Soloway, M. S. et al. Active surveillance; a reasonable management alternative for patients with prostate cancer: the Miami experience. BJU Int. 101, 165-169

Department of Urology, University of Miami Miller School of Medicine, Miami, Florida 33101, USA.
BJU International (Impact Factor: 3.53). 01/2008; 101(2):165-9. DOI: 10.1111/j.1464-410X.2007.07190.x
Source: PubMed


To examine the outcome of patients diagnosed with 'low-risk' prostate cancer managed by active surveillance (AS).
In all, 157 men with localized prostate cancer were followed on AS. The inclusion criteria for AS included: Gleason score of < or = 6, a serum prostate-specific antigen (PSA) level of < or = 15 ng/mL, stage < or = T2, low-volume disease and > 12 months of follow-up. The follow-up was rigorous, with PSA tests and a digital rectal examination every 3 months for 2 years, and a repeat biopsy 6-12 months after the initial diagnosis and yearly when indicated. Continuance of AS was based on the PSA doubling time, re-biopsy score, Gleason score, tumour volume, stage progression and patient preference.
In all 99 patients met the inclusion criteria; their mean age at diagnosis was 66 years, their mean PSA level 5.77 ng/mL and the mean follow-up 45.3 months. On initial repeat biopsy, 63% had no cancer and 34% had a Gleason sum of < or = 6. Eight patients were treated (three with hormones; five with curative intent); two had radical prostatectomy (one had pT2c pNO Gleason 7 disease); three had radiotherapy. The probability is that 85% would remain treatment-free at 5 years; no patient died from prostate cancer. The PSA doubling time and clinical stage at diagnosis were predictive of progression.
Patients who are followed on AS must be selected using narrowly defined inclusion criteria and closely followed with a standard regimen of PSA testing, digital rectal examination and repeat biopsy.

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    • "However, the best parameter for the identification of prostate cancer progression is still unclear. Several authors have suggested follow-up criteria including digital rectal examination, PSA follow-up and repeated prostate biopsy that should be used to decide whether intervention should be performed during AS [19–22]. Regarding imaging parameters, most of the literature does not recommend transrectal ultrasound (TRUS), since their efficacy has not been proven as a measure of progression during AS [23,24]. "
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    ABSTRACT: Purpose: 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. Methods: 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. Results: 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). Conclusions: 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.
    06/2014; 2(2):76-81. DOI:10.12954/PI.14044
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    • "The selection criteria for AS included a biopsy-derived Gleason score ≤6 in a single positive core, clinical stage ≤T1c, PSA ≤10 ng/mL, and unremarkable magnetic resonance imaging (MRI) results [3,6-12] (Table 1). Biopsy with transrectal ultrasonography was done using the 12-core biopsy scheme. "
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    ABSTRACT: This study was conducted to describe our early experience with active surveillance (AS). Between January 2008 and December 2012, 35 patients were treated with AS. Selection criteria included the following: Gleason score ≤6 with single positive core, clinical stage ≤T1c, prostate-specific antigen (PSA) ≤10 ng/mL, and unremarkable imaging results. On patient follow-up, we regularly measured PSA (every 3-6 months) and performed prostate biopsies (after 1 and 3 years). In the first year of follow-up, prostate biopsies were performed in 25 patients (13 patients, negative for cancer; 7 patients, Gleason score of 6 without progression; 5 patients, progression, treated with radical prostatectomy [RP]). In the third year of follow-up, prostate biopsies were performed in five patients (two patients, negative for cancer; one patient, Gleason score of 6 without progression; two patients, progression, treated with RP). Seven patients discontinued AS because of increased anxiety, and three patients were lost to follow-up. Overall, seven patients (28%) who experienced progression had a mean PSA doubling time (DT) of 7.54 years. Six patients had a PSA DT of more than 3 years, whereas one had a PSA DT of less than 3 years. This study was limited by its small sample size and short follow-up period. PSA kinetics did not correlate with progression, which suggests that regular biopsies should still be performed. AS is an available treatment option for patients with a low risk of prostate cancer but should only be used in carefully selected patients.
    Korean journal of urology 03/2014; 55(3):167-71. DOI:10.4111/kju.2014.55.3.167
    • "Systematic monitoring of these men serves to provide timely identification of any risk reclassification or disease progression, so that radical treatment can be applied within the window of curability to those who need it and AS can be continued in those with persisting low-risk features. However, in the absence of markers selectively differentiating low-risk from significant disease, it remains challenging to exclusively select those men in whom PCa will never lead to symptoms, let alone death, which has led to a variation of criteria for eligibility and risk reclassification or disease progression in different AS studies [1] [2] [3] [4] [5] [6]. In addition to tumour characteristics , competing risks for mortality should be considered when deciding on the best treatment for a patient [7]. "
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    ABSTRACT: Little is known about the outcome of radical prostatectomy (RP) in men initially followed on active surveillance (AS) for low-risk prostate cancer (PCa). Evaluate pathology findings after RP in our prospective AS cohort. All men participated in the Prostate Cancer Research International: Active Surveillance (PRIAS) study. Eligible men were initially diagnosed with low-risk PCa (clinical stage ≤ T2, prostate-specific antigen [PSA] ≤ 10 ng/ml, PSA density <0.2 ng/ml per ml, one or two positive biopsy cores, and Gleason score ≤ 6) and underwent RP between December 2006 and July 2011. The study protocol recommends RP in case of risk reclassification on repeat biopsy (Gleason score >6 and/or more than two positive cores) or a PSA doubling time ≤ 3 yr. Descriptive statistics were used to report on pathology findings for staging and grading. Pathology results were available in 167 out of 189 RP cases (88.4%). Median time to RP was 1.3 yr (range: 1.1-1.9). Protocol-based recommendations led to deferred RP in 143 men (75.7%); 24 men (12.7%) switched because of anxiety, and 22 (11.6%) had other reasons. Pathology results showed 134 (80.8%) organ-confined cases and 32 (19.2%) cases with extracapsular extension. Gleason scores ≤ 6, 3+4, 4+3, and 8 were found in 79 (47.3%), 64 (38.3%), 21 (12.6%), and 3 (1.8%) cases, respectively. Unfavourable RP results (pT3-4 and/or Gleason score ≥ 4+3) were found in 49 patients (29%), of whom 33 (67%) had a biopsy-related reason for deferred RP. RP results in men initially followed on AS show organ-confined disease and favourable Gleason grading in a majority of cases. Most men in our cohort had a protocol-based reason to switch to deferred RP. A main focus for AS protocols should be to improve the selection of patients at the time of inclusion to minimise reclassification of risk and preserve the chance for curative treatment, if indicated.
    European Urology 02/2012; 62(2):195-200. DOI:10.1016/j.eururo.2012.02.002 · 13.94 Impact Factor
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