstractsbyamethodologistandthepanelco-chairsrevealednonewevidencethat would warrant substantive modification of the ACS Prostate Cancer Survivorship Care Guidelines recommendations. In addition, this review identified nine studies that provided further support for the guidelines recommendations RESULTS OF ASCO CONTENT REVIEW The ASCO Endorsement Panel reviewed the ACS Prostate Cancer SurvivorshipCareGuidelinesandconcursthattherecommendationsareclear, thorough, andbasedonthemostrelevantandavailablescientificevidence in this content area and present options that will be acceptable to primary care physicians and patients. Overall, the ASCO Endorsement Panel agrees with the recommendations as stated in the guidelines, with the minor modifications and qualifications discussed here. DISCUSSION The ASCO Endorsement Panel wants to highlight and qualify some of the statements from the ACS Prostate Cancer Survivorship Care Guidelines regarding surveillance, assessment, and management of physical and psychosocial effects of prostate cancer and its treatment, as well as care coordination. Although most of the recommendations were accepted as is, qualifying and modifying statements were added to 13 recommendations, as follows. Recommendation 7 The ASCO Endorsement Panel added: Prostate cancer specialists may recommend more frequent prostate-specific antigen (PSA) monitoring during the early survivorship experience for some men, particularly men with higher risk of prostate cancer recurrence and/or men who may be candidates for salvage therapy. The exact schedule for PSA measurement should be determined by both the prostate cancer specialist and primary care physician in collaboration. The ASCO Endorsement Panel acknowledges that there are few data on which to base decisions surrounding optimal intensity of PSA monitoring after definitive treatment. It is well known that the risk of disease recurrence is highly contingent on disease-specific factors includingpretreatmentpsa,gleasonscore,andtumorstage,amongothers Given the heterogeneity in risk of recurrence, it is the opinion of the panel that close PSA monitoring in the early survivorship experience should be offered to patients at high risk for disease recurrence. Furthermore, close PSA monitoring should be offered to those patients who may be appropriate for early salvage local therapy. Recommendation 9 The ASCO Endorsement Panel added: Primary care physicians should discuss with the prostate cancer specialists the need for annual digital rectal examination (DRE), specifically as it relates to detection of disease recurrence in prostate cancer survivors. There is little evidence supporting the incremental yield of DRE in identifying disease recurrence among prostate cancer survivors. Moreover, it has been suggested that DRE be omitted from follow-up care. 17 The ASCO Endorsement Panel recognizes that some patients with prostate cancer may benefit from routine DRE, particularly those men undergoing active surveillance, those with high-risk disease and low pretreatment PSA, and those with a discordance between extent of disease and pretreatment PSA. The panel specifically believes that there is little by American Society of Clinical Oncology JOURNAL OF CLINICAL ONCOLOGY

7 Prostate Cancer Survivorship Care Guideline benefit in performing routine DREs in patients after radical prostatectomy without any biochemical evidence of disease. Accordingly, collaboration with the prostate cancer specialists is valuable to identify those patients who may benefit from routine DREs to optimize the ratio of benefit to physical and psychological harm related to routine DREs in prostate cancer survivors. Recommendation 10 The ASCO Endorsement Panel added: Patients and physicians should be informed of the increased risk of bladder and colorectal cancer (CRC) after pelvic radiation therapy. Patients should undergo routine screening for CRC as suggested by existing evidence-based guidelines and should undergo appropriate evaluation for any signs or symptoms suggestive of either bladder cancer or CRC. There is level-2a evidence 7,18-22 that patients undergoing pelvic irradiation are at increased risk of bladder cancer and CRC. Epidemiologic studies report a bladder cancer incidence rate of 5% to 6% in patients receiving radiation therapy for prostate cancer. 18 The risk of cancer of the rectum after radiation therapy for prostate cancer is similar to that of having a first-degree relative with CRC. 23 However, there is no evidence suggesting improvement in overall or disease-specific survival with increased intensity of CRC screening among men who have undergone radiotherapy for prostate cancer. Moreover, the panel thought it important to note that there are currently no guidelines that recommend routine screening for bladder cancer in the general population. Recommendation 11 The ASCO Endorsement Panel inserted the following italicized text in the recommendation: For survivors presenting with hematuria, perform a thorough evaluation to determine the cause of symptoms and to rule out bladder cancer, including urologist referral for cystoscopy and upper urinary tract evaluation. The additional text emphasizes the need for a thorough evaluation of the cause of symptoms. Recommendation 12 The ASCO Endorsement Panel inserted the following italicized text in the recommendation: cause of symptoms and to evaluate for colorectal cancer. The panel believed it necessary to underscore the importance of evaluation by the appropriate specialist (eg, radiation oncologist, gastroenterologist, colorectal surgeon) to identify the cause of a patient s symptoms, of which CRC is one possibility. Recommendation 13 The ASCO Endorsement Panel changed the wording of the recommendation from perform annual CBC to consider annual CBC to monitor hemoglobin levels and added particularly in men presenting with symptoms suggestive of anemia. The ACS guidelines 4 acknowledge the lack of evidence to support the routine treatment of asymptomatic anemia. Given the absence of evidence, the ASCO Endorsement Panel did not believe that routine screening for asymptomatic anemia in prostate cancer survivors receiving androgendeprivation therapy (ADT) merited ubiquitous recommendation. It is the opinion of the panel that men with symptoms suggestive of anemia should undergo evaluation with CBC. Recommendation 15 The ASCO Endorsement Panel added: For survivors experiencing rectal bleeding after radiation therapy, CRC should be ruled out, and appropriatemanagementshouldbediscussedwiththetreatingradiationoncologist. Management may include steroid suppositories to decrease inflammation, stool softeners, and dietary changes. The panel made this qualifying statement to offer management options to primary care physicians, to provide a rationale for such management, and to underscore the collaborative relationship between primary care and prostate cancer specialists that is necessary to ensure optimal prostate cancer survivorship care. Recommendation 18 The ASCO Endorsement Panel edited the recommendation to read as follows: Assess for distress/depression/psa anxiety at their initial visit, at appropriate intervals, and as clinically indicated and removed reference to the Distress Thermometer. A link to the ASCO Guideline on Depression and Anxiety 24 was also provided in the qualifying statement, given that it offers more detailed information on screening, assessment, and management of depression and anxiety in adults with cancer. The recommendation regarding frequency of assessment is consistent with recommendations furnished in the ASCO Guideline on Depression and Anxiety. Recommendation 22 The ASCO Endorsement Panel added: A collaborative strategy should be developed between the primary care physician and prostate cancer specialist to optimize bone health in men at risk for osteoporosis. This strategy should include a thorough discussion of the benefits and harms of bonetargeted agents. The panel agrees with ACS guidelines recommendations concerning the importance of attention to bone health in men at high risk for skeletal-related events (SREs). However, although there are demonstrated benefits of bone-targeted agents with respect to reduction in the risk of SREs, the potential benefits of these pharmacologic treatments must be weighed against the possible harms, particularly with respect to osteonecrosis of the jaw. The panel believed it necessary to underscore the need for close collaboration between the patient s primary care physician and prostate cancer specialist to best evaluate the balance of benefit and harm associated with bone-targeted therapy. Recommendation 24 The ASCO Endorsement Panel chose to remove reference to the Sexual Health Inventory for Men (SHIM) tool, because the use of specific screening and diagnostic instruments can be onerous in the primary care setting. Recommendation 33 The addition of bothersome was made to reflect heterogeneity in bother that is associated with urinary incontinence. Men not bothered by their urinary incontinence who are referred for evaluation may ultimately be subject to the risks of potentially invasive testing that is absent of appreciable benefit. Recommendation 34 The ASCO Endorsement Panel believes further research is required to validate this recommendation. The panel also added: Until that time, physicians should be aware of the development of vasomotor symptoms with ADT and should discuss with their patients the risks, benefits, and costs of available therapies for possible symptom relief. Recommendation 37 The ASCO Endorsement Panel edited the recommendation with the addition of including potential urinary, bowel, sexual, and by American Society of Clinical Oncology 7

8 Resnick et al hormonal symptoms and removed the following: use of a validated tool such as EPIC-CP [Expanded Prostate Cancer Index Composite for Clinical Practice] may be helpful in this assessment. The panel removed reference to the EPIC-CP considering the lack of assessment of rectal bleeding and other possible late effects experienced by prostate cancer survivors. The use of specific instruments, although often comprehensive, is frequently onerous in the primary care setting. The panel agrees with the ACS recommendation regarding the need for continual evaluation of the possible functional sequelae of prostate cancer and its treatment; however, the panel believed it was more appropriate to identify relevant functional domains that should be regularly assessed in the primary care setting. ENDORSEMENT RECOMMENDATION ASCO endorses the ACS Prostate Cancer Survivorship Care Guidelines by Skolarus et al 4 published in 2014 in CA: A Cancer Journal for Clinicians, with minor qualifying statements. ADDITIONAL RESOURCES More information, including a Data Supplement, Methodology Supplement, slide sets, clinical tools, and resources, is available at www. asco.org/endorsements/prostatesurvivorship. Patient information is available at AUTHORS DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST Disclosures provided by the authors are available with this article at AUTHOR CONTRIBUTIONS Administrative support: Christina Lacchetti Manuscript writing: All authors Final approval of manuscript: All authors REFERENCES 1. DeSantis CE, Lin CC, Mariotto AB, et al: Cancer treatment and survivorship statistics, CA Cancer J Clin 64: , de Moor JS MA, Parry C, Alfano CM, et al: Cancer survivors in the United States: Prevalence across the survivorship trajectory and implications for care. 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9 Prostate Cancer Survivorship Care Guideline AUTHORS DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST Prostate Cancer Survivorship Care Guideline: American Society of Clinical Oncology Clinical Practice Guideline Endorsement The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I Immediate Family Member, Inst My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO s conflict of interest policy, please refer to or jco.ascopubs.org/site/ifc. Matthew J. Resnick Consulting or Advisory Role: Dendreon, Photocure Research Funding: Genomic Health (Inst) Christina Lacchetti No relationship to disclose Jonathan Bergman No relationship to disclose Ralph J. Hauke Research Funding: US Oncology Research (Inst), Bristol-Myers Squibb (Inst), Prometheus (Inst), Hoosier Oncology Research (Inst) Karen E. Hoffman No relationship to disclose Terrence M. Kungel No relationship to disclose Alicia K. Morgans Honoraria: Myriad Genetics Consulting or Advisory Role: Myriad Genetics Travel, Accommodations, Expenses: Myriad Genetics David F. Penson Research Funding: Medivation (Inst), Astellas Pharma (Inst), Dendreon (Inst) by American Society of Clinical Oncology

10 Resnick et al Acknowledgment The American Society of Clinical Oncology Endorsement Panel thanks the two Clinical Practice Guidelines Committee (CPGC) reviewers, Ronald Chen, MD, MPH, and Julia Rowland, PhD, as well as the entire CPGC for their thoughtful reviews and insightful comments on this guideline endorsement. Appendix Table A1. American Society of Clinical Oncology Endorsement Panel Members for Prostate Cancer Survivorship Care Guideline Member Matthew J. Resnick, MD (co-chair) David F. Penson, MD (co-chair) Karen E. Hoffman, MD Alicia K. Morgans, MD Jonathan Bergman, MD Ralph J. Hauke, MD Terrence M. Kungel Affiliation Vanderbilt University Medical Center, Urologic Surgery and Health Policy, Nashville, TN Tennessee Valley Veterans Affairs Health Care System, Nashville, TN Vanderbilt University Medical Center, Urologic Surgery, Medicine, and Health Policy, Nashville, TN Tennessee Valley Veterans Affairs Health Care System, Nashville, TN University of Texas MD Anderson Cancer Center, Radiation Oncology, Houston, TX Vanderbilt-Ingram Cancer Center, Medical Oncology, Nashville, TN David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA Veterans Health Administration of Greater Los Angeles, Los Angeles, CA Nebraska Cancer Specialists, Omaha, NE Maine Coalition to Fight Prostate Cancer, Augusta, ME Practice Guidelines Implementation Network representative. Patient representative by American Society of Clinical Oncology JOURNAL OF CLINICAL ONCOLOGY