Pathologic Prostate Cancer Characteristics in Patients Eligible for Active Surveillance: A Head-to-Head Comparison of Contemporary Protocols
Department of Urology, Miller School of Medicine, University of Miami, Miami, FL 33101, USA. European Urology
(Impact Factor: 13.94).
03/2012; 62(3):462-8. DOI: 10.1016/j.eururo.2012.03.011
Although the rationale for active surveillance (AS) in patients with low-risk prostate cancer is well established, eligibility criteria vary significantly across different programs.
To compare the ability of contemporary AS criteria to identify patients with certain pathologic tumor features based on the results of an extended transrectal prostate biopsy.
The study cohort included 391 radical prostatectomy patients who had prostate cancer with Gleason scores ≤ 6 on transrectal biopsy with ≥ 10 cores.
Radical prostatectomy without neoadjuvant treatment. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We identified patients who fulfilled the inclusion criteria of five AS protocols including those of Epstein, Memorial Sloan-Kettering Cancer Center, Prostate Cancer Research International: Active Surveillance (PRIAS), University of California, San Francisco, and University of Miami (UM). We evaluated the ability of these criteria to predict three pathologic end points: insignificant disease defined using a classical and updated formulation, and organ-confined Gleason ≤ 6 prostate cancer. Measures of diagnostic accuracy and areas under the receiver operating curve were calculated for each protocol and compared.
A total of 75% of the patients met the inclusion criteria of at least one protocol; 23% were eligible for AS by all studied criteria. The PRIAS and UM criteria had the best balance between sensitivity and specificity for both definitions of insignificant prostate cancer and a higher discriminative ability for the end points than any criteria including patients with two or more positive cores. The Epstein criteria demonstrated high specificity but low sensitivity for all pathologic end points, and therefore the discriminative ability was not superior to those of other protocols.
Significant variations exist in the ability of contemporary AS criteria to predict pathologically insignificant prostate cancer at radical prostatectomy. These differences should be taken into account when making treatment choices in patients with low-risk prostate cancer.
Available from: PubMed Central
- "When comparing the 6 AS criteria analyzed in the current study, the criteria from University of Toronto can be considered the most inclusive one. In case of Toronto criteria, the discriminating ability to predict favorable PCa was suboptimal due to its high sensitivity and low specificity . For such reason, unlike other 5 criteria, the expansion of Toronto criteria to men with biopsy GS 3+4 probably contributed to significant increase in unfavorable pathology. "
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We analyzed whether expansion of existing active surveillance (AS) protocols to include men with biopsy Gleason score (GS) 3+4 prostate cancer (PCa) would significantly alter pathologic and biochemical outcomes of potential candidates of AS.
Among patients who underwent radical prostatectomy at our center between 2006 and 2013, we identified 577 patients (group A) who preoperatively fulfilled at least one of 6 different AS criteria. Also, we identified 217 patients (group B) with biopsy GS 3+4 but fulfilled non-GS criteria from at least one of 6 AS criteria. Designating group C as expanded group incorporating all patients in group A and B, we compared risk of unfavorable disease (pathologic GS ≥4+3 and/or pathologic T stage ≥pT3a) and biochemical recurrence (BCR)-free survival between groups.
Rates of unfavorable disease were not significantly different between patients of group A and C who met AS criteria from 5 institutions (all p>0.05), not including University of Toronto (p<0.001). Also BCR-free survivals were not significantly different between patients in group A and C meeting each of 6 AS criteria (all p>0.05). Among group B, PSAD>0.15 ng/mL/cm3 (p = 0.011) and tumor length of biopsy GS 3+4 core>4 mm (p = 0.007) were significant predictors of unfavorable disease. When these two criteria were newly applied in defining group B, rates of unfavorable disease in group A and B was 15.6% and 14.7%, respectively (p = 0.886).
Overall rate of pathologically aggressive PCa harbored by potential candidates for AS may not be increased significantly with expansion of criteria to biopsy GS 3+4 under most contemporary AS protocols. PSAD and tumor length of biopsy GS 3+4 core may be useful predictors of more aggressive disease among potential candidates for AS with biopsy GS 3+4.
Available from: Han Yong Choi
- "This could be because the data are based on low-risk prostate cancer and a favorable BCR rate was the natural result, or because of the relatively short follow-up period (approximately 2.5 years). Other studies showed no significant difference in BCR rate using different inclusion criteria [21,22]. Iremashvili et al.  compared pathologic cancer characteristics in patients grouped according to five different contemporary AS criteria and showed no significant difference in BCR-free survival. "
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To investigate the predictive factors of unfavorable prostate cancer in Korean men who underwent radical prostatectomy but eligible for active surveillance according to Epstein criteria.
We retrospectively reviewed the medical records of 2,036 patients who underwent radical prostatectomy for prostate cancer between 1994 and 2011. Among these, 233 patients were eligible for active surveillance based on Epstein criteria. Unfavorable prostate cancer was defined as pathologic Gleason sum ≥7 or non–organ-confined disease. We investigated pathologic outcomes and predictive factors for unfavorable prostate cancer.
Of 233 cases, 91 patients (39.1%) were pathologic Gleason sum ≥7, 11 (4.7%) had extracapsular extension, and three (1.3%) had seminal vesicle invasion. Ninety-eight patients (42.1%) had unfavorable prostate cancer. When comparing clinically insignificant and significant prostate cancer, there were significant differences in mean age (P=0.007), prostate volume (P=0.021), prostate-specific antigen (PSA) density (P=0.03), maximum tumor volume in biopsy core (P<0.001), and rate of two positive cores (P=0.001). On multivariate analysis, age (P=0.015), PSA density (P=0.017) and two positive cores (P=0.001) were independent predictive factors for unfavorable prostate cancer.
A significant proportion of patients who were candidates for active surveillance had unfavorable prostate cancer. Age, PSA density, and two positive cores were independent significant predictive factors for unfavorable prostate cancer. These factors should be considered when performing active surveillance.
Available from: Kyo Chul Koo
- "This study concluded that the TV threshold of IPC may be increased up to 1.3 mL in cases of organ-confined prostate cancer without Gleason grade 4/5 disease. Using this updated definition of IPC, the rate of misclassification for AS selection according to TV could be decreased . "
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We compared oncological outcomes according to tumor volume (TV) thresholds defining both classical and updated insignificant prostate cancer (IPC), since the TV threshold can be used as clinical parameter for active surveillance.
Between 2001 and 2012, we retrospectively analyzed 331 organ-confined prostate cancer patients who had preoperative Gleason score 6, preoperative PSA under 10 ng/mL and pathologic TV less than 1.3 mL. Among them, 81 of 331 (24.5%) had Gleason grade 4/5 disease postoperatively. Patients were stratified into two groups: (1) TV less than 0.5 mL, using the classical definition; and (2) TV between 0.5 mL and 1.3 mL, using the range of updated definition. We compared biochemical recurrence (BCR)-free survival and identified independent predictors of BCR in each group.
Group 2 had more Gleason grade 4/5 disease than group 1 (P<0.001). On multivariate analysis, Gleason grade 4/5 disease was not associated with BCR in group 1 (P=0.132). However, it was an independent predictor for BCR in group 2 (P=0.042). BCR-free survival were not significantly different according to the presence of Gleason grade 4/5 disease in group 1 (P=0.115). However, in group 2, it was significantly different according to the presence of Gleason grade 4/5 disease (P=0.041).
Although the TV thresholds of the two definitions of IPC vary only slightly, this difference was enough to result in different clinical course if Gleason grade 4/5 disease was present. Therefore, the updated IPC TV threshold should be carefully applied as clinical parameter for active surveillance.
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