Dataset Information

Estimating the risks and benefits of active surveillance protocols for prostate cancer: a microsimulation study.

ABSTRACT:

Objective

To estimate the increase in prostate cancer mortality (PCM) and the reduction in overtreatment resulting from different active surveillance (AS) protocols, compared with treating men immediately.

Patients and methods

We used a microsimulation model (MISCAN-Prostate), with the natural history of prostate cancer based on European Randomized Study of Screening for Prostate Cancer data. We estimated the probabilities of referral to radical treatment while on AS, depending on disease stage, using data from the Johns Hopkins AS cohort. We sampled 10 million men, representative of the US population, and projected the effects of applying AS protocols that differed by time between biopsies and compared these with the effects of treating men immediately.

Results

We found that AS with yearly follow-up biopsies for men with low-risk prostate cancer (? T2a stage and Gleason 6) increases the probability of PCM to 2.6% (1% increase) and reduces overtreatment from 2.5 to 2.1% (18.4% reduction). With biopsies every 3 years after the first year, PCM increases by 2.3% and overtreatment reduces from 2.5 to 1.9% (30.3% reduction). The inclusion of men in the intermediate-risk group (> T2a stage or Gleason 3+4) in AS protocols increases PCM by 2.7% and reduces overtreatment from 2.5 to 2.0% (23.1% reduction). These results may not apply to African-American men.

Conclusions

Offering AS to men with low-risk prostate cancer is relatively safe. Increasing the biopsy interval from yearly to up to every 3 years after the first year will significantly reduce overtreatment among men in the low-risk group, with limited PCM risk.

SUBMITTER: de Carvalho TM

PROVIDER: S-EPMC5859305 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Publications

Estimating the risks and benefits of active surveillance protocols for prostate cancer: a microsimulation study.

de Carvalho Tiago M TM Heijnsdijk Eveline A M EA de Koning Harry J HJ

BJU international 20160626 4

<h4>Objective</h4>To estimate the increase in prostate cancer mortality (PCM) and the reduction in overtreatment resulting from different active surveillance (AS) protocols, compared with treating men immediately.<h4>Patients and methods</h4>We used a microsimulation model (MISCAN-Prostate), with the natural history of prostate cancer based on European Randomized Study of Screening for Prostate Cancer data. We estimated the probabilities of referral to radical treatment while on AS, depending on ...[more]

PMID: 27222299

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Project description:Many men diagnosed with localized prostate cancer can postpone definitive treatment without raising their risk of metastasis or death from disease. Active surveillance (AS) is a method of monitoring select men, with the option of switching to active treatment upon signs of progression, thereby avoiding the well-known side-effects of surgery and radiotherapy. This review analyzes the data from long-running AS cohorts to determine the safety and efficacy of AS. We conducted a narrative review of recently published data, including 14 articles from 13 AS cohorts. The cohorts used varying inclusion criteria, with reported differences in clinical T stage and Gleason Score (Grade Group), among other features. Some studies (n=5) limited their cohorts to low-risk patients, while others (n=8) also included intermediate-risk patients. The heterogeneity of the cohorts produced mixed results, with the risk of prostate cancer metastasis ranging from 0.1-1.0% at 10 years and the risk of prostate cancer mortality ranging from 0-1.9% at 10 years. However, the majority of studies reported risks of less than 0.5% at 10 years for both metastasis and death. For most cohorts, half of men remained untreated for 5-10 years, with estimates ranging from 37% receiving active treatment in the Toronto cohort to 73% in the Prostate Cancer Research International AS (PRIAS) study. Current data do not support the use of negative magnetic resonance imaging (MRI) to avoid scheduled biopsy. Taken together, the data collected from these AS cohorts suggests that AS is a safe approach for men with low-grade prostate cancer and some men with intermediate risk disease. AS should be more broadly implemented for eligible patients to avoid the decreases in quality of life from undergoing active treatment. Studies expanding the inclusion criteria and further defining a subset of men with favorable intermediate-risk prostate cancer who might safely benefit from AS are needed to assess the long-term outcomes of using AS in intermediate-risk groups.

Project description:BackgroundActive 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.MethodsMen 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.ResultsImmediate 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.ConclusionsFor 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.

Project description:BackgroundThe routine clinical use of serum prostatic specific antigen (PSA) testing has allowed earlier detection of low-grade prostate cancer (PCa) with more favourable characteristics, leading to increased acceptance of management by active surveillance (AS). AS aims to avoid over treatment in men with low and intermediate-risk PCa and multiple governing bodies have described several AS protocols. This study provides a descriptive profile of the Guy's and St Thomas NHS Foundation Trust (GSTT) AS cohort as a platform for future research in AS pathways in PCa.MethodsDemographic and baseline characteristics were retrospectively collected in a database for patients at the GSTT AS clinic with prospective collection of follow-up data from 2012. Seven hundred eighty-eight men being monitored at GSTT with histologically confirmed intermediate-risk PCa, at least 1 follow-up appointment and diagnostic characteristics consistent with AS criteria were included in the profile. Descriptive statistics, Kaplan-Meier survival curves and multivariable Cox proportion hazards regression models were used to characterize the cohort.DiscussionA relatively large proportion of the cohort includes men of African/Afro-Caribbean descent (22%). More frequent use of magnetic resonance imaging and trans-perineal biopsies at diagnosis was observed among patients diagnosed after 2012. Those who underwent trans-rectal ultrasound diagnostic biopsy received their first surveillance biopsy 20 months earlier than those who underwent trans-perineal diagnostic biopsy. At 3 years, 76.1% men remained treatment free. Predictors of treatment progression included Gleason score 3 + 4 (Hazard ratio (HR): 2.41, 95% Confidence interval (CI): 1.79-3.26) and more than 2 positive cores taken at biopsy (HR: 2.65, CI: 1.94-3.62). A decreased risk of progressing to treatment was seen among men diagnosed after 2012 (HR: 0.72, CI: 0.53-0.98).ConclusionAn organised biopsy surveillance approach, via two different AS pathways according to the patient's diagnostic method, can be seen within the GSTT cohort. Risk of patients progressing to treatment has decreased in the period since 2012 compared with the prior period with more than half of the cohort remaining treatment free at 5 years, highlighting that the fundamental aims of AS at GSTT are being met. Thus, this cohort is a good resource to investigate the AS treatment pathway.

Project description:PURPOSE:While major prostate cancer active surveillance programs recommend repeat testing such as prostate specific antigen and prostate biopsy, to our knowledge compliance with such testing is unknown. We determined whether men in the community receive the same intensity of active surveillance testing as in prospective active surveillance protocols. MATERIALS AND METHODS:We performed a retrospective cohort study of men 66 years old or older in the SEER (Surveillance, Epidemiology and End Results)-Medicare database. These men were diagnosed with prostate cancer from 2001 to 2009, did not receive curative therapy in the year after diagnosis and underwent 1 or more post-diagnosis prostate biopsies. We used multivariable adjusted Poisson regression to determine the association of the frequency of active surveillance testing with patient demographics and clinical features. In 1,349 men with 5 years of followup we determined the proportion who underwent testing as intense as that recommended by the Sunnybrook Health Sciences Centre and PRIAS (Prostate Cancer Research International Active Surveillance) programs, including 14 or more PSA tests and 2 or more biopsies, and The Johns Hopkins program, including 10 or more prostate specific antigen tests and 4 or more biopsies. RESULTS:Among 5,192 patients undergoing active surveillance greater than 80% had 1 or more prostate specific antigen tests per year but fewer than 13% underwent biopsy beyond the first 2 years. Magnetic resonance imaging was rarely done during the study period. On multivariable analysis recent diagnosis and higher income were associated with a higher frequency of surveillance biopsy while older age and greater comorbidity were associated with fewer biopsies. African American men underwent fewer prostate specific antigen tests but a similar number of biopsies. During 5 years of active surveillance only 11.1% and 5.0% of patients met the testing standards of the Sunnybrook/PRIAS and The Johns Hopkins programs, respectively. CONCLUSIONS:In the community few elderly men receive the intensity of active surveillance testing recommended in major prospective active surveillance programs.

Dataset Information

Estimating the risks and benefits of active surveillance protocols for prostate cancer: a microsimulation study.

Objective

Patients and methods

Results

Conclusions

Publications

Estimating the risks and benefits of active surveillance protocols for prostate cancer: a microsimulation study.

Similar Datasets

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