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Lisa F Newcomb - One of the best experts on this subject based on the ideXlab platform.
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treatment in the absence of disease Reclassification among men on active surveillance for prostate cancer
Cancer, 2021Co-Authors: Peter Kirk, James D Brooks, Lisa F Newcomb, Yingye Zheng, Atreya Dash, Peter R Carroll, Kehao Zhu, Jeannette M Schenk, William J EllisAbstract:Background Maintaining men on active surveillance for prostate cancer can be challenging. Although most men who eventually undergo treatment have experienced clinical progression, a smaller subset elects treatment in the absence of disease Reclassification. This study sought to understand factors associated with treatment in a large, contemporary, prospective cohort. Methods This study identified 1789 men in the Canary Prostate Cancer Active Surveillance Study cohort enrolled as of 2020 with a median follow-up of 5.6 years. Clinical and demographic data as well as information on patient-reported quality of life and urinary symptoms were used in multivariable Cox proportional hazards regression models to identify factors associated with the time to treatment RESULTS: Within 4 years of their diagnosis, 33% of men (95% confidence interval [CI], 30%-35%) underwent treatment, and 10% (95% CI, 9%-12%) were treated in the absence of Reclassification. The most significant factor associated with any treatment was an increasing Gleason grade group (adjusted hazard ratio [aHR], 14.5; 95% CI, 11.7-17.9). Urinary quality-of-life scores were associated with treatment without Reclassification (aHR comparing "mostly dissatisfied/terrible" with "pleased/mixed," 2.65; 95% CI, 1.54-4.59). In a subset analysis (n = 692), married men, compared with single men, were more likely to undergo treatment in the absence of Reclassification (aHR, 2.63; 95% CI, 1.04-6.66). Conclusions A substantial number of men with prostate cancer undergo treatment in the absence of clinical changes in their cancers, and quality-of-life changes and marital status may be important factors in these decisions. Lay summary This analysis of men on active surveillance for prostate cancer shows that approximately 1 in 10 men will decide to be treated within 4 years of their diagnosis even if their cancer is stable. These choices may be related in part to quality-or-life or spousal concerns.
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performance of pca3 and tmprss2 erg urinary biomarkers in prediction of biopsy outcome in the canary prostate active surveillance study pass
Prostate Cancer and Prostatic Diseases, 2019Co-Authors: James D Brooks, Lisa F Newcomb, Yingye Zheng, Anna Faino, Daniella Bianchifrias, Matthew R Cooperberg, Marshall D Brown, Atreya Dash, Michael D FabrizioAbstract:For men on active surveillance for prostate cancer, biomarkers may improve prediction of Reclassification to higher grade or volume cancer. This study examined the association of urinary PCA3 and TMPRSS2:ERG (T2:ERG) with biopsy-based Reclassification. Urine was collected at baseline, 6, 12, and 24 months in the multi-institutional Canary Prostate Active Surveillance Study (PASS), and PCA3 and T2:ERG levels were quantitated. Reclassification was an increase in Gleason score or ratio of biopsy cores with cancer to ≥34%. The association of biomarker scores, adjusted for common clinical variables, with short- and long-term Reclassification was evaluated. Discriminatory capacity of models with clinical variables alone or with biomarkers was assessed using receiver operating characteristic (ROC) curves and decision curve analysis (DCA). Seven hundred and eighty-two men contributed 2069 urine specimens. After adjusting for PSA, prostate size, and ratio of biopsy cores with cancer, PCA3 but not T2:ERG was associated with short-term Reclassification at the first surveillance biopsy (OR = 1.3; 95% CI 1.0–1.7, p = 0.02). The addition of PCA3 to a model with clinical variables improved area under the curve from 0.743 to 0.753 and increased net benefit minimally. After adjusting for clinical variables, neither marker nor marker kinetics was associated with time to Reclassification in subsequent biopsies. PCA3 but not T2:ERG was associated with cancer Reclassification in the first surveillance biopsy but has negligible improvement over clinical variables alone in ROC or DCA analyses. Neither marker was associated with Reclassification in subsequent biopsies.
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refined analysis of prostate specific antigen kinetics to predict prostate cancer active surveillance outcomes
European Urology, 2018Co-Authors: Matthew R Cooperberg, James D Brooks, Lisa F Newcomb, Anna Faino, Atreya Dash, Peter R Carroll, James T Kearns, Ruth Etzioni, Michael D FabrizioAbstract:Abstract Background For men on active surveillance for prostate cancer, utility of prostate-specific antigen (PSA) kinetics (PSAk) in predicting pathologic Reclassification remains controversial. Objective To develop prediction methods for utilizing serial PSA and evaluate frequency of collection. Design, setting, and participants Data were collected from men enrolled in the multicenter Canary Prostate Active Surveillance Study, for whom PSA data were measured and biopsies performed on prespecified schedules. We developed a PSAk parameter based on a linear mixed-effect model (LMEM) that accounted for serial PSA levels. Outcome measurements and statistical analysis The association of diagnostic PSA and/or PSAk with time to Reclassification (increase in cancer grade and/or volume) was evaluated using multivariable Cox proportional hazards models. Results and limitations A total of 851 men met the study criteria; 255 (30%) had a Reclassification event within 5 yr. Median follow-up was 3.7 yr. After adjusting for prostate size, time since diagnosis, biopsy parameters, and diagnostic PSA, PSAk was a significant predictor of Reclassification (hazard ratio for each 0.10 increase in PSAk=1.6 [95% confidence interval 1.2–2.1, p Conclusions PSAk calculated using an LMEM statistically significantly predicts biopsy Reclassification. Models that use repeat PSA measurements outperform a model incorporating only diagnostic PSA. Model performance is similar using PSA assessed every 3 or 6 mo. If validated, these results should inform optimal incorporation of PSA trends into active surveillance protocols and risk calculators. Patient summary In this report, we looked at whether repeat prostate-specific antigen (PSA) measurements, or PSA kinetics, improve prediction of biopsy outcomes in men using active surveillance to manage localized prostate cancer. We found that in a large multicenter active surveillance cohort, PSA kinetics improves the prediction of surveillance biopsy outcome.
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role of surveillance biopsy with no cancer as a prognostic marker for Reclassification results from the canary prostate active surveillance study
European Urology, 2018Co-Authors: James T Kearns, James D Brooks, Lisa F Newcomb, Anna Faino, Atreya Dash, Michael D Fabrizio, William J Ellis, Peter R Carroll, Martin E Gleave, Todd M MorganAbstract:Abstract Background Many patients who are on active surveillance (AS) for prostate cancer will have surveillance prostate needle biopsies (PNBs) without any cancer evident. Objective To define the association between negative surveillance PNBs and risk of Reclassification on AS. Design, setting, and participants All men were enrolled in the Canary Prostate Active Surveillance Study (PASS) between 2008 and 2016. Men were included if they had Gleason ≤3+4 prostate cancer and Outcome measurements and statistical analysis Reclassification was defined as an increase in Gleason grade and/or an increase in the ratio of biopsy cores to cancer to ≥34%. PNB outcomes were defined as follows: (1) no cancer on biopsy, (2) cancer without Reclassification, or (3) Reclassification. Kaplan–Meier and Cox proportional hazard models were performed to assess the risk of Reclassification. Results and limitations A total of 657 men met inclusion criteria. On first surveillance PNB, 214 (32%) had no cancer, 282 (43%) had cancer but no Reclassification, and 161 (25%) reclassified. Among those who did not reclassify, 313 had a second PNB. On second PNB, 120 (38%) had no cancer, 139 (44%) had cancer but no Reclassification, and 54 (17%) reclassified. In a multivariable analysis, significant predictors of decreased future Reclassification after the first PNB were no cancer on PNB (hazard ratio [HR]=0.50, p =0.008), lower serum prostate-specific antigen, larger prostate size, and lower body mass index. A finding of no cancer on the second PNB was also associated with significantly decreased future Reclassification in a multivariable analysis (HR=0.15, p =0.003), regardless of the first PNB result. The major limitation of this study is a relatively small number of patients with long-term follow-up. Conclusions Men who have a surveillance PNB with no evidence of cancer are significantly less likely to reclassify on AS in the PASS cohort. These findings have implications for tailoring AS protocols. Patient summary Men on active surveillance for prostate cancer who have a biopsy showing no cancer are at a decreased risk of having worse disease in the future. This may have an impact on how frequently biopsies are required to be performed in the future.
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timing of adverse prostate cancer Reclassification on first surveillance biopsy results from the canary prostate cancer active surveillance study
The Journal of Urology, 2017Co-Authors: Liam C Macleod, James D Brooks, Lisa F Newcomb, Yingye Zheng, William J Ellis, Peter R Carroll, Martin E Gleave, Raymond S Lance, Peter S NelsonAbstract:Purpose: During active surveillance for localized prostate cancer, the timing of the first surveillance biopsy varies. We analyzed the Canary PASS (Prostate Cancer Active Surveillance Study) to determine biopsy timing influence on rates of prostate cancer adverse Reclassification at the first active surveillance biopsy.Materials and Methods: Of 1,085 participants in PASS, 421 had fewer than 34% of cores involved with cancer and Gleason sum 6 or less, and thereafter underwent on-study active surveillance biopsy. Reclassification was defined as an increase in Gleason sum and/or 34% or more of cores with prostate cancer. First active surveillance biopsy Reclassification rates were categorized as less than 8, 8 to 13 and greater than 13 months after diagnosis. Multivariable logistic regression determined association between Reclassification and first biopsy timing.Results: Of 421 men, 89 (21.1%) experienced Reclassification at the first active surveillance biopsy. Median time from prostate cancer diagnosis to...
Ballentine H Carter - One of the best experts on this subject based on the ideXlab platform.
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active surveillance of grade group 1 prostate cancer long term outcomes from a large prospective cohort
European Urology, 2020Co-Authors: Ballentine H Carter, Patricia Landis, Jonathan I Epstein, Mufaddal Mamawala, Jeffrey J Tosoian, Katarzyna J Macura, Demetrios N Simopoulos, Michael A GorinAbstract:Abstract Background Active surveillance (AS) is the preferred management option for most men with grade group (GG) 1 prostate cancer (PCa). Questions persist regarding long-term outcomes and the optimal approach to AS. Objective To determine survival and metastatic outcomes in AS patients. Secondary objectives were to measure the cumulative incidence and association of patient-level factors on biopsy grade Reclassification. Design, setting, and participants A prospective, active, open-enrollment cohort study was conducted from 1995 through July 2018 at a tertiary-care academic institution. Patients with very-low-risk or low-risk PCa were enrolled. Intervention AS with semiannual prostate-specific antigen (PSA) and digital rectal examination, serial prostate biopsy, and multiparametric magnetic resonance imaging (mpMRI). Outcome measurements and statistical analysis The 10- and 15-yr cumulative incidences of primary and secondary outcomes were determined. Results and limitations Overall, 1818 men were monitored on AS for a median of 5.0 yr (interquartile range 2.0–9.0). There were 88 non-PCa deaths, four PCa deaths, and one additional case of metastasis. The cumulative incidence of PCa-specific mortality or metastasis was 0.1% (95% confidence interval, 0.04–0.6%) at both 10 and 15 yr. The 5-, 10-, and 15-yr cumulative incidences of biopsy grade Reclassification were 21%, 30%, and 32%, respectively. On multivariable analysis, biopsy grade Reclassification was associated with older age, African-American race, PSA density, and increased cancer volume on biopsy, and men who underwent mpMRI prior to enrollment were less likely to undergo grade Reclassification. Our selection and monitoring are more stringent than many other contemporary AS programs. Conclusions In a large, single-institution, prospective AS cohort, the risk of cancer death or metastasis was Patient summary This study investigated long-term outcomes in patients with grade group 1 prostate cancer managed with active surveillance (AS). Ten years after enrolling in AS, the risk of metastasis or death from prostate cancer was
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intermediate and longer term outcomes from a prospective active surveillance program for favorable risk prostate cancer
Journal of Clinical Oncology, 2015Co-Authors: Jeffrey J Tosoian, Patricia Landis, Jonathan I Epstein, Mufaddal Mamawala, Bruce J Trock, Sacha Wolf, Ballentine H CarterAbstract:PurposeTo assess long-term outcomes of men with favorable-risk prostate cancer in a prospective, active-surveillance program.MethodsCurative intervention was recommended for disease Reclassification to higher cancer grade or volume on prostate biopsy. Primary outcomes were overall, cancer-specific, and metastasis-free survival. Secondary outcomes were the cumulative incidence of Reclassification and curative intervention. Factors associated with grade Reclassification and curative intervention were evaluated in a Cox proportional hazards model.ResultsA total of 1,298 men (median age, 66 years) with a median follow-up of 5 years (range, 0.01 to 18.00 years) contributed 6,766 person-years of follow-up since 1995. Overall, cancer-specific, and metastasis-free survival rates were 93%, 99.9%, and 99.4%, respectively, at 10 years and 69%, 99.9%, and 99.4%, respectively, at 15 years. The cumulative incidence of grade Reclassification was 26% at 10 years and was 31% at 15 years; cumulative incidence of curative i...
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conditional probability of Reclassification in an active surveillance program for prostate cancer
The Journal of Urology, 2015Co-Authors: Ridwan Alam, Ballentine H Carter, Patricia Landis, Jonathan I Epstein, Mufaddal MamawalaAbstract:Purpose: We evaluated the risk of prostate cancer Reclassification by time on active surveillance.Materials and Methods: From 1995 to 2014 we evaluated 557 and 251 men at very low and at low risk, respectively, who were on active surveillance and compliant with prostate biopsies. Our primary study outcome was Reclassification to higher risk disease by grade or extent. Freedom from Reclassification was estimated using the Kaplan-Meier approach with adjustment for covariates using the Cox proportional hazards model.Results: Within the first 2 years of surveillance patient survival free of Reclassification by grade (p = 0.20) and by any biopsy criteria (p = 0.25) was similar in men with very low and low risk disease. After 2 years men with low risk disease were 2.4 times more likely to be diagnosed with a Gleason score of greater than 6 than men with very low risk disease (p = 0.002, HR 2.4, 95% CI 1.9–3.5). Additionally, beyond 2 years on surveillance the risk of lifetime Reclassification by grade and by an...
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indications for intervention during active surveillance of prostate cancer a comparison of the johns hopkins and prostate cancer research international active surveillance prias protocols
BJUI, 2015Co-Authors: Max Kates, Ballentine H Carter, Bruce J Trock, Zhaoyong Feng, Jeffrey J Tosoian, Alan W PartinAbstract:Objective To analyse how patients enrolled in our biopsy based surveillance programme would fare under the Prostate Cancer Research International Active Surveillance (PRIAS) protocol, which uses PSA kinetics. Patients and Methods Since 1995, 1125 men with very-low-risk prostate cancer have enrolled in the AS programme at the Johns Hopkins Hospital (JHH), which is based on monitoring with annual biopsy. The PRIAS protocol uses a combination of periodic biopsies (in years 1, 4, and 7) and prostate-specific antigen doubling time (PSADT) to trigger intervention. Patients enrolled in the JHH AS programme were retrospectively reviewed to evaluate how the use of the PRIAS protocol would alter the timing and use of curative intervention. Results Over a median of 2.1 years of follow up, 38% of men in the JHH AS programme had biopsy Reclassification. Of those, 62% were detected at biopsy intervals corresponding to the PRIAS criteria, while 16% were detected between scheduled PRIAS biopsies, resulting in a median delay in detection of 1.9 years. Of the 202 men with >5 years of follow-up, 11% in the JHH programme were found to have biopsy Reclassification after it would have been identified in the PRIAS protocol, resulting in a median delay of 4.7 years to Reclassification. In all, 12% of patients who would have undergone immediate intervention under PRIAS due to abnormal PSA kinetics would never have undergone Reclassification on the JHH protocol and thus would not have undergone definitive intervention. Conclusions There are clear differences between PSA kinetics-based AS programmes and biopsy based programmes. Further studies should address whether and how the differences in timing of intervention impact subsequent disease progression and prostate cancer mortality.
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Reclassification rates are higher among african american men than caucasians on active surveillance
Urology, 2015Co-Authors: Debasish Sundi, Ballentine H Carter, Patricia Landis, Farzana A Faisal, Bruce J Trock, Zhaoyong Feng, Ashley E Ross, Edward M SchaefferAbstract:Objective To evaluate the risk of Reclassification on serial biopsy for Caucasian and African American (AA) men with very low-risk (VLR) prostate cancer enrolled in a large prospective active surveillance (AS) registry. Methods The Johns Hopkins AS registry is a prospective observational study that has enrolled 982 men since 1994. Including only men who met all National Comprehensive Cancer Network VLR criteria (clinical stage ≤T1, Gleason score ≤6, prostate-specific antigen [PSA] level <10 ng/mL, PSA density <0.15 ng/mL/cm3, positive cores <3, percent cancer per core ≤50), we analyzed a cohort of 654 men (615 Caucasians and 39 AAs). The association of race with Reclassification on serial biopsy was assessed with competing-risks regressions. Results AA men on AS were more likely than Caucasians to experience upgrading on serial biopsy (36% vs 16%; adjusted P <.001). Adjusting for PSA level, prostate size, volume of cancer on biopsy, treatment year, and body mass index, AA race was an independent predictor of biopsy Reclassification (subdistribution hazard ratio, 1.8; P = .003). Examining specific modes of Reclassification, AA race was independently associated with Reclassification by grade (subdistribution hazard ratio, 3.0; P = .002) but not by volume. Conclusion AA men with VLR prostate cancer followed on AS are at significantly higher risk of grade Reclassification compared with Caucasians. Therefore, if the goal of AS is to selectively monitor men with low-grade disease, AA men may require alternate selection criteria.
Peter Fiechter - One of the best experts on this subject based on the ideXlab platform.
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Reclassification of financial assets under ias 39 impact on european banks financial statements
Accounting in Europe, 2011Co-Authors: Peter FiechterAbstract:In response to the financial crisis, the IASB issued on 13 October 2008 an amendment to IAS 39 which enables entities to reclassify non-derivative financial assets held for trading and financial assets available-for-sale. This paper examines the influence of this controversial amendment on the 2008 financial statements of 219 European banks which apply IFRS. I find that approximately one-third of the sample banks have taken extensive advantage of these Reclassification opportunities. The mean Reclassification amount is 3.9% of total assets and 131% of the book value of equity, respectively. I further document that reclassifying banks avoid substantial fair value losses, and hence, report significantly higher levels of return on assets (ROA), return on equity (ROE), book value of equity and regulatory capital. In particular, the mean ROE switches sign from a negative ROE of −1.4% to a positive ROE of 1.3% due to gains from Reclassifications. Overall, this paper documents a substantial impact of the amendme...
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Reclassification of financial assets under ias 39 impact on european banks financial statements
Social Science Research Network, 2009Co-Authors: Peter FiechterAbstract:In response to the financial crisis, the IASB issued on 13 October 2008 an amendment to IAS 39 which enables entities to reclassify non-derivative financial assets held for trading and financial assets available-for-sale. This paper examines the influence of this controversial amendment on the financial statements 2008 of 219 European banks which apply IFRS. I find that approximately one-third of the sample banks have taken extensive advantage of these Reclassification opportunities. The mean Reclassification amount is 3.9% of total assets and 131% of the book value of equity, respectively. I further document that reclassifying banks avoid substantial fair value losses, and hence, report significant higher levels of return on assets (ROA), return on equity (ROE), book value of equity, and regulatory capital. In particular, the mean ROE switches signs from a negative ROE of –1.4% to a positive ROE of 1.3% due to gains from Reclassifications. Overall, this paper documents a substantial impact of the amendments on banks’ financial statements and suggests analysing these Reclassifications with particular caution.
Michael D Fabrizio - One of the best experts on this subject based on the ideXlab platform.
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performance of pca3 and tmprss2 erg urinary biomarkers in prediction of biopsy outcome in the canary prostate active surveillance study pass
Prostate Cancer and Prostatic Diseases, 2019Co-Authors: James D Brooks, Lisa F Newcomb, Yingye Zheng, Anna Faino, Daniella Bianchifrias, Matthew R Cooperberg, Marshall D Brown, Atreya Dash, Michael D FabrizioAbstract:For men on active surveillance for prostate cancer, biomarkers may improve prediction of Reclassification to higher grade or volume cancer. This study examined the association of urinary PCA3 and TMPRSS2:ERG (T2:ERG) with biopsy-based Reclassification. Urine was collected at baseline, 6, 12, and 24 months in the multi-institutional Canary Prostate Active Surveillance Study (PASS), and PCA3 and T2:ERG levels were quantitated. Reclassification was an increase in Gleason score or ratio of biopsy cores with cancer to ≥34%. The association of biomarker scores, adjusted for common clinical variables, with short- and long-term Reclassification was evaluated. Discriminatory capacity of models with clinical variables alone or with biomarkers was assessed using receiver operating characteristic (ROC) curves and decision curve analysis (DCA). Seven hundred and eighty-two men contributed 2069 urine specimens. After adjusting for PSA, prostate size, and ratio of biopsy cores with cancer, PCA3 but not T2:ERG was associated with short-term Reclassification at the first surveillance biopsy (OR = 1.3; 95% CI 1.0–1.7, p = 0.02). The addition of PCA3 to a model with clinical variables improved area under the curve from 0.743 to 0.753 and increased net benefit minimally. After adjusting for clinical variables, neither marker nor marker kinetics was associated with time to Reclassification in subsequent biopsies. PCA3 but not T2:ERG was associated with cancer Reclassification in the first surveillance biopsy but has negligible improvement over clinical variables alone in ROC or DCA analyses. Neither marker was associated with Reclassification in subsequent biopsies.
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refined analysis of prostate specific antigen kinetics to predict prostate cancer active surveillance outcomes
European Urology, 2018Co-Authors: Matthew R Cooperberg, James D Brooks, Lisa F Newcomb, Anna Faino, Atreya Dash, Peter R Carroll, James T Kearns, Ruth Etzioni, Michael D FabrizioAbstract:Abstract Background For men on active surveillance for prostate cancer, utility of prostate-specific antigen (PSA) kinetics (PSAk) in predicting pathologic Reclassification remains controversial. Objective To develop prediction methods for utilizing serial PSA and evaluate frequency of collection. Design, setting, and participants Data were collected from men enrolled in the multicenter Canary Prostate Active Surveillance Study, for whom PSA data were measured and biopsies performed on prespecified schedules. We developed a PSAk parameter based on a linear mixed-effect model (LMEM) that accounted for serial PSA levels. Outcome measurements and statistical analysis The association of diagnostic PSA and/or PSAk with time to Reclassification (increase in cancer grade and/or volume) was evaluated using multivariable Cox proportional hazards models. Results and limitations A total of 851 men met the study criteria; 255 (30%) had a Reclassification event within 5 yr. Median follow-up was 3.7 yr. After adjusting for prostate size, time since diagnosis, biopsy parameters, and diagnostic PSA, PSAk was a significant predictor of Reclassification (hazard ratio for each 0.10 increase in PSAk=1.6 [95% confidence interval 1.2–2.1, p Conclusions PSAk calculated using an LMEM statistically significantly predicts biopsy Reclassification. Models that use repeat PSA measurements outperform a model incorporating only diagnostic PSA. Model performance is similar using PSA assessed every 3 or 6 mo. If validated, these results should inform optimal incorporation of PSA trends into active surveillance protocols and risk calculators. Patient summary In this report, we looked at whether repeat prostate-specific antigen (PSA) measurements, or PSA kinetics, improve prediction of biopsy outcomes in men using active surveillance to manage localized prostate cancer. We found that in a large multicenter active surveillance cohort, PSA kinetics improves the prediction of surveillance biopsy outcome.
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role of surveillance biopsy with no cancer as a prognostic marker for Reclassification results from the canary prostate active surveillance study
European Urology, 2018Co-Authors: James T Kearns, James D Brooks, Lisa F Newcomb, Anna Faino, Atreya Dash, Michael D Fabrizio, William J Ellis, Peter R Carroll, Martin E Gleave, Todd M MorganAbstract:Abstract Background Many patients who are on active surveillance (AS) for prostate cancer will have surveillance prostate needle biopsies (PNBs) without any cancer evident. Objective To define the association between negative surveillance PNBs and risk of Reclassification on AS. Design, setting, and participants All men were enrolled in the Canary Prostate Active Surveillance Study (PASS) between 2008 and 2016. Men were included if they had Gleason ≤3+4 prostate cancer and Outcome measurements and statistical analysis Reclassification was defined as an increase in Gleason grade and/or an increase in the ratio of biopsy cores to cancer to ≥34%. PNB outcomes were defined as follows: (1) no cancer on biopsy, (2) cancer without Reclassification, or (3) Reclassification. Kaplan–Meier and Cox proportional hazard models were performed to assess the risk of Reclassification. Results and limitations A total of 657 men met inclusion criteria. On first surveillance PNB, 214 (32%) had no cancer, 282 (43%) had cancer but no Reclassification, and 161 (25%) reclassified. Among those who did not reclassify, 313 had a second PNB. On second PNB, 120 (38%) had no cancer, 139 (44%) had cancer but no Reclassification, and 54 (17%) reclassified. In a multivariable analysis, significant predictors of decreased future Reclassification after the first PNB were no cancer on PNB (hazard ratio [HR]=0.50, p =0.008), lower serum prostate-specific antigen, larger prostate size, and lower body mass index. A finding of no cancer on the second PNB was also associated with significantly decreased future Reclassification in a multivariable analysis (HR=0.15, p =0.003), regardless of the first PNB result. The major limitation of this study is a relatively small number of patients with long-term follow-up. Conclusions Men who have a surveillance PNB with no evidence of cancer are significantly less likely to reclassify on AS in the PASS cohort. These findings have implications for tailoring AS protocols. Patient summary Men on active surveillance for prostate cancer who have a biopsy showing no cancer are at a decreased risk of having worse disease in the future. This may have an impact on how frequently biopsies are required to be performed in the future.
James D Brooks - One of the best experts on this subject based on the ideXlab platform.
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treatment in the absence of disease Reclassification among men on active surveillance for prostate cancer
Cancer, 2021Co-Authors: Peter Kirk, James D Brooks, Lisa F Newcomb, Yingye Zheng, Atreya Dash, Peter R Carroll, Kehao Zhu, Jeannette M Schenk, William J EllisAbstract:Background Maintaining men on active surveillance for prostate cancer can be challenging. Although most men who eventually undergo treatment have experienced clinical progression, a smaller subset elects treatment in the absence of disease Reclassification. This study sought to understand factors associated with treatment in a large, contemporary, prospective cohort. Methods This study identified 1789 men in the Canary Prostate Cancer Active Surveillance Study cohort enrolled as of 2020 with a median follow-up of 5.6 years. Clinical and demographic data as well as information on patient-reported quality of life and urinary symptoms were used in multivariable Cox proportional hazards regression models to identify factors associated with the time to treatment RESULTS: Within 4 years of their diagnosis, 33% of men (95% confidence interval [CI], 30%-35%) underwent treatment, and 10% (95% CI, 9%-12%) were treated in the absence of Reclassification. The most significant factor associated with any treatment was an increasing Gleason grade group (adjusted hazard ratio [aHR], 14.5; 95% CI, 11.7-17.9). Urinary quality-of-life scores were associated with treatment without Reclassification (aHR comparing "mostly dissatisfied/terrible" with "pleased/mixed," 2.65; 95% CI, 1.54-4.59). In a subset analysis (n = 692), married men, compared with single men, were more likely to undergo treatment in the absence of Reclassification (aHR, 2.63; 95% CI, 1.04-6.66). Conclusions A substantial number of men with prostate cancer undergo treatment in the absence of clinical changes in their cancers, and quality-of-life changes and marital status may be important factors in these decisions. Lay summary This analysis of men on active surveillance for prostate cancer shows that approximately 1 in 10 men will decide to be treated within 4 years of their diagnosis even if their cancer is stable. These choices may be related in part to quality-or-life or spousal concerns.
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performance of pca3 and tmprss2 erg urinary biomarkers in prediction of biopsy outcome in the canary prostate active surveillance study pass
Prostate Cancer and Prostatic Diseases, 2019Co-Authors: James D Brooks, Lisa F Newcomb, Yingye Zheng, Anna Faino, Daniella Bianchifrias, Matthew R Cooperberg, Marshall D Brown, Atreya Dash, Michael D FabrizioAbstract:For men on active surveillance for prostate cancer, biomarkers may improve prediction of Reclassification to higher grade or volume cancer. This study examined the association of urinary PCA3 and TMPRSS2:ERG (T2:ERG) with biopsy-based Reclassification. Urine was collected at baseline, 6, 12, and 24 months in the multi-institutional Canary Prostate Active Surveillance Study (PASS), and PCA3 and T2:ERG levels were quantitated. Reclassification was an increase in Gleason score or ratio of biopsy cores with cancer to ≥34%. The association of biomarker scores, adjusted for common clinical variables, with short- and long-term Reclassification was evaluated. Discriminatory capacity of models with clinical variables alone or with biomarkers was assessed using receiver operating characteristic (ROC) curves and decision curve analysis (DCA). Seven hundred and eighty-two men contributed 2069 urine specimens. After adjusting for PSA, prostate size, and ratio of biopsy cores with cancer, PCA3 but not T2:ERG was associated with short-term Reclassification at the first surveillance biopsy (OR = 1.3; 95% CI 1.0–1.7, p = 0.02). The addition of PCA3 to a model with clinical variables improved area under the curve from 0.743 to 0.753 and increased net benefit minimally. After adjusting for clinical variables, neither marker nor marker kinetics was associated with time to Reclassification in subsequent biopsies. PCA3 but not T2:ERG was associated with cancer Reclassification in the first surveillance biopsy but has negligible improvement over clinical variables alone in ROC or DCA analyses. Neither marker was associated with Reclassification in subsequent biopsies.
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refined analysis of prostate specific antigen kinetics to predict prostate cancer active surveillance outcomes
European Urology, 2018Co-Authors: Matthew R Cooperberg, James D Brooks, Lisa F Newcomb, Anna Faino, Atreya Dash, Peter R Carroll, James T Kearns, Ruth Etzioni, Michael D FabrizioAbstract:Abstract Background For men on active surveillance for prostate cancer, utility of prostate-specific antigen (PSA) kinetics (PSAk) in predicting pathologic Reclassification remains controversial. Objective To develop prediction methods for utilizing serial PSA and evaluate frequency of collection. Design, setting, and participants Data were collected from men enrolled in the multicenter Canary Prostate Active Surveillance Study, for whom PSA data were measured and biopsies performed on prespecified schedules. We developed a PSAk parameter based on a linear mixed-effect model (LMEM) that accounted for serial PSA levels. Outcome measurements and statistical analysis The association of diagnostic PSA and/or PSAk with time to Reclassification (increase in cancer grade and/or volume) was evaluated using multivariable Cox proportional hazards models. Results and limitations A total of 851 men met the study criteria; 255 (30%) had a Reclassification event within 5 yr. Median follow-up was 3.7 yr. After adjusting for prostate size, time since diagnosis, biopsy parameters, and diagnostic PSA, PSAk was a significant predictor of Reclassification (hazard ratio for each 0.10 increase in PSAk=1.6 [95% confidence interval 1.2–2.1, p Conclusions PSAk calculated using an LMEM statistically significantly predicts biopsy Reclassification. Models that use repeat PSA measurements outperform a model incorporating only diagnostic PSA. Model performance is similar using PSA assessed every 3 or 6 mo. If validated, these results should inform optimal incorporation of PSA trends into active surveillance protocols and risk calculators. Patient summary In this report, we looked at whether repeat prostate-specific antigen (PSA) measurements, or PSA kinetics, improve prediction of biopsy outcomes in men using active surveillance to manage localized prostate cancer. We found that in a large multicenter active surveillance cohort, PSA kinetics improves the prediction of surveillance biopsy outcome.
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role of surveillance biopsy with no cancer as a prognostic marker for Reclassification results from the canary prostate active surveillance study
European Urology, 2018Co-Authors: James T Kearns, James D Brooks, Lisa F Newcomb, Anna Faino, Atreya Dash, Michael D Fabrizio, William J Ellis, Peter R Carroll, Martin E Gleave, Todd M MorganAbstract:Abstract Background Many patients who are on active surveillance (AS) for prostate cancer will have surveillance prostate needle biopsies (PNBs) without any cancer evident. Objective To define the association between negative surveillance PNBs and risk of Reclassification on AS. Design, setting, and participants All men were enrolled in the Canary Prostate Active Surveillance Study (PASS) between 2008 and 2016. Men were included if they had Gleason ≤3+4 prostate cancer and Outcome measurements and statistical analysis Reclassification was defined as an increase in Gleason grade and/or an increase in the ratio of biopsy cores to cancer to ≥34%. PNB outcomes were defined as follows: (1) no cancer on biopsy, (2) cancer without Reclassification, or (3) Reclassification. Kaplan–Meier and Cox proportional hazard models were performed to assess the risk of Reclassification. Results and limitations A total of 657 men met inclusion criteria. On first surveillance PNB, 214 (32%) had no cancer, 282 (43%) had cancer but no Reclassification, and 161 (25%) reclassified. Among those who did not reclassify, 313 had a second PNB. On second PNB, 120 (38%) had no cancer, 139 (44%) had cancer but no Reclassification, and 54 (17%) reclassified. In a multivariable analysis, significant predictors of decreased future Reclassification after the first PNB were no cancer on PNB (hazard ratio [HR]=0.50, p =0.008), lower serum prostate-specific antigen, larger prostate size, and lower body mass index. A finding of no cancer on the second PNB was also associated with significantly decreased future Reclassification in a multivariable analysis (HR=0.15, p =0.003), regardless of the first PNB result. The major limitation of this study is a relatively small number of patients with long-term follow-up. Conclusions Men who have a surveillance PNB with no evidence of cancer are significantly less likely to reclassify on AS in the PASS cohort. These findings have implications for tailoring AS protocols. Patient summary Men on active surveillance for prostate cancer who have a biopsy showing no cancer are at a decreased risk of having worse disease in the future. This may have an impact on how frequently biopsies are required to be performed in the future.
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timing of adverse prostate cancer Reclassification on first surveillance biopsy results from the canary prostate cancer active surveillance study
The Journal of Urology, 2017Co-Authors: Liam C Macleod, James D Brooks, Lisa F Newcomb, Yingye Zheng, William J Ellis, Peter R Carroll, Martin E Gleave, Raymond S Lance, Peter S NelsonAbstract:Purpose: During active surveillance for localized prostate cancer, the timing of the first surveillance biopsy varies. We analyzed the Canary PASS (Prostate Cancer Active Surveillance Study) to determine biopsy timing influence on rates of prostate cancer adverse Reclassification at the first active surveillance biopsy.Materials and Methods: Of 1,085 participants in PASS, 421 had fewer than 34% of cores involved with cancer and Gleason sum 6 or less, and thereafter underwent on-study active surveillance biopsy. Reclassification was defined as an increase in Gleason sum and/or 34% or more of cores with prostate cancer. First active surveillance biopsy Reclassification rates were categorized as less than 8, 8 to 13 and greater than 13 months after diagnosis. Multivariable logistic regression determined association between Reclassification and first biopsy timing.Results: Of 421 men, 89 (21.1%) experienced Reclassification at the first active surveillance biopsy. Median time from prostate cancer diagnosis to...
