While
the
use
of
focal
therapy
for
nonmetastatic
prostate
cancer
is
limited,
half
of
procedures
occurred
in
settings
that
are
not
supported
by
current
guidelines,
according
to
a
retrospective
study.

Among
over
1.1
million
men
diagnosed
with
nonmetastatic
prostate
cancer
from
2010
to
2023,
1.3%
received
focal
therapy,
and
51%
of
these
patients
had
low-,
high-,
or
very-high-risk
disease,
“settings
in
which
routine
use
is
not
supported
by
contemporary
guidelines,”
reported
Quoc-Dien
Trinh,
MD,
of
the
University
of
Pittsburgh
School
of
Medicine,
and
colleagues
in
a
research
letter
in


JAMA.

Current
guidelines
recommend
that
focal
therapy
—
healthy
tissue-sparing
techniques
that
specifically
target
individual
tumors
within
the
prostate
—
be
reserved
for
patients
with
intermediate-risk
disease
within
clinical
trials
or
prospective
registries.

“For
appropriately
selected
patients
with
intermediate-risk
disease,
focal
therapy
is
an
appealing
treatment
option
because
it
aims
to
preserve
quality
of
life
while
treating
the
cancer,”
Trinh
said
in
a

press
release.
“But
as
promising
new
technologies
become
more
widely
available,
it
is
important
to
understand
which
patients
are
most
likely
to
benefit
so
that
treatment
decisions
are
guided
by
evidence
and
aligned
with
clinical
guidelines.”

In
the
case
of
patients
with
low-risk
disease,
the
standard
strategy
is
active
surveillance.
Therefore,
focal
therapy
may
represent
overtreatment
for
these
patients.

On
the
other
hand,
focal
therapy
lacks
high-level
evidence
for
high-
and
very-high-risk
prostate
cancer.
Trinh
and
team
noted
that
radiotherapy
or
surgery
remain
standard
care
for
these
patients,
while
focal
therapy
raises
concerns
about
undertreatment,
“given
the
need
for
durable
oncologic
control
and
lack
of
evidence
supporting
focal
therapy.”

Commercial
availability
and
recent
reimbursement
increases
may
have
intensified
patient
and
physician
interest
in
focal
therapy,
which
has
emerged
as
an
alternative
to
treating
or
removing
the
entire
prostate
for
certain
selected
intermediate-risk
patients,
the
authors
explained.

In
an

accompanying
editorial,
Daniel
Spratt,
MD,
of
Case
Western
Reserve
University
in
Cleveland,
and
colleagues
noted
that
“focal
therapy
should
not
be
sold
as
an
interchangeable
middle
option
between
radical
prostatectomy
and
active
surveillance.”

The
prospective
trial
evidence
for
focal
therapy
is
limited
to
mostly
1-
and
2-year
outcomes
from
small
single-group
cohorts,
they
wrote,
and
the
modalities
used
—
including
cryotherapy,
high-intensity
focused
ultrasound,
microwave,
laser,
waterjet,
or
ultrasound
ablation
—
“each
deserve
evaluation
on
their
own
evidence.”

“It
is
troubling
when
social
and
financial
pressure
bends
clinical
judgment
toward
experimental
therapy
given
outside
a
trial,”
Spratt
and
colleagues
wrote.
“Investigators
are
wrong
about
their
hypotheses
all
the
time,
and
randomized
trials
are
how
they
find
out.”

Trinh
and
colleagues
used
the
National
Cancer
Database
to
identify
1,179,384
men
ages
50
and
older
who
were
diagnosed
with
nonmetastatic
prostate
cancer
between
2010
and
2023
and
seen
at
U.S.
centers
with
Commission
on
Cancer
accreditation.

Of
the
15,672
patients
who
received
focal
therapy,
49%
had
intermediate-risk
disease,
including
2,786
with
favorable
intermediate
risk
and
4,901
with
unfavorable
intermediate
risk.

From
2010
to
2023,
the
rate
of
focal
therapy
did
not
significantly
change
in
patients
with
low-risk
disease
(1.8%
vs
2.2%,

P=0.46
for
trend).

Among
those
with
favorable
intermediate-risk
disease,
focal
therapy
rates
significantly
increased
(2.1%
to
2.9%),
while
decreases
were
seen
in
those
with
unfavorable
intermediate
risk
(2.5%
to
1.9%),
high
risk
(2.1%
to
0.9%),
and
very
high
risk
(1.8%
to
0.5%;
all

P<0.001
for
trend).

The
authors
also
determined
that
modality-specific
patterns
changed
from
2010
to
2023,
with
cryotherapy
use
decreasing
from
79.8%
to
19.1%,
while
use
of
laser
ablation
increased
from
14.6%
to
45.8%,
and
high-intensity
focused
ultrasound
increased
from
5.6%
to
35.1%.

In
multivariable
analysis,
adjusted
predicted
probabilities
of
focal
therapy
were
higher
among
older
patients
and
those
with
low-risk
disease,
higher
comorbidity
burden,
non-private
insurance,
treatment
at
community
facilities,
and
treatment
at
higher-volume
facilities.

The
authors
acknowledged
that
their
study
had
limitations.
For
example,
they
observed
that
focal
therapy
performed
outside
Commission
on
Cancer-accredited
centers
is
likely
underrepresented,
and
that
data
on
oncologic
outcomes,
toxicity,
quality
of
life,
retreatment,
and
costs
were
unavailable.

In
addition,
they
were
unable
to
capture
clinical
factors
influencing
treatment
selection,
such
as
tumor
multifocality,
clinical
trial
or
registry
participation,
and
patient
preference.

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