A decision analysis comparing 3 active surveillance protocols for the treatment of patients with low-risk prostate cancer.

BACKGROUND: Active surveillance (AS) is a viable management option for approximately 50% of men who are newly diagnosed with prostate cancer. To the authors' knowledge, no direct comparisons between the different variants of AS protocols have been conducted to date. The authors developed a microsimulation decision model to evaluate which of 3 alternative AS protocols is optimal for men with low-risk prostate cancer, and compared each of these with immediate treatment. METHODS: Men who were diagnosed with low-risk prostate cancer at age 65 years were modeled as having been treated with either immediate therapy or via each of 3 AS protocols. Modeled AS protocols represent those in the literature; a modified AS protocol was included in a sensitivity analysis. Immediate therapy included radical prostatectomy, external-beam radiotherapy, or brachytherapy. Outcome measures were quality-adjusted life-years (QALYs) and costs. Cost-effectiveness analysis and deterministic and probabilistic sensitivity analyses were performed. RESULTS: Immediate therapy produced fewer QALYs than all variants of AS. Of the AS protocols evaluated, biennial biopsy was found to be the only efficient option, with an incremental cost-effectiveness ratio of $3490 per QALY compared with immediate therapy. It delayed the need for curative therapy by a mean of 56 months, and was found to be preferred in >86.9% of cases in probabilistic sensitivity analysis. A modified version of low-intensity AS dominated all other options. CONCLUSIONS: For a 65-year-old man with low-risk prostate cancer, AS with biennial biopsy appears to be highly cost-effective compared with common alternatives. An AS protocol using triennial biopsy was found to dominate all other strategies and should be considered for men who are comfortable with a longer period between biopsies. The optimal strategy depends on a patient's tolerance for periodic biopsies and comfort with delaying radical treatment. Physicians should incorporate these patient preferences into decision making.

The Cost-Effectiveness of Prostate Cancer Detection with the Use of Prostate Health Index.

BACKGROUND: Clinical trial results suggested that prostate-specific antigen (PSA) screening can reduce prostate cancer mortality. Nevertheless, because the specificity of the PSA test for cancer detection is low, it leads to many negative biopsies. The Beckman Coulter Prostate Health Index (PHI) testing demonstrates improved specificity compared with the PSA-only screening and therefore may improve the cost-effectiveness of prostate cancer detection. OBJECTIVE: To examine the cost-effectiveness of adding PHI testing to improve cancer detection for men with elevated serum PSA. METHODS: A microsimulation model, based on the results of the European Randomized Study of Screening for Prostate Cancer trial, was used to evaluate the effects of PSA screening and PHI reflex testing. We predicted the numbers of prostate cancers, negative biopsies, deaths, quality-adjusted life-years gained, and cost-effectiveness of both PSA (cutoff 3 ng/mL) and PHI (cutoff 25) testing methods for a European population, screened from age 50 to 75 years at 4-year intervals. RESULTS: When the PHI test was added to the PSA screening, for men with a PSA between 3 and 10 ng/mL, the model predicted a 23% reduction in negative biopsies. This would lead to a 17% reduction in costs for diagnostics and 1% reduction in total costs for prostate cancer. The cost-effectiveness (3.5% discounted) was 11% better. Limitations found were the modeling assumptions on the sensitivity and specificity of PHI by tumor stage and cutoff values. CONCLUSIONS: Compared with PSA-only screening, the use of a PHI test can substantially reduce the number of negative biopsies and improve the cost-effectiveness of prostate cancer detection.

Regional and national guideline recommendations for digital ano-rectal examination as a means for anal cancer screening in HIV positive men who have sex with men: a systematic review.

BACKGROUND: Although anal cancer is common in HIV positive men who have sex with men, few centres offer systematic screening. Regular digital ano-rectal examination (DARE) is a type of screening that has been recommended by some experts. How widely this forms part of HIV management guidelines is unclear. METHODS: The protocol was registered prospectively (CRD42013005188; http://www.crd.york.ac.uk/PROSPERO/). We systematically reviewed 121 regional and national HIV guidelines and searched for guidelines from http://hivinsite.ucsf.edu/global?page=cr-00-04#SauguidelineX, PubMed and Web of Science databases up to 5th August 2013 for recommendations of DARE as a means of anal cancer screening in HIV positive MSM. Guidelines were examined in detail if they were clinical guidelines, including both prevention and treatment protocols and were in English. Guidelines were excluded if they were restricted to limited areas (e.g. antiretroviral therapy only, children or pregnant women, strategies for prevention/testing). Information was extracted regarding recommendation of DARE as a screening method, the frequency of DARE recommended, target population for screening and the strength of evidence supporting this. RESULTS: 30 regional and national guidelines were included and examined in detail. Only 2 recommended DARE. The 'European AIDS Clinical Society Guidelines' recommends DARE every 1-3 years for HIV positive MSM whilst the 'US Guideline for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents' recommends an annual DARE for the HIV + population in general. None of these guidelines specify the age of commencing screening. In each case, the highest level of evidence supporting these two recommendations was expert opinion. CONCLUSIONS: Few HIV guidelines discuss or recommend DARE as a means of anal cancer screening. Studies of the efficacy, acceptability and cost-effectiveness of DARE are needed to assess its role in anal cancer screening.

Observation versus initial treatment for men with localized, low-risk prostate cancer: a cost-effectiveness analysis.

BACKGROUND: Observation is underutilized among men with localized, low-risk prostate cancer. OBJECTIVE: To assess the costs and benefits of observation versus initial treatment. DESIGN: Decision analysis simulating treatment or observation. DATA SOURCES: Medicare schedules, published literature. TARGET POPULATION: Men aged 65 and 75 years who had newly diagnosed low-risk prostate cancer (prostate-specific antigen level <10 µg/L, stage ≤T2a, Gleason score ≤3 + 3). TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTION: Treatment (brachytherapy, intensity-modulated radiation therapy, or radical prostatectomy) or observation (active surveillance [AS] or watchful waiting [WW]). OUTCOME MEASURES: Quality-adjusted life expectancy and costs. RESULTS OF BASE-CASE ANALYSIS: Observation was more effective and less costly than initial treatment. Compared with AS, WW provided 2 additional months of quality-adjusted life expectancy (9.02 vs. 8.85 years) at a savings of $15,374 ($24,520 vs. $39,894) in men aged 65 years and 2 additional months (6.14 vs. 5.98 years) at a savings of $11,746 ($18,302 vs. $30,048) in men aged 75 years. Brachytherapy was the most effective and least expensive initial treatment. RESULTS OF SENSITIVITY ANALYSIS: Treatment became more effective than observation when it led to more dramatic reductions in prostate cancer death (hazard ratio, 0.47 vs. WW and 0.64 vs. AS). Active surveillance became as effective as WW in men aged 65 years when the probability of progressing to treatment on AS decreased below 63% or when the quality of life with AS versus WW was 4% higher in men aged 65 years or 1% higher in men aged 75 years. Watchful waiting remained least expensive in all analyses. LIMITATION: Results depend on outcomes reported in the published literature, which is limited. CONCLUSION: Among these men, observation is more effective and costs less than initial treatment, and WW is most effective and least expensive under a wide range of clinical scenarios. PRIMARY FUNDING SOURCE: National Cancer Institute, U.S. Department of Defense, Prostate Cancer Foundation, and Institute for Clinical and Economic Review.

Economic evaluation of the introduction of the Prostate Health Index as a rule-out test to avoid unnecessary biopsies in men with prostate specific antigen levels of 4-10 in Hong Kong.

A recent study showed that the Prostate Health Index may avoid unnecessary biopsies in men with prostate specific antigen 4-10ng/ml and normal digital rectal examination in the diagnosis of prostate cancer in Hong Kong. This study aimed to conduct an economic evaluation of the impact of adopting this commercially-available test in the Hong Kong public health service to determine whether further research is justified. A cost-consequence analysis was undertaken comparing the current diagnostic pathway with a proposed diagnostic pathway using the Prostate Health Index. Data for the model was taken from a prospective cohort study recruited at a single-institution and micro-costing studies. Using a cut off PHI score of 35 to avoid biopsy would cost HK$3,000 and save HK$7,988 per patient in biopsy costs and HK$511 from a reduction in biopsy-related adverse events. The net cost impact of the change was estimated to be HK$5,500 under base case assumptions. At the base case sensitivity and specificity for all grades of cancer (61.3% and 77.5% respectively) all grade cancer could be missed in 4.22% of the population and high grade cancer in 0.53%. The introduction of the prostate health index into the diagnostic pathway for prostate cancer in Hong Kong has the potential to reduce biopsies, biopsy costs and biopsy-related adverse events. Policy makers should consider the clinical and economic impact of this proposal.

Optimal cost-effective staging evaluations in prostate cancer.

A new diagnosis of prostate cancer presents to both the patient and physician questions regarding the best approach for further assessing the extent of disease prior to selecting a treatment strategy. In addition to the initial clinical data such as serum prostate-specific antigen level, findings on digital rectal examination, and core biopsy Gleason score, several procedures and imaging modalities are available to further stage newly diagnosed prostate cancer. A substantial percentage of the cost of managing prostate cancer is directly related to staging evaluations. Often, staging evaluations are performed that have limited test performance characteristics, subject the patient to unnecessary morbidity, or simply do not provide additional useful clinical information. It is important that the physician be familiar with the indications for the available staging modalities as well as the test performance characteristics in order to proceed appropriately and in an economically judicious fashion. This paper reviews the literature on this topic and summarizes previous experiences with procedures and imaging modalities for staging newly diagnosed prostate cancer.

Cost-effectiveness of percent free PSA for prostate cancer detection in men with a total PSA of 4-10 ng/ml.

OBJECTIVE: To assess the cost-effectiveness of two diagnostic strategies for prostate cancer in men with prostate-specific antigen (PSA) levels of 4-10 ng/ml and normal digital rectal examination (DRE). DESIGN: Cost-effectiveness analysis was performed using a decision tree model. Data collection and a systematic review of patients at the Urology Department (Carlos Haya Hospital) were made. 101 patients over the age of 40 with PSA levels of 4-10 ng/ml and normal DRE were selected. Transrectal ultrasound-guided prostate biopsy (TRUS-Bx) and percent free PSA testing prior to TRUS-Bx were performed. The outcome measures used were the incremental cost-effectiveness ratio, and costs were calculated through activity-based costing. The effectiveness was measured by means of the number of detected cases, test utility and actual cases (detected cases minus lost cases). RESULTS: Using base-case analysis, the strategy of percent free PSA + TRUS-Bx was found to be the most cost-effective. The incremental cost-effectiveness ratio for free PSA + TRUS-Bx compared with TRUS-Bx was EUR 2,277.40. Strategy 2 (TRUS-Bx) would be more cost-effective if the cost of percent free PSA increased to EUR 21.64 or if prostate cancer prevalence increased to 26%. CONCLUSIONS: The use of percent free PSA prior to TRUS-Bx is the most cost-effective diagnostic strategy. However, this result is very sensitive and strategy 2 (TRUS-Bx) would be more cost-effective if the cost of the percent free PSA increased to EUR 21.64 or if the prevalence of prostate cancer increased to above 26%.