How can we expand active surveillance criteria in patients with low‐ and intermediate‐risk prostate cancer without increasing the risk of misclassification? Development of a novel risk calculator

Gandaglia, Giorgio; Bergh, Roderick C.N. van den; Tilki, Derya; Fossati, Nicola; Ost, Piet; Surcel, C.; Sooriakumaran, Prasanna; Tsaur, Igor; Valério, Massimo; Kretschmer, Alexander; Zaffuto, Emanuele; Salomon, Laurent; Montorsi, Francesco; Graefen, Markus; Poel, Henk van der; Taille, Alexandre de la; Briganti, Alberto; Ploussard, Guillaume

doi:10.1111/bju.14391

Cited by 31 publications

(23 citation statements)

References 34 publications

(54 reference statements)

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“…Last but not least, the mentioned nomogram risk-threshold value of 25% was associated with significantly lower estimated frequency of csPCa that would be recommended for AS (11.3%), relative to the same four established AS inclusion criteria: PRIAS (∆:-14.3%), JH (∆:-5.9%), low risk (∆:-17.2%) and low risk or low volume ISUP GG2 (∆:-18.0%). These csPCa estimated rates are consistent with previous reports (6,7) and with Gandaglia et al (12) findings, which reported a minimum csPCa rate of 12-15%, despite the use of several AS inclusion criteria. However, it should be stated that our results were obtained by testing the predictive model in the population where it was developed.…”

Section: Discussionsupporting

confidence: 93%

“…Recently, Gandaglia et al [ 12 ] combined PSA, cT stage, ISUP GG, number of positive cores, and PSA‐D, to develop a novel risk calculator to increase the number of AS‐eligible patients. With an AUC of 0.75, the Gandaglia et al [ 12 ] nomogram allowed the inclusion of ~10% more patients in AS compared to the PRIAS criteria. We therefore combined clinical, biopsy and mpMRI parameters to create a novel nomogram to further increase the number of AS‐eligible patients, without increasing the risk of csPCa.…”

Section: Discussionmentioning

confidence: 99%

“…Principally, attempts have been made to increase the number of AS‐suitable patients, without increasing disease misclassification risk [ 2 ]. Recently, Gandaglia et al [ 12 ] developed a risk calculator that combines clinical and biopsy information. The application of this novel risk score resulted in an absolute increase of ~10% in the number of patients eligible for AS, when compared to the Prostate Cancer Research International: Active Surveillance (PRIAS) criteria, without any significant increase in the risk of aggressive disease.…”

Section: Introductionmentioning

confidence: 99%

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A novel nomogram to identify candidates for active surveillance amongst patients with International Society of Urological Pathology (ISUP) Grade Group (GG) 1 or ISUP GG2 prostate cancer, according to multiparametric magnetic resonance imaging findings

et al. 2020

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Objectives To develop a novel nomogram to identify candidates for active surveillance (AS) that combines clinical, biopsy and multiparametric magnetic resonance imaging (mpMRI) findings; and to compare its predictive accuracy to, respectively: (i) Prostate Cancer Research International: Active Surveillance (PRIAS) criteria, (ii) Johns Hopkins (JH) criteria, (iii) European Association of Urology (EAU) low‐risk classification, and (iv) EAU low‐risk or low‐volume with International Society of Urological Pathology (ISUP) Grade Group (GG) 2 classification. Patients and Methods We selected 1837 patients with ISUP GG1 or GG2 prostate cancer (PCa), treated with radical prostatectomy (RP) between 2012 and 2018. The outcome of interest was the presence of unfavourable disease (i.e., clinically significant PCa [csPCa]) at RP, defined as: ISUP GG ≥3 and/or pathological T stage (pT) ≥3a and/or pathological N stage (pN) 1. First, logistic regression models including PRIAS, JH, EAU low‐risk, and EAU low‐risk or low‐volume ISUP GG2 binary classifications (not eligible vs eligible) were used. Second, a multivariable logistic regression model including age, prostate‐specific antigen density (PSA‐D), ISUP GG, and the percentage of positive cores (Model 1) was fitted. Third, Prostate Imaging‐Reporting and Data System (PI‐RADS) score (Model 2), extracapsular extension (ECE) score (Model 3) and PI‐RADS + ECE score (Model 4) were added to Model 1. Only variables associated with higher csPCa rates in Model 4 were retained in the final simplified Model 5. The area under the receiver operating characteristic curve (AUC), calibration plots and decision curve analyses were used. Results Of the 1837 patients, 775 (42.2%) had csPCa at RP. Overall, 837 (47.5%), 986 (53.7%), 348 (18.9%), and 209 (11.4%) patients were eligible for AS according to, respectively, the EAU low‐risk, EAU low‐risk or low‐volume ISUP GG2, PRIAS, and JH criteria. The proportion of csPCa amongst the EAU low‐risk, EAU low‐risk or low‐volume ISUP GG2, PRIAS and JH candidates was, respectively 28.5%, 29.3%, 25.6% and 17.2%. Model 4 and Model 5 (in which only PSA‐D, ISUP GG, PI‐RADS and ECE score were retained) had a greater AUC (0.84), compared to the four proposed AS criteria (all P < 0.001). The adoption of a 25% nomogram threshold increased the proportion of AS‐eligible patients from 18.9% (PRIAS) and 11.4% (JH) to 44.4%. Moreover, the same 25% nomogram threshold resulted in significantly lower estimated risks of csPCa (11.3%), compared to PRIAS (Δ: −14.3%), JH (Δ: −5.9%), EAU low‐risk (Δ: −17.2%), and EAU low‐risk or low‐volume ISUP GG2 classifications (Δ: −18.0%). Conclusion The novel nomogram combining clinical, biopsy and mpMRI findings was able to increase by ~25% and 35% the absolute frequency of patients suitable for AS, compared to, respectively, the PRIAS or JH criteria. Moreover, this nomogram significantly reduced the estimated frequency of csPCa that would be recommended for AS compared to, respectively, the PRIAS, JH, EAU low‐risk, and EAU low‐risk or low‐vo...

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A novel nomogram to identify candidates for active surveillance amongst patients with International Society of Urological Pathology (ISUP) Grade Group (GG) 1 or ISUP GG2 prostate cancer, according to multiparametric magnetic resonance imaging findings

et al. 2020

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“…Further options that may add value to AS patient selection include the use of multiparametric prostate magnetic resonance imaging, given its high negative predictive value for large high-grade cancers, and novel risk calculators that may increase the number of intermediate-risk patients eligible for AS without increasing the risk of misclassification [29]. However, recent studies have demonstrated that genomic classifiers are more accurate than MRI in predicting the presence of AP [30].…”

Section: Discussionmentioning

confidence: 99%

Decipher identifies men with otherwise clinically favorable-intermediate risk disease who may not be good candidates for active surveillance

Herlemann

Huang

Alam

et al. 2019

Prostate Cancer Prostatic Dis

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Background We aimed to validate Decipher to predict adverse pathology (AP) at radical prostatectomy (RP) in men with National Comprehensive Cancer Network (NCCN) favorable-intermediate risk (F-IR) prostate cancer (PCa), and to better select FIR candidates for active surveillance (AS). Methods In all, 647 patients diagnosed with NCCN very low/low risk (VL/LR) or FIR prostate cancer were identified from a multi-institutional PCa biopsy database; all underwent RP with complete postoperative clinicopathological information and Decipher genomic risk scores. The performance of all risk assessment tools was evaluated using logistic regression model for the endpoint of AP, defined as grade group 3−5, pT3b or higher, or lymph node invasion. Results The median age was 61 years (interquartile range 56-66) for 220 patients with NCCN FIR disease, 53% classified as low-risk by Cancer of the Prostate Risk Assessment (CAPRA 0−2) and 47% as intermediate-risk (CAPRA 3−5). Decipher classified 79%, 13% and 8% of men as low-, intermediate-and high-risk with 13%, 10%, and 41% rate of AP, respectively. Decipher was an independent predictor of AP with an odds ratio of 1.34 per 0.1 unit increased (p value = 0.002) and remained significant when adjusting by CAPRA. Notably, FIR with Decipher low or intermediate score did not associate with significantly higher odds of AP compared to VL/LR. Conclusions NCCN risk groups, including FIR , are highly heterogeneous and should be replaced with multivariable riskstratification. In particular, incorporating Decipher may be useful for safely expanding the use of AS in this patient population.

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“…Thus, several studies focus on the improvement of mpMRI findings in the active surveillance setting, for example, by implementing imaging findings in risk calculators. For instance, the risk calculator by Gandaglia et al [28] was designed to improve the selection of intermediate-risk PCa patients suitable for active surveillance by incorporating mpMRI findings. Summarizing the findings of this trial, the use of this risk score resulted in an absolute increase of 10% in the number of patients eligible for active surveillance and was validated recently [29].…”

Section: Implication Of Comprehensive Evaluation For Therapy Decisionmentioning

confidence: 99%

Intermediate-risk Prostate Cancer—A Sheep in Wolf’s Clothing?

Heidegger

Hamdy

Bergh

et al. 2023

European Urology Oncology

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This case-based discussion describes a 65-year-old man newly diagnosed with International Society of Urological Pathology (ISUP) grade 2 prostate cancer (PCa). According to the European Association of Urology classification system, the patient harbors an intermediate-risk cancer. In step-by step discussion, we elaborate guideline-based treatment modalities for intermediate-risk PCa focused on debating active surveillance versus active treatment. Thereby, we discuss the importance of patient characteristics, including age, hereditary factors, life expectancy and comorbidity status, findings of multiparametric magnetic resonance imaging, as well as prostate-specific antigen (PSA) density and PSA kinetics, in predicting the clinical course of the disease. In addition, we focus on cribriform pathology as a predictor of adverse outcomes and critically discuss its relevance in patient management. Lastly, we outline genomic stratification in ISUP 2 cancer as a future tool to predict PCa aggressiveness. Patient summary: Based on current guidelines, patients with intermediate-risk prostate cancer are treated actively or can alternatively undergo an active surveillance approach when favorable risk factors are present. One major issue is to discriminate between patients who benefit from an active therapy approach and those who benefit from a deferred treatment. Therefore, reliable biomarkers and early predictors of disease progression are needed urgently.

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How can we expand active surveillance criteria in patients with low‐ and intermediate‐risk prostate cancer without increasing the risk of misclassification? Development of a novel risk calculator

Abstract: The use of a novel risk score for AS selection would result in an absolute increase of 10% in the number of patients eligible for this approach without increasing the risk of misclassification.

Cited by 31 publications

References 34 publications

A novel nomogram to identify candidates for active surveillance amongst patients with International Society of Urological Pathology (ISUP) Grade Group (GG) 1 or ISUP GG2 prostate cancer, according to multiparametric magnetic resonance imaging findings

A novel nomogram to identify candidates for active surveillance amongst patients with International Society of Urological Pathology (ISUP) Grade Group (GG) 1 or ISUP GG2 prostate cancer, according to multiparametric magnetic resonance imaging findings

Decipher identifies men with otherwise clinically favorable-intermediate risk disease who may not be good candidates for active surveillance

Intermediate-risk Prostate Cancer—A Sheep in Wolf’s Clothing?

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