Eric Rose Brief on Management of Localized Prostate Surgery

Topic Proposal for Robert Bree Collaborative

Eric Rose, M.D., F.A.A.F.P.

September 12, 2011

Topic Proposal for Robert Bree Collaborative:
Management of Localized Prostate Cancer

Summary

Localized prostate cancer (prostate cancer confined to the prostate gland) is highly common and accounts for substantial health care costs. However, such cancers are often indolent, and aggressive treatment may offer limited benefits, with significant risks. Conservative management approaches such as “active surveillance” can be appropriate choices in some cases, but are rarely chosen. Non-evidence-based variation in practice patterns in the treatment of localized prostate cancer have been documented, and men with prostate cancer often lack knowledge of the risks and benefits of different management approaches at the time that they make treatment decisions. Increasing awareness of the risks and benefits of different management options for localized prostate cancer, including conservative management, could increase patients’ awareness of their options and their role in choosing treatment, and may reduce costs of care.

Background

Prostate cancer is very common, with an estimated lifetime incidence of approximately 17 percent. However, due to the fact that it is often of low aggressiveness, and that its incidence increases with advancing age, it only causes death in approximately 2.7 percent of men.[1],[2]

Prostate cancer is considered “localized” when it is stage T1 (non-palpable) and T2 (palpable but limited to the prostate), with no involvement of lymph nodes or distant metastasis. In approximately 90 percent of patients diagnosed with prostate cancer, the cancer is localized at the time of diagnosis.[3]

Substantial variation in practice patterns

A 2010 study of 11,892 men with localized prostate cancer treated at 36 different clinical sites concluded that “Substantial variation exists in management of localized prostate cancer that is not explained by measurable factors… data suggest both overtreatment of low-risk disease and undertreatment of high-risk disease”[4]

There is evidence of specialty-driven bias in treatment recommendations: In a survey of over 1,000 urologists and radiologists, for the same hypothetical patient, 93 percent of urologists indicated they would recommend surgery as the primary treatment, and 72 percent of radiation oncologists indicated they would recommend radiotherapy.[5]

High utilization and/or cost growth trends in Washington State without better outcomes

Various options exist in the management of localized prostate cancer (such as surgery, radiation, or hormonal “androgen deprivation” treatment). Available evidence does not clearly distinguish one option as more or less appropriate than others.[6],[7]. In low-risk cases, active treatment may have little impact on survival. Conservative approaches, such as “active surveillance”, in which patients undergo repeated physical exam, PSA testing, and prostatic biopsy on a fixed schedule, have been associated with low mortality in clinical trials.[8],[9] Nonetheless, 94 percent of patients with localized prostate cancer choose treatment rather than watchful waiting or surveillance. [10]

Prostate cancer treatment accounted for $9.9 billion in health care costs in the United States in 2006[11]. Costs of care vary markedly with choice of initial treatment option. In one study that followed a cohort of over 13,000 men over age 66 for five years, 5-year incremental costs of care ranged from $9,130 for patients whose initial management approach was watchful waiting, to $26,896 for those whose initial management was hormonal therapy.[12]

Newer, costlier treatments for prostate cancer, such as robotic minimally-invasive prostatectomy, were estimated to have accounted for $350 million in incremental costs among men diagnosed with prostate cancer in the U.S. in 2005.[13]

A source of waste and inefficiency in care delivery

As above, practice patterns vary widely with a trend towards adoption of newer, more expensive therapeutic approaches, often with limited benefit.

More to the point, patients are often not fully aware of options or the consequences of treatment modalities that they have chosen. In one survey of men with newly-diagnosed prostate cancer, the majority overestimated the survival benefit of treatment (including those with high levels of health literacy)[14], and a majority could not correctly answer at least half of the items in a quiz regarding advantages and disadvantages of various treatments for localized prostate cancer[15]. Examples of the questions on this quiz are:

After surgery, the common complication is:

a)Pain on urination

b)Urine leakage

c)Diarrhea

d)Impotence

e)None of these

(correct answer is d)

One out of three patients who have surgery will need to wear diapers because of bladder control problems

• True
• False

(correct answer is “true”).

Patient Safety issues

Treatments for early-stage prostate cancer can be associated with serious adverse effects, including urinary, bowel, and sexual dysfunction.[16] As noted above, there is evidence that patients lack knowledge of these risks at the time they make decisions as to treatment.

Prostate cancer is more common, and associated with higher mortality, in men of African descent, and African-American men may not be aware of this increased risk.[17]

What data are available to support that there is waste, variation, high utilization, excess costs?

See above

Are the waste and quality aspects of this topic avoidable?

It is highly likely that an approach that seeks to inform patients with localized prostate cancer of their options and the consequences of each will have benefit. It is a truism when a patient has to make a decision among treatment options, if he is better informed, the result will be more likely to be consistent with his values and priorities. Furthermore, it may be (though I am not aware of any studies to this effect) that well-informed patients will be more likely to choose less-expensive options such as active surveillance.

Are there proven means/strategies to address this topic?

See above

Does the availability of data and established guidelines make this topic a prospect for developing a statewide solution by July 2012that could bring meaningful improvement to the delivery system?

Yes:

• The National Comprehensive Cancer Network guidelines propose active surveillance as a management option depending on the overall risk, as determined by stage, histologic grade (“Gleason score”), and prostate specific antigen level, and estimated life expectancy.[18]
• The American Urological Association’s current guidelines state “Active surveillance, interstitial prostate brachytherapy, external beam radiotherapy, and radical prostatectomy are all options for treatment of the low-risk patient. Study outcomes data do not provide clear-cut evidence for the superiority of any one treatment…Patient preferences and health conditions related to urinary, sexual, and bowel function should be considered in decision making. Particular treatments have the potential to improve, to exacerbate or to have no effect on individual health conditions in these areas, making no one treatment modality preferable for all

patients.”.7

These guidelines support a shared decision-making model incorporating careful consideration of risks and benefits and the patient’s preferences. Tools to raise public awareness and support such a process, with safeguards to protect patients’ decision-making autonomy, could help to ensure that management of localized prostate cancer is consistent with each patients’ values, and may also result in lower costs of care.

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[1]American Cancer Society. What are the key statistics about prostate cancer? retrieved September 11, 2011.

[2]Lu-Yao GL, Albertsen PC, Moore DF, et al. Outcomes of localized prostate cancer following conservative management. JAMA 2009;302:1202–1209.

[3] National Cancer Institute. Cancer advances in focus: prostate cancer. http://www.cancer.gov/cancertopics/factsheet/cancer-advances-in-focus/FS12_7.pdf. Accessed September 11, 2011.

[4]CooperbergMR, BroeringJM, Carroll PR. Time trends and local variation in primary treatment of localized prostate cancer. J Clin.Oncol. 2010; 28(7): 1117-23

[5]Fowler FJ, McNaughton CM, Albertsen PC, et al. Comparison of recomnendations by urologists and radiation oncologists for treatment of clinically localized prostate cancer. JAMA 2000;283(24):3217-3222.

[6] Wilt TJ, MacDonald R, Rutks I, et al. Systematic review: Comparative effectiveness and harms of treatments for clinically localized prostate cancer. Ann Intern Med 2008;148:435–448

[7] Thompson I, Thrasher JB, Aus G, et al. Guideline for the management of clinically localized prostate cancer: 2007 update. J Urol 2007;177:2106–2131

[8]Stattin P, Holmberg E, Johansson JE, et al. Outcomes in localized prostate cancer: National Prostate Cancer Register of Sweden follow-up study. J. Nat. Ca Inst. 2010;102(13):950-958.

[9] Van den Bergh RC, Essink-Bot ML, RoobolMJ, et al. Outcomes of men with screen-detected prostate cancer eligible for active surveillance who were managed expectantly. Eur. Urol. 2009;55(1):1-8.

[10] Harlan SR, CooperbergMR, Elkin EP, et al. Time trends and characteristics of men choosing watchful waiting for initial treatment of localized prostate cancer: results from CaPSURE. J. Urol. 2003;170(5):1804-1807.

[11] National Cancer Institute. Cancer Trends Progress Report – 2009/2010 Update. http://progressreport.cancer.gov/, retrieved September 11, 2011.

[12]Claire F. Snyder, Kevin D. Frick, Amanda L. Blackford, Robert J. Herbert, Bridget A. Neville, Michael A. Carducci, and Craig C. Earle. How does initial treatment choice affect short-term and long-term costs for clinically localized prostate cancer? Cancer, 2010; DOI: 10.1002/cncr.25517

[13] Nguyen PL Xiangmei G Lipsitz SR et al. Cost Implications of the Rapid Adoption of Newer Technologies for Treating Prostate Cancer. J ClinOncol. 2011 29(12):1517-24.

[14] Mohan R, Beydoun H, Barnes-Ely ML eta l. Patients’ survival expectations before localized prostate cancer treatment by treatment status. J. Am. Board Fam. Med. 2009;22(3):247-256

[15]Beydoun HA, Mohan R, Beydoun MA, et al. Development of a scale to assess patient misperceptions about treatment choices for localized prostate cancer. BJU Int. 2010;106(3):334-341.

[16]Wei JT, Dunn RL, Sandler HM, et al. Comprehensive comparison of health-related quality of life after contemporary therapies for localized prostate cancer. J ClinOncol 2002;20:557–566

[17]Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010 60(5):277-300.

[18]National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Prostate Cancer, version 4.2011. retrieved September 11, 2011.