Original Article: Clinical Investigationiju_3125 185..

192
Early quality of life outcomes in patients with prostate
cancer managed by high-dose-rate brachytherapy
as monotherapy
Akira Komiya,
1
Yasuyoshi Fujiuchi,
1
Takatoshi Ito,
1
Akihiro Morii,
1
Kenji Yasuda,
1
Akihiko Watanabe,
1
Tetsuo Nozaki,
1
Hiroaki Iida,
1
Kuninori Nomura
2
and Hideki Fuse
1
Departments of
1
Urology and
2
Diagnostic and Therapeutic Radiology, Graduate School of Medicine and Pharmaceutical Sciences for
Research, University of Toyama, Toyama, Japan
Abbreviations & Acronyms
ADT = androgen deprivation
therapy
AE = adverse events
CT = computed tomography
CTCAE = Common
Terminology Criteria for
Adverse Events
CTV = clinical target volume
EBRT = external beam
radiation therapy
ED = erectile dysfunction
FACT-P = Functional
Assessment of Cancer
Therapy-Prostate
GI = gastrointestinal
GTV = gross tumor volume
GU = genitourinary
HDR-BT = high-dose-rate
brachytherapy
IIEF = International Index of
Erectile Function
Questionnaire
IPSS = International Prostate
Symptom Score
LDR-BT = low-dose-rate
brachytherapy
M = month
MRI = magnetic resonance
imaging
NS = not signicant
PCa = prostate cancer
PSA = prostate-specic antigen
QOL = quality of life
TRUS = transrectal ultrasound
W = week
Y = year
Correspondence: Akira Komiya
M.D., Ph.D., Department of Urology,
Graduate School of Medicine and
Pharmaceutical Sciences for
Research, University of Toyama,
2630 Sugitani, Toyama-shi, Toyama
930-0194, Japan. Email:
komiya@med.u-toyama.ac.jp
Received 6 February 2012; accepted
26 July 2012.
Online publication 21 August 2012
Objectives: To evaluate the early quality of life outcomes in prostate cancer patients
managed by high-dose-rate brachytherapy as monotherapy.
Methods: Atotal of 51 patients with cT1cT3aN0M0 prostate cancer treated between
July 2007 and January 2010 were included in this study. The average age was 69 years,
and the average initial serumprostate-specic antigen was 10.98 ng/mL. Atotal of 25, 18
and eight patients were considered to be low, intermediate and high risk, respectively.
All patients received one implant of Ir-192 and seven fractions of 6.5 Gy within 3.5 days
for a total prescribed dose of 45.5 Gy. For high-risk prostate cancer, neoadjuvant andro-
gen deprivation therapy was carried out for at least 6 months, and continued after
high-dose-rate brachytherapy. Quality of life outcomes were measured by using the
International Prostate Symptom Score, the Functional Assessment of Cancer Therapy-
Prostate and the International Index of Erectile Function Questionnaire. The oncological
outcome was assessed by serum prostate-specic antigen and diagnostic imaging.
Adverse events were also recorded.
Results: The Functional Assessment of Cancer Therapy-Prostate scores decreased for
a few months after high-dose-rate brachytherapy, and recovered to pretreatment con-
dition thereafter. The International Prostate Symptom Score signicantly increased
2 weeks after treatment for each of its items and their sum, and it returned to baseline
after 12 weeks. Sexual function decreased at 2 and 4 weeks, and recovered after
12 weeks. Severe complications were rare. Within a median follow up of 17.2 months,
two patients showed a prostate-specic antigen recurrence.
Conclusions: High-dose-rate brachytherapy for prostate cancer is a feasible treat-
ment modality with acceptable toxicity and only a limited impact on the quality of life.
Key words: high-dose-rate brachytherapy, Ir-192, prostate cancer, radiation therapy.
Introduction
PCa is a leading cause of death in Western countries. The incidence and mortality of PCa are
also increasing in Japan, despite efforts to screen patients to provide an early diagnosis, and
despite intensive efforts to treat this disease.
1,2
Similar to other countries, PCa screening has
induced stage migration to early-stage disease in Japan. In parallel with this change, the
number of modalities for PCa treatment has been increasing, especially for localized PCa.
3
However, there is no denitive difference in the efcacy among curative therapies, although
each PCa treatment was reported to be associated with a distinct pattern of changes in QOL
domains related to urinary, sexual, bowel and hormonal function.
47
Only one randomized
Scandinavian trial showed an improvement in metastasis-free, prostate cancer-specic and
overall survival among patients who underwent prostatectomy against watchful waiting.
8
The other treatments have not been proven to have any survival advantages against controls.
Therefore, it is difcult to determine the best treatment option. In this context, it is important
bs_bs_banner
International Journal of Urology (2013) 20, 185192 doi: 10.1111/j.1442-2042.2012.03125.x
2012 The Japanese Urological Association 185
to show outcomes of certain treatments, not only in their
oncological aspects, but also their impact on the patient
QOL.
HDR-BT for PCa is a treatment modality for curative
intent against localized to locally advanced PCa. In terms of
high conformity and dose escalation, HDR-BT mono-
therapy seems to be one of the most efcient methods.
HDR-BT for PCa is often used in combination with EBRT.
8,9
A few authors have reported the use of HDR-BT as mono-
therapy without EBRT. However, there is a lack of informa-
tion about the oncological outcomes, and particularly about
the QOL outcomes, for this treatment in the literature. In the
present study, we evaluated early oncological and QOL
outcomes in patients with PCa managed by HDR-BT as
monotherapy.
Methods
Patients
A total of 51 patients with clinical T1cT3aN0M0 PCa
treated between July 2007 and January 2010 in the Depart-
ment of Urology and Radiology at Toyama University Hos-
pital were enrolled in the present study (Table 1). The
average age of the patients was 69 years, and the average
initial serum PSA was 10.98 ng/mL. All patients had
biopsy-proven adenocarcinoma of the prostate. Clinical
staging was carried out by digital rectal examinations,
TRUS, CT, MRI and bone scan. The patients were divided
into subgroups according to the DAmico risk classica-
tion.
10
A total of 25 patients were classied as having low-
risk, 18 with intermediate- and eight with high-risk PCa. All
patients received one implant of Ir-192 and seven fractions
of 6.5 Gy within 3.5 days for a total prescribed dose of
45.5 Gy. ADT was not planned for the low- and
intermediate-risk groups. Referred low-intermediate risk
patients who had already undergone ADT discontinued this
treatment after HDR-BT. For the patients with high-risk
PCa, neo-adjuvant ADT was carried out for more than
6 months, and this treatment was intended to continue for
more than 2 years after HDR-BT. The present study was
carried out in compliance with the Declaration of Helsinki.
The institutional review board of the University of Toyama
approved the present study.
Implant technique
The implant technique was described in detail in the report
by Yoshioka et al.
11
In brief, it involved continuous epidural
anesthesia, real-time TRUS guidance, the use of metallic
applicators and applicator stoppers (Trocar Point Needles
and Needle Stoppers; Nucletron, Veenendaal, The Nether-
lands), and an original template and its cover plate (TAISEI-
MEDICAL, Osaka, Japan).
Under real-time TRUS monitoring of the largest cross-
section of the prostate, the applicators were placed on the
line encompassing the prostate (with or without extracapsu-
lar invasion) and within the prostate, but sparing the urethra,
basically at 11.5-cm intervals. For the posterior (rectal)
side, the applicators were placed 03 mm inside the pros-
tatic capsule. The top 2 cm of the catheters was placed
within the urinary bladder, cephalad to the prostate/seminal
vesical junction.
Special attention was paid to applicator xation to avoid
displacement. The template was rmly pressed directly
against the perineal skin during the implant procedures. In
addition, throughout the overall treatment time, it was
sutured rmly to the perineal skin with silk threads at six
points, and four pieces of 5.1-cm wide and >50-cm long
elastic tape (ELASTIKON; Johnson & Johnson, Arlington,
VA, USA) were used to x the template to the lower abdomi-
nal skin, perineal skin, and skin of the buttocks.
Treatment planning and irradiation
The GTV was equal to the volume of the prostate. If extra-
capsular invasion was observed or was strongly suspected,
that area was included in the GTV. The CTV comprised the
GTV plus 5 mm in all directions except for the posterior
Table 1 Characteristics of the patients undergoing HDR-BT
Mean SD Median
Age (years) 68.9 6.3 69
Initial PSA (ng/mL) 10.98 10.64 8
Duration of follow up (months) 18.2 9.6 17.3
Initial prostate volume (mL) 31.1 16.7 27.1
No. positive cores by prostate
biopsy
2.6 1.9 2
No. applicator needles 13.1 1.9 13
n
Clinical stages T1c 28
T2a 13
T2b 9
T3a 1
Biopsy Gleason Score 3+3 29
3+4 10
4+3 5
>4+4 7
DAmico risk classication Low 25
Intermediate 18
High 8
Neoadjuvant androgen
deprivation
+ 19
- 32
A KOMIYA ET AL.
186 2012 The Japanese Urological Association
(rectal) margin. The posterior margin varied from 2 to 5 mm
depending on the distance to the rectal wall. The planned
target volume was equal to the CTV, except in the cranial
direction, for which it was greater. The top 2 cm of the
applicators were placed within the urinary bladder, so that
the planned target volume included a 1-cm margin in the
cranial direction from the CTV. This margin was established
as prevention not only of the cold area at the base of the
prostate, but also of distal displacement of the applicators.
One hour before each irradiation fraction, a urinary balloon
catheter was clamped in place to keep the urine within the
urinary bladder so that the opposite side of the bladder wall
and the rectosigmoid colon were kept away from the irra-
diation eld.
The treatment planning was carried out with the aid of
the PLATO software program (Nucletron, Veenendaal, The
Netherlands) using geometric optimization and one pre-
scription dose point (5 mm distant from one source). The
source dwell positions were located on the prostate surface
and inside the prostate (except in the cranial direction, for
which it was located 1 cm outside the prostate).
Patients remained in bed under epidural anesthesia for
3.5 days from Tuesday to Friday and underwent irradiation
twice daily, with an interval of at least 6 h. We used gradu-
ated compression stockings and intermittent external pneu-
matic calf compression for prevention of deep vein
thrombosis. The treatment consisted of seven fractions of
6.5 Gy each (total 45.5 Gy). The isoeffective dose used in
the present study corresponded to approximately 96.69 or
86.45 Gy administered at 2 Gy/fraction according to the
linear-quadratic model, assuming an alpha/beta ratio of 2 or
3 for PCa, respectively.
1214
Prophylactic antibiotics were
given twice daily from the day of implant through to day 5.
11
We used continuous epidural anesthesia during the whole
period of this treatment, and this is usually enough for pain
control.
Follow up and toxicity analysis
Urologists and radiation oncologists carried out the follow
up evaluations at regular intervals (every 3 months). CT,
MRI, TURS and bone scans were carried out as required.
The oncological outcome was assessed by serum PSA
levels, DRE, CT, MRI, TRUS and bone scans. After provid-
ing their informed consent, the patients were given a set of
questionnaires including the IPSS, FACT-P and the IIEF to
be completed before HDR-BT, and also at 2, 4 and
12 weeks, and 6, 9, 12 and 24 months after HDR-BT, and to
be returned at that time. The patient QOL outcomes were
measured by these questionnaires. Adverse events were
described using the CTCAE v.3.0. Late toxicity was dened
as symptoms that persisted or presented beyond 6 months
after treatment completion.
In the present study, we dened two types of recurrence:
biochemical recurrence and clinical recurrence. Clinical
recurrence was determined by clinical evidence of recur-
rence (e.g. detection of metastasis on a CT scan or bone
scan). Biochemical recurrence was determined according to
the Houston criteria; that is, when the rst PSA rise of at
least 2 ng/mL greater than the nadir was observed.
15
The
progression-free survival curves were calculated by the
KaplanMeier method.
Statistical analysis
An unpaired two-tailed t-test was used for comparisons
between the baseline and each point of time of follow up in
the QOL analyses. Values of P < 0.05 were considered to be
signicant.
Results
QOL outcomes
FACT-P
The FACT-P total score was not changed signicantly during
follow up (Fig. 1a). The FACT-P score in the physical well-
being domain was decreased at 2 and 4 weeks, but was
recovered by 12 weeks (Fig. 1b). The FACT-P score in the
social/family well-being domain was decreased at 12 weeks
and 9 months, but recovered by 1 year (Fig. 1c). The
FACT-P scores in the emotional or functional well-being
domains were not changed signicantly (Fig. 1d,e). The
FACT-P score in the additional concerns domain (prostate-
related symptoms) signicantly decreased at 2 and 4 weeks,
but recovered thereafter (Fig. 1f).
IIEF
The erectile function did not change signicantly in the
patients with neoadjuvant ADT, as assessed by the IIEF
(Fig. 2a). In contrast, this function was signicantly
impaired at 2 and 4 weeks in the patients without neoadju-
vant ADT (Fig. 2b). However, after 12 weeks, it was not
different from the pretreatment status. IIEF scores were not
statistically different between the two groups.
IPSS
Lower urinary tract symptoms were assessed by the IPSS.
The IPSS total score was increased signicantly at 2 and
4 weeks, but had recovered to pretreatment values by
12 weeks (Fig. 2c). In storage and voiding symptom sub-
scores, the same changes were observed (Fig. 2d,e). The
IPSS QOL score also showed the same change (Fig. 2f).
QOL in HDR-BT monotherapy for PCa
2012 The Japanese Urological Association 187
PSA decline and survival
PSA decline to less than 4 ng/mL was achieved in 90.2% of
the patients at 3 months after HDR-BT. During a median
follow up of 17.2 months, two cases showed PSA failure
with no evidence of metastasis. One was the initial fth
patient in our experience with low-risk PCa (initial PSA
4.5 ng/mL; biopsy Gleason score 3 + 3 = 6; T1cN0M0),
who showed PSA failure at 30 months after HDR-BT. Pros-
tate needle biopsy was carried out at PSA failure; however,
no malignant cells were found. Therefore, this patient is still
under observation without any additional treatments and his
PSA is stable. The other was the initial sixth patient in our
experience with low-risk PCa (initial PSA 4.6 ng/mL;
biopsy Gleason score 3 + 3 = 6; T1cN0M0), who showed
PSA failure at 27 months after HDR-BT. Prostate needle
biopsy was carried out at PSA failure and prostatic adeno-
carcinoma with a Gleason score of 3 + 4 was found. There-
fore, androgen deprivation therapy with leuprolide acetate
and bicalutamide was started, and serum PSA level had
declined to less than 0.01 ng/mL at the last follow up. The
others did not show PSA or clinical progression during
follow up (Fig. 3).
Toxicities
Only a few patients experienced severe AE in this cohort
(Table 2). Acute toxicities were mainly grades 12 GU
events including urinary retention, urinary frequency/
urgency, pain or hemorrhage. Grade 1 or 2 AE were found in
39 (76.5%) patients. One patient experienced a grade 3 hem-
orrhage, which was managed by transurethral coagulation.
Acute GU toxicities were generally related to applicator
placement. GI or non-GU/GI toxicities were mainly grade 1.
Late toxicities were less common and mostly in the grade 1
or 2 category, which were found in 24 (47.1%) patients. Two
patients complained of grade 3 ED. In another ve patients
with ED, phosphodiesterase 5 inhibitors were effective.
Discussion
Currently, patients with localized or locally advanced PCa
have a number of treatment options; however, there is a lack
of information regarding the differences in survival after the
different treatments. Therefore, the QOL outcome of each
treatment is one of the key factors that should inuence the
patients decision. In this context, we evaluated the early
Fig. 1 Changes in the FACT-P scores.
(a) The FACT-P total score. (b) The physi-
cal well-being. (c) The social/family well-
being. (d) The emotional well-being. (e)
The functional well-being. (f) Additional
concerns. *P < 0.05 versus before
HDR; **P < 0.01 versus before HDR;
***P < 0.001 versus before HDR.
24 24 18 23 20 18 13 3 n 38 43 41 41 37 31 22 5 n
25 29 26 26 21 21 16 5 n
36 38 34 41 32 30 21 6 n 39 42 40 42 34 32 20 6 n
39 41 42 41 35 34 24 6 n
(a) (b)
(c)
(e) (f)
(d)
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Before 2W 4W 12W 6M 9M 1Y 2Y
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NS
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A KOMIYA ET AL.
188 2012 The Japanese Urological Association
QOL and oncological outcomes related to HDR-BT in
patients with clinically localized or locally advanced PCa.
Although the follow-up period was too short to adequately
analyze disease control, we found good QOL outcome after
HDR-BT. The health-related QOL as assessed by the
FACT-P was impaired for a few months, but recovered in a
relatively short period of time. Scores in the physical well-
being and the additional concern domains decreased at 2 and
4 weeks. This could be a result of treatment procedure and
impaired urinary function. Scores in the social/family well-
being domain decreased at 12 weeks and 9 months; the
score at 6 months was not signicantly different from the
scores at 12 weeks and 9 months. Therefore, it can be said
that the social/family well-being was impaired from
3 months to 9 months after HDR-BT. It is difcult to dene
Fig. 2 Sexual and urinary functions. (a)
The changes in the IIEF score in patients
with neoadjuvant androgen deprivation
therapy. (b) The changes in the IIEF score
in patients without neoadjuvant andro-
gen deprivation therapy. (c) The changes
in the IPSS total score. (d) The changes in
the IPSS storage symptoms subscore. (e)
The changes in the IPSS voiding symp-
toms subscore. (f) The changes in the
IPSS QOL score. *P < 0.05 versus before
HDR; **P < 0.01 versus before HDR;
***P < 0.001 versus before HDR.
9 12 13 12 13 10 6
Before 2W 4W 12W 6M 9M 1Y Before 2W 4W 12W 6M 9M 1Y
Before 2W 4W 12W 6M 9M 1Y 2Y
Before 2W 4W 12W 6M 9M 1Y 2Y Before 2W 4W 12W 6M 9M 1Y 2Y
Before 2W 4W 12W 6M 9M 1Y 2Y
n 16 15 14 13 13 18 10 n
19 48 43 43 39 33 23 6 n 19 45 43 42 38 32 23 6 n
19 48 43 43 39 33 23 6 n 19 48 43 43 38 33 23 6 n
(a) (b)
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(n=51)
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.6
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Fig. 3 PSA progression-free survival in all patients.
QOL in HDR-BT monotherapy for PCa
2012 The Japanese Urological Association 189
the reason for this change. The other domains and FACT-P
total score did not show signicant change over time. Sexual
function as assessed by the IIEF did not change signicantly,
except for at the initial 4 weeks in the patients without ADT.
Decrease in IIEF at 2 and 4 weeks seemed to be a result of
treatment trauma rather than radiation-induced erectile dys-
function. Much of radiation therapy-induced erectile dys-
function will not usually be apparent until 25 years of
follow up. In the patients with neoadjuvant ADT, the change
in sexual function was similar to those without neoadjuvant
ADT; however, the difference was not statistically signi-
cant. IIEF scores before HDR-BT were slightly lower than
in those without ADT, and most of the cases discontinued
ADT after HDR-BT. This means sexual function did not
recover after cessation of ADT at least until 1 year, possibly
as a result of delay in recovery of testicular function.
Urinary functions, as assessed by the IPSS, were also
impaired for a few months, but improved thereafter. These
ndings are the rst report of the HDR-BT monotherapy-
related QOL outcomes, and can provide important informa-
tion to help prostate cancer patients choose which therapy
they wish to receive.
The QOL decline observed within the rst 2 weeks is
likely related to the treatment procedure and the effects of
the radiation; patients have to remain in bed under epidural
anesthesia for 4 days and 3 nights with applicator needles
placed from the perineal skin to the prostate and urinary
bladder. This might be a disadvantage of HDR-BT mono-
therapy. However, this treatment is completed within 4 days,
which can thus explain the early recovery in the QOL scores.
Although the treatment protocols were different, there
have been a few reports about the survival outcome after
HDR-BT monotherapy. Martinez et al. reported the PSA
progression-free survival to be 98% at 3 years and 91% at
5 years after HDR-BT monotherapy (38 Gy/4 fractions/
2 days).
12,16
Yoshioka et al. reported 83% progression-free
survival at 5 years after 54 Gy/9 fractions/5 days.
17
The
follow up in the present study was too short to adequately
judge disease control. However, PSA failure was observed
in two cases from the low-risk group, which were the initial
fth and sixth patients from the beginning of this treatment
in Toyama University Hospital, Toyama-shi, Japan. Longer-
term results will eventually dilute that effect with additional
successful patient accrual.
Early and late toxicities were mild, and severe complica-
tions were rare in the present study. In the literature, grade 3
or higher adverse events were reported in 03.8% of patients
and 0% of the patients for acute GU and GI toxicities,
respectively. Grade 3 or higher late GU and GI toxicities
were observed in 1.211% and 01.2% of patients after
HDR-BT.
13,1820
The present results are comparable with the
previous reports. In particular, urethral stricture as a late
toxicity was rare and found as grade 2 in only one patient.
This might be a result of the outcome of our efforts to reduce
the radiation dose to the urethra, which is the most important
organ at risk in HDR-BT. Rare urethral stricture also might
be a result of short follow up, or simply not being examined
unless patients complain of urinary symptoms.
HDR-BT + EBRT has recently been the most common
treatment procedure, especially for locally advanced PCa.
Table 2 Toxicities
Adverse events Acute toxicities Late toxicities
Grade (CTCAE v.3.0) Grade (CTCAE v.3.0)
1 2 3 4 1 2 3 4
GU Urinary retention 5 10 0 0 2 2 0 0
Urinary frequency/urgency 4 2 0 0 5 0 0 0
Pain urethra 9 2 0 0 2 1 0 0
Hemorrhage bladder or urethra 0 9 1 0 0 2 0 0
Stricture urethra 0 0 0 0 0 1 0 0
Subtotal (%) 38 (74.5) 1 (2.0) 17 (33.3) 0 (0.0)
GI Anorexia 1 0 0 0 0 1 0 0
Constipation 2 0 0 0 0 0 0 0
Pain anus 1 0 0 0 1 0 0 0
Hemorrhage anus 1 0 0 0 1 0 0 0
Subtotal (%) 5 (9.8) 0 (0.0) 3 (5.9%) 0 (0.0)
Non-GU/GI Erectile dysfunction 0 2 0 0 1 5 2 0
Pain head/headache 1 0 0 0 0 0 0 0
Pain extremity-limb 0 1 0 0 0 0 0 0
Subtotal (%) 4 (7.8) 0 (0.0) 6 (11.8%) 2 (3.9)
Total (%) 39 (76.5) 1 (2.0) 24 (47.1) 2 (3.9)
A KOMIYA ET AL.
190 2012 The Japanese Urological Association
Mohammed et al. reported a comparison of toxicities
between HDR-BT and HDR-BT + EBRT.
21
The incidences
of any acute grade 3 GI or GU toxicities were 8% for both
BTand EBRT + HDR. Any late GUtoxicities grade 3 were
present in 5% and 12% for HDR-BT, and HDR-BT + EBRT,
respectively. Patients receiving EBRT + HDR had a higher
incidence of urethral stricture and retention, whereas dysuria
was most common in patients receiving HDR-BT. Any
grade 3 late GI toxicities were 0.3% and 1% for the
HDR-BT and HDR-BT + EBRT groups. The differences
were most pronounced for rectal bleeding, with 3-year rates
of 0.9%and 6%for HDR-BT and HDR-BT + EBRT, respec-
tively. Therefore, acute toxicity was the same, but the chronic
toxicity was greater for combined HDR-BT + EBRT than it
was for HDR-BT monotherapy. Regarding the QOL out-
comes in HDR-BT + EBRT, the FACT-P and IPSS scores
were reported to recover at approximately 23 months.
2224
In
comparison with these studies, the present study demon-
strated that HDR-BT monotherapy showed comparable or
even better GU/GI toxicities and QOL recovery.
The results in terms of erectile dysfunction varied. Morton
et al. showed a decrease in IIEF score at 612 months and a
recovery at 24 months after HDR-BT plus EBRT.
24
In con-
trast, Nohara et al. reported that 80% of their patients main-
tained erectile function at 1 year after HDR-BT + EBRT.
9
Our cohort did not showa signicant decrease in IIEF scores,
except for the ones at 2 and 4 weeks after HDR-BT, which
seemed better than the result in HDR-BT + EBRT.
Another seed implant technique, LDR-BT, is also carried
out to treat localized PCa. After LDR-BT, Feigenberg et al.
reported that the FACT-P scores remained below the base-
line in 2034% of patients at 1 year.
25
Lee et al. reported that
the decline in the total FACT-P score at 1 and 3 months
improved at 1 year after LDR-BT.
26
Urinary function usually
requires approximately 1 year to recover to the baseline
level by IPSS.
25,27
Therefore, LDR-BT impairs HR-QOL
longer than HDR-BT monotherapy as compared with the
present data. ED is also observed after LDR-BT. Merrick
et al. reported ED in 60% of patients at 1 year, and 50% at
3 years after LDR-BT.
28
Wyler et al. reported potency in
50% of patients at 524 months, and 30% at 2553 months
after LDR-BT.
29
Martinez suggested HDR-BT might
compare favorably to LDR-BT in terms of ED, but it was not
statistically signicant;
16
however, our cohort did not show a
signicant decrease in IIEF. Although LDR-BT is a simple
procedure, the inuence on the health-related QOL, urinary
function and sexual function seem to be prolonged com-
pared with HDR-BT.
There were limitations in the present study. Patients
followup was relatively short. The sample size was relatively
small. The results could have been different if the study was
carried out in a larger cohort with longer follow-up periods.
In addition, we could not describe QOL during the insertion
of the applicator needles. If patients were asked to ll out the
questionnaires during insertion of applicators for HDR-BT,
the scores might have been much worse. IIEF could have
been much worse, because sexual intercourse was impos-
sible during insertion of applicators. IPSS should have been
much worse, because a Foley catheter was placed in the
urethra and urinary bladder, which means patients could not
urinate. General QOL should have been worse, because
patients must keep lying on their back during insertion of
applicators for HDR-BT. However, we did not collect QOL
data during this procedure, because these sorts of studies are
usually carried out to compare QOL before and after treat-
ments. Therefore, the examination of QOL during treatment
is not usually carried out. For example, a representative QOL
outcome study by Sanda et al. showed QOL in patients who
underwent radical prostatectomy, external-beam radio-
therapy or brachytherapy at the time-points of pretreatment,
2 months, 6 months, 12 months and 24 months, but not
during the treatments.
7
It is also impossible to investigate
QOL during radical prostatectomy under general anesthesia.
IPSS is a questionnaire that inquires about urinary symptoms
during the past 1 month. IIEF is a questionnaire that inquires
about erectile function during the past 4 weeks. FACT-P also
inquires about prostate cancer therapy-related QOL during
the past 7 days. Therefore, these questionnaires are not
designed for real time assessment of QOL. In any case, the
present study showed that recovery was fast when assessed
by FACT-P, IIEF and IPSS.
In conclusion, the present study suggests that HDR-BT
for localized or locally advanced PCa is a feasible treatment
modality with limited inuence on patient QOL, and accept-
able acute and late toxicities. Further studies are required
to conrm these results and to determine the oncological
outcomes.
Acknowledgments
We are grateful to Ms Yoko Kawauchi, and Dr Yoshihiro
Asao and Dr Keisuke Ichimatsu for their valuable advice
and suggestions.
Conict of interest
None declared.
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192 2012 The Japanese Urological Association