National Comprehensive Cancer Network Risk Group Research Articles

Performance characteristics of prostate-specific antigen density and biopsy core details to predict oncological outcome in patients with intermediate to high-risk prostate cancer underwent robot-assisted radical prostatectomy

BackgroundMany urologic surgeons refer to biopsy core details for decision making in cases of localized prostate cancer (PCa) to determine whether an extended resection and/or lymph node dissection should be performed. Furthermore, recent reports emphasize the predictive value of prostate-specific antigen density (PSAD) for further risk stratification, not only for low-risk PCa, but also for intermediate- and high-risk PCa. This study focused on these parameters and compared respective predictive impact on oncologic outcomes in Japanese PCa patients.MethodsTwo-hundred and fifty patients with intermediate- and high-risk PCa according to the National Comprehensive Cancer Network (NCCN) classification, that underwent robot-assisted radical prostatectomy at a single institution, and with observation periods of longer than 6 months were enrolled. None of the patients received hormonal treatments including antiandrogens, luteinizing hormone-releasing hormone analogues, or 5-alpha reductase inhibitors preoperatively. PSAD and biopsy core details, including the percentage of positive cores and the maximum percentage of cancer extent in each positive core, were analyzed in association with unfavorable pathologic results of prostatectomy specimens, and further with biochemical recurrence. The cut-off values of potential predictive factors were set through receiver-operating characteristic curve analyses.ResultsIn the entire cohort, a higher PSAD, the percentage of positive cores, and maximum percentage of cancer extent in each positive core were independently associated with advanced tumor stage ≥ pT3 and an increased index tumor volume > 0.718 ml. NCCN classification showed an association with a tumor stage ≥ pT3 and a Gleason score ≥8, and the attribution of biochemical recurrence was also sustained. In each NCCN risk group, these preoperative factors showed various associations with unfavorable pathological results. In the intermediate-risk group, the percentage of positive cores showed an independent predictive value for biochemical recurrence. In the high-risk group, PSAD showed an independent predictive value.ConclusionsPSAD and biopsy core details have different performance characteristics for the prediction of oncologic outcomes in each NCCN risk group. Despite the need for further confirmation of the results with a larger cohort and longer observation, these factors are important as preoperative predictors in addition to the NCCN classification for a urologic surgeon to choose a surgical strategy.

Time to metastasis or death in non-metastatic castrate resistant prostate cancer (nmCRPC) patients by National Comprehensive Cancer Network (NCCN) risk groups.

5027 Background: Interventions in nmCRPC are the last defense against metastasis, which drives health care cost and mortality. To assess the value of such interventions we must analyze risk factors for metastasis and death. Methods: This was a retrospective study of data (Optum electronic health record database, 2007 – 2016) from men with a prostate cancer diagnosis, 2 rising PSA levels ≥1 week apart, castrate level ( < 50 ng/dL) testosterone (T) and no ICD-9/10 code or therapy indicating metastasis. Gleason grade (G) and PSA data up to and including nmCRPC index date (ie, date of 2nd PSA rise) were used to assign NCCN risk groups: Low (G ≤6 and PSA < 10 ng/mL), Intermediate (IM) (G = 7 or 10 ≤ PSA ≤ 20 ng/mL) or High (G ≥ 8 or PSA > 20 ng/mL). The LP/NG group comprised men with PSA < 10 ng/mL (LP) and missing G (NG). A Cox proportional hazard model, adjusted for age, race, comorbidity index score, T level, therapy type and bone scans was used to compare LP/NG, IM and High with the Low risk group. Results: Among 1008 men with nmCRPC (mean age 76 years; 12% African American), 553 developed metastases and 430 died during follow-up. Mean time to metastasis was 28, 22, 15, 13 months in the Low, LP/NG, IM, and High groups, respectively. In the Low group, 9 of 29 (31%) men developed metastases, vs 131/285 (46%) in the LP/NG group (hazard ratio [HR] = 1.70, 95% confidence interval [CI]: 0.86-3.35), 175/320 (55%) in the IM group (HR = 2.52, 95% CI: 1.28-4.91) and 238/374 (64%) in the High group (HR = 3.63, 95% CI: 1.85-7.10). Mean time to death was 32, 30, 24, 21 months in the Low, LP/NG, IM, High groups, respectively. There were 8 deaths in the Low group (27.6%), vs 101 (35.4%) (HR = 1.35, 95% CI: 0.65-2.79) in the LP/NG group, 124 (38.8%) (HR = 1.79, 95% CI: 0.87-3.70) in the IM group and 197 (52.7%) (HR = 2.96, 95% CI: 1.45-6.05) in the High group. The High risk group was more likely to develop metastasis during the first year and die within the first 2 years. Conclusions: Metastasis and death occurred earlier and more frequently in the Intermediate and High groups relative to the Low risk group. These findings may further inform diagnostic and management strategies for combating disease progression.

Prospective study of a 17-GENE RT-PCR-based assay for prediction of high risk pathology at radical prostatectomy.

36 Background: A biopsy-based 17 gene tissue-based RTPCR assay (Oncotype Dx Genomic Prostate Score, GPS) has been validated in retrospective cohorts as a predictor of adverse pathology and biochemical recurrence in prostate cancer (PCa) patients who underwent radical prostatectomy (RP). The National Comprehensive Cancer Network (NCCN) recommends that men with pathologic Gleason Score (pGS) > 8, pT3+, and/or Lymph Node positive disease (i.e. high risk surgical pathology, HRSP) consider adjuvant therapy after RP. We report herein on GPS at biopsy as a predictor of HRSP in men presenting with clinically low-risk PCa. Methods: As part of an ongoing observational study of GPS (N = 1200), we performed an exploratory analysis in men who elected RP as initial disease management. Descriptive statistics were reported. Binary logistic regression was performed to determine the association between GPS and HRSP. The odds ratio (OR) per 20 GPS units and 95% confidence interval (CI) were reported. All analyses were conducted with SAS 9.4. Results: Of the 1,200 patients enrolled in the study, 150 (21 sites) selected RP for initial management; 122 (19 sites) had biopsy and surgical pathology data available for analysis.Median age was 63 (range 50-79) years, with 38% > 65 yrs. There were 72 (59%), 39 (32%), and 11 (9%) patients who had NCCN Intermediate-, Low-, and Very Low-Risk disease, respectively Median GPS was 30 (IQR 20-40, range 8-82). Biological risk (GPS+NCCN) differed from NCCN risk in 28 cases (23%). At surgery, 29 /122 (24%) of patients had HRSP; of these, 1 had NCCN Very Low-, 8 had Low-, and 20 had Intermediate-Risk cancer at diagnosis. GPS was a significant predictor of HRSP (OR per 20 GPS units: 2.1; 95% CI: [1.2, 4.0]; p-value 0.02). No other clinical factor was significantly associated with HRSP. GPS remained significant after adjusting for NCCN risk group (OR per 20 GPS units: 2.0; 95% CI 1.1-3.8, p = 0.03). Incorporation of GPS increased the AUC for prediction of HRSP from 0.57 (NCCN alone) to 0.65 (NCCN + GPS) Conclusions: GPS derived from biopsy tissue is an independent predictor of HRSP. This information may be valuable in treatment planning for men with clinically low risk PCa who are at risk for HRSP.

Adaptive cone-beam CT planning improves long-term biochemical disease-free survival for 125I prostate brachytherapy

PurposeDetermining the independent effect of additional intraoperative adaptive C-arm cone-beam CT (CBCT) planning vs. transrectal ultrasound (TRUS)-guided interactive planning alone in 125I brachytherapy for prostate cancer (PCa) on biochemical disease-free survival (BDFS). Methods and materialsT1/T2-stage PCa patients receiving TRUS-guided brachytherapy from 2000 to 2014 were analyzed. From October 2006, patients received additional intraoperative adaptive CBCT planning for dosimetric evaluation and subsequent remedial seed placement in underdosed areas. Patients were stratified according to the National Comprehensive Cancer Network (NCCN) risk classification. Kaplan–Meier analysis was used to estimate BDFS (primary outcome), overall survival, and PCa-specific survival (secondary outcomes). Cox regression was used to assess the relation between CBCT use and biochemical failure (BF) and overall mortality. ResultsIn all, 1623 patients were included. Median followup was 99 months (interquartile range 70–115) for TRUS patients (n = 613) and 51 months (interquartile range 29–70) for CBCT patients (n = 1010). BF occurred 203 times and 206 patients died, 26 from PCa. For TRUS and CBCT patients, 7-year BDFS was 87.2% vs. 93.5% (log rank: p = 0.04) for low, 75.9% vs. 88.5% (p < 0.001) for intermediate, and 57.1% vs. 85.0% for high-risk patients (p < 0.001). For TRUS and CBCT patients, 7-year PCa-specific survival was 96.0% vs. 100% (p < 0.0001). After Cox regression, CBCT patients had lower hazard of BF: hazard ratio (HR) 0.25 (95% confidence interval [CI]: 0.18–0.33; p < 0.0001). Corrected for confounders, CBCT remained a predictor of BF: HR 0.51 (95% CI: 0.31–0.86; p = 0.01) but not for overall mortality: HR 0.66 (95% CI: 0.40–1.07; p = 0.09). ConclusionsAdditional intraoperative adaptive CBCT planning in 125I prostate brachytherapy leads to a significant increase in BDFS in all NCCN risk groups.

The Comparison of Stereotactic Body Radiation Therapy and Intensity-Modulated Radiation Therapy for Prostate Cancer by NCCN Risk Groups.

The primary objective of this study is to compare freedom from biochemical failure (FFBF) between stereotactic body radiation therapy (SBRT) and intensity-modulated radiation therapy (IMRT) for patients with organ confined prostate cancer treated between 2007 through 2012 utilizing the 2015 National Comprehensive Cancer Network (NCCN) risk stratification guidelines. A secondary objective is to compare our updated toxicity at last follow-up compared with pretreatment with respect to bowel, bladder, sexual functioning, and need for invasive procedures between the two groups. We retrospectively reviewed 270 consecutive men treated with either SBRT (n = 150) or IMRT (n = 120) at a community hospital with two distinct radiation departments and referral patterns. Charts were reviewed for pretreatment and treatment factors including race, age, clinical T stage, initial PSA, Gleason score, use of androgen deprivation therapy, treatment with SBRT vs. IMRT, as well as stratification by 2015 NCCN guidelines. Kaplan-Meier (KM) methodology was used to estimate FFBF, with statistical comparisons accomplished using log rank tests. Multivariable Cox proportional hazard modeling was used to establish independent factors prognostic of biochemical failure. Descriptive statistics were used to describe toxicity graded by a modified Radiation Therapy Oncology Group (RTOG) late radiation morbidity scoring system. Significant prognostic factors in univariate analysis for FFBF included NCCN risk groups (p = 0.0032), grade (p = 0.019), and PSA (p = 0.008). There was no significant difference in FFBF between SBRT vs. IMRT (p = 0.46) with 6-year actuarial FFBF of 91.9% for SBRT and 88.9% for IMRT. Multivariable analysis revealed only the NCCN risk stratification to be significant predictor for FFBF (p = 0.04). Four-year actuarial FFBF by NCCN risk stratification was 100% very low risk, 100% low risk, 96.5% intermediate risk, 94.5% high risk, and 72.7% very high risk. There were no grade 3 gastrointestinal or genitourinary toxicities for either SBRT or IMRT at last follow-up. No significant difference in FFBF was found between SBRT and IMRT for organ confined prostate cancer in multivariable analysis within this retrospective data set. Overall toxicity was low. The 2015 NCCN risk stratification was validated in this population and was the only significant factor for FFBF in multivariable analysis.

Patient-specific Meta-analysis of 2 Clinical Validation Studies to Predict Pathologic Outcomes in Prostate Cancer Using the 17-Gene Genomic Prostate Score

To perform patient-specific meta-analysis (MA) of two independent clinical validation studies of a 17-gene biopsy-based genomic assay as a predictor of favorable pathology at radical prostatectomy. Patient-specific MA was performed on data from 2 studies (732 patients) using the Genomic Prostate Score (GPS; scale 0-100) together with Cancer of the Prostate Risk Assessment (CAPRA) score or National Comprehensive Cancer Network (NCCN) risk group as predictors of the likelihood of favorable pathology (LFP). Risk profile curves associating GPS with LFP by CAPRA score and NCCN risk group were generated. Decision curves and receiver operating characteristic curves were calculated using patient-specific MA risk estimates. Patient-specific MA-generated risk profiles ensure more precise estimates of LFP with narrower confidence intervals than either study alone. GPS added significant predictive value to each clinical classifier. A model utilizing GPS and CAPRA provided the most risk discrimination. In decision-curve analysis, greater net benefit was shown when combining GPS with each clinical classifier compared with the classifier alone. The area under the receiver operating characteristic curve improved from 0.68 to 0.73 by adding GPS to CAPRA, and 0.64 to 0.70 by adding GPS to NCCN risk group. The proportion of patients with LFP >80% increased from 11% using NCCN risk group alone to 23% using GPS with NCCN. Using GPS with CAPRA identified the highest proportion-31%-of patients with LFP >80%. Patient-specific MA provides more precise risk estimates that reflect the complete body of evidence. GPS adds predictive value to 3 widely used clinical classifiers, and identifies a larger proportion of low-risk patients than identified by clinical risk group alone.

Does the addition of targeted prostate biopsies to standard systemic biopsies influence treatment management for radiation oncologists?

To study the management impact that magnetic resonance imaging (MRI)-guided targeted prostate biopsies could provide relative to using only non-targeted systematic biopsies in men with clinically localized prostate cancer (PCa). A consecutive series of untreated men undergoing Artemis (MRI-ultrasonography fusion) biopsies between March 2010 and June 2013 was evaluated in this retrospective, institutional review board-approved study. Fusion biopsy included MRI-targeted and systematic sampling at the same session. 3-Tesla multiparametric MRI was performed at a median of 2weeks before biopsy. Patients were included if ≥1 systematic core was found to harbour PCa. The impact of the information obtained from targeted vs systematic biopsies was studied with regard to the following: Gleason score (GS), National Comprehensive Cancer Network (NCCN) risk reclassification, cancer core length, percentage of core positive for tumour involvement, and percentage of positive biopsy cores. The study sample included 215 men (mean ± sd age 66 ± 8years). The median (range) prostate-specific antigen (PSA) was 6.0 (0.7-181)ng/mL. The mean number of total biopsy samples was 18 (12 systematic and six targeted samples). Of 215 men, 34 (16%) had a higher GS on targeted vs systematic biopsy. A total of 21/183 men (12%) were stratified into a higher NCCN risk group when incorporating targeted biopsy GS results and 18/101 men (18%) were upgraded to intermediate- or high-risk from the low-risk group. Among the 34 men whose cancer severity was upgraded, increases in cancer core length, percentage of tumour involvement and percentage of cores involved were all statistically significant (P< 0.01). Targeted prostate biopsy provided information about GS, NCCN risk and tumour volume beyond that obtained in systematic biopsies, specifically increasing the proportions of men in the intermediate- and high-risk groups. Such men may be recommended for additional treatments (pelvic nodal irradiation or hormonal therapy). The appropriateness of changing treatment because of targeted biopsy results is still unclear.

MP4-03 CONTEMPORARY ACTIVE SURVEILLANCE RATES FOR NEWLY DIAGNOSED PROSTATE CANCER PATIENTS IN COMMUNITY UROLOGY PRACTICES

You have accessJournal of UrologyProstate Cancer: Epidemiology & Natural History I1 Apr 2015MP4-03 CONTEMPORARY ACTIVE SURVEILLANCE RATES FOR NEWLY DIAGNOSED PROSTATE CANCER PATIENTS IN COMMUNITY UROLOGY PRACTICES Jeremy Shelton, Phillip Buffington, Alec Koo, and Neal Shore Jeremy SheltonJeremy Shelton More articles by this author , Phillip BuffingtonPhillip Buffington More articles by this author , Alec KooAlec Koo More articles by this author , and Neal ShoreNeal Shore More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.146AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Active surveillance (AS) is an evidence-based option for the management of men with lower risk prostate cancer (PCa), There is, however, a paucity of data on its contemporary use - particularly in community-based urology practices- and concern exists regarding overtreatment. We sought to characterize the contemporary use of AS in a geographically diverse population of community-based urology practices. METHODS We performed a retrospective chart abstraction in 8 urology practices from 7 states (California, Colorado, Oregon, Ohio, Indiana, North Carolina and South Carolina), analyzing initial treatment choices among men ≤75 years old diagnosed during 2013 and 2014 with very low, low and intermediate risk prostate cancer, as per National Comprehensive Cancer Network (NCCN) criteria. A minimum of 6 months of documented follow-up from initial diagnosis was mandated for inclusion. AS was defined as either the specific documentation of AS in the chart, or, in the absence of documented treatment, as the occurrence of at least one PSA and one office visit within 6 months of diagnosis. We performed univariate analysis with the chi-square test and multinomial regression to evaluate the correlation of NCCN risk group, race, age, and urology practice on treatment choice. RESULTS Of 2464 incident cases, 1401 met inclusion criteria and 252 (17.3%) had very low-, 526 (36.1%) low- and 623 (42.7%) intermediate risk disease. The mean age was 63.6; 72.3% were white, 12.37% black, 4.2% other and 10.3% unknown. Initial primary therapeutic decisions are shown in the table. In multivariate analysis, risk group (p<0.001), age (p<0.001) and urology practice (p<0.001) predicted choice of active surveillance, while race (p=0.43) did not. Surgery and radiation use was equivalent within risk groups, with a trend toward higher use of surgery among men with intermediate risk disease, of whom 44.6% received surgery and 32.2% received radiation (p<0.06). CONCLUSIONS This contemporary analysis of 1401 patients from 8 geographically diverse, community-based large urology group practices within the US demonstrates a high adoption of active surveillance as an initial choice for men with newly diagnosed PCa. Variation in the rate of AS between practices may be an opportunity for educational benchmarking. Primary therapy choice by NCCN∗ risk group among men with incident prostate cancer in 2013 and 2014 treated in community urology practices Primary Therapy Very Low, n (%) Low, n (%) Intermediate, n (%) Total, n (%) Active surveillance 177 (70.2) 206 (39.2) 48 (7.7) 431 (30.1) Surgery 28 (11.1) 147 (28.0) 278 (44.6) 453 (32.3) Radiotherapy 30 (11.9) 125 (23.8) 207 (32.2) 362 (25.8) No follow-up 12 (4.8) 34 (6.5) 53 (8.5) 99 (7.1) Other 5 (2.0) 14 (2.7) 37 (5.9) 56 (4.0) Total 252 526 623 1,401 ∗ National Comprehensive Cancer Network © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e27-e28 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jeremy Shelton More articles by this author Phillip Buffington More articles by this author Alec Koo More articles by this author Neal Shore More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

A Biopsy-based 17-gene Genomic Prostate Score Predicts Recurrence After Radical Prostatectomy and Adverse Surgical Pathology in a Racially Diverse Population of Men with Clinically Low- and Intermediate-risk Prostate Cancer

BackgroundBiomarkers that are validated in independent cohorts are needed to improve risk assessment for prostate cancer (PCa). ObjectiveA racially diverse cohort of men (20% African American [AA]) was used to evaluate the association of the clinically validated 17-gene Genomic Prostate Score (GPS) with recurrence after radical prostatectomy and adverse pathology (AP) at surgery. Design, setting, and participantsBiopsies from 431 men treated for National Comprehensive Cancer Network (NCCN) very low-, low-, or intermediate-risk PCa between 1990 and 2011 at two US military medical centers were tested to validate the association between GPS and biochemical recurrence (BCR) and to confirm the association with AP. Metastatic recurrence (MR) was also evaluated. Outcome measurements and statistical analysisCox proportional hazards models were used for BCR and MR, and logistic regression was used for AP. Central pathology review was performed by one uropathologist. AP was defined as primary Gleason pattern 4 or any pattern 5 and/or pT3 disease. Results and limitationsGPS results (scale: 0–100) were obtained in 402 cases (93%); 62 men (15%) experienced BCR, 5 developed metastases, and 163 had AP. Median follow-up was 5.2 yr. GPS predicted time to BCR in univariable analysis (hazard ratio per 20 GPS units [HR/20 units]: 2.9; p<0.001) and after adjusting for NCCN risk group (HR/20 units: 2.7; p<0.001). GPS also predicted time to metastases (HR/20 units: 3.8; p=0.032), although the event rate was low (n=5). GPS was strongly associated with AP (odds ratio per 20 GPS units: 3.3; p<0.001), adjusted for NCCN risk group. In AA and Caucasian men, the median GPS was 30.3 for both, the distributions of GPS results were similar, and GPS was similarly predictive of outcome. ConclusionsThe association of GPS with near- and long-term clinical end points establishes the assay as a strong independent measure of PCa aggressiveness. Tumor aggressiveness, as measured by GPS, and outcomes were similar in AA and Caucasian men in this equal-access health care system. Patient summaryPredicting outcomes in men with newly diagnosed prostate cancer is challenging. This study demonstrates that a new molecular test, the Genomic Prostate Score, which can be performed on a patient's original prostate needle biopsy, can predict the aggressiveness of the cancer and help men make decisions regarding the need for immediate treatment of their cancer.

Prostate-Specific Antigen Bounce After Dose-Escalated Radiation Therapy for Prostate Cancer is an Independent Predictor for Distant Metastasis, Cancer-Specific Survival, and Overall Survival

Prostate-Specific Antigen Bounce After Dose-Escalated Radiation Therapy for Prostate Cancer is an Independent Predictor for Distant Metastasis, Cancer-Specific Survival, and Overall Survival

Increasing Use of Dose-Escalated External Beam Radiation Therapy for Men With Nonmetastatic Prostate Cancer

To examine recent practice patterns, using a large national cancer registry, to understand the extent to which dose-escalated external beam radiation therapy (EBRT) has been incorporated into routine clinical practice for men with prostate cancer. We conducted a retrospective observational cohort study using the National Cancer Data Base, a nationwide oncology outcomes database in the United States. We identified 98,755 men diagnosed with nonmetastatic prostate cancer between 2006 and 2011 who received definitive EBRT and classified patients into National Comprehensive Cancer Network (NCCN) risk groups. We defined dose-escalated EBRT as total prescribed dose of ≥75.6 Gy. Using multivariable logistic regression, we examined the association of patient, clinical, and demographic characteristics with the use of dose-escalated EBRT. Overall, 81.6% of men received dose-escalated EBRT during the study period. The use of dose-escalated EBRT did not vary substantially by NCCN risk group. Use of dose-escalated EBRT increased from 70.7% of patients receiving treatment in 2006 to 89.8% of patients receiving treatment in 2011. On multivariable analysis, year of diagnosis and use of intensity modulated radiation therapy were significantly associated with receipt of dose-escalated EBRT. Our study results indicate that dose-escalated EBRT has been widely adopted by radiation oncologists treating prostate cancer in the United States. The proportion of patients receiving dose-escalated EBRT increased nearly 20% between 2006 and 2011. We observed high utilization rates of dose-escalated EBRT within all disease risk groups. Adoption of intensity modulated radiation therapy was strongly associated with use of dose-escalated treatment.

MP62-11 OUTCOMES OF SCHEDULED VERSUS FOR CAUSE BIOPSY REGIMENS FOR PROSTATE CANCER ACTIVE SURVEILLANCE

You have accessJournal of UrologyProstate Cancer: Localized VII1 Apr 2014MP62-11 OUTCOMES OF SCHEDULED VERSUS FOR CAUSE BIOPSY REGIMENS FOR PROSTATE CANCER ACTIVE SURVEILLANCE Tareq Altartir, Christine Murekeyisoni, Diana Mehedint, Eric Kauffman, James Mohler, and Kristopher Attwood Tareq AltartirTareq Altartir More articles by this author , Christine MurekeyisoniChristine Murekeyisoni More articles by this author , Diana MehedintDiana Mehedint More articles by this author , Eric KauffmanEric Kauffman More articles by this author , James MohlerJames Mohler More articles by this author , and Kristopher AttwoodKristopher Attwood More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1968AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Accumulating data support active surveillance as a valid option for National Comprehensive Cancer Network (NCCN)low or select intermediate risk prostate cancer (CaP) patients. However, the need for, and timing of, surveillance prostate biopsy remains controversial. We compared 2 surveillance regimens that differed in whether or not patients were monitored with annual/biannual biopsy in addition to clinically indicated biopsy. METHODS 308 consecutive men who chose active surveillance for CaP management at an NCCN cancer center with ¡Ý 6 months follow-up were reviewed retrospectively. Patients were divided into 2 groups at initiation of surveillance; group 1 included patients of one surgeon who underwent biopsy based on clinical concern alone (for cause biopsy); group 2 included patients of 4 surgeons who intended biopsy annually or biannually in addition to for cause biopsy. The primary outcome measure was progression to treatment, and the secondary outcome measure was clinicopathologic progression in NCCN risk classification. Time to progression was compared between groups using Kaplan-Meier methods and log-rank tests. RESULTS Baseline characteristics of groups 1 and 2 were similar with respect to age, race, PSA, stage, Gleason grade, and NCCN risk group. At a mean/median follow-up of 36/29 months (range 6-212) for group 1 and 51/47 months (range 6-142) for group 2, no patient died of CaP and 1 patient developed metastasis in Group 2 after 123 months. Adjusting for differences in follow-up time, there was no significant difference between the 2 groups in rate of conversion to treatment (Figure). Group 2 trended towards increased risk for progression to a higher NCCN risk group, but this did not reach statistical significance (Figure). CONCLUSIONS The risks of conversion to treatment and NCCN risk group progression are similar whether or not one performs scheduled biopsy in addition to for cause biopsy. Longer follow- up with attention to metastasis and cancer-specific mortality outcomes is needed to identify the ideal surveillance program. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e721 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Tareq Altartir More articles by this author Christine Murekeyisoni More articles by this author Diana Mehedint More articles by this author Eric Kauffman More articles by this author James Mohler More articles by this author Kristopher Attwood More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

The impact of pelvic magnetic resonance imaging on risk stratification in patients with localized prostate cancer.

130 Background: We aimed to determine the impact of multiparametric magnetic resonance imaging (MRI) of the prostate on established risk stratification criteria in patients with clinically localized adenocarcinoma of the prostate (ACP). Methods: We included patients who had undergone multiparametric prostate MRI at our institution as part of their initial workup for ACP. Traditional risk stratification criteria (prostate specific antigen, clinical T stage, biopsy Gleason score) were recorded, and the initial National Comprehensive Cancer Network (NCCN) risk group was calculated. The NCCN risk group was then recalculated incorporating MRI findings. The impact of MRI findings on changes in risk group classification was evaluated using the Stuart-Maxwell test for marginal homogeneity. Results: Of 71 patients analyzed, 11 (15.5%), 39 (54.9%), and 21 (29.6%) had low, intermediate, and high risk disease, respectively. MRI findings led to risk group upstaging in 12 cases (16.9%). The highest yield was demonstrated in patients with intermediate-risk disease, in whom MRI led to upstaging in 25.6% of patients. The Stuart-Maxwell test demonstrated a significant difference between pre-MRI and post-MRI risk group classifications (p &lt;0.01) for the entire cohort. Pre-MRI and post-MRI risk groups for all patients are shown in the table, with off-diagonal elements representing risk group changes. MRI findings resulted in clearly documented changes in the treatment strategy for 5 patients (7.0%), including addition of androgen deprivation therapy in 2 patients, elimination of definitive therapy in 2 patients determined to have metastatic disease, and elimination of a brachytherapy boost in one patient. Conclusions: In our cohort of patients with clinically localized ACP, MRI findings often led to significant changes in risk stratification and treatment. Our findings support the routine use of MRI in the workup of patients with clinically localized ACP, particularly those with intermediate risk disease . [Table: see text]

A case‐mix‐adjusted comparison of early oncological outcomes of open and robotic prostatectomy performed by experienced high volume surgeons

To compare early oncological outcomes of robot assisted laparoscopic prostatectomy (RALP) and open radical prostatectomy (ORP) performed by high volume surgeons in a contemporary cohort. We reviewed patients who underwent radical prostatectomy for prostate cancer by high volume surgeons performing RALP or ORP. Biochemical recurrence (BCR) was defined as PSA ≥ 0.1 ng/mL or PSA ≥ 0.05 ng/mL with receipt of additional therapy. A Cox regression model was used to evaluate the association between surgical approach and BCR using a predictive model (nomogram) based on preoperative stage, grade, volume of disease and PSA. To explore the impact of differences between surgeons, multivariable analyses were repeated using surgeon in place of approach. Of 1454 patients included, 961 (66%) underwent ORP and 493 (34%) RALP and there were no important differences in cancer characteristics by group. Overall, 68% of patients met National Comprehensive Cancer Network (NCCN) criteria for intermediate or high risk disease and 9% had lymph node involvement. Positive margin rates were 15% for both open and robotic groups. In a multivariate model adjusting for preoperative risk there was no significant difference in BCR rates for RALP compared with ORP (hazard ratio 0.88; 95% CI 0.56-1.39; P = 0.6). The interaction term between nomogram risk and procedure type was not statistically significant. Using NCCN risk group as the covariate in a Cox model gave similar results (hazard ratio 0.74; 95% CI 0.47-1.17; P = 0.2). The interaction term between NCCN risk and procedure type was also non-significant. Differences in BCR rates between techniques (4.1% vs 3.3% adjusted risk at 2 years) were smaller than those between surgeons (2.5% to 4.8% adjusted risk at 2 years). In this relatively high risk cohort of patients undergoing radical prostatectomy we found no evidence to suggest that ORP resulted in better early oncological outcomes then RALP. Oncological outcome after radical prostatectomy may be driven more by surgeon factors than surgical approach.

306 VALIDATION OF D'AMICO, SEATTLE, AND NCCN RISK STRATIFICATIONS FOR PROSTATE CANCER IN JAPANESE POPULATION

You have accessJournal of UrologyProstate Cancer: Staging1 Apr 2011306 VALIDATION OF D'AMICO, SEATTLE, AND NCCN RISK STRATIFICATIONS FOR PROSTATE CANCER IN JAPANESE POPULATION Takuya Koie, Noriko Tokui, Teppei Okamoto, Kengo Imanishi, Yuichiro Suzuki, Naoki Sugiyama, Tohru Yoneyama, Shingo Hatakeyama, Shigemasa Kudoh, Kazuyuki Mori, Takahiro Yoneyama, Noritaka Kamimura, and Chikara Ohyama Takuya KoieTakuya Koie Hirosaki, Japan More articles by this author , Noriko TokuiNoriko Tokui Hirosaki, Japan More articles by this author , Teppei OkamotoTeppei Okamoto Hirosaki, Japan More articles by this author , Kengo ImanishiKengo Imanishi Hirosaki, Japan More articles by this author , Yuichiro SuzukiYuichiro Suzuki Hirosaki, Japan More articles by this author , Naoki SugiyamaNaoki Sugiyama Hirosaki, Japan More articles by this author , Tohru YoneyamaTohru Yoneyama Hirosaki, Japan More articles by this author , Shingo HatakeyamaShingo Hatakeyama Hirosaki, Japan More articles by this author , Shigemasa KudohShigemasa Kudoh Hirosaki, Japan More articles by this author , Kazuyuki MoriKazuyuki Mori Hirosaki, Japan More articles by this author , Takahiro YoneyamaTakahiro Yoneyama Hirosaki, Japan More articles by this author , Noritaka KamimuraNoritaka Kamimura Hirosaki, Japan More articles by this author , and Chikara OhyamaChikara Ohyama Hirosaki, Japan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.399AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The incidence of prostate cancer (Pca) is rapidly increasing in Asian population. A validated risk stratification for Asian people is necessary for appropriate treatment selection. AUA guideline recommends D'Amico's risk stratification for Pca. Other than D'Amico's risk stratification, Seattle group and National Comprehensive Cancer Network (NCCN) also postulate their own risk stratification. We examined whether these risk stratifications are applicable in Japanese population. METHODS From September 1993 to March 2010, 541 patients underwent radical prostatectomy for clinical stage T1c-T3 prostate cancer at our institution. The present study enrolled 370 patients who did not received neoadjuvant or adjuvant therapy. Biochemical recurrence-free survival (BRFS) rates were estimated using the Kaplan–Meier method, and the BRFS rates in the D'Amico, Seattle, and NCCN risk groups were compared using the log-rank statistic. RESULTS The mean age of the enrolled patients was 67.1 years, the median initial prostate-specific antigen (PSA) level was 7.61ng/ml, and the mean follow-up period was 44.4 months. According to D'Amico's risk stratification, 35, 280, and 60 patients were grouped into low-, intermediate-, and high-risk groups, respectively. On the basis of the Seattle risk stratification, 35, 282, and 53 patients were grouped into low-, intermediate-, and high-risk groups, respectively. According to the NCCN risk stratification, 30, 271, and 69 patients were grouped in low-, intermediate-, and high-risk groups, respectively. The BRFS rates at 44.4 months in the D'Amico low-, intermediate-, and high-risk groups were 83.1%, 79.6%, and 46.8%, respectively (P < 0.0001 at low and intermediate risk vs. high risk). The BRFS rates in the Seattle low-, intermediate-, and high-riskgroups were 79.8%, 79.8%, and 46.8%, respectively (P < 0.0001 at low and intermediate risk vs. high risk). The BRFS rates in the NCCN low-, intermediate-, and high-risk groups were 79.8%, 82.6%, and 46.8%, respectively (P < 0.0001 at low and intermediate risk vs. high risk). There was no statistically significant difference in BRFS between low-and intermediate-group in any risk stratifications. CONCLUSIONS The present risk stratification systems applied for biochemical recurrence after surgery could not discriminate Low- and Int-risk group in Japanese population. A new risk stratification is necessary for Asian population. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e124-e125 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Takuya Koie Hirosaki, Japan More articles by this author Noriko Tokui Hirosaki, Japan More articles by this author Teppei Okamoto Hirosaki, Japan More articles by this author Kengo Imanishi Hirosaki, Japan More articles by this author Yuichiro Suzuki Hirosaki, Japan More articles by this author Naoki Sugiyama Hirosaki, Japan More articles by this author Tohru Yoneyama Hirosaki, Japan More articles by this author Shingo Hatakeyama Hirosaki, Japan More articles by this author Shigemasa Kudoh Hirosaki, Japan More articles by this author Kazuyuki Mori Hirosaki, Japan More articles by this author Takahiro Yoneyama Hirosaki, Japan More articles by this author Noritaka Kamimura Hirosaki, Japan More articles by this author Chikara Ohyama Hirosaki, Japan More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...

The Percent of Positive Biopsy Cores Improves Prediction of Prostate Cancer–Specific Death in Patients Treated With Dose-Escalated Radiotherapy

To examine the prognostic utility of the percentage of positive cores (PPC) at the time of prostate biopsy for patients treated with dose-escalated external beam radiation therapy. We performed a retrospective analysis of patients treated at the University of Michigan Medical Center to at least 75 Gy. Patients were stratified according to PPC by quartile, and freedom from biochemical failure (nadir + 2 ng/mL), freedom from metastasis (FFM), cause-specific survival (CSS), and overall survival (OS) were assessed by log-rank test. Receiver operator characteristic (ROC) curve analysis was used to determine the optimal cut point for PPC stratification. Finally, Cox proportional hazards multivariate regression was used to assess the impact of PPC on clinical outcome when adjusting for National Comprehensive Cancer Network (NCCN) risk group and androgen deprivation therapy. PPC information was available for 651 patients. Increasing-risk features including T stage, prostate-specific antigen, Gleason score, and NCCN risk group were all directly correlated with increasing PPC. On log-rank evaluation, all clinical endpoints, except for OS, were associated with PPC by quartile, with worse clinical outcomes as PPC increased, with the greatest impact seen in the highest quartile (>66.7% of cores positive). ROC curve analysis confirmed that a cut point using two-thirds positive cores was most closely associated with CSS (p = 0.002; area under ROC curve, 0.71). On univariate analysis, stratifying patients according to PPC less than or equal to 66.7% vs. PPC greater than 66.7% was prognostic for freedom from biochemical failure (p = 0.0001), FFM (p = 0.0002), and CSS (p = 0.0003) and marginally prognostic for OS (p = 0.055). On multivariate analysis, after adjustment for NCCN risk group and androgen deprivation therapy use, PPC greater than 66.7% increased the risk for biochemical failure (p = 0.0001; hazard ratio [HR], 2.1 [95% confidence interval (CI), 1.4-3.0]) and FFM (p = 0.05; HR, 1.7 [95% CI, 1.1-2.9]) and marginally increased the risk for CSS (p = 0.057; HR, 2.1 [95% CI, 1.0-4.6]). PPC at the time of biopsy adds prognostic value for clinically meaningful endpoints for patients treated with dose-escalated radiation therapy. This was particularly true for NCCN-defined intermediate- and high-risk patients.

Improved Biochemical Outcomes With Statin Use in Patients With High-Risk Localized Prostate Cancer Treated With Radiotherapy

To investigate the association between 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) and biochemical and survival outcomes after high-dose radiotherapy (RT) for prostate cancer. A total of 1711 men with clinical stage T1-T3 prostate cancer were treated with conformal RT to a median dose of 81 Gy during 1995-2007. Preradiotherapy medication data were available for 1681 patients. Three hundred eighty-two patients (23%) were taking a statin medication at diagnosis and throughout RT. Nine hundred forty-seven patients received a short-course of neoadjuvant and concurrent androgen-deprivation therapy (ADT) with RT. The median follow-up was 5.9 years. The 5- and 8-year PSA relapse-free survival (PRFS) rates for statin patients were 89% and 80%, compared with 83% and 74% for those not taking statins (p=0.002). In a multivariate analysis, statin use (hazard ratio [HR] 0.69, p=0.03), National Comprehensive Cancer Network (NCCN) low-risk group, and ADT use were associated with improved PRFS. Only high-risk patients in the statin group demonstrated improvement in PRFS (HR 0.52, p=0.02). Across all groups, statin use was not associated with improved distant metastasis-free survival (DMFS) (p=0.51). On multivariate analysis, lower NCCN risk group (p=0.01) and ADT use (p=0.005) predicted improved DMFS. Statin use during high-dose RT for clinically localized prostate cancer was associated with a significant improvement in PRFS in high-risk patients. These data suggest that statins have anticancer activity and possibly provide radiosensitization when used in conjunction with RT in the treatment of prostate cancer.