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the primary strategy for 1359 (48%). Compared with those
treated with immediate RP, men undergoing delayed
surgery were more likely to have Gleason score 7 or greater
(69.2% vs 48.8%, respectively, p = 0.004). However, no
difference was found considering positive margin rates,
extraprostatic extension, seminal vesicle invasion, or lymph
node metastases
Predicting adverse pathologic features at RP in low-risk
PCa patients might be of paramount importance for selecting
appropriate AS candidates. However, it has to be highlighted
that typically patients underwent RP after a single diagnostic
biopsy. In contrast, patients included in AS protocols often
undergo multiple staging biopsies and frequent MRIs.
3.5. AS
AS is an attractive option for patients with low-risk PCa.
Tosoian et al reported data of 1298 very-low and low-
risk PCa patients enrolled in an AS protocol between
1995 and 2014. The surveillance protocol included semian-
nual PSA and digital rectal examinations with an annual 12–
14 core biopsies for most men. Curative intervention was
recommended for disease reclassification, defined as biopsy
findings no longer meeting the inclusion criteria. The
median treatment-free survival (TFS) rate was 8.5 yr and
cumulative incidence of TFS was 50% and 43% at 10 yr and
15 yr. Cancer-specific survival at 10 yr and 15 yr were both
99.9%. The excellent long-term results reflect the strict
inclusion criteria, rigorous follow-up, and low threshold for
recommending treatment.
Godtman et al updated the experience of the
Go¨ teborg screening trial (ISRCTN54449243) which enrolled
very low-, low-, and intermediate-risk PCa patients
between 1995 and 2014 to AS. Patients had PSA every 3–
12 mo and biopsy in cases of progression (defined as PSA
and/or T-stage progression) or every 2–3 yr in men with
stable disease. For men with very low-risk cancer, 15-yr
cancer-specific survival was 100% but decreased to 94% for
men with low-risk PCa.
The Prostate Cancer Research International Active
Surveillance group recently reported the largest known
AS experience. The original inclusion criteria were Gleason
6, clinical stage cT2c, PSA 10 ng/ml, two or fewer cores
positive for PCa, PSA density 0.2 ng/ml/cm3
[1_TD$DIFF], and fitness for
curative treatment. Inclusion criteria and follow-up
schemes were modified over the study period. Changes
regarded the inclusion of patients with minimal Gleason
3 + 4 ( 10% tumor involvement per biopsy core, maximum
2 cores positive) if aged 70 yr. Follow-up strategy required
a PSA test every 3 mo and a digital rectal examination every
6 mo for the 1st 2 yr. Thereafter, PSA was done every 6 mo
and digital rectal examination yearly. Repeat biopsies were
scheduled at 1 yr, 4 yr, 7 yr, and 10 yr after diagnosis.
Follow-up and criteria to switch to active treatment also
changed during the study period. Through 2014 they were
Gleason 7, more than two positive cores, stage > cT2, or
PSA doubling time <3 yr (if at least 4 PSA values are
available). Subsequently, these criteria were changed
because of the high number of patients who dropped from
AS and concerns for high rates of unnecessary treatment
Table 3 – Characteristics of studies evaluating the role of surgery in patients with low-risk prostate cancer
References Design Study period Population Pathologic findings
Dinh et al 2015 Population based-SEER 2010–2011 10 273 Low-risk D‘Amico patients pGS >6: 44%
pT3–T4 N0–1: 9.7%
Song et al 2014 Retrospective 2007–2012 382 Low-risk D‘Amico PCa pGS 3 + 4: 44.7%
pGS4 + 3: 8.9%
pGS 8–10: 1.7%
pT3–T4: 13.3%
PSM: 16.2%
Weiner et al 2015 Retrospective 2010–2011 17 943 Low-risk D‘Amico PCa pGS >6: 42.8%
pT3–4: 9.3%
pN1 or pGs >6 or pT3–4: 45.2%
PSM: 15.8%
Mullins et al 2012 Retrospective 1983–2010 1560 Low-risk D‘Amico pGS 7: 27.8%
pGS 8–10: 1.9%
pT3–T4 or 7 GS: 38.3%
LNI: 0.6%
Imnadze et al 2016 Retrospective 1998–2008 1102 Low risk pGS 7: 49%
pGS 8–10: 0.7%
pT3–T4: 16%
LNI: 0.7%
PSM: 11%
Carlsson et al 2016 Prospective multicentric 2008–2011 338 Very low-risk patients pT3–T4 or >6 pGS: 34.5%
pGS >6: 31.5%
PSM: 16.4%
Beauval et al 2012 Retrospective 2003–2008 919 Very low-risk patients pGS 3 + 4: 26.1%
pGS 4 + 3: 7%
pGS 8–10: 1.2%
pT3–T4: 23.5%
PSM: 12.5%
PCa = prostate cancer; pGS = pathological Gleason score; PSM = prostate specific membrane antigen.
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