Predictors of adverse pathology on radical prostatectomy specimen in men initially enrolled in active surveillance for low-risk prostate cancer.
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ABSTRACT: Purpose
To evaluate clinical variables, including magnetic resonance imaging (MRI) predictive of adverse pathology (AP) at radical prostatectomy (RP) in men initially enrolled in active surveillance (AS).Methods
A population-based cohort study of men diagnosed with low-risk prostate cancer (PCa), in Stockholm County, Sweden, during 2008-2017 enrolled in AS their intended primary treatment followed by RP. AP was defined as ISUP grade group ≥ 3 and/or pT-stage ≥ T3. Association between clinical variables at diagnosis and time to AP was evaluated using Cox regression and multivariate logistic regression to evaluate the association between AP and clinical variables at last biopsy before RP.Results
In a cohort of 6021 patients with low-risk PCa, 3116 were selected for AS and 216 underwent RP. Follow-up was 10 years, with a median time on AS of 23 months. 37.7% of patients had AP at RP. Clinical T-stage [Hazard ratio (HR): 1.81, 95% confidence interval (CI) 1.04-3.18] and PSA (HR: 1.31, 95% CI 1.17-1.46) at diagnosis and age [Odds Ratio (OR): 1.09, 95% CI 1.02-1.18), PSA (OR: 1.22, 95% CI 1.07-1.41), and PI-RADS (OR 1.66, 95% CI 1.11-2.55)] at last re-biopsy were significantly associated with AP.Conclusion
PI-RADS score is significantly associated with AP at RP and support current guidelines recommending MRI before enrollment in AS. Furthermore, age, cT-stage, and PSA are significantly associated with AP.
SUBMITTER: Bjornebo L
PROVIDER: S-EPMC8217019 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:PurposeThe optimal timing of postoperative radiotherapy (RT) after radical prostatectomy (RP) is unclear. We hypothesized that a genomic classifier (GC) would provide prognostic and predictive insight into the development of clinical metastases in men receiving post-RP RT and inform decision making.Patients and methodsGC scores were calculated from 188 patients with pT3 or margin-positive prostate cancer, who received post-RP RT at Thomas Jefferson University and Mayo Clinic between 1990 and 2009. The primary end point was clinical metastasis. Prognostic accuracy of the models was tested using the concordance index for censored data and decision curve analysis. Cox regression analysis tested the relationship between GC and metastasis.ResultsThe cumulative incidence of metastasis at 5 years after RT was 0%, 9%, and 29% for low, average, and high GC scores, respectively (P = .002). In multivariable analysis, GC and pre-RP prostate-specific antigen were independent predictors of metastasis (both P < .01). Within the low GC score (< 0.4), there were no differences in the cumulative incidence of metastasis comparing patients who received adjuvant or salvage RT (P = .79). However, for patients with higher GC scores (? 0.4), cumulative incidence of metastasis at 5 years was 6% for patients treated with adjuvant RT compared with 23% for patients treated with salvage RT (P < .01).ConclusionIn patients treated with post-RP RT, GC is prognostic for the development of clinical metastasis beyond routine clinical and pathologic features. Although preliminary, patients with low GC scores are best treated with salvage RT, whereas those with high GC scores benefit from adjuvant therapy. These findings provide the first rational selection of timing for post-RP RT.
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Project description:BackgroundArousal incontinence (AI) occurs during physical or psychological sexual stimulation in men and has been described after radical prostatectomy (RP).AimThe goals of this study are to describe the characteristics of men experiencing AI, outline the nature of their symptoms, and assess for predictors of this condition.MethodsA survey with questions on AI, stress urinary incontinence (SUI), the International Index of Erectile Function and International Prostate Symptom Score were sent out to men who had undergone an RP within the past 24 months at a single institution. The data were deidentified and analyzed using descriptive statistics. Comparisons between men with and without AI were made using t-tests and χ2 and Fisher exact tests. Logistic regression in univariable and multivariable analyses were used to define predictors of AI.Main outcome measuresThe outcomes of this study included prevalence of AI, symptom severity and timing, patient and patient-perceived partner bother, management strategies used by the patients, and concurrent SUI.Results226 (32%) men completed the survey. Of these men, almost half (49%) experienced AI at some point during their recovery. Improvement over time was endorsed by 62% of men. 57% of men reported AI in less than half of the sexual encounters, with the amount of urine leakage being equivalent to a tablespoon or less in 88% of men. On univariate analysis, increasing degree of SUI, as measured by pads per day, was associated with AI (P = .01). A lower International Prostate Symptom Score was also associated (P = .05). On multivariate analysis, the absence of hypertension and pads per day were associated with AI (P = .01 for both).Clinical implicationsAI occurred in almost half of the respondents in our series. Thus, AI should be discussed with patients before surgery to allow for realistic expectations.Strengths & limitationsStrengths of this study include the largest patient population analyzed to date regarding AI and that it is the only one to address timing and patient experiences with the use of validated instruments for erectile and urinary function. Limitations include single-center data, non-validated AI patient-reported outcomes, and poor survey response rate.ConclusionBased on the available data, AI is reported by almost half of men after RP and is associated with SUI. Bach PV, Salter CA, Katz D, et al. Arousal Incontinence in Men Following Radical Prostatectomy: Prevalence, Impact and Predictors. J Sex Med 2020;16:1947-1952.
| S-EPMC7526796 | biostudies-literature
Project description:BackgroundProstate-specific antigen (PSA) screening more frequently detects early stage prostate cancer (PC). However, adverse pathologic features (APFs) after radical prostatectomy (RP) in low-risk PC occur. Previous related studies had utilized outdated staging criteria or small sample cohorts. In this study, we analyzed predictors of APFs after RP in low-risk PC using classification under the current criteria.Materials and methodsWe retrospectively reviewed medical records of 546 low-risk PC patients who had undergone RP. Low-risk PC was defined as PC with clinical T1-T2a, Gleason score ≤ 6, and PSA levels < 10 ng/mL. Clinical and pathological parameters were analyzed to predict APFs. APFs were defined as extracapsular extension (ECE), seminal vesicle invasion (SVI), or positive surgical margins (PSM). We analyzed our data using univariable and multivariable logistic regression analyses, as well as receiver operator characteristics to predict APFs.ResultsAmong 546 patients, ECE, SVI, and PSM were present in 199 (36.4%), 8 (1.5%), and 179 cases (32.8%), respectively. PSM had a significant correlation with preoperative high PSA levels and number of positive cores obtained. ECE/SVI was also significantly correlated with PSA levels and number of positive cores. As a result, presence of APFs after RP was associated with high PSA levels and large number of positive cores. PSA > 4.5 ng/mL and number of positive cores > 2 in low-risk PC were significantly associated with APFs, and suggested as cut-off values for predicting APFs.ConclusionsPSA > 4.5 ng/mL and number of positive cores > 2 in low-risk PC were associated with presence of APFs and patients with such records should be considered carefully to provide active surveillance.
| S-EPMC5944136 | biostudies-literature
Project description:BACKGROUND: The controversies concerning possible overtreatment of prostate cancer, highlighted by debate over PSA screening, have highlighted active surveillance (AS) as an alternative management option for appropriate men. Regional differences in the underlying prevalence of PSA testing may alter the pre-test probability for high-risk disease, which can potentially interfere with the performance of selection criteria for AS. In a multicentre study from three different countries, we examine men who were initially suitable for AS according to the Toronto and Prostate Cancer Research International: Active Surveillance (PRIAS) criteria, that underwent radical prostatectomy (RP) in regards to:1.the proportion of pathological reclassification(Gleason score ≥7, ≥pT3 disease),2.predictors of high-risk disease,3.create a predictive model to assist with selection of men suitable for AS. METHODS: From three centres in the United Kingdom, Canada and Australia, data on men who underwent RP were retrospectively reviewed (n=2329). Multivariable logistic regression was performed to identify predictors of high-risk disease. A nomogram was generated by logistic regression analysis, and performance characterised by receiver operating characteristic curves. RESULTS: For men suitable for AS according to the Toronto (n=800) and PRIAS (410) criteria, the rates for upgrading were 50.6, 42.7%, and upstaging 17.6, 12.4%, respectively. Significant predictors of high-risk disease were:•Toronto criteria: increasing age, cT2 disease, centre of diagnosis and number of positive cores.•PRIAS criteria: increasing PSA and cT2 disease.Cambridge had a high pT3a rate (26 vs 12%). To assist selection of men in the United Kingdom for AS, from the Cambridge data, we generated a nomogram predicting high-risk features in patients who meet the Toronto criteria (AUC of 0.72). CONCLUSION: The proportion of pathological reclassification in our cohort was higher than previously reported. Care must be used when applying the AS criteria generated from one population to another. With more stringent selection criteria, there is less reclassification but also fewer men who may benefit from AS.
| S-EPMC3493756 | biostudies-other
Project description:BackgroundLittle is known about the consequences of delaying radical prostatectomy (RP) after Active Surveillance (AS) according to stringent or wider entry criteria. We investigated the association between inclusion criteria and rates, and timing of adverse pathological findings (APFs) among patients in GAP3 cohorts.MethodsAPFs (GG ≥ 3, pT ≥ 3, pN > 0 and positive surgical margins [R1]) were accounted for in very low-risk (VLR: grade group [GG] 1, cT1, positive cores < 3, PSA < 10 ng/mL, PSA density [PSAD] < 0.15 ng/mL/cm3) and low-risk (LR: GG1, cT1-2, PSA ≤ 10 ng/mL) patients undergoing subsequent RP. The Kaplan-Meier method and log-rank test analyzed APF-free survival. Stratified mixed effects models analyzed association.ResultsOut of 21,169 patients on AS, 1742 (VLR: 721; LR: 1021) underwent delayed RP. Most (60.8%) did not have APFs. APFs occurred more frequently (44.6% vs. 31.7%; OR 1.54, p < 0.001) and earlier (median time: 40.3 vs. 62.6 months; p < 0.001) in LR patients, and consisted of pT ≥ 3 (OR 1.47, p = 0.013) or R1 (OR 1.80, p < 0.001), but not of GG ≥ 3 or node involvement. Age (OR 1.05, p < 0.001), PSAD (OR 23.21, p = 0.003), and number of positive cores (OR 1.16, p = 0.004) were independently associated with APFs.ConclusionsAS stands as a safe option for low-risk patients, and most do not have APFs at surgery. Wider entry criteria are associated with pT3 and R1. The prognostic implications remain uncertain.
| S-EPMC9332009 | biostudies-literature
Project description:ObjectiveTo validate the 17-gene Oncotype DX Genomic Prostate Score (GPS) as a predictor of adverse pathology (AP) in African American (AA) men and to assess the distribution of GPS in AA and European American (EA) men with localized prostate cancer.MethodsThe study populations were derived from 2 multi-institutional observational studies. Between February 2009 and September 2014, AA and EA men who elected immediate radical prostatectomy after a ≥10-core transrectal ultrasound biopsy were included in the study. Logistic regressions, area under the receiver operating characteristics curves (AUC), calibration curves, and predictive values were used to compare the accuracy of GPS. AP was defined as primary Gleason grade 4, presence of any Gleason pattern 5, and/or non-organ-confined disease (≥pT3aN0M0) at radical prostatectomy.ResultsOverall, 96 AA and 76 EA men were selected and 46 (26.7%) had AP. GPS result was a significant predictor of AP (odds ratio per 20 GPS units [OR/20 units] in AA: 4.58; 95% confidence interval (CI) 1.8-11.5, P = .001; and EA: 4.88; 95% CI 1.8-13.5, P = .002). On multivariate analysis, there was no significant interaction between GPS and race (P >.10). GPS remained significant in models adjusted for either National Comprehensive Cancer Network (NCCN) risk group or Cancer of the Prostate Risk Assessment (CAPRA) score. In race-stratified models, area under the receiver operating characteristics curves for GPS/20 units was 0.69 for AAs vs 0.74 for EAs (P = .79). The GPS distributions were not statistically different by race (all P >.05).ConclusionIn this clinical validation study, the Oncotype DX GPS is an independent predictor of AP at prostatectomy in AA and EA men with similar predictive accuracy and distributions.
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Project description:ImportanceActive surveillance is recommended for patients with very low-risk (VLR) and low-risk (LR) prostate cancer. Despite controversy, recent clinical guidelines state surveillance may be considered for men with low-volume intermediate-risk (LVIR) disease.ObjectiveTo compare rates of adverse pathologic findings among VLR, LR, and LVIR men electing immediate radical prostatectomy and evaluate criteria to define if a favorable intermediate-risk group minimizing risk exists.Design, setting, and participantsThis was a cohort study of men (2005-July 2016) with clinically localized VLR (1264 patients), LR (4849 patients), and LVIR (608 patients) (1-2 cores, Gleason 3 + 4 = 7, prostate-specific antigen [PSA] level <20 ng/mL) prostate cancer undergoing radical prostatectomy evaluated retrospectively at Johns Hopkins Hospital.InterventionsRadical prostatectomy.Main outcomes and measuresThe proportions of men found to have at least Gleason 4 + 3 = 7 disease and other adverse pathologic features were compared by risk group. Log-binomial regression calculated relative risk (RR) of adverse pathologic findings in the LVIR cohort compared with VLR and LR cohorts. Analyses were repeated in subgroups of the LVIR population who otherwise met criteria for VLR (T1c, PSA density [PSAD] <0.15 ng/mL/cm3, ≤50% cancer in any core) and LR (≤T2a, PSA level <10 ng/mL) disease. Rates of adverse pathologic findings within the LVIR group were calculated based on various clinical thresholds, and univariable and multivariable logistic regression analyses were performed to identify predictors of adverse pathologic findings.ResultsThe rate of adverse pathologic findings was significantly higher for LVIR disease (150 of 608 patients [24.7%]; RR, 4.50; 95% CI, 3.73-5.43; P < .001) compared with LR disease (280 of 4849 [5.8%]), and LVIR disease (RR, 5.14; 95% CI, 3.84-6.89; P < .001) compared with men with VLR disease (60 of 1264 [4.7%]). Restriction of LVIR men to additional criteria did not significantly affect results. There were no preoperative clinical or pathologic criteria that could identify a subgroup of the LVIR population with rates of adverse pathologic findings comparable with those of the VLR and LR cohorts. PSAD was a significant predictor of adverse pathologic findings, but Gleason score had the largest effect (odds ratio, 4.30 (95% CI, 3.40-5.44; P < .001).Conclusions and relevanceNearly 25% of men (150 of 608) electing immediate radical prostatectomy with low-volume, Gleason 3 + 4 prostate cancer on biopsy are found to harbor adverse surgical pathologic findings. These data do not support the presence of a "favorable" subgroup among included patients and could have important implications for active surveillance in similar patients with Gleason 3 + 4 = 7 prostate cancer.
| S-EPMC5833628 | biostudies-literature
Project description:PurposeTo evaluate the incidence and locations of positive surgical margin (PSM) among Chinese men undergoing RARP and identify the preoperative predictors for PSM.MethodsWe retrospectively identified 393 patients who underwent RARP according to inclusion criteria by single surgeon in our hospital. PSM was defined as the presence of cancer adjacent to inked surface of the specimen and categorized into four groups based on locations: apex, posterolateral, base, and multifocal. Logistic regression analysis was performed to identify the predictors of overall and location-specific PSM.ResultsThe overall PSM rate was 133/393 (34%). The PSM rates for pT2, pT3, and pT4 stage were 63/278 (23%), 50/89 (56%), and 20/26 (77%), respectively. The estimated rates for apical, posterolateral, basal, and multifocal PSM were 8%, 4%, 7%, and 14%, respectively. In univariate analysis, overall PSM related to tPSA, f/tPSA, percentage of positive needles, and Gleason score. Multifocal PSM correlated with smoking history, drinking history, tPSA, f/tPSA, percentage of positive needles, and Gleason score. In multivariate analysis, percentage of positive needles reminded the only independent predictor for overall (OR = 10.5, 95% CI: 2.58-44.4) and basal PSM (OR = 24.0, 95% CI: 3.22-179.4). The f/tPSA (OR = 2.59, 95% CI: 2.18-5.71) and percentage of positive needles (OR = 31.0, 95% CI: 3.17-303) were independent risk factors for multifocal PSM.ConclusionThe multifocal sites were the most common location of positive surgical margin, followed by apical and basal sites among Chinese patients undergoing RARP. The percentage of positive needles was an independent predictor for overall, basal, and multifocal PSM.
| S-EPMC8645302 | biostudies-literature
Project description:PurposeKorean patients with prostate cancer (PC) typically present with a more aggressive disease than patients in Western populations. Consequently, it is unclear if the current criteria for active surveillance (AS) can safely be applied to Korean patients. Therefore, this study was conducted to define appropriate selection criteria for AS for patients with PC in Korea.Materials and methodsWe conducted a multicenter retrospective study of 2,126 patients with low risk PC who actually underwent radical prostatectomy. The primary outcome was an unfavorable disease, which was defined by non-organ confined disease or an upgrading of the Gleason score to ? 7 (4+3). Predictive variables of an unfavorable outcome were identified by multivariate analysis using randomly selected training samples (n=1,623, 76.3%). We compared our selected criteria to various Western criteria for the primary outcome and validated our criteria using the remaining validation sample (n=503, 23.7%).ResultsA non-organ confined disease rate of 14.9% was identified, with an increase in Gleason score ? 7 (4+3) of 8.7% and a final unfavorable disease status of 20.8%. The following criteria were selected: Gleason score ? 6, clinical stage T1-T2a, prostate-specific antigen (PSA) ? 10 ng/mL, PSA density < 0.15 ng/mL/mL, number of positive cores ? 2, and maximum cancer involvement in any one core ? 20%. These criteria provided the lowest unfavorable disease rate (11.7%) when compared to Western criteria (13.3%-20.7%), and their validity was confirmed using the validation sample (5.9%).ConclusionWe developed AS criteria which are appropriate for Korean patients with PC. Prospective studies using these criteria are now warranted.
| S-EPMC5784641 | biostudies-literature
Project description:IntroductionOrgasm-associated incontinence, climacturia, is one of the lesser studied radical prostatectomy (RP) complications. Little is known about patient bother related to this condition, specifically, its prevalence and predictors.AimTo ascertain the prevalence and predictors of patient bother associated with climacturia.MethodsPatients presenting for the evaluation of sexual dysfunction after RP at a single center were queried on various domains of sexual dysfunction. This included orgasmic dysfunction and sexual incontinence (including climacturia and arousal incontinence). Patients were specifically asked about the frequency and amount of climacturia. In addition, questions addressed patient bother and the perceived bother of their partners. Descriptive statistics were used for patient characteristics. A t-test was used for comparing the frequency of patient and partner bother, and the Pearson correlation test compared relationships between bother and predictors. Multivariable analysis was conducted to define predictors of climacturia-associated bother.Main outcome measureThe main outcome measures was the prevalence and predictors of climacturia-associated patient bother and perceived partner bother.ResultsClimacturia was reported by 23% of 3,207 consecutive men analyzed. Bother of any degree was experienced by 45% of these patients, and 14% reported partner bother related to this condition. Patient bother was associated with perceived partner bother (P < .001) and inversely correlated with relationship duration (P < .001). The overall frequency and quantity of climacturia were also predictive (P < .001 for both). In the adjusted model, all of these factors remained significant.Clinical implicationsGiven the prevalence of this condition and the bother associated with it, this complication should be discussed with patients preoperatively.Strength & limitationsStrengths include a large study population and specific questions on climacturia-associated bother. Limitations include the fact that it is a single-center study and no direct partner questioning occurred.ConclusionClimacturia and its associated bother are common after RP. The predictors of patient bother include perceived partner bother, shorter relationship duration, and increasing frequency and quantity of climacturia. Salter CA, Bach PV, Miranda E, et al. Bother Associated With Climacturia After Radical Prostatectomy: Prevalence and Predictors. J Sex Med 2020;17:731-736.
| S-EPMC7546516 | biostudies-literature