EURURO Vol. 72 No. 2

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Several studies reported excellent outcomes for low
risk PCa patients treated with HIFU. Feijoo et al
recently reported data of 67 patients with low-risk PCa
treated with HIFU where 75% had a negative biopsy at
6 mo after treatment. Complications were reported in a
small portion of men (8% Clavien-Dindo grade 2 and 2.8%
grade 3) and full continence was achieved in all patients.
Potency (defined as International Index of Erectile
Function score 22) was maintained in 11 of 21 patients.
These findings confirm previous data of Ahmed et al
which reported similar results in 41 PCa patients (11 low-
risk PCa). Excellent functional outcomes were reported
while 77% of patients were free of tumor at 6-mo biopsy.
In general, the quality of evidence is poor and further data
are required.
Current guidelines recommend cryotherapy as an option
in organ confined PCa and with minimal tumor extension
. The usage of focal cryoablation is increasing over
whole-gland cryoablation as oncological outcomes appear
similar (in select patients) with lower rates of urinary,
sexual, or bowel dysfunction Negative follow-up
prostate biopsy was reported in 55–86% of patients.
Considering functional outcomes, complete continence
was achieved 98.4–100%. However, the use of different
definitions of potency and the lack of preoperative
functional data makes it difficult to fully evaluate this
outcome. In the largest study evaluating erectile
function after cryoablation, maintenance of spontaneous
erection was reported in 58% of patients.
Donnelly et al and Robinson et al reported the
only randomized control trial comparing focal versus
whole-gland therapy: cryosurgery versus EBRT. Overall,
244 patients with localized PCa were randomized, but of
these only 20 had low-risk characteristics (10 treated with
cryosurgery and 10 with EBRT). With a median follow-up of
100 mo, 3-yr disease progression was observed in 23.9% and
23.7% of patients treated with cryoablation and EBRT,
respectively. However, no analyses were done considering
low-risk PCa only.
These results were confirmed in a recent meta-analysis
where data from 3995 patients across 19 studies compared
cryotherapy versus RP versus EBRT . There was no
evidence that mortality (4-yr survival was 93% for
cryotherapy and 91% for EBRT) or other specific outcomes
were different between cryotherapy and EBRT. However, all
the studies included were considered at high risk of
selection bias. Considering functional outcomes, urinary
incontinence at 1 yr was lower for cryosurgery than for RP.
Considering overall complications, no significant difference
was reported; however, patients treated with cryosurgery
or EBRT had lower rates of urethral stricture than patients
treated with RP.
3.7. Standard diagnosis and implications for research in low-
risk PCa
The classification of localized PCa into low-, intermediate-,
and high-risk groups has provided a useful system for
Table 5 – Selection of studies evaluating outcomes of low-risk prostate cancer patients treated with focal therapy
References Energy Study
period
Patients Median
follow-up (mo)
Inclusion
criteria
Functional
outcomes
Survival
[8_TD$DIFF] HIFU 2007–2010 41 patients.
11 low risk
6 PSA 15 ng/ml,
Gleason score 4 + 3,
stage T2
100% Pad free at 3 mo
and 12 mo
IIEF-15 scores were
similar at baseline
and 12 mo (p = 0 06)
77% of patients were free of
cancer at 6-mo biopsy
[9_TD$DIFF] HIFU 2009–2013 71 12 Unilateral, clinical
stage T1c–T2a,
maximum positive
biopsies < 33%,
Gleason score
7 (3 + 4),
PSA < 15 ng/ml
100% continence.
At 3 mo no significant
changes for both IPSS
and ICS.
IIEF-5 score 22 was
maintained in 11 of 21
preoperatively potent
patients
Negative control biopsy was
noted in 75% evaluated
patients; specifically, negative
biopsy in the treated lobe was
seen in 83% patients
[10_TD$DIFF] Cryotherapy 2009–2012 48 13 Unilateral, cT1c–cT2a,
PSA < 10 ng/ml,
low volume index
lesion, and GS 6
Urinary symptoms were
unchanged. No difference
at 6 mo in IIEF-5 score
Follow-up prostate biopsies
negative for the treated lobe
in 86%
[11_TD$DIFF] Cryotherapy 2002–2011 73 44 Unilateral
low-intermediate PCa
Continence and potency
was achieved in 100%
and 86% of patients,
respectively
75% had negative
postoperative biopsies.
Matched-pair comparison
with RP revealed similar
oncologic outcomes
[15_TD$DIFF] Cryotherapy 2002–2009 77 24 Low D‘Amico risk
(57%)
Continence: 100%
The mean IIEF score
decreases were 4.9 and
1.9 points, at 6 mo and
12 mo, respectively
Of the 22 patients, 10 (45.5%)
had confirmed prostate cancer.
Overall biochemical and
pathological progression-free
survival rates were 72.7%
and 87%
GS = Gleason score; ICS = International Continence Society; IIEF = International Index of Erectile Function; IPSS = International Prostate Symptom Score;
PCa = prostate cancer; PSA = prostate-specific cancer; RP = radical prostatectomy.
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