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1 ORIGINAL CONTRIBUTION Comparison of ations by Urologists and Oncologists for Treatment of Clinically Localized Prostate Cancer Floyd J. Fowler, Jr, PhD Mary McNaughton Collins, MD, MPH Peter C. Albertsen, MD, MS Anthony Zietman, MD Diana B. Elliott, BA Michael J. Barry, MD ABOUT 0 00 MEN WILL BE diagnosed as having prostate cancer in the United States this year, most with clinically localized disease. The majority of these men will choose among primary therapies: radical prostatectomy, external beam radiotherapy, or brachytherapy. The choice among these therapies is not easy. Because most prostate cancers are found in men in their 60s and 0s, and because these cancers generally grow slowly, many prostate cancer patients are destined to die of competing medical problems. 2 For others, especially men with poorly differentiated tumors or high prostate-specific antigen (PSA) levels, these therapies may not be curative. Moreover, while cohort studies following surgery and external beam radiotherapy patients for 0 to years have been done, patients receiving contemporary brachytherapy have not been followed up that long. Meanwhile, all of these therapies have the potential to create adverse effects or complications. For editorial comment see p 2. Context Multiple treatment options are available for men with prostate cancer, but therapeutic recommendations may differ depending on the type of specialist they consult. Objective To define and contrast the distribution of management recommendations by urologists and radiation oncologists for a spectrum of men with prostate cancer. Design, Setting, and Participants Mail survey sent in 99 to a random sample of physicians in the United States, who were listed as urologists (response rate 6%, n=0) and radiation oncologists (response rate 6%, n=9) in the American Medical Association Registry of Physicians and practicing at least 20 hours per week. Main Outcome Measure Questionnaire addressing beliefs and practices regarding prostate cancer management. Results Forty-three percent of radiation oncologists vs 6% of urologists would recommend routine prostate-specific antigen testing for men aged 0 years and older. For men with moderately differentiated, clinically localized cancers, and a more than 0-year life expectancy, 9% of urologists chose radical prostatectomy as the preferred treatment option, while 2% of radiation oncologists believed surgery and external beam radiotherapy were equivalent treatments. For most tumor grades and prostate-specific antigen levels, both specialty groups were significantly more likely to recommend the treatment in their specialty than the other treatment. Both groups reported giving patients similar estimates of the risks of complications due to surgery and radiation. Neither group favored watchful waiting in their treatment management except for a subset of men with life expectancies of less than 0 years and cancers with very favorable prognoses (Gleason score of or and prostate-specific antigen level ng/ml). Conclusions Based on this study, while urologists and radiation oncologists do agree on a variety of issues regarding detection and treatment of prostate cancer, specialists overwhelmingly recommend the therapy that they themselves deliver. JAMA. 2000;2: Author Affiliations: Center for Survey Research, University of Massachusetts, Boston (Dr Fowler and Ms Elliott); Medical Practices Evaluation Center (Drs McNaughton Collins and Barry) and the Department of Oncology (Dr Zietman), Massachusetts General Hospital, Boston; and the Division of The clinical judgment of the physicians who counsel patients can play a critical role in the treatments chosen. In a 9 survey, urologists and radiation oncologists were asked what they personally would do if they were diagnosed as having clinically localized prostate cancer. In that survey, 9% of US urologists said they would choose a radical prostatectomy, while 92% of radiation oncologists said they would choose external beam radiotherapy. Urology, University of Connecticut Health Center, Farmington (Dr Albertsen). Corresponding Author and Reprints: Michael J. Barry, MD, Medical Practices Evaluation Center, Massachusetts General Hospital, 0 Staniford St, 9th Floor, Boston, MA 02 ( mbarry@partners.org) American Medical Association. All rights reserved. (Reprinted) JAMA, June 2, 2000 Vol 2, No. 2 2 Downloaded From: on /0/20

2 Table. Selected Respondent Characteristics Figure. ation of Routine Prostate-Specific Antigen (PSA) Testing for Men by Age % ing Routine PSA Testing Oncologists (n = 9) Urologists (n = 0) P = P<.00 P =.92 P< P< >0 Patient Age, y Obviously, depending on which physicians they consult, patients might well expect to get different counsel about optimal management. We were interested in extending our understanding of the differences between specialties beyond simply their preferences for treatment. We also P<.00 oncologists and urologists were asked: Do you recommend that primary care physicians include PSA testing as a part of the routine physical examination for men who are at average risk of prostate cancer, who are [each age group]? Oncologists, % (n = 9) Age, y Urologists, % (n = 0) P Value Sex Men 99 Women.00 Type of medical practice Solo 2 2 Single specialty group 0.00 Multispecialty group Average clinical time* Source of income Salaried 0 Mixture Fee-for-service Working at a hospital with a residency training program Yes 2 No 9 *Indicates the percentage of total professional time spent in clinical practice..0 wanted to see whether the different specialties continued to have such polar views regarding treatment 0 years later, well into the era of PSA testing. To these ends, in 99, we surveyed a nationwide random sample of practicing US urologists and radiation oncologists. METHODS A random sample of physicians who listed their specialty as either urology or radiation oncology were selected from the American Medical Association Master List of Physicians. Subsequently, the offices of the sampled physicians were contacted by telephone to verify the address and specialty, that they were not in residency training, and that they were in clinical practice for at least 20 hours weekly. Physicians then were sent a pretested questionnaire, a cover letter, and $0. A reminder postcard was sent to all sampled individuals; another survey instrument and cover letter were sent to nonrespondents after about weeks. Finally, for those physicians who had not responded to the questionnaire, follow-up telephone calls were made to the physicians offices to encourage response and to identify subjects who needed another questionnaire. The survey instrument for urologists contained questions about the diagnosis and treatment of benign prostatic hyperplasia and prostatitis, as well as prostate cancer. The instrument for radiation oncologists focused almost exclusively on prostate cancer. Whenever it made sense, comparable questions were asked of both specialties. RESULTS Questionnaires were returned by 6% of eligible radiation oncologists (n=9) and 6% of eligible urologists (n=0). TABLE compares the characteristics of the respondents in the 2 specialties. Responding urologists were older, more often male, more likely to be in solo practice, and less likely to be salaried. When respondents and nonrespondents were compared, using data from the file from which the sample was drawn, no significant differences were noted in terms of age or region of the country. Urologists who graduated from medical school less than 20 years previously were more likely to respond than earlier graduates. Physicians in multispecialty groups were also more likely to respond than physicians in solo practice in both specialties. FIGURE compares both groups of specialists answers to questions about their recommendations for routine PSA testing. For men up through age 0 years, members of the 2 specialties made similar recommendations. Urologists are slightly more aggressive about screening than radiation oncologists but significantly more aggressive when patients are men in their 0s. The clearer trend, however, is the much more aggressive stance of radiation oncologists regarding PSA testing for men 0 years and older, and particularly for men older than years. For example, while only 6% of urologists recommend routine PSA testing for men older than 0 years, % of the radiation oncologists do so. 2 JAMA, June 2, 2000 Vol 2, No. 2 (Reprinted) 2000 American Medical Association. All rights reserved. Downloaded From: on /0/20

3 FIGURE 2 presents these specialists beliefs about when aggressive treatments actually have a survival benefit. This figure presents the percentage of respondents saying that there is definitely or probably a survival benefit for each of the main therapies for men with clinically localized, moderately differentiated prostate cancer and less or more than a 0-year life expectancy, respectively. Although there are numerous statistically significant differences between the 2 groups given the large sample sizes, there is also considerable consistency in their answers. The majority of both groups of specialists think that all therapies have survival benefit for men with a 0-year or longer life expectancy; only a minority think there is benefit from any of the treatments for men with less than a 0-year life expectancy. More of both types of specialists, though, believe that radiation, either by external beam or brachytherapy, is more likely to offer a survival benefit for men with less than a 0-year life expectancy than a radical prostatectomy. Indeed, that perception is slightly but significantly more common among urologists than among radiation oncologists. Figure 2 also demonstrates that members of each specialty are generally somewhat more likely than those in the other specialty to believe in the efficacy of the treatments that they perform, and are also a little less positive about the survival benefits of the treatment offered by the other specialty group. TABLE 2 presents physicians responses to questions about head-tohead comparisons of the effectiveness of the major therapies. When comparing radical prostatectomy and external beam radiotherapy for patients with life expectancies of 0 years or longer, urologists are almost all convinced (9%) that radical prostatectomy is better. On the other hand, radiation oncologists perceptions (2%) are that surgery and radiotherapy are equivalent. Almost a third of urologists think neither treatment has survival value for men with less than a 0- year life expectancy, while only 9% of radiation oncologists agree. When deciding among treatment options, prostate cancer patients need to consider not only the effectiveness of the options at extending life, but also their adverse effects. Sexual dysfunction and incontinence are 2 potential adverse effects of aggressive therapy for prostate cancer. How are the likelihoods of these adverse effects presented to patients by urologists and radiation oncologists? TABLE presents the risks of these complications that the respondents said they quote to their patients. Table is most striking in how similarly the 2 groups estimate the probability of complications associated with surgery and radiation. Respondents were also asked to choose their preferred treatment for patients with tumors of varying Gleason scores and PSA levels. In FIGURE and FIGURE, the patient profiles are ordered based on the decreasing likelihood that such a cancer would be organconfined at surgical staging. 6 Subjects were given the options of expectant management (watchful waiting) and androgen deprivation (as primary therapy) in addition to the potentially curative therapies. For this analysis, both forms of radiotherapy were considered together. Both groups of specialists have some members (0%-20%) who are willing to consider watchful waiting for patients with cancers with Gleason scores Figure 2. Treatment Expectations for Clinically Organ-Confined, Moderate-Grade Prostate Cancers and Less or More Than 0-Year Life Expectancies Patients With Life Expectancy <0 y 6 9 Urologists (n = 0) Oncologists (n = 9) 22 Brachytherapy External Beam Radical Prostatectomy Patients With Life Expectancy 0 y % Who Say Treatments Have a Survival Benefit The left side of the figure shows the responses when asked: For a patient with clinically localized cancer (stage A or B, moderate grade), who has a life expectancy of less than 0 years, do you think that [name of treatment] as the primary therapy offers a survival benefit? The right side of the figure shows the responses when asked: For a patient with clinically localized cancer (stage A or B, moderate grade), whose life expectancy is clearly greater than 0 years, do you think [name of treatment] as the primary therapy offers a survival benefit? Table 2. Comparison of Treatments for Organ-Confined, Moderate-Grade Prostate Cancer* Comparison of Treatments (Patient Life Expectancy) Oncologists, % Urologists, % Radical prostatectomy vs external beam radiation ( 0 y) (n = 9) (n = 0) better 0 9 Both the same 6 0 Prostatectomy better 2 Neither offers survival benefit 9 2 Do not know 2 Radical prostatectomy vs external beam radiation ( 0 y) (n = 9) (n = 0) better 0 Both the same 2 6 Prostatectomy better 20 9 Neither offers survival benefit 0 Do not know 2 Brachytherapy vs external beam radiation ( 0 y) (n = ) (n = 9) Brachytherapy better 2 0 Both the same External beam radiation better Neither offers survival benefit 2 Do not know 20 *P.00 for all comparisons. Exact question wording: For a patient with clinically localized cancer (stage A or B, moderate grade), who has a life expectancy clearly [less or greater] than 0 years, how do you think [treatment and treatment 2] compare in terms of the survival benefit they offer? 2000 American Medical Association. All rights reserved. (Reprinted) JAMA, June 2, 2000 Vol 2, No Downloaded From: on /0/20

4 Table. Average Percentage Estimates of Chance for Loss of Sexual Function and Some Permanent Wetness for Various Prostate Cancer Treatment Options* Permanent Loss of Sexual Function, % Some Permanent Wetness, % Oncologists Urologists Oncologists Urologists Treatment (n = ) (n = 9) (n = 0) (n = ) External beam radiation Brachytherapy Non nerve-sparing prostatectomy Unilateral nerve-sparing prostatectomy Bilateral nerve-sparing prostatectomy *All differences between specialties were significant (P.0) with the exception of estimates for the permanent loss of sexual fuctioning for unilateral nerve-sparing prostatectomy (P =.99). The number of respondents differed slightly from question to question due to nonresponse. The numbers reflected are the maximum number of respondents to questions in this series. Exact question wording: A patient of yours with prostate cancer is 6 and has full sexual function and no sign of incontinence. What would you tell him his chances are of having loss of sexual functioning (permanent loss of the ability to have intercourse) and some incontinence (indefinitely experiencing leaking or wetness, enough to regularly wear a pad) for the following treatment options? Figure. ations of Androgen Deprivation and Watchful Waiting for Men With Clinically Localized Prostate Cancers 6 2 Urologists (n = 0) Oncologists (n = 9) 2 Gleason Score & PSA Level, ng/ml of or and PSA levels no higher than ng/ml. Beyond that low-risk subset, essentially no one in either group is willing to recommend watchful waiting (Figure ). As one would expect from the preceding data, the majority of both groups of specialists would recommend for most patients the therapy that they themselves deliver. However, there is a subset of radiation oncologists who indicated a preference for surgery for low-grade, low-psa tumors. There are very few urologists who prefer radiation for such tumors (Figure ). As Gleason scores reach or, both groups start to consider androgen deprivation as a primary therapy (Figure ). Urologists also begin to recommend radiation more often in relationship to surgery as Gleason scores and PSA levels increase (Figure ). As the probability of organ-confined disease decreases, urologists become divided about the value of surgery. For tumors with Gleason scores of or higher, or a Gleason score of with a high PSA level, they become as likely to recommend androgen deprivation or radiation as they do surgery. However, there is a substantial minority who continue to recommend surgery even when tumors are likely to be extracapsular. oncologists, on the other hand, continue to recommend radiation for higher-risk tumors. Finally, physicians were asked whether they believed that the main potentially curative prostate cancer therapies are overused or underused in the United States (TABLE ). A majority of radiation oncologists believe that radical prostatectomy is overused (2%), and about half think that radiation and brachytherapy are underused. In contrast, % of urologists think that radical prostatectomy is used at about the right rate and % think that external beam radiation is overused. Substantial percentages of both radiation oncologists and urologists believe that brachytherapy is both overused and underused, and a higher proportion express no opinion than for the other 2 primary therapies. COMMENT Although urologists and radiation oncologists differed in many of their beliefs regarding prostate cancer treatment, they also demonstrated agreement on a variety of issues. First, despite controversy over the value of PSA screening,, responding physicians in both these specialties are virtually unanimous in their recommendation that PSA testing be done routinely at least until around age years. For men older Androgen Deprivation Watchful Waiting The left side of the figure shows the responses recommending androgen deprivation treatment when asked: A prostate cancer patient of yours is 6, in good health, and has a negative digital rectal examination result and no evidence of extraprostatic spread. Which primary treatment would you be most likely to recommend for localized prostate cancer if this patient has the following biopsy results [list of Gleason/ PSA profiles]? The right side of the figure shows the responses recommending watchful waiting. than years, the 2 specialties differ, with radiation oncologists being considerably more positive about testing older men. This position is consistent with radiation oncologists perceptions that they have a therapy to offer that (according to nearly a majority) is beneficial to men even with less than a 0-year life expectancy. Second, despite the lack of published supporting evidence from randomized clinical trials, the vast majority of physicians in both specialties believe that all therapies offer a sur- 220 JAMA, June 2, 2000 Vol 2, No. 2 (Reprinted) 2000 American Medical Association. All rights reserved. Downloaded From: on /0/20

5 Figure. ations of Radical Prostatectomy and Therapy for Men With Clinically Localized Prostate Cancer Radical Prostatectomy Urologists (n = 0) Oncologists (n = 9) Gleason Score -6-6 & PSA Level, ng/ml External Beam The left side of the figure shows the responses recommending radical prostatectomy when asked: A prostate cancer patient of yours is 6, in good health, and has a negative digital rectal examination result and no evidence of extraprostatic spread. Which primary treatment would you be most likely to recommend for localized prostate cancer if this patient has the following biopsy results [list of Gleason/PSA profiles]? The right side of the figure shows the responses recommending external beam radiation. vival advantage for men with a 0- year or more life expectancy. Third, with respect to patients with less than a 0-year life expectancy, only a minority of members of either specialty thinks that any therapy offers a survival advantage. Within both groups, however, there are more physicians who think that radiation therapy offers a survival advantage than think that surgery does. Fourth, specialists generally agree on the probabilities of complications of all Table. Perceived Rates of Use of Treatments for Prostate Cancer* Treatment Oncologists Urologists Radical prostatectomy (n = 2) (n = 99) Overused 2 Underused 0 Used at about the right rate 6 No opinion 2 External beam (n = 2) (n = 99) radiation Overused Underused 0 Used at about the right rate No opinion 2 Brachytherapy (n = ) (n = 96) Overused 26 0 Underused 2 Used at about the right rate 20 2 No opinion 0 22 *P.00 for all comparisons. treatments. Both groups perceive surgery as being more likely to produce incontinence and sexual dysfunction than radiotherapy. Both urologists and radiation oncologists are generally convinced that nerve-sparing surgery substantially reduces the rate at which patients experience sexual dysfunction. Disagreements about probabilities of adverse effects, then, do not account for the differences in treatment recommendations noted between the specialties. Some recent studies actually suggest, however, that these estimated risks of complications for all treatments may be low, and particularly low for nerve-sparing radical prostatectomy. 9- Fifth, physicians from the 2 specialties are remarkably similar in the extent to which they would recommend either watchful waiting or androgen deprivation as primary therapies for particular subsets of men based on Gleason scores and PSA levels. Less than 2% of members of either specialty would recommend watchful waiting to men with a tumor with a Gleason score of, despite the fact that these patients appear to have an essentially normal life expectancy without aggressive treatment. Members of both specialties feel much more comfortable if patients with any degree of prostate cancer receive one of the major primary therapies. When the Gleason scores (-) and PSA levels ( 0 ng/ ml) are higher, increasing numbers in both specialties, eventually nearing half, would recommend androgen deprivation as the primary therapy. oncologists continue to recommend radiation for tumors with a higher likelihood of capsular penetration, while urologists appear more dubious about the value of surgery. This finding may reflect a difference in perspectives about when the 2 local therapies are likely to be still curative; that is, radiation oncologists may believe tumors with some degree of capsular penetration may still be effectively treated with radiation, while urologists may doubt that surgery will cure such tumors. Sixth, despite a relative shortage of long-term follow-up data, members of both specialties generally seem to accept brachytherapy as being at least as effective as external beam radiotherapy. Urologists seem to be slightly more positive about brachytherapy than about external beam radiation therapy. Of course, the most dramatic difference between these 2 groups of specialists is that members of each specialty tend to believe in the therapy that they themselves deliver. oncologists (2%) tend to believe that their therapy is just as good as radical prostatectomy for men with moderately differentiated, clinically localized cancer while urologists (9%) are overwhelmingly convinced that radical prostatectomy is better. This difference is critical in understanding what treatment recommendations patients are likely to hear. Presumably, the radiation therapists can justify their preference for recommending external beam radiotherapy on the basis that they believe it works just as well as surgery. In contrast, urologists believe that while men who have surgery do indeed have higher risks of sexual dysfunction and incontinence, cancer control is better with surgery, and thus radical prostatectomy is preferred American Medical Association. All rights reserved. (Reprinted) JAMA, June 2, 2000 Vol 2, No Downloaded From: on /0/20

6 While clinical trials have not proven that patient outcomes are improved by aggressive treatment with surgery or radiation, neither have they proven these treatments ineffective. Given our findings, it is also important to point out that the descriptions of the effectiveness of surgery and radiation therapy that patients receive from urologists and radiation oncologists would be expected to be quite different. Although some patients might find it confusing to hear quite different treatment recommendations from experienced physicians with access to the same medical literature, scheduling consultations with a member of each specialty may be the best approach to ensure that patients get a balanced picture regarding aggressive treatment options before making a decision. Neither group of specialists studied was supportive of expectant management for any but a limited subset of men; primary care physicians appear no more enthusiastic. Interestingly, however, when patients hear comprehensive presentations regarding the risks and benefits of all potential treatments, a substantial minority appears to choose expectant management. 6, Given that many more men are now being diagnosed as having prostate cancer than will ever die of it, expectant management would appear to be appropriate for some men. More research is needed to define those subgroups of men for whom an expectant approach is a reasonable, or even optimal, management strategy. An added challenge will be to ensure any such insights are effectively communicated to patients facing a treatment decision for prostate cancer. Funding/Support: This study was funded by grant HS 09 from the Agency for Healthcare Research and Quality (formerly the Agency for Health Care Policy and Research) to the Patient Outcomes Research Team. REFERENCES. Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, CA Cancer J Clin. 2000;0:-. 2. Albertsen PC, Hanley JA, Gleason DF, Barry MJ. Competing risk analysis of men aged to years at diagnosis managed conservatively for clinically localized prostate cancer. JAMA. 99;20: Lu-Yao GL, Yao SL. Population-based study of longterm survival in patients with clinically localised prostate cancer. Lancet. 99;9: D Amico AV, Whittington R, Malkowicz B, et al. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 99;20: Moore MJ, O Sullivan BO, Tannock IF. How expert physicians would wish to be treated if they had genitourinary cancer. J Clin Oncol. 9;6: Partin AW, Kattan MW, Subong ENP, et al. Combination of prostate-specific antigen, clinical stage, and Gleason score to predict pathological stage of localized prostate cancer. JAMA. 99;2:-.. US Preventive Services Task Force. Screening for prostate cancer: commentary on the recommendations of the Canadian Task Force on the periodic health examination. Am J Prev Med. 99;0:- 9.. American College of Physicians. Screening for prostate cancer: Clinical Guideline, Part III. Ann Intern Med. 99;26: Fowler FJ, Barry MJ, Lu-Yao G, et al. Outcomes of external-beam radiation therapy for prostate cancer: a study of Medicare beneficiaries in three Surveillance, Epidemiology, and End Results areas. J Clin Oncol. 996;: Jonler M, Messing EM, Rhodes RP, et al. Sequelae of radical prostatectomy. Br J Urol. 99;: 2-.. Jonler M, Ritter MA, Brinkman R, et al. Sequelae of definitive radiation therapy for prostate cancer localized to the pelvis. Urology. 99;: Talcott JA, Rieker P, Propert KJ, et al. Patientreported impotence and incontinence after nervesparing radical prostatectomy. J Natl Cancer Inst. 99; 9:-2.. Stanford J, Feng Z, Hamilton A, et al. Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: The Prostate Cancer Outcomes Study. JAMA. 2000;2: Albertsen PC, Fryback DG, Storer BE, et al. Longterm survival among men with conservatively treated localized prostate cancer. JAMA. 99;2: Fowler FJ, Bin L, McNaughton Collins M, et al. Prostate cancer screening and beliefs about treatment efficacy: a national survey of primary care physicians and urologists. Am J Med. 99;0: Wilt TJ, Brawer MK. The Prostate cancer Intervention Versus Observation Trial (PIVOT). Oncology. 99;:-9.. Ontel E, Hamond C, Wasson JH, et al. Assessment of the feasibility and impact of shared decision making in prostate cancer. Urology. 99;: JAMA, June 2, 2000 Vol 2, No. 2 (Reprinted) 2000 American Medical Association. All rights reserved. Downloaded From: on /0/20