Surveillance For Early Prostate Cancer Research Articles

Medium-term follow up of active surveillance for early prostate cancer at a non-academic institution.

To report oncological outcomes of active surveillance (AS) at a single non-academic institution adopting the standardised Prostate Cancer Research International Active Surveillance (PRIAS) protocol. Competing risk analyses estimated the incidence of overall mortality, metastases, conversion to treatment, and grade reclassification. The incidence of reclassification and adverse pathological findings at radical prostatectomy were compared between patients fulfilling all PRIAS inclusion criteria vs those not fulfilling at least one. We analysed 341 men with Grade Group 1 prostate cancer (PCa) followed on AS between 2010 and 2022. There were no PCa deaths, two patients developed distant metastases and were alive at the end of the study period. The 10-year cumulative incidence of metastases was 1.9% (95% confidence interval [CI] 0.33-6.4%). A total of 111 men were reclassified, and 127 underwent definitive treatment. Men not fulfilling at least one PRIAS inclusion criteria (n = 43) had a higher incidence of reclassification (subdistribution hazards ratio 1.73, 95% CI 1.07-2.81; P = 0.03), but similar rates of adverse pathological findings at radical prostatectomy. Metastases in men on AS at a non-academic institution are as rare as those reported in established international cohorts. Men followed without stringent inclusion criteria should be counselled about the higher incidence of reclassification and reassured they can expect rates of adverse pathological findings comparable to those fulfilling all criteria. Therefore, AS should be proposed to all men with low-grade PCa regardless of whether they are followed at academic institutions or smaller community hospitals.

Prospective Implementation and Early Outcomes of a Risk-stratified Prostate Cancer Active Surveillance Follow-up Protocol

BackgroundActive surveillance (AS) is a major management option for men with early prostate cancer. Current guidelines however advocate identical AS follow-up for all without considering different disease trajectories. We previously proposed a pragmatic three-tier STRATified CANcer Surveillance (STRATCANS) follow-up strategy based on different progression risks from clinic-pathological and imaging features. ObjectiveTo report early outcomes from the implementation of the STRATCANS protocol in our centre. Design, setting, and participantsMen on AS were enrolled into a prospective stratified follow-up programme. InterventionThree tiers of increasing follow-up intensity based on National Institute for Health and Care Excellence (NICE): Cambridge Prognostic Group (CPG) 1 or 2, prostate-specific antigen density, and magnetic resonance imaging (MRI) Likert score at entry. Outcome measurements and statistical analysisRates of progression to CPG ≥3, any pathological progression, AS attrition, and patient choice for treatment were assessed. Differences in progression were compared with chi-square statistics. Results and limitationsData from 156 men (median age 67.3 yr) were analysed. Of these, 38.4% had CPG2 disease and 27.5% had grade group 2 disease at diagnosis. The median time on AS was 4 yr (interquartile range 3.2–4.9) and 1.5 yr on STRATCANS. Overall, 135/156 (86.5%) men remained on AS or converted to watchful waiting and 6/156 (3.8%) stopped AS by choice by the end of the evaluation period. Of the 156 patients, 66 (42.3%) were allocated to STRATCANS 1 (least intense follow-up), 61 (39.1%) to STRATCANS 2, and 29 (18.6%) to STRATCANS 3 (highest intensity). By increasing STRATCANS tier, progression rates to CPG ≥3 and any progression events were 0% and 4.6%, 3.4% and 8.6%, and 7.4% and 22.2%, respectively (p = 0.019). Modelling resource usage suggested potential reductions in appointments by 22% and MRI by 42% compared with current NICE guideline recommendations (first 12 months of AS). The study is limited by short follow-up, a relatively small cohort, and being single centre. ConclusionsA simple risk-tiered AS strategy is possible with early outcomes supporting stratified follow-up intensity. STRATCANS implementation could de-escalate follow-up in men at a low risk of progression while husbanding resources for those who need closer follow-up. Patient summaryWe report a practical way to personalise follow-up for men on active surveillance for early prostate cancer. Our method may allow reductions in the follow-up burden for men at a low risk of disease change while maintaining vigilance for those at a higher risk.

A0275 - Development of novel machine learning algorithms for real-time progression risk recalibration during active surveillance for early prostate cancer

A0275 - Development of novel machine learning algorithms for real-time progression risk recalibration during active surveillance for early prostate cancer

Quality of life in active surveillance for early prostate cancer.

Recently, the prevalence of the prostate-specific antigen screening test for early-stage prostate cancer has increased, but this has also resulted in an increase in insignificant cancers. The treatment outcome of early-stage prostate cancer is excellent, but such a radical treatment also leaves the patient with undesired adverse consequences. To resolve such problems, attention should be paid to active surveillance as a modern treatment option. This study aimed to systematically review the literature about quality of life in prostate cancer patients undergoing active surveillance. Evidence was acquired from PubMed databases in March 2019 using quality of life, prostate cancer, well-being, anxiety, depression, stress, outcomes, active surveillance, radiation therapy and radical prostatectomy as keywords. Five clinical active surveillance studies measured health-related quality of life and related psychological factors, and seven compared active surveillance with other treatments (radical therapy and hormone therapy). Active surveillance was superior to radical therapy for urinary and sexual function. Furthermore, most patients who opted for active surveillance showed lower anxiety and fear of progression, whereas health-related quality of life was maintained. Although active surveillance has the advantage of being non-invasive, its diagnosis and follow-up protocols are unreliable. Because such uncertainty can affect patients' quality of life, utilization of imaging modalities, such as magnetic resonance imaging, and the development of new biomarkers are required.

Outcomes of the patients with pT0 on first protocol biopsy during active surveillance for early prostate cancer: From the PRIAS-JAPAN study.

20 Background: We assessed the outcomes of the patients with pT0 on first protocol biopsy during active surveillance(AS) from the analysis Japanese cohort forming part of the Prostate Cancer Research International: Active Surveillance (PRIAS) study. Methods: PRIAS-JAPAN started in January 2010. 39 institutions are participating in this study. The inclusion criteria for the PRIAS study are as follows: clinical stage T1c/T2, PSA ≤ 10 ng/ml, PSA density (PSAD) < 0.2 ng/ml per milliliter, one or two positive biopsy cores, and Gleason score (GS) ≤ 6 at initial diagnostic biopsy.In this analysis, we defined the patients presenting no reclassification with cancer after first protocol biopsy as NR-CA group and the patients presenting no reclassification showing pT0 as NR-noCA group. We compared AS remaining rate, pathological outcomes in extra biopsy and second protocol biopsy at 4 years between two groups. Results: First protocol biopsy was performed on 514 patients. 191 patients were in NR-noCA group and 199 patients were in NR-CA group. Patients background of NR-noCA group was as follows: Median age was 68, median PSA was 5.6ng/ml, and median prostate volume was 38.4cc. T1c were in 183 and T2a were in 8. At the time of first protocol biopsy, there was no significant differences about PSA parameters and pathological factors between NR-noCA group and NR-CA group. Also, extra biopsy performing rate (NR-noCA group vs NR-CA group; 5.75% vs 7.53%) and implementation rate of second protocol biopsy at 4 years (75.6% vs 63.6%) showed no significant differences. On second protocol biopsy, number of cancer positive cores were significantly smaller and rate of pT0 was higher in NR-noCA group. After five years, both group showed comparable AS remaining rate (76.9 vs 75.3%). Thirty eight patients of NR-noCA group selected definitive therapy and surgery was the most frequently chosen treatment option. Conclusions: Although rate of pT0 on second biopsy was higher in NR-noCA group, there was no significant difference between both groups in AS remaining rate. The patients in NR-noCA group tended to choose surgery as a definitive therapy. Clinical trial information: UMIN000002874.

A longitudinal assessment of health-related quality of life in patients undergoing active surveillance for early prostate cancer in Japan (PRIAS-JAPAN).

56 Background: There are few reports of the health-related quality of life (HRQOL) of Asian prostate cancer patients who choice active surveillance. We evaluate HRQOL in participants of the Prostate Cancer Research International Active Surveillance study (PRIAS-JAPAN). Methods: The participants’ general HRQOL was assessed longitudinally using the Short Form 8 Health Survey (SF-8) at enrollment and annually thereafter until discontinuation of active surveillance (AS). We compared the quality of life and baseline score of participants with that of the general population (Norm-based scoring [NBS] 50) using paired t-test and the mixed models. Age-adjusted logistic regression was applied to the 3-year AS remaining rate. Results: The SF-8 questionnaire was administered to 570 patients (median age, 68 [range, 45–87] years). We evaluated 484, 328, 140, 84, and 68 patients at enrollment and 1, 2, 3, and 4 years thereafter. At enrollment, the mean physical component summary (PCS) score and all subscales revealed better HRQOL than NBS. No significant difference was noted in mental component summary (MCS) compared to NBS at enrollment. However, MCS at 1, 2, and 4 years was higher than the NBS. PCS slightly diminished in 4 years, whereas MCS at all time points showed no change. Age-adjusted logistic regression showed an OR of 1.66 (95% CI: 1.047–2.632, P = 0.0313) on 3-year AS remaining rate in favor of patients with above median MCS at enrollment. Conclusions: Men who were enrolled into the PRIAS-JAPAN study had better HRQOL than that of NBS. PCS decreased but MCS did not. The AS remaining rate was influenced by baseline MCS.

Population-based analysis of treatment receipt in prostate cancer patients who initially pursued active surveillance (AS).

6517 Background: Active surveillance for early prostate cancer may reduce over-treatment based on publications of patients managed in clinical trials or at high volume academic centers. In these se...

222 ACTIVE SURVEILLANCE FOR EARLY PROSTATE CANCER COMPARED WITH IMMEDIATE TREATMENT: A UNITED STATES - CANADIAN ECONOMIC COMPARISON

You have accessJournal of UrologyProstate Cancer: Epidemiology & Natural History (I)1 Apr 2013222 ACTIVE SURVEILLANCE FOR EARLY PROSTATE CANCER COMPARED WITH IMMEDIATE TREATMENT: A UNITED STATES - CANADIAN ECONOMIC COMPARISON Alice Dragomir, Fabio Cury, and Armen Aprikian Alice DragomirAlice Dragomir Montreal, Canada More articles by this author , Fabio CuryFabio Cury Montreal, Canada More articles by this author , and Armen AprikianArmen Aprikian Montreal, Canada More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.1602AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Active surveillance is an accepted management strategy for patients with low-risk prostate cancer. The costs associated with active surveillance (AS) strategy compared with immediate treatment (IT) were recently evaluated in the US healthcare system by Keegan et al (Cancer, 2012). The corresponding estimates in the Canadian context are unknown. Objectives The main objective of this study was to evaluate the costs associated with active surveillance and treatment in Canadian context over a 6-year and 11-year period following the diagnosis of prostate cancer. The secondary objective was to compare the US and Canadian cost estimates, and to develop a model able to provide estimates including additional treatment cost and the rate of death, elements not considered in the previous study. METHODS A Markov model with Monte-Carlo microsimulations was developed and adapted to estimate the Canadian cost of prostate cancer under the IT and AS strategies. The patients on AS were assumed to receive delayed treatment at a rate of 7% per year for the first 5-year period of follow-up, and of 4.5% for the following 5-year period. The model assumptions were derived from Keegan et al. in order to allow direct comparison. Cost assignments All costs were assigned in Canadian dollars ($) and reflect Quebec's public health system (RAMQ). The costs of drugs, costs of medical procedures related to treatments and medical visit costs were based on RAMQ's lists. Other Canadian published sources were used to complete cost calculation. RESULTS With AS, the average cost of prostate cancer management over the 6-year period was estimated at $6,394 (95% Confidence Interval: $6,323 to $6,474) per patient. The average cost corresponding to the IT strategy was estimated at $11,765 per patient. In addition, 30% of patients on AS will have received a delayed treatment and have incurred higher costs estimated at $12,210 per patient. CONCLUSIONS Our study demonstrates that AS could offer important economic benefits from the Canadian health system perspective, estimated at $69 million over a 6-year period for each annual cohort of incident prostate cancer. The US and Canadian evaluation of costs shows differences principally attributed to medical costs. These figures translate into a relative reduction of cost for prostate cancer management obtained with AS of approximately 36% in US when compared to 46% in Canada. This is mainly attributed to the relatively low cost of AS in the Canadian system. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e92 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Alice Dragomir Montreal, Canada More articles by this author Fabio Cury Montreal, Canada More articles by this author Armen Aprikian Montreal, Canada More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Disease insight and treatment perception of men on active surveillance for early prostate cancer

Survey (prospective cohort). 1b. To investigate the levels of knowledge of prostate cancer and the perception of active surveillance (AS) in men on AS, as AS for early prostate cancer instead of radical treatment might partly solve the over-treatment dilemma in this disease, but might be experienced as a complex and contradictory strategy by patients. In all, 150 Dutch men recently diagnosed with early prostate cancer participating in a prospective protocol-based AS programme (PRIAS study) received questionnaires, including a 15-item measure on their general knowledge of prostate cancer, and open-ended questions on the most important disadvantages and advantages of AS, and on the specific perception of AS. We assessed knowledge scores and explored potentially associated factors, the stated (dis)advantages and specific perceptions. The questionnaire response rate was 86% (129/150). Participants provided correct answers to a median (interquartile range) of 13 (12-14) of 15 (87%) knowledge items. Younger and higher educated men had higher knowledge scores. In line with a priori hypotheses, the most frequently reported advantage and disadvantage of AS were the delay of side-effects and the risk of disease progression, respectively. Specific negative experiences included the feeling of losing control over treatment decisions, distress at follow-up visits, and the desire for a more active participation in disease management. No conceptually wrong understandings or expectations of AS were identified. We found adequate knowledge of prostate cancer levels and realistic perceptions of the AS strategy in patients with early prostate cancer and on AS. These findings suggest adequate counselling by the physician or patient self-education.

Anxiety and distress during active surveillance for early prostate cancer

Patients on active surveillance (AS) for early prostate cancer (PC) may experience feelings of anxiety and distress while living with "untreated" cancer. In this study, these feelings were quantified, and their associations with various psychologic, medical, demographic, and decision-related factors were assessed. Men with recently diagnosed PC who participated in a prospective protocol-based AS program (the Prostate Cancer Research International: Active Surveillance study [PRAIS]) received a questionnaire (N = 150). Scores concerning decisional conflict (the Decisional Conflict Scale), depression (the Center for Epidemiologic Studies Depression Scale), generic anxiety (the abridged State-Trait Anxiety Inventory), and PC-specific anxiety (the Memorial Anxiety Scale for Prostate Cancer) were compared with reference values and the literature. Associations with scores on physical health (the Medical Outcomes Study 12-item short-form Physical Component Summary), personality (the Eysenck Personality Questionnaire), shared decision-making, knowledge of PC, and demographic and medical parameters were determined with univariate and multivariate linear regression analyses. The questionnaire response rate was 86% (129 of 150 men). Of all respondents, 81%, 92%, 83%, and 93% scored better than reference values for clinically significant uncertainty regarding the treatment decision, depression, generic anxiety, and PC-specific anxiety, respectively. Scores were comparable to or more favorable than those of men (reported in literature) who underwent other treatments for localized PC. In multivariate analysis, the following associations emerged: a perceived important role of the physician in shared decision-making was associated with higher decisional conflict, better physical health was associated with lower depression, neurotic personality was associated with higher depression and with generic and PC-specific anxiety, and higher prostate-specific antigen level was associated with higher PC-specific anxiety. Men on protocol-based AS mainly reported favorable levels of anxiety and distress. A neurotic personality score was associated with unfavorable effects. These findings may help to optimize patient selection for AS or to select men for supportive measures.

Editorial Comment on: Prostate-Specific Antigen Kinetics in Clinical Decision-Making During Active Surveillance for Early Prostate Cancer—A Review

den Bergh et al is timely, outlining the benefits and limitations of this approach [3]. Although serial PSAs are an excellent indicator of cancer biology when the prostate has been removed or destroyed, in an expectant management setting, they can be difficult to interpret. Because PSA arises from both benign and malignant epithelial cells, PSA usually increases over time. The consequence is that while active surveillance has become widely accepted, there is no consensus as to how it is best accomplished. In particular, there are debates over the criteria for eligibility and the optimal triggers for reclassifying individual patients as high risk. Is there any way to make PSA measurements more interpretable in expectant management patients? One possibility is the use of 5a-reductase inhibitors (5ARIs) to suppress the benign component of PSA production. This approach is being formally tested in the Reduction by Dutasteride of Clinical Progression Events in Expectant Management (REDEEM) trial, in which expectant management patients are being randomized to dutasteride or placebo for 3 yr, with repeat biopsies after 18 and 36 mo [4]. However, it would be naive to think that 5ARIs only suppress PSA from benign tissue, given the estimation that finasteride decreased tumor burden by at least 50% in the Prostate Cancer Prevention Trial (PCPT) [5]. Alternatively, a rising PSA in a man taking a 5ARI could be interpreted as demonstrating the presence of a cancer whose growth is not being controlled. At present this is a hypothesis, but one that should be clarified by the results of ongoing clinical trials.

Editorial Comment on: Prostate-Specific Antigen Kinetics in Clinical Decision-Making During Active Surveillance for Early Prostate Cancer—A Review

[18] Freedland SJ, Dorey F, Aronson WJ. Preoperative PSA velocity and doubling time do not predict adverse pathologic features or biochemical recurrence after radical prostatectomy. Urology 2001;57:476–80. [19] Guidelines on prostate cancer. 2007. European Association of Urology Web site. http://www.uroweb.org. Accessed February 11, 2008. [20] Clinical practice guidelines in oncology. Prostate cancer v.2.2007. National Comprehensive Cancer Network Web site. http://www.nccn.org. Accessed February 11, 2008. [21] Choo R, Klotz L, Deboer G, Danjoux C, Morton GC. Wide variation of prostate-specific antigen doubling time of untreated, clinically localized, low-to-intermediate grade, prostate carcinoma. BJU Int 2004;94:295–8. [22] Roemeling S, Roobol MJ, de Vries SH, et al. Active surveillance for prostate cancers detected in three subsequent rounds of a screening trial: characteristics, PSA doubling times, and outcome. Eur Urol 2007;51:1244–51. [23] Carter HB, Walsh PC, Landis P, Epstein JI. Expectant management of nonpalpable prostate cancer with curative intent: preliminary results. J Urol 2002;167:1231–4. [24] Schmid HP, McNeal JE, Stamey TA. Observations on the doubling time of prostate cancer. The use of serial prostate-specific antigen in patients with untreated disease as a measure of increasing cancer volume. Cancer 1993;71:2031–40. [25] Khan MA, Carter HB, Epstein JI, et al. Can prostate-specific antigen derivatives and pathological parameters predict significant change in expectant management criteria for prostate cancer? J Urol 2003;170:2274–8. [26] Khatami A, Aus G, Damber JE, Lilja H, Lodding P, Hugosson J. PSA doubling time predicts the outcome after active surveillance in screening-detected prostate cancer: results from the European randomized study of screening for prostate cancer, Sweden section. Int J Cancer 2007;120: 170–4. [27] Stephenson AJ, Aprikian AG, Souhami L, et al. Utility of PSA doubling time in follow-up of untreated patients with localized prostate cancer. Urology 2002;59:652–6.

Predictors of Histological Disease Progression in Untreated, Localized Prostate Cancer

Active surveillance for early prostate cancer is a policy of close monitoring with radical treatment targeted at cases with evidence of disease progression. There is no consensus on the need for or optimum timing of repeat biopsies as part of active surveillance. In a prospective cohort study of active surveillance 119 patients with untreated localized prostate cancer (T1/2a), prostate specific antigen less than 15 ng/ml, Gleason score 3 + 4 or less and 50% or less positive cores underwent repeat biopsy after 18 to 24 months. Histological disease progression was defined as primary Gleason grade 4 or greater, greater than 50% positive cores or a Gleason score increase from 6 or less to 7 or greater. The risk of histological disease progression was analyzed with respect to baseline clinical factors. Median patient age was 66 years and median initial prostate specific antigen was 6.6 ng/ml. Histological disease progression was seen in 33 of 119 cases (28%). On multivariate analysis prostate specific antigen density (p = 0.002) and maximum percent involvement of any core (p = 0.04) were significant independent determinants of histological disease progression. Progression was seen in 22 of 40 cases (55%) with prostate specific antigen density 0.2 ng/ml/ml or greater and greater than 15% maximum involvement of any core. Progression was seen in 2 of 33 cases (6%) with prostate specific antigen density less than 0.2 ng/ml/ml and 15% or less maximum involvement of any core. Repeat biopsy should be an integral part of active surveillance for untreated localized prostate cancer. Immediate repeat biopsy should be considered in patients who elect active surveillance but who have prostate specific antigen density greater than 0.2 ng/ml/ml. These findings must be validated in a cohort of patients with extended biopsies at diagnosis and followup.

1415: Active Surveillance for Early Prostate Cancer: Initial Results

1415: Active Surveillance for Early Prostate Cancer: Initial Results

Prostatic Complications of Testosterone Replacement Therapy

The prostatic complications of testosterone replacement therapy have received little clinical attention. We describe three hypogonadal men who had prostatic disease (adenocarcinoma in two) detected in relation to such therapy. Literature review suggests that surveillance for early prostate cancer is appropriate during replacement therapy in men over the age of 50 years. We discuss the selective use of digital rectal examination, transrectal sonography, directed prostate biopsy, and prostate-specific antigen determinations before therapy and in subsequent follow-up in this age group of men during androgen replacement.

Prostatic complications of testosterone replacement therapy

• The prostatic complications of testosterone replacement therapy have received little clinical attention. We describe three hypogonadal men who had prostatic disease (adenocarcinoma in two) detected in relation to such therapy. Literature review suggests that surveillance for early prostate cancer is appropriate during replacement therapy in men over the age of 50 years. We discuss the selective use of digital rectal examination, transrectal sonography, directed prostate biopsy, and prostate-specific antigen determinations before therapy and in subsequent follow-up in this age group of men during androgen replacement. (<i>Arch Intern Med</i>. 1989;149:2365-2366)