A decision analysis comparing 3 active surveillance protocols for the treatment of patients with low-risk prostate cancer (original) (raw)
Related papers
European Urology, 2012
Background: Active surveillance (AS) protocols for low-risk prostate cancer (PCa) generally include repeat prostate biopsies at predefined follow-up intervals. Objective: To study the outcome of routinely obtained 1-yr repeat biopsies and factors predicting reclassification to higher risk, to contribute to risk stratification for men on AS. Design, setting, and participants: We analysed men with low-risk PCa (clinical stage T2, prostate-specific antigen (PSA) 10 ng/ml, PSA density <0.2 ng/ml per millilitre, one or two positive biopsy cores, and Gleason score 6) who had been included in a prospective AS protocol. Interventions: PSA was measured 3-monthly and the first volume-dependent repeat biopsy was scheduled 1 yr after diagnosis, independent of PSA doubling time (PSA-DT). Reclassification to higher risk disease on repeat biopsy was defined as Gleason score 7 or 3 positive cores. Measurements: We analysed whether baseline patient characteristics and PSA-DT were associated with reclassification to more aggressive PCa on repeat biopsy. Results and limitations: A first repeat biopsy was taken in 757 patients after median follow-up of 1.03 yr. The results of repeat biopsies were favourable (no or low-risk PCa) in 594 patients (78.5%) and led to reclassification of risk in 163 (21.5%). Analysis showed that reclassification to higher risk was significantly influenced by the number of initial positive cores (two vs one) (odds ratio [OR]: 1.8; p = 0.002) and higher PSA density (OR: 2.1; p = 0.003). The outcome was not significantly influenced by age, clinical stage, total number of biopsy cores, or PSA. Adding PSA-DT at time of repeat biopsy to the model showed PSA-DT <3 yr to be significantly associated with reclassification to higher risk (OR: 1.7; p = 0.015). Data on tumour involvement per biopsy core were not available. Conclusions: Clinical features at baseline and during follow-up in our AS cohort are significantly associated with short-term reclassification to higher risk on repeat biopsy. These characteristics can potentially be used for risk stratification of men with PCa who are apparently at favourable risk. Trial registration: The current program is registered at the Dutch Trial Register with identification number ID NTR1718 (http://www.trialregister.nl/trialreg/admin/rctview. asp?TC=1718).
Journal of Urology, 2020
Purpose: COMPARE (COMparing treatment options for ProstAte cancer) aimed to evaluate and quantify the trade-offs patients make between different aspects of active surveillance and definitive therapy. Methods: A Discrete Choice Experiment (DCE) tool was used to elicit patients' preferences for different treatment characteristics in 34 urology departments. Patients with localised prostate cancer completed the DCE within one week of being diagnosed and before they made treatment decisions. The DCE was pre-tested (N=5) and piloted (n=106) with patients. Patients chose their preferred treatment profile based on six characteristics: treatment type (active surveillance, focal therapy, radical therapy), return to normal activities, erectile function, urinary function, not needing more cancer treatment and 10-15 year cancer-specific survival. Different tools were designed for low-intermediate (n=468) and high-risk (n=166) patients. An error-components conditional logit model was used to estimate preferences and trade-offs between treatment characteristics. Results: Low-intermediate risk patients were willing to trade 6.99% absolute decrease in survival to have active surveillance over definitive therapy. They were willing to trade 0.75%, 0.46% and 0.19% absolute decrease in survival for a one-month reduction in time-to-return to normal activities, and 1% absolute improvements in urinary and sexual function, respectively. High-risk patients were willing to trade 3.10%, 1.04% and 0.41% absolute decrease in survival for a one-month reduction in time-to-return to normal activities and 1% absolute improvements in urinary and sexual function, respectively. Conclusions: Patients with low-intermediate risk prostate cancer preferred active surveillance to definitive therapy. Patients of all risks were willing to trade-off cancer-specific survival for improved quality-of-life.
BJU International, 2007
To examine the outcome of patients diagnosed with &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;low-risk&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; prostate cancer managed by active surveillance (AS). In all, 157 men with localized prostate cancer were followed on AS. The inclusion criteria for AS included: Gleason score of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; or = 6, a serum prostate-specific antigen (PSA) level of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; or = 15 ng/mL, stage &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; or = T2, low-volume disease and &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 12 months of follow-up. The follow-up was rigorous, with PSA tests and a digital rectal examination every 3 months for 2 years, and a repeat biopsy 6-12 months after the initial diagnosis and yearly when indicated. Continuance of AS was based on the PSA doubling time, re-biopsy score, Gleason score, tumour volume, stage progression and patient preference. In all 99 patients met the inclusion criteria; their mean age at diagnosis was 66 years, their mean PSA level 5.77 ng/mL and the mean follow-up 45.3 months. On initial repeat biopsy, 63% had no cancer and 34% had a Gleason sum of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; or = 6. Eight patients were treated (three with hormones; five with curative intent); two had radical prostatectomy (one had pT2c pNO Gleason 7 disease); three had radiotherapy. The probability is that 85% would remain treatment-free at 5 years; no patient died from prostate cancer. The PSA doubling time and clinical stage at diagnosis were predictive of progression. Patients who are followed on AS must be selected using narrowly defined inclusion criteria and closely followed with a standard regimen of PSA testing, digital rectal examination and repeat biopsy.
European Urology, 2010
Background: With the advent of prostate-specific antigen (PSA) screening and the increase in the number of transrectal ultrasound-guided biopsy cores, there has been a dramatic rise in the incidence of low-risk prostate cancer (LRPC). Because >97% of men with LRPC are likely to die of something other than prostate cancer, it is critical that patients give thought to whether early curative treatment is the only option at diagnosis. Objective: To identify a group of men with LRPC who may not require initial treatment and monitor them on our active surveillance (AS) protocol, to determine the percentage treated and the outcome and to analyze the quality-of-life data. Design, setting, and participants: We defined patients eligible for AS as Gleason 6, PSA 10, and two or fewer biopsy cores with 20% tumor in each core. Measurements: Kaplan Meier analysis was used to predict the 5-year treatment free survival. Logistic regression determined the predictors of treatment. Data on sexual function, continence, and outcome were obtained and analyzed. Results and limitations: The AS cohort consisted of 230 patients with a mean age of 63.4 yr; 86% remained on AS for a mean follow-up of 44 mo. Thirty-two of the 230 patients (14%) were treated for a mean follow-up of 33 mo. Twelve had a total prostatectomy (TP). The pathologic stage of these patients was similar to initially treated TP patients with LRPC. Fourteen underwent radiation therapy, and six underwent androgen-deprivation therapy. Fifty percent of patients had no tumor on the first rebiopsy, and only 5% of these patients were subsequently treated. PSA doubling time and clinical stage were not predictors of treatment. No patient progressed after treatment. Among the AS patients, 30% had incontinence, yet <15% were bothered by it. As measured by the Sexual Health Inventory for Men, 49% of patients had, at a minimum, moderate (16) erectile dysfunction. Conclusions: If guidelines for AS are narrowly defined to include only patients with Gleason 6, tumor volume 20% in one or two biopsy cores, and PSA levels 10, few patients are likely to require treatment. Progression-free survival of those treated is likely to be equivalent to patients with similar clinical findings treated at diagnosis.
European Urology, 2013
A better understanding of the independent predictors of disease progression for prostate cancer (PCa) patients is needed to improve the selection of ideal candidates for active surveillance (AS) and refine the surveillance regimen. To examine the association of clinical and pathologic characteristics, as well as patterns of surveillance biopsy results, with the risk of progression in men on AS. The retrospective study consisted of men with PCa who were on AS in the prospectively maintained University of California, San Francisco, institutional database from 1996 to 2011. Strict criteria for AS were prostate-specific antigen (PSA) ≤10 ng/ml, clinical stage T1 or T2, biopsy Gleason grade 6, &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;33% positive cores, and &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;50% tumor in any single core. Men were then categorized based on results of their confirmatory surveillance biopsy. Disease progression was defined as an increase in Gleason grade and/or biopsy volume beyond prespecified cut points. Serial biopsy patterns over the course of surveillance were stratified by confirmatory biopsy findings: negative, positive without progression, and positive with progression. Multivariable logistic regression models were used to evaluate predictors of progression during AS. A total of 465 men met inclusion criteria (median follow-up: 51 mo). Of these men, 23% had negative confirmatory biopsies. Only 3% of the men (1 of 30) progressed by the fourth surveillance biopsy following a biopsy pattern of negative confirmatory and negative third biopsy findings. Negative confirmatory biopsy and lower PSA density (both p&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;0.01) were independently associated with decreased odds of biopsy progression at 3 yr. The main limitation of this study is its observational nature. The patterns of surveillance biopsy results yield additional important information in AS. Negative confirmatory biopsy and PSA density are important independent predictors of progression on AS and may be used to better counsel men opting for AS.
Patient preferences for management of localized prostate cancer
Western journal of medicine, 1996
We designed this study to determine whether patients with early localized prostate cancer prefer surgical intervention over watchful waiting, which aspects of the 2 management strategies influence patient preferences, and whether there are patient characteristics that predict their preferences for 1 strategy over the other. Structured interviews were used with 140 male patients seen consecutively at a university-based Department of Veterans Affairs Medical Center outpatient clinic. The mean age of the patients was 66.3 years. Of the 140 patients, 53% preferred surgical treatment, 42% preferred observation, 4% preferred that their physician make the decision, and 1% preferred radiotherapy. Of 74 patients selecting surgical intervention, 92% (68) reported that the possibility of complete tumor removal was the strongest factor influencing their decision. Of those selecting observation, 80% (47/59) reported being most influenced by the complications of an operation. Older patients were significantly (P < .002) more likely to prefer expectant management. We conclude that tumor excision is an important factor influencing patient preferences for treatment, irrespective of survival benefits. This factor should be considered when designing approaches to providing information to patients about alternative treatments.
Super active surveillance for low-risk prostate cancer | Opinion: Yes
International braz j urol, 2019
Prostate cancer is the most common solid tumor in men in western countries. Notwithstanding, its high incidence, most patients survive their prostate cancer diagnosis and die from other causes (1). This low cancer death event rate poses remarkable challenges for both patients and their treating physicians. Fundamentally the "overs", meaning overdiagnosis and overtreatment (2). Both particularly important as significant issues for patients arise as consequences of treatment. Distastefully, urinary incontinence and erectile dysfunction, among other, both exerting substantial impact in quality of life (3). This decade has witnessed results from three randomized trials. These robust studies clearly pointed to a limited benefit of definitive intervention such as surgery or radiation vs. surveillance modalities. The lack of differences in all cause survival and the relative low rate of metastasis 10 and 15 years after diagnosis have changed dramatically our knowledge on what is best to do when a man presents with a newly diagnosed prostate cancer (4-6). Not surprisingly, active surveillance (AS) has become a definitive alternative and common option. This strategy of management certainly decreased the morbidity rates associated to radical surgery or radiation (7). Specifically, AS is now a preferred option for many men with low-risk prostate cancer, gaining worldwide adoption due to robust data and is currently highlighted by many guidelines as the best treatment strategy for men with low risk (8, 9). What constitutes the best approach to AS is an open question, as many protocols currently exists. However, to the patient selection questions, the field of urology sets the tone in low risk-PSA <10 ng/ml, WHO GG1 and a clinical stage T1c/T2a. There are several stricter protocols that have been developed and tested for AS. The Epstein criteria of ≤2 positive cores, <50% core involvement, and PSA density <0.15 ng/ml/cm³ carries 10 years rates of overall survival, cancer-specific survival, and metastasis-free survival of 94%, 99.9%, and 99.4%, respectively. Importantly, at 15 years, oncological outcomes such as metastasis-free survival and cancer specific survival change little (10). In Canada, specifically Klotz and collaborators have reported on single-arm cohorts of low-risk patients (Gleason score ≤6 and serum PSA level ≤10 ng/mL) and favorable intermediate-risk patients (serum PSA ≤15 ng/mL or a Gleason score of 7 [3+4]). The investigators reported 10-and 15-year metastasis-free survival rates of 96% and 95% vs 91% and 82% for low vs. intermediate
BMC Health Services Research, 2014
Background: There is an on-going debate about whether to perform surgery on early stage localised prostate cancer and risk the common long term side effects such as urinary incontinence and erectile dysfunction. Alternatively these patients could be closely monitored and treated only in case of disease progression (active surveillance). The aim of this paper is to develop a decision-analytic model comparing the cost-utility of active surveillance (AS) and radical prostatectomy (PE) for a cohort of 65 year old men with newly diagnosed low risk prostate cancer.
European Urology Oncology, 2019
Background: The optimal follow-up regimen for men after a benign prostate biopsy remains unknown. Objective: To investigate long-term outcomes for men after an initial benign prostate biopsy. Design, setting, and participants: All men with a benign biopsy in the first screening round of the Göteborg prostate cancer (PC) screening trial were included. The follow-up period was January 1, 1995-May 15, 2017. Intervention: Prostate-specific antigen (PSA) tests were performed every second year (upper median age limit 69 yr). Men with PSA 3 ng/ml underwent prostate biopsy (sextant biopsy up to 2009). Outcome measurements and statistical analysis: The 20-yr cumulative PC incidence and PC mortality were calculated using the 1 minus Kaplan-Meier method. Results and limitations: Of 452 men with a benign biopsy and followed for a median of 21.1 yr, 169 were diagnosed with PC and five died from PC. The 20-yr cumulative PC incidence and PC mortality were 40.0% and 1.4%, respectively. The corresponding figures were 38.8% and 0.6% for men with initial PSA 10 ng/ml, and 64.4% and 21.4% for PSA >10 ng/ml. The proportion of men untreated at final follow-up was similar in the two PSA groups (22% vs 23%). The use of sextant biopsy for many years of the trial is a limitation. Conclusions: Men with an initial benign prostate biopsy run a very low risk of dying from PC when participating in a screening program. However, if followed for a long period, many men will be diagnosed and treated for PC. Low-intensity follow-up, as in the Göteborg trial, appears sufficient for men with PSA 10 ng/ml after a benign biopsy. Patient summary: This study shows that men who participate in a prostate cancer screening trial have a low risk of dying from prostate cancer if the first biopsy does not show cancer.