The impact of reducing the frequency of prostate specific antigen (PSA) testing among men on active surveillance for prostate cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5092-5092
Author(s):  
Matthew R. Cooperberg ◽  
Lisa F. Newcomb ◽  
Elissa C. Brown ◽  
Shanshan Zhao ◽  
Ziding Feng ◽  
...  

5092 Background: Active surveillance is a management strategy for men with low risk prostate cancer. Most surveillance regimens include routine PSA assessments, typically performed q 3 mos, although recent studies have questioned the utility of short-term PSA kinetics. Moreover, frequent PSA assessments may be associated with repeated intervals of anxiety around the time of testing, decreasing overall quality of life and potentially leading to avoidable interventions. We hypothesized that PSA assessment q 6 mos rather than q 3 mos would yield similar PSA kinetics calculations. Methods: We analyzed data from the Prostate Active Surveillance Study (PASS), a prospective, multicenter cohort accruing data and biospecimens from men on surveillance at 9 sites across North America. In PASS, PSAs are measured q 3 mos, with high completeness of data. We included data from men who had at least 5 PSA assessments after diagnosis, separated by ≥6 months (most had 10 PSAs separated by 3 months). PSA doubling time (PSADT) was calculated as ln(2) divided by the slope of a regression line drawn through the 5 PSAs. PSADT3 and PSADT6 were defined as the PSADT calculated from q 3 mos and q 6 mos data, respectively; for PSADT6, PSAs between each 6-month measurement were ignored. In each case, PSADT of 0-3 years defined progression, and PSADT > 3 years or declining PSA defined non-progression. Results: 161 men had sufficient PSA followup for analysis. 133 had no progression by either PSADT3 or PSADT6, and 16 progressed by both PSADT calculations. 4 and 8 men, respectively, progressed only by the PSADT3 or PSADT6 calculation but not by the other calculation. The κ score for agreement of progression ascertainment between PSADT3 and PSADT6 was 0.68, and McNemar’s test indicated no statistically significant difference between the two assessments (p=0.39). Conclusions: Calculating PSADT using 6-month rather than 3-month PSA assessments does not significantly change ascertainment of PSA progression in men on surveillance. Our finding suggests that surveillance protocols may reduce the frequency of PSA testing, potentially reducing unnecessary biopsy procedures and patient anxiety due to more frequent PSA measurements.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 72-72
Author(s):  
Hong Zhang ◽  
Edward M. Messing ◽  
Hamza Ahmed ◽  
Yuhchyau Chen

72 Background: Active surveillance is now accepted initial management for men who have localized prostate cancer with low risk of disease progression. Many criteria have been used for patient identification, including Gleason score (GS) obtained from prostate biopsy. Because of concerns of sampling error, some have recommended repeated biopsy before committing to active surveillance. However, there is limited information about the risk of missing high grade disease using the current standard biopsy approach. This study seeks to compare GS difference from biopsy and surgery to provide an estimated rate of GS upgrade. Methods: The Surveillance, Epidemiology, and End Results (SEER) program was used to identify men with American Joint Committee on Cancer stage T1-2cN0M0 prostate cancer diagnosed between January 2010 and December 2010. Patients who underwent prostatectomy were selected for further analysis. Based on prostate-specific antigen (PSA) levels and GS, cases were divided into low (PSA <=10 and GS <=6) and intermediate (10<PSA<=20 or GS=7) risk groups. The rates of GS upgrade were reported for each group. Chi-square tests were used to assess differences in categorical variables (e.g. age and race) between groups of GS upgrade and no change/downgrade. Results: A total of 10,282 men were evaluated, with 9.2% (n=942) having low-risk disease, and 90.8% (n=9340) having intermediate-risk disease. Among men with low-risk prostate cancer, 22.3% (n=210) had GS upgrade and 0.8% (n=8) had GS 8 disease. Among men with intermediate risk disease, 26.2% (n=2446) had GS upgrade and 2.3% (n=214) had GS 8 disease. There was no statistically significant difference in either age or race distribution among men who had GS upgrade versus no change or downgrade at the time of surgery. Conclusions: A substantial number of low- and intermediate-risk prostate cancer patients had GS upgrade at the time of surgery, but few had upgraded to GS 8 high risk disease. These observations suggest that repeat biopsy prior to active surveillance may not be necessary.


2018 ◽  
Vol 12 (1) ◽  
pp. 54-59
Author(s):  
Ekrem Islamoglu ◽  
Erdem Kisa ◽  
Cem Yucel ◽  
Orcun Celik ◽  
Ozgur Cakmak ◽  
...  

Purpose: We assessed the outcomes of men with low-risk prostate cancer enrolled in active surveillance. Methods: From January 2008, patients in our clinic who were classified as having low-risk prostate cancer according to the D’Amico classification were included in the protocol. Follow-up consisted of regular prostate-specific antigen tests, digital rectal examinations and biopsies. Outcomes were compared between men who progressed and those who did not, and survival analysis was obtained. Results: The mean follow-up period was 46 months. A total of six patients received curative treatment during follow-up as a result of meeting progression criteria. The mean follow-up time from the beginning of active surveillance until curative therapy was 27.1 months. Four of our 64 patients lost their lives due to diseases other than prostate cancer, none of the patients were lost due to prostate cancer. When patients who showed progression and those who did not were compared in terms of positive core numbers and the core tumour percentage we found no significant difference between the two groups ( P>0.05) Conclusion: Active surveillance seems to be a safe and feasible practice in men with low-risk prostate cancer. Gleason score, clinical stage and initial prostate-specific antigen seem to be the most definite criteria for the selection of patients, while it is thought that the number of positive cores is a matter that can be dealt with more flexibility. Level of evidence: Not applicable for this multicentre audit.


Author(s):  
Ian M. Thompson

Overview: Prostate cancer is a ubiquitous disease, affecting as many as two-thirds of men in their 60s. Through widespread prostate-specific antigen (PSA) testing, increasing rates of prostate biopsy, and increased sampling of the prostate, a larger fraction of low-grade, low-volume tumors have been detected, consistent with tumors often found at autopsy. These tumors have historically been treated in a manner similar to that used for higher-grade tumors but, more recently, it has become evident that with a plan of active surveillance that reserves treatment for only those patients whose tumors show evidence of progression, very high disease-specific survival can be achieved. Unfortunately, the frequency of recommendation of an active surveillance strategy in the United States is low. An alternative strategy to improve prostate cancer detection is through selected biopsy of those men who are at greater risk of harboring high-grade, potentially lethal cancer. This strategy is currently possible through the use of risk assessment tools such as the Prostate Cancer Prevention Trial Risk Calculator ( www.prostate.cancer.risk.calculator.com ) as well as others. These tools can predict with considerable accuracy a man's risk of low-grade and high-grade cancer, allowing informed decision making for the patient with a goal of detection of high-risk disease. Ultimately, other biomarkers including PCA3, TMPRSS2:ERG, and [-2]proPSA will likely aid in discriminating these two types of cancer before biopsy.


2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Daniel W. Smith ◽  
Diliana Stoimenova ◽  
Khadijah Eid ◽  
Al Barqawi

Prostate cancer is one of the most prevalent cancers among men in the United States, second only to nonmelanomatous skin cancer. Since prostate-specific antigen (PSA) testing came into widespread use in the late 1980s, there has been a sharp increase in annual prostate cancer incidence. Cancer-specific mortality, though, is relatively low. The majority of these cancers will not progress to mortal disease, yet most men who are diagnosed opt for treatment as opposed to observation or active surveillance (AS). These men are thus burdened with the morbidities associated with aggressive treatments, commonly incontinence and erectile dysfunction, without receiving a mortality benefit. It is therefore necessary to both continue investigating outcomes associated with AS and to develop less invasive techniques for those who desire treatment but without the significant potential for quality-of-life side effects seen with aggressive modalities. The goals of this paper are to discuss the problems of overdiagnosis and overtreatment since the advent of PSA screening as well as the potential for targeted focal therapy (TFT) to bridge the gap between AS and definitive therapies. Furthermore, patient selection criteria for TFT, costs, side effects, and brachytherapy template-guided three-dimensional mapping biopsies (3DMB) for tumor localization will also be explored.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18019-e18019
Author(s):  
Nicolette Taku ◽  
Vivek Narayan ◽  
Scarlett Bellamy ◽  
Neha Vapiwala

e18019 Background: Consensus guidelines recommend that active surveillance (AS) be considered in the management of men with low risk prostate cancer (LRPC). The evidence supporting this recommendation is largely derived from studies in which men of African descent were underrepresented; thus, the appropriate implementation of AS in this population remains controversial. The objective of our study was to evaluate the prevalence and clinical predictors of an AS approach in black men (BM) diagnosed with LRPC following the 2010 inclusion of AS in LRPC management consensus guidelines. Methods: BM (N = 15,242) and non-Hispanic white men (WM) (N = 86,655) diagnosed with LRPC (as defined by PSA ≤ 10 ng/ml, Gleason score ≤ 6, clinical stage T1 – T2a) between 2010 and 2013 were identified from the National Cancer Database. Logistic regression models were used to assess the likelihood of pursuing an AS strategy over time, as well as to examine associations between sociodemographic characteristics (SDCs) and the receipt of AS. Results: Overall, 9% of BM with LRPC were managed with AS. On univariate analysis, the likelihood of BM undergoing AS increased from 2010 and was statistically significant ( p < 0.001) for all subsequent years (2011: OR = 1.54, 95% CI 1.30-1.82; 2012: OR = 2.19, 95% CI 1.82-2.60; 2013: OR = 2.55, 95% CI 2.15-3.02). Uninsured BM were twice as likely as those with private insurance to pursue AS (OR 1.97, 95% CI 1.51-2.58, p < 0.001). BM seen at academic cancer programs were also more likely to be managed with AS, when compared to those seen at community cancer centers (OR 1.47, 95% CI 1.37-1.60, p < 0.001). BM were less likely than WM to receive AS (OR = 0.82, 95% CI 0.77 to 0.87, p < 0.001). On multivariate analysis adjusted for SDCs, there was no significant difference in AS utilization between the two ethnic groups. Conclusions: The utilization of AS for BM with LRPC appears to be increasing, may be influenced by SDCs, and may not differ from the AS utilization for WM with LRPC. Given the observed elevated rates of post-prostatectomy adverse pathologic features among BM, further evaluation of the determinants of AS utilization and scrutinous consideration of the appropriateness of AS in this population is warranted.


2009 ◽  
Vol 27 (1) ◽  
pp. 100-105 ◽  
Author(s):  
Yu-Ning Wong ◽  
Stephen Freedland ◽  
Brian Egleston ◽  
Gary Hudes ◽  
J. Sanford Schwartz ◽  
...  

Purpose To determine the impact of adjuvant androgen deprivation therapy (ADT) for patients who have node-positive prostate cancer in the prostate-specific antigen (PSA) era. Patients and Methods We used linked Surveillance, Epidemiology and End Results-Medicare data to construct a cohort of men who underwent radical prostatectomy (RP) between 1991 and 1999 and who had positive regional lymph nodes. We classified men as receiving adjuvant ADT if they received ADT within 120 days of RP, and we compared them to the men who had not received adjuvant ADT. We used propensity scores to balance potential confounders of receiving adjuvant ADT (ie, tumor characteristics, extent of nodal disease, demographics, receipt of radiation therapy) and Cox proportional hazard methods to measure the impact of adjuvant ADT on overall survival (OS), stratified by propensity score quintile. We conducted a sensitivity analysis that used 90, 150, 180, and 365 days as the definition for adjuvant ADT. Results A total of 731 men were identified, 209 of whom received ADT within 120 days of RP. There was no statistically significant difference in OS between the adjuvant ADT and non-ADT group (HR, 0.97; 95% CI, 0.71 to 1.27). There was no statistically significant survival difference with 90, 150, 180, and 365 days as the adjuvant ADT definition. Conclusion Deferring immediate ADT in men with positive lymph nodes after RP may not significantly compromise survival. Because observational studies should be considered hypothesis-generating studies, these results should be validated in a prospective fashion in a similar patient population.


2015 ◽  
Vol 94 (3) ◽  
pp. 330-336
Author(s):  
Marco Randazzo ◽  
Josef Beatrice ◽  
Andreas Huber ◽  
Rainer Grobholz ◽  
Lukas Manka ◽  
...  

Introduction: Very low-risk prostate cancer (PCa) is being increasingly managed by active surveillance (AS). Our aim was to assess the influence of the origin of diagnosis on PCa characteristics and treatment rates among men with very low-risk PCa in our prospective AS cohort. Methods: Overall, 191 men with very low-risk PCa fulfilling Epstein-criteria underwent protocol-based AS. These men originated either from the prospective population-based screening program (P-AS) or were diagnosed by opportunistic screening (O-AS). Results: Overall, n = 86 (45.0%) originated from the P-AS group, whereas n = 105 (55.0%) from the O-AS group. On univariate Cox regression analysis, age (HR 0.96, 95% CI 0.92-1.00; p = 0.05), origin of diagnosis (HR 0.72, 95% CI 0.41-1.28; p = 0.001), number of positive cores (HR 2.15, 95% CI 1.18-3.90; p = 0.01) and maximum core involvement (HR 1.03, 95% CI 0.99-1.05; p = 0.05) were predictors for treatment necessity. On multivariate analysis, age (HR 0.95, 95% CI 0.89-0.99; p = 0.05), number of positive cores (HR 2.07, 95% CI 1.10-3.88; p = 0.02), maximum core involvement (HR 1.03, 95% CI 1.00-1.06; p = 0.04) but not origin of diagnosis were independent predictors for treatment necessity. Four men developed biochemical recurrence (all from O-AS group [p = 0.05]). Conclusion: The origin of PCa diagnosis in men undergoing AS had no influence on disease progression and treatment necessity.


2021 ◽  
pp. JCO.21.00596
Author(s):  
Anthony V. D'Amico ◽  
Wanling Xie ◽  
Elizabeth McMahon ◽  
Marian Loffredo ◽  
Shana Medeiros ◽  
...  

PURPOSE Although docetaxel is not recommended when managing men with unfavorable-risk prostate cancer (PC) given negative or inconclusive results from previous randomized trials, unstudied benefits may exist. METHODS Between September 21, 2005, and January 13, 2015, we randomly assigned 350 men 1:1 with T1c-4N0M0 unfavorable-risk PC to receive radiation therapy (RT) and androgen deprivation therapy (ADT) plus docetaxel (60 mg/m2 once every 3 weeks for three cycles before RT and 20 mg/m2 once weekly during RT) versus ADT + RT. We evaluated the treatment effect of adding docetaxel to ADT + RT on the primary end point of overall survival (OS) and the incidence of RT-induced cancers and explored whether the impact of the treatment effect on OS differed within prostate-specific antigen (PSA) subgroups (< 4, > 20 v 4-20 ng/mL) using the interaction test for heterogeneity adjusted for age and PC prognostic factors. RESULTS After a median follow-up of 10.2 years, 89 men died (25.43%); of these, 42 from PC (47.19%). Although OS was not significantly increased in the docetaxel arm (the restricted mean survival time over 10 years was 9.11 v 8.82 years; P = .22), significantly fewer RT-induced cancers were observed (10-year estimates: 0.61% v 4.90%; age-adjusted hazard ratio of 0.13; 95% CI, 0.02 to 0.97; P = .046). The treatment effect of adding docetaxel to ADT + RT on OS significantly differed in men with a PSA < 4 ng/mL versus 4-20 ng/mL (adjusted hazard ratio: 0.27 and 1.51, respectively) because of less PC-specific mortality on the docetaxel arm (0.00% v 28.57%) among men with PSA < 4 ng/mL. CONCLUSION Adding docetaxel to ADT + RT did not prolong OS in men with unfavorable-risk PC, but decreased RT-induced cancer incidence, and may prolong OS in the subgroup of men with a PSA < 4 ng/mL by reducing PC-specific mortality.


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