Risk Of Reclassification Research Articles

Annual mpMRI surveillance: PI-RADS upgrading and increasing trend correlated with patients who harbor clinically significant disease

IntroductionProstate cancer screening has routinely identified men with very low- or low-risk disease, per the National Comprehensive Cancer Network guidelines. Current literature has demonstrated that the most appropriate management strategy for these patients is active surveillance (AS). The mainstay of AS includes periodic biopsies and biannual prostate-specific antigen tests. However, multiparametric magnetic resonance imaging (mpMRI) is uniquely posed to improve patient surveillance. This study aimed to evaluate the utility of an annual mpMRI in patients on AS, focusing on radiologic upgrading and Prostate Imaging-Reporting and Data System (PI-RADS) trends as indicators of clinically significant disease. MethodsThis prospective, single intuition, study enrolled 208 patients on AS who had at least two biopsies and 1 mpMRI with a median follow-up of 5.03 years. The main outcome variable was time to Gleason grade (GG) reclassification. ResultsAfter delineating patients on their initial PI-RADS score, men with score 3 and 5 lesions at first MRI had comparable GG reclassification-free survival to their counterparts. Conversely, men with initial PI-RADS 4 lesions showed a lower 5-year GG reclassification-free survival compared to those with PI-RADS score 1–2. The cohort was then subset to 70 patients who obtained ≥2 mpMRIs on protocol. Men experiencing uptrending mpMRI scores had an increased risk of GG reclassification, with a 35.4% difference in 5 year GG reclassification-free survival probability on the Kaplan-Meier curve analysis. ConclusionIn conclusion, this study demonstrates that for men on AS with stable recapitulated disease, an annual MRI may replace repeat biopsies after confirmatory sampling has been obtained. On the other hand, men who initiate AS with PI-RADS 4 and/or who display uptrending mpMRI scores require periodic biopsies along with repeat imaging. This study highlights the utility of integrating an annual MRI into AS protocols, thus promising a more effective approach to management.

The Impact of Physical Activity on the Outcomes of Active Surveillance in Prostate Cancer Patients: A Scoping Review

Introduction: Active surveillance has emerged as a valid therapeutic option in patients with low-risk prostate cancer, allowing for the deferral of definitive treatment until the time of possible disease progression. Although it is known that physical activity plays a protective role in the onset and progression of this tumor, its impact on patients with low-risk disease who are managed with active surveillance remains unclear. Our scoping review aims to summarize the existing evidence on this subject. Evidence Acquisition: On 9 April 2023, a systematic search was conducted using the PubMed and Scopus databases. The search employed the combination of the following terms: (“prostate cancer” OR “prostate tumor”) AND (“active surveillance”) AND (“physical activity” OR “physical exercise” OR “physical intensive activity” OR “intensive exercise”) AND (“lifestyle”). Out of the 506 identified articles, 9 were used for the present scoping review, and their results were reported according to the PRISMA-ScR statement. Evidence Synthesis: We discovered a lack of uniformity in the assessment of PA and its stratification by intensity. There was no consensus regarding what constitutes cancer progression in patients choosing expectant management. In terms of the impact of PA on AS outcomes, conflicting results were reported: some authors found no correlation, while others (six of total studies included) revealed that active men experience smaller increases in PSA levels compared to their sedentary counterparts. Additionally, higher levels of exercise were associated with a significantly reduced risk of PCa reclassification. Conclusion: Due to the heterogeneity of the methodologies used in the available studies and the conflicting results reported, it is not possible to draw definitive conclusions concerning the role physical activity may play in the risk of prostate cancer progression in men managed with active surveillance.

Oncological Outcomes in Men With Favorable Intermediate Risk Prostate Cancer Enrolled in Active Surveillance.

To evaluate the long-term oncological outcomes in men with intermediate risk prostate cancer (PCa) enrolled in active surveillance (AS). From April 2015 to December 2022, 30 men with Gleason score 3+4/ISUP Grade Group2 (GG2), greatest percentage of cancer (GPC) ≤50%, Gleason pattern 4 ≤10%, ≤3 positive biopsy cores were enrolled in AS. All patients underwent confirmatory transperineal saturation biopsy (SPBx: 20 cores) 12 months from diagnosis plus multiparametric magnetic resonance (mpMRI) evaluation. At the last follow-up, 68Ga prostate-specific membrane antigen (PSMA) positron-emission tomography (PET)/computed tomography (CT) was added: lesions with PIRADS score ≥3 and/or standardized uptake value (SUVmax) >5 were submitted to four targeted cores. Three out of 30 (10%) men with GG2 PCa were reclassified at confirmatory biopsy. At the last follow-up (median 5.2 years), only 2 of 27 (7.4%) men were reclassified and 23/30 (76.6%) continued AS. Men with favorable GG2 PCa enrolled in AS have good long-term oncological results. The use of selective criteria (i.e., SPBx, mpMRI, PSMA PET/CT) reduces the risk of reclassification.

Risk of reclassification of GPC into a fixed-term employment contract

What conditions in the GPC contract entail the risk of reclassification into a fixed-term employment contract? Is it possible to conclude a GPC agreement with a loader if this position is present in the state of the institution? How to prove that the GPC contract is not labor?

Optimal Long-Term Health Insurance Contracts: Characterization, Computation, and Welfare Effects

Abstract Reclassification risk is a major concern in health insurance where contracts are typically 1 year in length but health shocks often persist for much longer. While most health systems with private insurers pair short-run contracts with substantial pricing regulations to reduce reclassification risk, long-term contracts with one-sided insurer commitment have significant potential to reduce reclassification risk without the negative side effects of price regulation, such as adverse selection. We theoretically characterize optimal long-term insurance contracts with one-sided commitment, extending the literature in directions necessary for studying health insurance markets. We leverage this characterization to provide a simple algorithm for computing optimal contracts from primitives. We estimate key market fundamentals using data on all under-65 privately insured consumers in Utah. We find that dynamic contracts are very effective at reducing reclassification risk for consumers who arrive at the market in good health, but they are ineffective for consumers who come to the market in bad health, demonstrating that there is a role for the government insurance of pre-market health risks. Individuals with steeply rising income profiles find front-loading costly, and thus relatively prefer ACA-type exchanges. Switching costs enhance, while myopia moderately compromises, the performance of dynamic contracts.

MP38-08 IS A CONFIRMATORY PROSTATE BIOPSY BEFORE ENTRY INTO AN ACTIVE SURVEILLANCE PROTOCOL STILL NECESSARY IN THE ERA OF PROSTATE CANCER DIAGNOSIS WITH MRI-GUIDED BIOPSY?

You have accessJournal of UrologyCME1 Apr 2023MP38-08 IS A CONFIRMATORY PROSTATE BIOPSY BEFORE ENTRY INTO AN ACTIVE SURVEILLANCE PROTOCOL STILL NECESSARY IN THE ERA OF PROSTATE CANCER DIAGNOSIS WITH MRI-GUIDED BIOPSY? Omri Schwarztuch Gildor, Anna Itshak, Yarden Fleischer, Ilan Leibovitch, Itay Sagy, and Itay Sternberg Omri Schwarztuch GildorOmri Schwarztuch Gildor More articles by this author , Anna ItshakAnna Itshak More articles by this author , Yarden FleischerYarden Fleischer More articles by this author , Ilan LeibovitchIlan Leibovitch More articles by this author , Itay SagyItay Sagy More articles by this author , and Itay SternbergItay Sternberg More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003276.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In patients with low-risk prostate cancer who are considering active surveillance (AS), it is common to repeat a biopsy within a year of diagnosis, as a confirmatory biopsy. The necessity of this biopsy was tested in the era before diagnosis based on MRI and showed a risk of 25-35% for reclassification in the confirmatory biopsy. Currently, most biopsies and new diagnoses of patients with a tumor suitable for AS are performed under the guidance of MRI. Our goal is to check the chance of reclassification when the diagnosis was made with an MRI-guided biopsy. METHODS: A retrospective review of all confirmatory biopsies performed at our center between 2015-2021. Data were collected about the diagnostic biopsy and the confirming biopsy based on the medical sheet and the pathological report. RESULTS: Of the 114 patients who underwent a confirmatory biopsy during the study period, 75 (65.8%) were diagnosed with a TRUS biopsy (group 1) and 39 (34.2%) with an MRI-guided biopsy (group 2). Patient age, PSA level, prostate size, PSA-D, and MRI findings were similar between groups. All confirmatory biopsies were performed with MRI guidance and included also systematic sampling. Reclassification to grade group (GG) ≥ 2 in the confirming biopsy was found in 31/75 (41.3%) and 15/39 (38.5%) patients in groups 1 and 2, respectively. This difference is not statistically significant (p=0.77). Similar reclassification rate (3/8, 37.5%) occurred in a subgroup (of group 2) of patients with previous negative systematic biopsy. In 9/75 (12.0%) and 4/39 (10.3%) patients in groups 1 and 2, respectively, the MRI-guided samples were found without significant prostate cancer and reclassification was made only because of the systematic samples. CONCLUSIONS: The risk of reclassification in a confirmatory biopsy continues to be significant even in the era of MRI-guided diagnosis of prostate cancer. We emphasize the importance of continuing to perform confirmatory biopsies and ensuring systematic sampling alongside sampling the region of interest. Source of Funding: Self funding © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e526 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Omri Schwarztuch Gildor More articles by this author Anna Itshak More articles by this author Yarden Fleischer More articles by this author Ilan Leibovitch More articles by this author Itay Sagy More articles by this author Itay Sternberg More articles by this author Expand All Advertisement PDF downloadLoading ...

MP38-03 DOES PROSTATE CANCER FAMILY HISTORY HAVE AN IMPACT ON ACTIVE SURVEILLANCE ADHERENCE IN MEN WITH LOW- OR FAVOURABLE INTERMEDIATE RISK DISEASE?

You have accessJournal of UrologyCME1 Apr 2023MP38-03 DOES PROSTATE CANCER FAMILY HISTORY HAVE AN IMPACT ON ACTIVE SURVEILLANCE ADHERENCE IN MEN WITH LOW- OR FAVOURABLE INTERMEDIATE RISK DISEASE? Riccardo Leni, Armando Stabile, Giorgio Gandaglia, Vito Cucchiara, Marco Bandini, Elio Mazzone, Leonardo Quarta, Paolo Zaurito, Francesco De Cobelli, Giorgio Brembilla, Nicola Fossati, Lugano, Switzerland, Emanuele Zaffuto, Marco Moschini, Giulio Avesani, Federico Dehò, Francesco Montorsi, and Alberto Briganti Riccardo LeniRiccardo Leni More articles by this author , Armando StabileArmando Stabile More articles by this author , Giorgio GandagliaGiorgio Gandaglia More articles by this author , Vito CucchiaraVito Cucchiara More articles by this author , Marco BandiniMarco Bandini More articles by this author , Elio MazzoneElio Mazzone More articles by this author , Leonardo QuartaLeonardo Quarta More articles by this author , Paolo ZauritoPaolo Zaurito More articles by this author , Francesco De CobelliFrancesco De Cobelli More articles by this author , Giorgio BrembillaGiorgio Brembilla More articles by this author , Nicola FossatiNicola Fossati More articles by this author , Lugano Lugano More articles by this author , Switzerland Switzerland More articles by this author , Emanuele ZaffutoEmanuele Zaffuto More articles by this author , Marco MoschiniMarco Moschini More articles by this author , Giulio AvesaniGiulio Avesani More articles by this author , Federico DehòFederico Dehò More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003276.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Men with family history (FH) of prostate cancer (PCa) on active surveillance (AS) for low grade PCa are at higher risk of reclassification. In these patients, however, adherence to AS may be influenced by factors other than reclassification. We assessed the relationship between FH and AS drop-out without evidence of reclassification compared to patients without FH. METHODS: We identified 779 men on AS for grade group 1 or 2 PCa at our Institution (2005-2021). Reclassification was defined as an increase in Gleason score from diagnosis. The cumulative incidence function estimated the 5-year discontinuation rate without reclassification according to FH (any-degree, vs no FH), with discontinuation for reclassification as a competing event. The Fine and Gray model was used to derive the adjusted sub-distribution hazard ratios (aSHR). A sensitivity analysis was conducted incorporating a definition of volume reclassification (>33% of cores involved or >50% of a single core involved), and the NCCN definition of strong FH (≥1 first-degree or ≥2 second-degree relatives). To assess clinical utility, we evaluated rates of adverse pathology ([AP], grade group ≥2, extracapsular extension, or positive lymph nodes) in 246 men who underwent delayed radical prostatectomy (RP) according to the reason for discontinuation. RESULTS: Median age was 65 years (59-70 yrs), 135 men (18%) had FH, and 112 (14%) had strong FH. Median follow-up was 50 months, the overall 5-year reclassification rate was 42%. The overall 5-year rate of discontinuation without reclassification was 23% (n=118). The cumulative incidence of 5-year discontinuation without reclassification in patients with, vs without FH was 27% vs 15% (aSHR 1.61, p=0.029). The effect of FH on discontinuation without reclassification remained significant in all sensitivity analyses. No difference was observed in terms of AP at delayed RP according to FH in those reclassified vs those treated without reclassification (all p>0.05). CONCLUSIONS: Although FH is associated with higher risk of reclassification, almost a third of men with positive FH discontinue AS without evidence of progression. The absence of a difference in AP rates at delayed RP should guide patient counseling about safety of AS also in men with FH. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e524 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Riccardo Leni More articles by this author Armando Stabile More articles by this author Giorgio Gandaglia More articles by this author Vito Cucchiara More articles by this author Marco Bandini More articles by this author Elio Mazzone More articles by this author Leonardo Quarta More articles by this author Paolo Zaurito More articles by this author Francesco De Cobelli More articles by this author Giorgio Brembilla More articles by this author Nicola Fossati More articles by this author Lugano More articles by this author Switzerland More articles by this author Emanuele Zaffuto More articles by this author Marco Moschini More articles by this author Giulio Avesani More articles by this author Federico Dehò More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement PDF downloadLoading ...

MP38-18 INCORPORATING THE PRECISE RECOMMENDATIONS TO EVALUATE PROGRESSION IN MEN ON ACTIVE SURVEILLANCE FOR LOW-GRADE PROSTATE CANCER: WHICH PATIENTS WITH LOW PRECISE SCORE NEED A CONFIRMATORY BIOPSY?

You have accessJournal of UrologyCME1 Apr 2023MP38-18 INCORPORATING THE PRECISE RECOMMENDATIONS TO EVALUATE PROGRESSION IN MEN ON ACTIVE SURVEILLANCE FOR LOW-GRADE PROSTATE CANCER: WHICH PATIENTS WITH LOW PRECISE SCORE NEED A CONFIRMATORY BIOPSY? Riccardo Leni, Giorgio Gandaglia, Armando Stabile, Vito Cucchiara, Elio Mazzone, Giuseppe Rosiello, Daniele Robesti, Antony Pellegrino, Mattia Longoni, Pietro Scilipoti, Emanuele Zaffuto, Francesco De Cobelli, Brembilla Giorgio, Francesco Giganti, Francesco Montorsi, and Alberto Briganti Riccardo LeniRiccardo Leni More articles by this author , Giorgio GandagliaGiorgio Gandaglia More articles by this author , Armando StabileArmando Stabile More articles by this author , Vito CucchiaraVito Cucchiara More articles by this author , Elio MazzoneElio Mazzone More articles by this author , Giuseppe RosielloGiuseppe Rosiello More articles by this author , Daniele RobestiDaniele Robesti More articles by this author , Antony PellegrinoAntony Pellegrino More articles by this author , Mattia LongoniMattia Longoni More articles by this author , Pietro ScilipotiPietro Scilipoti More articles by this author , Emanuele ZaffutoEmanuele Zaffuto More articles by this author , Francesco De CobelliFrancesco De Cobelli More articles by this author , Brembilla GiorgioBrembilla Giorgio More articles by this author , Francesco GigantiFrancesco Giganti More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003276.18AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The PRECISE score evaluates MRI characteristics for prostate cancer (PCa) patients with serial scans during active surveillance (AS). Although patients with reassuring characteristics at follow-up MRI (PRECISE 1-3) might have low risk of reclassification, a subgroup of these men should receive a re-biopsy. METHODS: We identified 207 PCa patients on AS (2016-2022) with at least two consecutive MRIs assessed with the PRECISE recommendations. Follow-up biopsies were performed at clinical or radiological progression. One radiologist reviewed the images and retrospectively assigned the PRECISE score. Reclassification was defined as an increase in biopsy grade group from baseline biopsy. Kaplan-Meier analyses assessed reclassification-free survival (RFS). Cox regression tested the prognostic impact of the first PRECISE score. Multivariable Cox regression tested predictors of reclassification among men with reassuring characteristics (PRECISE 1-3). RESULTS: Overall, 144 men had visible lesions (PI-RADS 3-5) at baseline scan. At a median follow-up of 43 months, 21 patients had MRI regression (PRECISE 1-2), 54 were stable without lesions (PRECISE 3), 98 were stable with lesions (PRECISE 3), and 34 had progression (PRECISE 4-5). The 5-year RFS for PRECISE 1-2, non-visible 3, visible 3, and 4-5 was 85%, 73%, 57%, and 52% (Figure 1a). A PRECISE score of 4-5 was an independent predictor of reclassification (HR 4.62, p=0.01). At two years from the second MRI, RFS was 91% for PI-RADS 1-3 and PSAD <0.15 ng/cc/cc, and 55% for either PI-RADS 4-5 or PSAD ≥0.15 ng/cc/cc (p<0.001, Figure 1b). At multivariable analyses suspicious findings at the second scan (PI-RADS 4-5, HR 3.47, p=0.001), and PSAD ≥0.15 ng/cc/cc (HR 2.17, p=0.03) were independently associated with reclassification among men with PRECISE 1-3 score. CONCLUSIONS: Up to 50% of men with PRECISE 1-3 MRIs and PSAD ≥0.15 ng/cc/cc or PI-RADS 4-5 lesions at first MRI experience reclassification at 2-year. Despite stable MRI, these patients should undergo a re-biopsy. In patients with signs of progression, or persistence of visible lesions, a more stringent follow-up is warranted. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e531 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Riccardo Leni More articles by this author Giorgio Gandaglia More articles by this author Armando Stabile More articles by this author Vito Cucchiara More articles by this author Elio Mazzone More articles by this author Giuseppe Rosiello More articles by this author Daniele Robesti More articles by this author Antony Pellegrino More articles by this author Mattia Longoni More articles by this author Pietro Scilipoti More articles by this author Emanuele Zaffuto More articles by this author Francesco De Cobelli More articles by this author Brembilla Giorgio More articles by this author Francesco Giganti More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement PDF downloadLoading ...

MP38-11 IS THERE AN IMPACT OF THE CENTER PERFORMING BASELINE MULTIPARAMETRIC MRI ON ACTIVE SURVEILLANCE OUTCOMES IN PROSTATE CANCER PATIENTS?

You have accessJournal of UrologyCME1 Apr 2023MP38-11 IS THERE AN IMPACT OF THE CENTER PERFORMING BASELINE MULTIPARAMETRIC MRI ON ACTIVE SURVEILLANCE OUTCOMES IN PROSTATE CANCER PATIENTS? Riccardo Leni, Armando Stabile, Giorgio Gandaglia, Vito Cucchiara, Giuseppe Rosiello, Elio Mazzone, Gabriele Sorce, Francesco Pellegrino, Simone Scuderi, Daniele Robesti, Donato Cannoletta, Mario De Angelis, Leonardo Quarta, Paolo Zaurito, Giorgio Brembilla, Francesco De Cobelli, Francesco Montorsi, and Alberto Briganti Riccardo LeniRiccardo Leni More articles by this author , Armando StabileArmando Stabile More articles by this author , Giorgio GandagliaGiorgio Gandaglia More articles by this author , Vito CucchiaraVito Cucchiara More articles by this author , Giuseppe RosielloGiuseppe Rosiello More articles by this author , Elio MazzoneElio Mazzone More articles by this author , Gabriele SorceGabriele Sorce More articles by this author , Francesco PellegrinoFrancesco Pellegrino More articles by this author , Simone ScuderiSimone Scuderi More articles by this author , Daniele RobestiDaniele Robesti More articles by this author , Donato CannolettaDonato Cannoletta More articles by this author , Mario De AngelisMario De Angelis More articles by this author , Leonardo QuartaLeonardo Quarta More articles by this author , Paolo ZauritoPaolo Zaurito More articles by this author , Giorgio BrembillaGiorgio Brembilla More articles by this author , Francesco De CobelliFrancesco De Cobelli More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003276.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Magnetic resonance imaging (MRI) of the prostate has been incorporated as a tool to confirm eligibility for active surveillance (AS). The impact of radiologist expertise on MRI diagnostic performance has been widely demonstrated. However, the increased number of centers performing MRI has increased the variability of both quality and performance. In this study, we assessed the diagnostic accuracy of MRI performed at a single high volume center vs external centers for patients under AS. METHODS: We identified 535 men on AS at our Institution with baseline MRI and at least one surveillance biopsy (sBx). MRIs were stratified according to centers performing the scan (high volume single center performing > 500 MRIs per year vs external centers) and to the detection of visible lesions (negative: PI-RADS 1-2, positive: PI-RADS 3-5). Reclassification was defined as increase in Gleason score at sBx, or higher disease volume ( >33% of involved cores, or >50% of a single core involved). Reclassification-free survival (RFS) was estimated with the Kaplan-Meier method. A Cox model tested the prognostic impact of the center performing MRI according to lesion visibility, after adjusting for covariates. RESULTS: Median age was 65 years (IQR 59-70), 52% (n=280) and 48% (n=255) of patients underwent baseline MRI at our Institution (internal) vs external Institutions. A lower proportion of negative scans was observed among the external MRI scans (18% vs 35%, p<0.001). After a median follow-up of 43 months, 47% (n=253) of men were reclassified. The 5-year RFS was 76% vs 40% for internal vs external negative MRI scans (p<0.001). A negative external MRI was associated with a 1.98-fold increased risk of reclassification compared to a negative internal MRI (95% CI 1.07-3.65, p=0.03). In contrast, the 5-year RFS was 37% vs 35% for internal vs external positive MRI scans, respectively (p=0.2). CONCLUSIONS: We demonstrated that the negative predictive value of MRI scans performed at high volume centers is significantly higher compared to MRIs performed externally. Our findings indirectly support the need for centralization of MRIs in men on AS, as well as the invariable need of follow-up biopsies for those with negative MRIs performed externally. Source of Funding: None. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e528 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Riccardo Leni More articles by this author Armando Stabile More articles by this author Giorgio Gandaglia More articles by this author Vito Cucchiara More articles by this author Giuseppe Rosiello More articles by this author Elio Mazzone More articles by this author Gabriele Sorce More articles by this author Francesco Pellegrino More articles by this author Simone Scuderi More articles by this author Daniele Robesti More articles by this author Donato Cannoletta More articles by this author Mario De Angelis More articles by this author Leonardo Quarta More articles by this author Paolo Zaurito More articles by this author Giorgio Brembilla More articles by this author Francesco De Cobelli More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement PDF downloadLoading ...

Is Active Surveillance an Option for the Management of Men with Low-grade Prostate Cancer and a Positive Family History? Results from a Large, Single-institution Series

BackgroundFamily history (FH) of prostate cancer (PCa) is associated with an increased risk of PCa and adverse disease features. However, whether patients with localized PCa and FH could be considered for active surveillance (AS) remains controversial. ObjectiveTo assess the association between FH and reclassification of AS candidates, and to define predictors of adverse outcomes in men with positive FH. Design, setting, and participantsOverall, 656 patients with grade group (GG) 1 PCa included in an AS protocol at a single institution were identified. Outcome measurements and statistical analysisKaplan-Meier analyses assessed the time to reclassification (GG ≥2 and GG ≥3 at follow-up biopsies) overall and according to FH status. Multivariable Cox regression tested the impact of FH on reclassification and identified the predictors among men with FH. Men treated with delayed radical prostatectomy (n = 197) or external-beam radiation therapy (n = 64) were identified, and the impact of FH on oncologic outcomes was assessed. Results and limitationsOverall, 119 men (18%) had FH. The median follow-up was 54 mo (interquartile range 29–84 mo), and 264 patients experienced reclassification. The 5-yr reclassification-free survival rate was 39% versus 57% for FH versus no FH (p = 0.006), and FH was associated with reclassification to GG ≥2 (hazard ratio [HR] 1.60, 95% confidence interval [CI] 1.19–2.15, p = 0.002). In men with FH, the strongest predictors of reclassification were prostate-specific antigen (PSA) density (PSAD), high-volume GG 1 (≥33% of cores involved or ≥50% of any core involved), and suspicious magnetic resonance imaging (MRI) of the prostate (HRs 2.87, 3.04, and 3.87, respectively; all p < 0.05). No association between FH, adverse pathologic features, and biochemical recurrence was observed (all p > 0.05). ConclusionsPatients with FH on AS are at an increased risk of reclassification. Negative MRI, low disease volume, and low PSAD identify men with FH and a low risk of reclassification. Nonetheless, sample size and wide CIs entail caution in drawing conclusions based on these results. Patient summaryWe tested the impact of family history in men on active surveillance for localized prostate cancer. A significant risk of reclassification, but not adverse oncologic outcomes after deferred treatment, prompts the need for cautious discussion with these patients, without precluding initial expectant management.

Incorporation size of lymph node metastasis focus and pre-ablation stimulated Tg could more effectively predict clinical outcomes in differentiated thyroid cancer patients without distant metastases.

The size of lymph node metastasis (LNM) and pre-ablation stimulated Tg (ps-Tg) were key predictors of clinical prognosis in differentiated thyroid cancer (DTC) patients, however, very few studies combine the above two as predictors of clinical prognosis of DTC patients. Persistent/recurrent disease and clinicopathologic factors were analyzed in 543 DTC patients without distant metastases who underwent LN dissection, near-total/total thyroidectomy, and radioiodine ablation. In the multivariate analysis, size of LNM, ps-Tg, and the activity of 131I significantly correlated with long-term remission. The optimal cutoff size of LNM 0.4 cm-1.4 cm (intermediate-risk patients) and >1.4cm (high-risk patients) increased the recurrence risk (hazard ratio [95% CI], 4.674 [2.881-7.583] and 13.653 [8.135-22.913], respectively). Integration of ps-Tg into the reclassification risk stratification showed that ps-Tg ≤ 10.0 ng/mL was relevant to a greatly heightened possibility of long-term remission (92.2%-95.4% in low-risk patients, 67.3%-87.0% in intermediate-risk patients, and 32.3%-57.7% in high-risk patients). The cutoff of 0.4cm and 1.4cm for a definition of size of LNM in DTC patients without distant metastases can reclassify risk assessment, and incorporating ps-Tg could more effectively predict clinical outcomes and modify the postoperative management plan.

Impact of an Expanded Definition of Family History on Outcomes of Active Surveillance for Prostate Cancer.

Despite family history being an established risk factor for prostate cancer, the role of a broader definition of family history inclusive of not just prostate cancer but other genetically related malignancies has not been investigated in the active surveillance population. Here, we evaluate the impact of an expanded definition of family history on active surveillance outcomes. Patients undergoing active surveillance for prostate cancer at Massachusetts General Hospital from 1997-2019 with detailed data available on family cancer history were identified. Primary outcome was biopsy progression-free survival, and secondary outcomes were treatment-free survival, adverse pathological features at prostatectomy, and biochemical recurrence after treatment. Statistical analyses were conducted using the Kaplan-Meier method and Cox regression. Among 855 evaluable patients, 300 (35.1%) patients had any family history of prostate cancer, and 95 (11.1%) had a family history of related malignancies suggestive of a hereditary cancer syndrome. Family history of prostate cancer alone was not associated with biopsy progression, whereas family history suggestive of a hereditary cancer syndrome was associated with a significantly increased risk of biopsy progression (HR 1.43, 95%CI 1.01-2.02), independent of other known clinicopathological risk factors in multivariable analysis. Similarly, family history suggestive of a hereditary cancer syndrome was associated with significantly lower treatment-free survival (HR 1.58, 95%CI 1.14-2.18) in multivariable analysis. No significant association was found between family history and adverse features on surgical pathology or biochemical recurrence. An expanded family history suggestive of a hereditary cancer syndrome is an independent predictor of biopsy progression during active surveillance. Men with such a family history may still be offered active surveillance but should be counseled regarding the higher risk of disease progression.

Validating the total cancer location density metric for stratifying patients with low-risk localized prostate cancer at higher risk of grade group reclassification while on active surveillance.

To validate a previously proposed prognostic metric, Total Cancer Location (TCLo) density, in a contemporary cohort of men with grade group (GG) 1 prostate cancer (PCa) on active surveillance (AS). We evaluated 123 patients who entered AS with maximum GG1 PCa at diagnostic and/or confirmatory biopsy. TCLo was defined as the total number of PCa locations identified on both biopsy sessions. TCLo density was calculated as TCLo / prostate volume [ml]. Primary endpoint was progression-free survival (PFS), defined as time from confirmatory biopsy to grade group reclassification (GGR) on repeat biopsy or prostatectomy. Optimal cut-point for TCLo density was predefined in a previously reported cohort and applied to this contemporary cohort. Kaplan-Meier and multivariable Cox regression analysis were used to estimate the association of predictors with PFS. During median follow-up of 7.8 years, (IQR 7.3-8.2) 34 men had GGR. Using previously defined cut-points, PFS at 5-years was 60% (95% CI: 44%-81%) vs. 89% (95% CI: 83%-96%) in men with high (≥0.06 ml-1) vs. low (<0.06 ml-1) TCLo density, and 63% (95% CI: 48%-82%) vs. 90% (95% CI: 83%-96%) in men with high (≥3) vs. low (≤2) TCLo (log-rank test: P < 0.0001, respectively). Adjusting for age, prostate volume, percent of positive cores and PSA, both higher TCLo density (HR [per 0.01 ml-1 increase]: 1.18, 95% CI: 1.05-1.33, P = 0.005) and TCLo (HR: 1.69, 95% CI: 1.20-2.38, P = 0.002) were associated with shorter PFS. The previously suggested prognostic value of TCLo density was confirmed in this validation cohort. TCLo alone performed similarly well. Patients with high TCLo density (≥0.06 ml-1) or TCLo (>2) were at greater risk of GGR while on AS. With external validation, these metric may help guide risk-adapted surveillance protocols.

P876 Disease course of Inflammatory Bowel Disease Unclassified in adult patients : a population-based study (1988-2014)

Abstract Background Inflammatory bowel disease unclassified (IBDU) represents 1 to 20 % of inflammatory bowel disease (IBD). There are few data on the natural history of IBDU. The aim of this study was to evaluate the disease course of IBDU in a population-based cohort. Methods All patients diagnosed with IBDU between 1988 and 2014, aged &amp;gt; 17 years at diagnosis, and prospectively enrolled in a population-based registry, were followed until diagnostic reclassification as Crohn’s disease (CD) or ulcerative colitis (UC), or date of loss of follow-up. Clinical presentations at diagnosis of IBDU, CD or UC were compared. The probability of diagnostic reclassification of IBDU during follow-up was studied by the Kaplan-Meier method, and its variation factors by Cox models. Results A total of 480 patients with an initial diagnosis of IBDU were included, representing 3.6% of incident IBD cases in the registry. The probability of IBDU diagnosis within IBD significantly decrease over the study period (6.2% from 1988 to 1996, 3.3% from 1997 to 2005 and 2.1% from 2006 to 2014, p&amp;lt;0.0001). Small bowel exploration and gastroscopy rates at diagnosis were significantly lower in IBDU than in UC and CD. Of these 480 patients, 388 were followed up, with a median duration of 2.4 years (IQR: 0.5-9.5). The cumulative probability of reclassification of IBDU was 17% at 1 year, 41% at 5 years, and 54% at 10 years (median time since initial diagnosis: 8.0 years (IQR: 6.3-12.0)); the probability of reclassification to UC was 10% at 1 year, 22% at 5 years, and 30% at 10 years, and to CD was 5%, 13%, and 18%, respectively. The median time to diagnostic reclassification decreased over the study period (14.3 years (IQR: 9.0-17.2) in 1988-1996, 5.1 years (3.1-9.4) in 1997-2005, and 5.6 years (3.4-8.3) in 2006-2014, p&amp;lt;0.0001), in parallel with an increased rate of reclassification during the most recent periods of diagnosis (HR: 1.76 in 1997-2005 and 1.67 in 2006-2014). Presence of rectal bleeding at diagnosis and 1st degree family history of IBD were respectively associated with risk of reclassification to UC (HR: 1.65, p=0.044) and CD (HR: 2.72, p=0.0134). Exposure to anti-TNF increased significantly after diagnostic reclassification (HR: 4.05, p&amp;lt;0.0001). During follow-up, 13.4 % of patients with IBDU required surgery. Conclusion In this population-based study, almost half of the patients with an initial diagnosis of IBDU were reclassified during follow-up, after a median time from diagnosis of 8 years. The rate of IBDU and the delay to diagnostic reclassification decreased over the study period, presumably due to an improvement in primary diagnostic evaluation.

Gradual increase in sweat chloride concentration is associated with a higher risk of CRMS/CFSPID to CF reclassification.

Universal implementation of cystic fibrosis (CF) newborn screening (NBS) has led to the diagnostic dilemma of infants with CF screen-positive, inconclusive diagnosis (CFSPID), with limited guidance regarding prognosis and standardized care. Rates of reclassification from CFSPID to CF vary and risk factors for reclassification are not well established. We investigated whether clinical characteristics are associated with the risk of reclassification from CFSPID to a CF diagnosis. Children with a positive CF NBS were recruited from two sites in California. Retrospective, longitudinal, and cross-sectional data were collected. A subset of subjects had nasal epithelial cells collected for CF transmembrane conductance regulator(CFTR) functional assessment. Multivariate logistic regression was used to assess the risk of reclassification. A total of 112 children completed the study (CF = 53, CFSPID = 59). Phenotypic characteristics between groups showed differences in pancreatic insufficiency prevalence, immunoreactive trypsinogen (IRT) levels, and Pseudomonas aeruginosa (PSA) colonization. Spirometry measures were not different between groups. Nasal epithelial cells from 10 subjects showed 7%-30% of wild-type (WT)-CFTR (wtCFTR) function in those who reclassified and 27%-67% of wtCFTR function in those who retained the CFSPID designation. Modeling revealed that increasing sweat chloride concentration (sw[Cl- ]) and PSA colonization were independent risk factors for reclassification to CF. Increasing sw[Cl- ] and a history of PSA colonization are associated with the risk of reclassification from CFSPID to CF in a population with high IRT and two CFTR variants. A close follow-up to monitor phenotypic changes remains critical in this population. The role of CFTR functional assays in this population requires further exploration.

Dietary Patterns and Risk of Gleason Grade Progression among Men on Active Surveillance for Prostate Cancer: Results from the Canary Prostate Active Surveillance Study

Modifiable lifestyle factors, such as following a healthy dietary pattern may delay or prevent prostate cancer (PCa) progression. However, few studies have evaluated whether following specific dietary patterns after PCa diagnosis impacts risk of disease progression among men with localized PCa managed by active surveillance (AS). 564 men enrolled in the Canary Prostate Active Surveillance Study, a protocol-driven AS study utilizing a pre-specified prostate-specific antigen monitoring and surveillance biopsy regimen, completed a food frequency questionnaire (FFQ) at enrollment and had ≥ 1 surveillance biopsy during follow-up. FFQs were used to evaluate adherence to the Dietary Guidelines for Americans (Healthy Eating index (HEI))-2015, alternative Mediterranean Diet (aMED), and Dietary Approaches to Stop Hypertension (DASH) dietary patterns. Multivariable-adjusted hazards ratios (HRs) and 95% confidence intervals were estimated using Cox proportional hazards models. During a median follow-up of 7.8 years, 237 men experienced an increase in Gleason score on subsequent biopsy (grade reclassification). Higher HEI-2015, aMED or DASH diet scores after diagnosis were not associated with significant reductions in the risk of grade reclassification during AS. However, these dietary patterns have well-established protective effects on chronic diseases and mortality and remain a prudent choice for men with prostate cancer managed by AS.

Confirmatory transperineal saturation prostate biopsy combined with mpMRI decrease the reclassification rate in men enrolled in Active Surveillance: Our experience in 100 men submitted to eight-years scheduled biopsy.

The reclassification rate for clinically significant prostate cancer (csPCa) in men enrolled in Active Surveillance (AS) as been prospectively evaluated. One hundred patients with very low risk PCa underwent after 8 years a scheduled transperineal prostate biopsy (SPBx = 20 cores) combined with additional mpMRI/TRUS fusion biopsies (4 cores) of lesions PI-RADS scores ≥ 3. All the patients, after initial diagnosis, previously had mpMRI evaluation combined with transperineal saturation prostate biopsy (confirmatory and 3-year scheduled biopsy). Risk reclassification at repeat biopsy triggering the recommen-dation for active treatment was defined as over 3 or more than 10% of positive cores, Gleason score > 6/ISUP Grade Group ≥ 2, greatest percentage of cancer (GPC) > 50%. Multiparametric MRI was suspicious (PI-RADS ≥ 3) in 30 of 100 cases (30.0%); 70 (70.0%) vs. 20 (20.0%) vs. 10 (10.0%) patients had a PI-RADS score ≤ 2 vs. 3 vs. 4, respec-tively. Two (2.0%) patients with PI-RADS score 3 and 4 were upgraded (ISUP Grade Group 2); SPBx and MRI/TRUS fusion biopsy diagnosed 100% and 0% of csPCa, respectively. Transperineal SPBx combined with mpMRI at ini-tial confirmatory biopsy allow to select an high number of men at very low risk of reclassification during the AS follow up (2.0%of the cases at 8 years from diagnosis); these data could be use-ful to reduce the number of scheduled repeated prostate biopsy during the AS follow up.

Genomic Testing in Localized Prostate Cancer Can Identify Subsets of African Americans With Aggressive Disease.

Personalized genomic classifiers have transformed the management of prostate cancer (PCa) by identifying the most aggressive subsets of PCa. Nevertheless, the performance of genomic classifiers to risk classify African American men is thus far lacking in a prospective setting. This is a prospective study of the Decipher genomic classifier for National Comprehensive Cancer Network low- and intermediate-risk PCa. Study-eligible non-African American men were matched to African American men. Diagnostic biopsy specimens were processed to estimate Decipher scores. Samples accrued in NCT02723734, a prospective study, were interrogated to determine the genomic risk of reclassification (GrR) between conventional clinical risk classifiers and the Decipher score. The final analysis included a clinically balanced cohort of 226 patients with complete genomic information (113 African American men and 113 non-African American men). A higher proportion of African American men with National Comprehensive Cancer Network-classified low-risk (18.2%) and favorable intermediate-risk (37.8%) PCa had a higher Decipher score than non-African American men. Self-identified African American men were twice more likely than non-African American men to experience GrR (relative risk [RR] = 2.23, 95% confidence interval [CI] = 1.02 to 4.90; P = .04). In an ancestry-determined race model, we consistently validated a higher risk of reclassification in African American men (RR = 5.26, 95% CI = 1.66 to 16.63; P = .004). Race-stratified analysis of GrR vs non-GrR tumors also revealed molecular differences in these tumor subtypes. Integration of genomic classifiers with clinically based risk classification can help identify the subset of African American men with localized PCa who harbor high genomic risk of early metastatic disease. It is vital to identify and appropriately risk stratify the subset of African American men with aggressive disease who may benefit from more targeted interventions.

MP43-05 UPFRONT MRI IS THE NEW STANDARD, HAVE CONFIRMATORY BIOPSIES BECOME OBSOLETE?

You have accessJournal of UrologyCME1 May 2022MP43-05 UPFRONT MRI IS THE NEW STANDARD, HAVE CONFIRMATORY BIOPSIES BECOME OBSOLETE? Henk Luiting, Ivo Izaak de Vos, Sebastiaan Remmers, Egbert Boevé, Chris Bangma, Riccardo Valdagni, Peter Chiu, Axel Semjonow, Viktor Berge, Karl Tully, Antti Rannikko, Frédéric Staerman, and Monique Roobol Henk LuitingHenk Luiting More articles by this author , Ivo Izaak de VosIvo Izaak de Vos More articles by this author , Sebastiaan RemmersSebastiaan Remmers More articles by this author , Egbert BoevéEgbert Boevé More articles by this author , Chris BangmaChris Bangma More articles by this author , Riccardo ValdagniRiccardo Valdagni More articles by this author , Peter ChiuPeter Chiu More articles by this author , Axel SemjonowAxel Semjonow More articles by this author , Viktor BergeViktor Berge More articles by this author , Karl TullyKarl Tully More articles by this author , Antti RannikkoAntti Rannikko More articles by this author , Frédéric StaermanFrédéric Staerman More articles by this author , and Monique RoobolMonique Roobol More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002609.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The AUA guidelines recommend confirmatory biopsies in all patients within two years after diagnosis whereas the EAU guidelines recommend refraining from confirmatory biopsies during active surveillance (AS) in patients diagnosed with upfront MRI. Data on these recommendations is conflicting and limited to highly experienced centers. The objective of this study is to add to the current evidence and to determine the risk difference for grade group (GG) reclassification on confirmatory biopsies between patients included with and without upfront MRI. METHODS: The PRIAS study is a multicenter prospective study providing clinical data of patients on AS. The inclusion criteria and recommended follow up schedule are available on www.prias-project.org. In this analysis, we selected patients diagnosed with or without upfront MRI, who underwent (a second) MRI before confirmatory biopsies. All subsequently underwent targeted biopsies (±systematic biopsies (SBx)) in lesions PIRADS ≥3, or SBx in case of no lesion. Multivariable logistic regression analysis was performed to determine the risk difference for GG reclassification at confirmatory biopsies between patients included with and without upfront MRI. RESULTS: In total, 732 patients underwent MRI informed confirmatory biopsies at a median PSA of 6.4 (interquartile range 4.6-8.4) ng/ml. 524 patients were diagnosed without upfront MRI and 208 with upfront MRI. Biopsy outcome and the outcome of multivariable logistic regression analysis are shown in Figure 1. At confirmatory biopsy, 108 (21%) patients without upfront MRI reclassified whereas 39 (19%) patients with upfront MRI reclassified. Reclassification to GG ≥3 was seen in 6% and 7% of the patients without and with upfront MRI respectively. No significant difference in risk for reclassification at confirmatory biopsies was seen between the two groups (OR 1.11 (95%CI 0.72-1.73), p=0.6), whereas MRI outcome, DRE outcome and PSA density were significant predictors for reclassification. CONCLUSIONS: Our results show that upfront MRI does not reduce reclassification rates at confirmatory biopsy and as such does not support the EAU guidelines recommendation to simply omit confirmatory biopsies if upfront MRI is used. In preventing unnecessary biopsies during AS, our results highlight the importance of MRI outcome. Source of Funding: - © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e741 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Henk Luiting More articles by this author Ivo Izaak de Vos More articles by this author Sebastiaan Remmers More articles by this author Egbert Boevé More articles by this author Chris Bangma More articles by this author Riccardo Valdagni More articles by this author Peter Chiu More articles by this author Axel Semjonow More articles by this author Viktor Berge More articles by this author Karl Tully More articles by this author Antti Rannikko More articles by this author Frédéric Staerman More articles by this author Monique Roobol More articles by this author Expand All Advertisement PDF DownloadLoading ...

A Multivariable Approach Using Magnetic Resonance Imaging to Avoid a Protocol-based Prostate Biopsy in Men on Active Surveillance for Prostate Cancer—Data from the International Multicenter Prospective PRIAS Study

BackgroundThere is ongoing discussion whether a multivariable approach including magnetic resonance imaging (MRI) can safely prevent unnecessary protocol-advised repeat biopsy during active surveillance (AS). ObjectiveTo determine predictors for grade group (GG) reclassification in patients undergoing an MRI-informed prostate biopsy (MRI-Bx) during AS and to evaluate whether a confirmatory biopsy can be omitted in patients diagnosed with upfront MRI. Design, setting, and participantsThe Prostate cancer Research International: Active Surveillance (PRIAS) study is a multicenter prospective study of patients on AS (www.prias-project.org). We selected all patients undergoing MRI-Bx (targeted ± systematic biopsy) during AS. Outcome measurements and statistical analysisA time-dependent Cox regression analysis was used to determine the predictors of GG progression/reclassification in patients undergoing MRI-Bx. A sensitivity analysis and a multivariable logistic regression analysis were also performed. Results and limitationsA total of 1185 patients underwent 1488 MRI-Bx sessions. The time-dependent Cox regression analysis showed that age (per 10 yr, hazard ratio [HR] 0.84 [95% confidence interval {CI} 0.71–0.99]), MRI outcome (Prostate Imaging Reporting and Data System [PIRADS] 3 vs negative HR 2.46 [95% CI 1.56–3.88], PIRADS 4 vs negative HR 3.39 [95% CI 2.28–5.05], and PIRADS 5 vs negative HR 4.95 [95% CI 3.25–7.56]), prostate-specific antigen (PSA) density (per 0.1 ng/ml cm3, HR 1.20 [95% CI 1.12–1.30]), and percentage positive cores on the last systematic biopsy (per 10%, HR 1.16 [95% CI 1.10–1.23]) were significant predictors of GG reclassification. Of the patients with negative MRI and a PSA density of <0.15 ng/ml cm3 (n = 315), 3% were reclassified to GG ≥2 and 0.6% to GG ≥3. At the confirmatory biopsy, reclassification to GG ≥2 and ≥3 was observed in 23% and 7% of the patients diagnosed without upfront MRI and in 19% and 6% of the patients diagnosed with upfront MRI, respectively. The multivariable analysis showed no significant difference in upgrading at the confirmatory biopsy between patients diagnosed with or without upfront MRI. ConclusionsAge, MRI outcome, PSA density, and percentage positive cores are significant predictors of reclassification at an MRI-informed biopsy. Patients with negative MRI and a PSA density of <0.15 ng/ml cm3 can safely omit a protocol-based prostate biopsy, whereas in other patients, a multivariable approach is advised. Being diagnosed with upfront MRI appears not to significantly affect reclassification risk; hence, a confirmatory MRI-Bx cannot totally be omitted yet. Patient summaryA protocol-based prostate biopsy while on active surveillance can be omitted in patients with negative magnetic resonance imaging (MRI) and prostate-specific antigen density <0.15 ng/ml cm3. A confirmatory biopsy cannot simply be omitted in all patients diagnosed with upfront MRI.