Conclusions

Published evidence indicates that no one therapy can be considered preferred for localized prostate cancer due to limitations in quality of the body of comparative effectiveness evidence (Appendix C, Tables C76 and C77). All treatment options result in adverse effects (primarily urinary, bowel, and sexual) though the severity and frequency may vary between treatments and according to the provider/hospital. Even if differences in therapeutic efficacy exist, differences in AEs, convenience, and costs are likely to be important factors in individual patient decision making. Despite this uncertainty, patient-reported satisfaction with any individual therapy received is high (Appendix C, Table C78). Satisfaction is associated with adverse treatment effects and perception that the tumor was eradicated. However, data from nonrandomized trials are inadequate to reliably assess comparative effectiveness and adverse effects. Additional RCTs are needed, especially in men with PSA-detected prostate cancer, that compare outcomes between, rather than within, major treatment options.

Limitations in the existing evidence include: 1) few randomized trials directly compared the relative effectiveness between, rather than within, major treatment categories; 2) many randomized trials are inadequately powered to provide long-term survival outcomes with the majority reporting biochemical progression or recurrence as the main outcomes; 3) some randomized trials were old, conducted prior to prostate cancer detection with PSA testing, and used technical treatment aspects that may not reflect current practice so their results may not be generalizable to modern practice settings; 4) wide variation existed in reporting and definitions of outcomes, tumor and patient characteristics; 5) there was little reporting of outcomes according to major patient and tumor characteristics; and 6) emerging technologies while increasingly utilized have not been evaluated in randomized trials or even in long-term prospective controlled studies.

No RCTs reported head-to-head comparisons of treatment outcomes stratified by race/ethnicity, and most did not provide baseline racial characteristics. Available data were largely from case series. Few studies reported head-to-head comparisons, and there was limited adjustment for confounding factors. Reports of modest treatment differences according to race/ethnicity in some nonrandomized reports have not been consistently reported in well-powered studies. One subgroup analysis of an RCT suggested that the comparative effectiveness of RP vs. WW on overall and disease specific survival may be limited to men less than age 65. However, this study had few men with PSA-detected prostate cancers, and there was little other high-quality evidence of a differential effect of treatments based on age. While differences exist in the incidence and morbidity of prostate cancer based on patient age, and there are differences in the treatments offered to men at different age ranges, few studies directly compared the treatment effects of different therapies across age groups.

Results from national administrative databases and surveys suggested that provider/hospital characteristics including procedure volume, physician specialty, and geographic region affect outcomes. Patient outcomes varied in different locations and were associated with provider and hospital volume independent of patient and disease characteristics. Screening practices can influence the characteristics of patients diagnosed and tumors detected. Screening practices and treatment choices varied by physician specialty and across regions of the United States. These did not correlate with clinician availability. Clinicians were more likely to recommend procedures they performed regardless of tumor grades and PSA levels.

Regional variation existed in physician availability and ratio of urologists and radiation oncologists per 100,000 adult citizens based on surveys conducted by the American Medical Association, screening practice, incidence, mortality, and treatment selection. The direction of regional variation was not always consistent. Several studies reported geographic variation at the county, state, or U.S. Census region level. Overall there were many different methods used to report geographic variation, so pooling of results was difficult; when results were pooled, the geographic regions used were quite large.

Surgeon RP volume was not associated with RP-related mortality and positive surgical margins. However, the relative risk of surgery-related complications adjusted for patient age, race, and comorbidity, and hospital type and location was lower in patients treated by higher volume surgeons. Urinary complications and incontinence were lower among surgeons that performed more than 10 RPs per year. The length of hospital stay was shorter in patients operated by surgeons who performed more RPs per year. Cost was not associated with surgeon volume.

Hospital volume and teaching status were associated with patient outcomes. Despite different definitions of “high” and “low” hospital volumes in individual studies, pooled analysis showed that surgery-related mortality and late urinary complications were lower and length of stay was shorter in hospitals that performed more RPs per year. Hospital readmission rates were lower in hospitals with greater volume. Teaching hospitals had a lower rate of surgery-related complications and higher scores of operative quality. Several studies found differences in treatment and outcome based on whether the patient was seen in an HMO or fee-for-service organization and whether the patient was a Medicare beneficiary. Variability in the use of ADT was more attributable to individual differences among urologists than tumor or patient characteristics.

Little data existed on the comparative effectiveness of treatments based on PSA levels, histologic score, and tumor volume to identify low, intermediate, and high risk tumors. The aforementioned RCT of RP vs. WW noted that the relative benefit of surgery did not vary according to baseline PSA level, tumor volume, or histologic grade. We focused on baseline PSA levels and Gleason histologic score. The natural history of PSA-detected tumors is not known because few men remain untreated for a long followup period. One report assessed 20-year outcomes in the United States from a cohort of 767 men with prostate cancer detected prior to PSA testing and treated with WW. Histologic grade was associated with overall and prostate cancer-specific survival. Men with low grade prostate cancers had a minimal risk of dying from prostate cancer (Gleason score 2–4, 7 percent died due to prostate cancer). Men with high grade prostate cancers had a high probability of dying from their disease within 10 years of diagnosis regardless of their age at diagnosis (Gleason score of 8–10, 53 percent died due to prostate cancer). Estimates from large ongoing screening trials suggest that PSA increases the time of detection by 5–15 years. Therefore, it is likely that men with PSA-detected tumors will have better 20 year disease-specific survival than this cohort.

Most RCTs did not exclude participants based on PSA levels or tumor histology and few provided comparative analysis according to these factors. Secondary analysis of one randomized trial concluded that disease-specific mortality at 10 years due to RP compared to WW differed according to age but not baseline PSA level or Gleason score. Men with Gleason scores 8–10 were more likely to have evidence of biochemical recurrence than men with Gleason scores 2–6, regardless of whether treatment was RP alone or combined with NHT. High dose EBRT was more effective in controlling biochemical failure than conventional dose therapy in both low risk disease (PSA <10 ng/ml; stage ≤T2a tumors; or Gleason ≤6) and higher risk disease. When the higher risk subjects were further divided into intermediate risk and high risk groups, the benefit of high dose therapy remained for the intermediate risk but not for the high risk patients.

Based on very limited nonrandomized trial data, disease-specific survival was similar for men treated with EBRT compared to RP in men with baseline PSA >10 ng/ml. Men with Gleason scores 8–10 were more likely to have biochemical reoccurrence than men with Gleason scores 2–6 regardless of type of treatment.

Remaining Issues and Future Research Needs

• Based on the findings from this comparative effectiveness review, the following high priority gaps in knowledge in the diagnosis, prevention, and treatment of localized prostate cancer were identified, along with research suggestions to close those gaps:
• The comparative effectiveness and adverse effects associated with the major treatment options for clinically localized prostate cancer is not well known. This is due to the paucity of high-quality information from large, long-term RCTs, especially in the PSA era. Because the magnitude of relative effectiveness appears fairly small and may be influenced by multiple patient, tumor, and provider confounding factors, data from nonrandomized studies are unable to accurately provide this information. The highest priority for closing this gap is designing, activating, and completing large-scale RCTs that evaluate the long-term relative effectiveness and AEs of the primary treatment modalities in men with PSA-detected prostate cancer. Key outcomes include overall survival, disease-specific survival, metastatic-free survival, standard definitions of biochemical free survival, AEs, quality of life, and costs. Previously initiated RCTs in the United States of brachytherapy vs. RP for men with low-risk prostate cancer, EBRT vs. RP, and cryotherapy were closed due to lack of recruitment. Consumer-based (patient, spouse, partner, family) support groups can play a key role by advocating for initiation of these RCTs, and encouraging patient/provider participation and adequate funding.
• Emerging technologies are becoming popular and include laparoscopic and robotic-assisted prostatectomy, proton-beam and intensity modulated radiation therapy, cryotherapy, and high frequency ultrasound prostatectomy. Despite their increasing use, no randomized trials have been conducted. These technologies need to be studied in large RCTs to assess long-term tumor control, complications, costs, and survival. Studies evaluating learning curves and volume-outcome relationships for new technologies are needed.
• Widespread use of PSA testing for early cancer detection has been associated with an increase in the incidence of prostate cancer. The vast majority of prostate cancers currently detected in the United States are found due to PSA testing, a situation vastly different from 10–15 years previously when prostate cancers were primarily detected based on digital rectal examination or tissue specimens obtained during transurethral resection of the prostate for treatment of benign prostatic obstruction. Furthermore, men are receiving multiple PSA tests, beginning at earlier ages, and continuing well into their 80s. Additionally, the criteria for an abnormal PSA test has become more inclusive (i.e., lower PSA levels, rate of PSA change, nomograms incorporating patient race, family history, digital rectal examination results, etc.) and the number of prostate specimens obtained during prostate biopsy (from six to 12 specimens and then “saturation techniques”) has increased. More men are being labeled as abnormal with increasing use of prostate biopsies and serendipitous detection of asymptomatic prostate cancer having prolonged latent phase even without treatment. Patient and tumor characteristics among men with prostate cancer diagnosed in the future are likely to be different than men diagnosed in the past and currently. For example, systematic histologic upgrading of tumor specimens (by approximately one grade) has occurred compared to previous pathologic assessment. Currently it is unusual for men with prostate cancers to receive a Gleason sum less than 6. This leads to individuals with a histologic sum based on current grading having an improved prognosis compared to historical controls, regardless of treatment provided.
• Relatively few men with prostate cancer are treated with WW. However, because the long-term natural history of these tumors is likely to be very good and the risk of disease spread/death lower than currently exists, it is increasingly important to determine the natural history of prostate cancers detected with new PSA testing and biopsy strategies. This is particularly important in men with life expectancies less than about 15 years based on advanced age or comorbidities where results indicate that PSA testing is still routinely conducted in about one-third. Based on information from long-term studies evaluating the natural history of localized prostate cancer and the results from the few RCTs evaluating surgery with WW detected in the era prior to PSA testing, many more men are diagnosed with prostate cancer than will develop clinically related problems, including death, local, or metastatic spread due to the disease, even with no initial treatment. Results from ongoing randomized screening trials are needed to determine if detection and treatment reduce mortality. To reduce treatment-related morbidity and costs, while still providing opportunity for disease eradication in men who may need intervention, discovery and validation of biomarkers are needed that can reliably identify cancers requiring therapy and assist in determining the relative effectiveness of therapies.
• Tumor risk categories incorporating histologic score, stage, and PSA levels are associated with prostate cancer outcomes. They are widely incorporated in treatment decisionmaking. Age, race, and comorbid conditions may influence treatment decisionmaking, effectiveness, and adverse effects. Studies rarely stratified outcomes for individual treatments according to these factors. Few RCTs have been conducted, and even fewer are of sufficient size to determine if outcomes vary overall or differentially according to these factors. Determining the relative effectiveness/adverse effects of treatments likely requires conducting RCTs of sufficient size and use of standardized reporting of outcomes according to these tumor and patient characteristics. However, the field of research needed is broad and large high-quality prospective cohort studies or cancer registries that identify patients at the time of diagnosis and proceed to collect comprehensive patient, tumor and treatment decision selection characteristics could help target future RCTs to the most promising research questions. Where large differences in outcomes might exist, high quality observational studies may be useful for estimating comparative effectiveness in high priority patient and tumor subgroups that have not been adequately addressed in randomized trials. However, clinicians, patients, policymakers and researchers need to be aware of the limitations of these lower quality studies in accurately estimating comparative effectiveness. Standardized/validated methods to determine cause-specific survival and biochemical, quality of life outcomes, and treatment-related AEs are needed for all future research designs. The American Society of Therapeutic Radiation Oncologists and the AUA have proposed standard methods for assessing PSA recurrence following therapy.
• There is considerable interest in identifying strategies to prevent or delay the onset/progression of prostate cancer. To date, only the 5 alpha reductase inhibitor, finasteride, has been specifically evaluated in large-scale prevention RCTs. Concern regarding long-term adverse effects and costs of this agent, as well the possibility that it may result in a greater incidence of potentially serious high-grade malignancies, has limited its clinical use. Research is needed to determine if dietary or other pharmacologic interventions prevent prostate cancer. The ongoing Selenium and Vitamin E Chemoprevention Trial (SELECT) is currently addressing these two options alone or in combination vs. placebo. The 5 alpha reductase inhibitor, dutasteride is also being evaluated. Other potential preventive agents include 5 alpha reductase inhibitors, lycopenes in tomato-based foods and soy based products. RCTs are needed that will evaluate whether these agents prevent and/or slow the progression of existing prostate cancer.
• Prostate cancer screening with widespread PSA testing is common even in the elderly or those with comorbid conditions. It is frequently requested by patients and recommended by physicians, despite the lack of evidence that such a strategy reduces overall or disease-specific mortality or morbidity. Widespread PSA testing has been associated with a marked increase in prostate cancer incidence and a shift in the type/stage of cancers detected. Long-term outcomes of PSA-detected cancers are not well known. Two screening trials in progress will help determine if prostate cancer screening reduces overall and disease-specific morbidity and mortality. The Prostate, Lung, Colorectal and Ovarian (PLCO) Screening Trial in the United States ³⁰⁰ and the European Randomized Study of Screening for Prostate Cancer (ERSPC) trial ³⁰¹ in Europe should provide results around 2009. The PLCO trial is an effectiveness trial of mass screening with PSA testing. Subsequent management of subjects with elevated PSA levels is left to usual care. The ERSPC trial is designed more as an efficacy study with management of elevated PSA levels specified by protocol. These studies should give complementary information. The Prostate Testing for Cancer and Treatment (ProtecT) feasibility study aimed to examine the accuracy of PSA testing compared with histologically confirmed prostate cancer among 8,505 males in 18 primary care centers. The positive predictive value of PSA >3 ng/ml was 0.23 (95 percent CI 0.18; 0.28) in males 50–59 years and 0.33 (95 percent CI 0.29; 0.38) in males 60–69 years. ³⁰²
• A search ofwww.clinicaltrials.gov for randomized trials of localized prostate cancer identified 30 references to ongoing trials. However, few were directly comparing the primary treatment options and/or were adequately powered to assess survival. Due to the lack of RCTs, the comparative effectiveness and adverse effects of different treatment options for localized prostate cancer (especially those detected by PSA testing) is not known. Basing treatment decisions on comparative effectiveness results from nonrandomized data is problematic due to the poor methodologic quality of nonrandomized reports and the risk of biased outcomes. To provide patients with reliable information, RCTs need to be conducted to determine if outcomes vary according to patient, tumor, and/or provider characteristics. Two ongoing trials are evaluating primary treatment options in men with primarily PSA-detected clinically-localized prostate cancer. The U.S. based VA/NCI/AHRQ funded CSP#407: PIVOT is comparing RP vs. WW in 731 men and completed recruitment. ⁶⁵ Results are due after 2010. The ProtecT study, based in the United Kingdom is comparing surgery (RP), radiotherapy (radical conformal), and active monitoring (monitoring with regular check ups). Studies in development include cryotherapy vs. EBRT and RP vs. expectant management in men with “low risk” prostate cancer with delayed intervention based on repeat PSA testing and prostate biopsy results.
• Decisions regarding treatment for early stage prostate cancer are limited by little data comparing quality of care according to provider, facility, and other healthcare system factors. Furthermore, there is increasing evidence that factors related to the structure and process of health care are associated with clinically relevant outcomes. However, little information is available for prostate cancer treatment. Structure of care includes the equipment, resources, and provider experience necessary to provide care. Process of care refers to technical and interpersonal elements of care that transpire between doctor and patient. Preliminary work suggests that the indicated variables can be reliably assessed, but their validity in predicting quality of prostate cancer care and outcomes remains to be established. Proposed quality of care indicators for early-stage prostate cancer have been developed using a RAND Global Quality Assessment Tool following the conceptual framework established by Donabedian. Future studies need to identify systemwide structure and process measures associated with improved quality of prostate cancer care, disseminate these results so that they are widely available for patients, health care providers, and policymakers; and implement programs to improve and enhance their application in routine clinical care.
• Patients and family members are faced with a vast array of information related to detection and treatment of prostate cancer. It is increasingly difficult for them (and their physicians) to accurately assess this information and incorporate it into decisionmaking. Systematic reviews of educational materials have found that the majority of these are not evidence based and rather promote a particular treatment approach. In order to assist patients, family members, and health care providers match treatment selection with personal preference, a new generation of education materials and multidisciplinary health care teams are needed. These should describe all standard treatments and provide comprehensive and up-to-date information about the risks and benefits of each treatment. Key features include: 1) accuracy of information; 2) balanced presentation of treatment options; and 3) comprehensibility to the average reader/viewer. Examining different formats (e.g., print, vs. CD-ROMs vs. websites) length/depth of information, and presentation of risk/benefit communication (words, figures, tables, items of numeracy) is important. It is hoped that this comparative effectiveness review and the accompany patient and clinician guides will serve as a model for development of future decisionmaking guides. These reports aim to identify and evaluate quality and strength of evidence regarding the comparative effectiveness and adverse effects of treatments according to key patient, tumor, and provider factors. The resulting patient/clinician guides are developed by individuals with communication/dissemination skills who are separate from authors of the evidence report.
• Many factors are involved in patient decisionmaking and may differ according to patient and tumor characteristics. A greater understanding of factors related to patient decisionmaking is needed. Interventions to assist patients incorporate numerical risks for various outcomes and minimize undue influence from misconceptions and/or anecdotal evidence are needed.

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