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- Clinical Experience -
Individualized prostate biopsy strategy for Chinese patients
with different prostate-specific antigen levels
Bo Dai1,4, Ding-Wei Ye1,
4, Yun-Yi Kong2, 4, Yi-Jin
Shen1, 4, Bo-Hua Wang3, 4
1>Department of Urology, 2
Department of Pathology and 3Department of Ultrasound, Cancer Hospital, and
4Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China
Abstract
Aim: To evaluate the best individualized prostate biopsy strategies for Chinese patients with suspected prostate
cancer. Methods: The present study included 221 Chinese patients who underwent transrectal ultrasound guided
prostate biopsies for the first time. All patients underwent the same 10-core biopsy protocol. In addition to the Hodge
sextant technique, four more biopsies were obtained from the base and middle regions of bilateral peripheral zones.
The differences between 10-core and sextant strategies in cancer detection among patients with different prostate
specific anitgen (PSA) levels were evaluated. The relationship between PSA level, number of positive biopsy cores
and organ-confined cancer rate in prostate cancer patients was also
analyzed. Results: The overall prostate cancer
detection rate was 40.7% in the 221 patients. The 10-core strategy increased cancer detection by 6.67% (6/90) in our
patients (P < 0.05). The increased cancer detection rates decreased significantly when the patient PSA level increased
from 0_20 ng/mL to 20.1_50 ng/mL and > 50 ng/mL
(P < 0.01). The number of positive biopsy cores in prostate
cancer patients increased significantly with increasing patient PSA level
(P < 0.01). The rate of organ-confined
prostate cancer decreased significantly with increasing patient PSA level
(P < 0.01).
Conclusion: The extended 10-core strategy is recommended for Chinese patients with
PSA ¡Ü 20 ng/mL and the sextant strategy is recommended for
those with PSA > 50 ng/mL. For patients with PSA ranging from 20.1 ng/mL to 50 ng/mL, the 10-core strategy
should be applied in patients with life
expectancy ¡Ý 10 years and the sextant strategy should be applied in those with
life expectancy < 10 years. (Asian J Androl 2008 Mar; 10: 325_331)
Keywords: prostate; prostatic neoplasms; diagnosis; biopsy; Asian continental ancestry group
Correspondence to: Dr Ding-Wei Ye, Department of Urology, Cancer Hospital, Fudan University, Shanghai 200032, China.
Tel: +86-21-6417-5590 ext. 1807 Fax: +86-21-6443-8640
E-mail: dwye@shca.org.cn
Received 2007-06-11 Accepted 2007-10-02
DOI: 10.1111/j.1745-7262.2008.00345.x
1 Introduction
Prostate cancer is one of the most common cancers in the world. The estimated number of cases worldwide was
513 000 in the year of 2000 [1]. However, the incidence rate of prostate cancer varies widely among countries and
racial groups. The age-standardized incidence rate of prostate cancer was 173.8/100 100 in the USA in 2002 as
compared with 7.7/100 000 in the city of Shanghai, China in 2000 [2, 3].
Because of the low incidence rate, extremely limited data regarding the diagnosis and treatment of prostate
cancer in Chinese patients have been reported in English language articles.
Transrectal ultrasound (TRUS) guided prostate core needle biopsy has become the standard method for
diagnosing prostate cancer in developed countries since Hodge
et al. [4] proposed the systematic sextant biopsy protocol in
1989. Recently, the value of this sextant biopsy strategy was challenged by the extended prostate biopsy strategies,
which can increase cancer detection rate by more than 30% [5]. Therefore, an increasing number of medical centers
in the developed world have begun to apply extended
biopsy strategies [5]. However, the equipment and
techniques of TRUS-guided prostate biopsy were introduced
into China less than a decade ago and very limited data or
experience from Chinese patients in this field have been
reported. In the present study, we investigated the
efficiency of the TRUS-guided systematic 10-core biopsy
strategy for Chinese patients who were suspected of
having prostate cancer and who underwent biopsy for
the first time. The purpose of the present study is to
find out the best prostate biopsy strategy for Chinese
patients.
2 Materials and methods
2.1 Patients
Between March 2005 and February 2007, 221 Chinese patients who underwent TRUS-guided prostate
biopsies for the first time at our institution were included
in this study. Indications for prostate biopsy were
abnormal digital rectal examination (DRE) and/or serum
prostate specific anitgen (PSA) level greater than
4.0 ng/mL. The DRE and PSA results of each patient were available
before biopsy. 500 mg levofloxacin once daily and
400 mg metronidazole twice daily were administered to
each patient orally 3 days before biopsy and another
3 days after biopsy. All patients received an enema 2 h
before biopsy procedures. For patients who were
diagnosed with prostate cancer, further investigations such
as abdomen ultrasound, pelvic computed tomography scan and bone scintigraphy were performed to evaluate
clinical stages and to determine therapeutic plans. All
patients were interviewed through telephone 2 weeks after
biopsy about the complications.
2.2 Biopsy technique
All patients were placed in the left lateral decubitus
position with knees and hips flexed 90 degrees. All
biopsies were performed with a Falcon 2101 EXL type
transrectal ultrasound scanner, an 8808 5-10 MHz type
probe and a UA 1257 type biopsy adaptor (B-K Medical,
Herlev, Denmark). All patients were thoroughly
examined by TRUS before biopsy procedures and prostate
volumes were calculated by the ellipsoid prostate
formula [6]. All lesions detected by TRUS were recorded
in detail. An 18-gauge Bard Magnum core biopsy needle
mounted on a spring loaded automatic biopsy gun (Bard,
Covington, GA, USA) was used to obtain 22 mm long
core samples.
All patients underwent the same 10-core biopsy
protocol regardless of the ultrasound appearance of the
prostate. In addition to the Hodge sextant technique [4],
4 more biopsies were obtained from the lateral peripheral
zones by positioning the probe just medial to the lateral
edge of the prostate at the base and middle regions
bilaterally, as described by Ravery
et al. [7] and Eskico-rapci
et al. [8].
2.3 Pathological evaluation
All 10 biopsy specimens were labeled according to
the site and submitted separately in 10 formalin-filled
containers to the Department of Pathology at our institution. The core from each container was
embedded in a block individually and at least five sections were
obtained from each block. The pathological diagnosis
was given to each core and the individual Gleason score
was given to each core containing prostate cancer. The
atypical cases were further evaluated with
immunohistochemical markers, such as AMACR, p63,
34βE12, PSA, PAP and so on. If only biopsies from the four
lateral peripheral zones had been positive for cancer, we
would have concluded that the conventional sextant
protocol missed the diagnosis of prostate cancer.
2.4 Statistical analysis
SPSS 11.0 for Windows (SPSS, Chicago, IL, USA)
was used for the statistical evaluation. Differences
between the prostate cancer and non-prostate cancer
patients were evaluated using the Mann-Whitney
U-test for continuous variables, the
χ2-test and the Pearson
χ2-test for discontinuous variables. The McNemar test was used
to compare the cancer detection rates between the
10-core and the sextant biopsy strategies. The Pearson
χ2-test was used to compare the improvements in cancer
detection of the 10-core strategy in patients with
different PSA levels. The Kruskal-Wallis H-test and the Pearson
χ2-test were used for comparison of positive biopsy core
number and organ-confined prostate cancer rate
according to prostate cancer patient PSA level. A probability of
less than 5% (P < 0.05) was considered statistically
significant.
3 Results
The overall prostate cancer detection rate was
40.7% (90/221) in the whole study group. Table 1 shows
clinical characteristics of the prostate cancer patients and
the non-cancer patients. Median patient age, median PSA
level, median PSA density (PSAD), abnormal DRE rate
and abnormal TRUS rate were significantly higher in
prostate cancer patients. The cancer detection rate
increased significantly with increasing serum PSA level.
The cancer detection rate also increased significantly with
increasing patient age.
Table 2 lists clinical and pathological characteristics
of our 90 prostate cancer patients. Of our prostate
cancer patients, 76.7% (69/90) had lymph node or distant
metastases at the time of diagnosis. Only 16.7% (15/90)
of patients who had clinical stages ¡Ü T3N0M0 were
treated by radical prostatectomy or radical radiotherapy.
In this study, only 21.1% (19/90) prostate cancer
patients had biopsy Gleason scores of less than 7 and there
was no clinically insignificant cancer.
Table 3 shows that as compared with the sextant
strategy, the 10-core strategy increased the cancer
detection rate by 6.67% (6/90) in the whole group of
patients. The improvement in cancer detection of the 10-core
strategy decreased significantly with increasing patient
serum PSA level. In patients whose PSA levels were greater
than 50 ng/mL, the sextant biopsy strategy could detect
the same number of cancers as the 10-core strategy did.
The median number of positive biopsy cores in
prostate cancer patients increased significantly from 2 cores
to 5 and 10 cores when the patient PSA level increased
from 0_20 ng/mL to 20.1_50 ng/mL and > 50 ng/mL
(Table 4). However, the proportion of organ-confined
prostate cancer decreased significantly from 64.3% to
12.5% and 0% when the prostate cancer patient's PSA
level increased from 0_20 ng/mL to 20.1_50 ng/mL and
> 50 ng/mL, respectively (Table 4).
There were only two (0.9%) major complications requiring hospitalization in our group: one delayed severe
rectal bleeding and one confirmed systemic infection.
The two patients recovered shortly after appropriate
therapies. Other minor complications included
hematuria in 55.2% (122/221), short-term rectal bleeding in
24.9% (55/221), urinary tract infection in 4.1% (9/221)
and voiding difficulties in 1.8% (4/221) of patients.
Patients with minor complications were treated as
outpatients and recovered quickly.
4 Discussion
Although the TRUS-guided prostate biopsy is the gold
standard for diagnosing prostate cancer, the best
strategy for biopsy remains controversial [9]. An increasing
number of studies from developed countries indicate that
the traditional sextant biopsy strategy is insufficient for
diagnosing prostate cancer as compared with the extended
biopsy strategies, which detect probably 30% more
cancers without increasing the number of clinically
insignificant cancers [5, 8_10]. TRUS-guided prostate
biopsy has not been wildly applied in China and other
developing countries. Because of the different incidence
rates of prostate cancer, different economic conditions
and different cultural backgrounds, the experiences from
the developed world in this field might not be terribly
useful for Chinese patients and other developing countries.
As one of the largest cancer centers in China, our
center is outfitted with TRUS equipment and we have
performed TRUS-guided extended 10-core biopsy in 221
patients over the past 2 years. The overall cancer
detection rate was 40.7% in our patients. This rate is higher
than the data from some contemporary developed-world
studies [5, 7_10]. The median patient age, median PSA
level, median PSAD, abnormal DRE rate and abnormal
TRUS rate were significantly higher in our cancer
patients than in non-cancer patients, consistent with
previous developed-world studies [7, 8, 10]. In our series,
there were 63 (28.5%) patients whose PSA levels were
greater than 50 ng/mL before biopsy and 95.2% (60/63)
of these patients were diagnosed with prostate cancer.
In developed-world studies, there are very few patients
with PSA levels > 50 ng/mL before biopsy and some studies
even only include patients with PSA levels of less than
10 ng/mL or 20 ng/mL [5]. This major difference
explains the higher cancer detection rate in our Chinese
patients whose prostate cancer incidence rate was
extremely low. For the same reason, in our 90 cancer
patients there were only 15 (16.7%) patients with
clinical stages ¡Ü T3N0M0 and 69 (76.7%) of patients had
regional lymph nodes or distant metastases at the time of
diagnosis. In contrast, because of PSA screening programs, most prostate cancer patients in developed
countries are diagnosed at early stages with low PSA
levels [11]. In the USA, an estimated 91% of the new
cases of prostate cancer are expected to be diagnosed at
local or regional stages [2, 11]. In patients with PSA
levels of 4_10 ng/mL, the cancer detection rate was only
6.9% in the present study, which is much lower than the
25%_35% cancer detection rate in previous
developed-world studies [5, 7_10]. Another study also found
cancer detection rates of Chinese patients with different PSA
levels to be much lower than those in men from
developed countries with the same PSA levels [12]. This
phenomenon might be a result of different genetic factors,
environmental conditions and lifestyles between men in
China and men in developed countries [13].
In the whole group of our patients, the prostate
cancer detection rates of the 10-core strategy and the
sextant strategy were 40.7% and 38.5%, respectively. The
10-core strategy could only be detected in 6.67% (6/90)
more cancers, which was markedly less than in some
pervious developed-world studies [5, 7_10]. After
classifying our patients according to different serum PSA
levels, we found that the extended 10-core biopsy
stra-tegy increased cancer detection by 35.7% (5/14) over the
sextant strategy in Chinese patients with PSA
¡Ü 20ng/mL. However, the improvement in cancer detection decreased
to 6.25% (1/16) and 0% when patient PSA levels increased to 20.1_50 ng/mL and > 50 ng/mL (Table 3).
Published developed-world studies investigating the
diagnostic value of the extended prostate biopsy strategies
seldom consider the effect of patient PSA level on
cancer detection improvement [5, 7_10]. A recently
published review article comparing cancer detection rates of
different extended prostate biopsy strategies concludes
that strategies with 12 cores detect 31% more cancers
than the sextant strategy [5]. Nevertheless, some
studies investigated by this review only included patients with
PSA < 10 ng/mL, others only included patients with PSA
< 20 ng/mL, and others included patients with the
highest PSA level of 37.4_240 ng/mL [5]. Therefore, the
relation between the patient PSA level and the cancer
detection improvement of the extended biopsy strategies
was not considered by the authors of the review.
Because the proportion of patients with PSA > 20 ng/mL
was very low in those developed-world studies, the overall
cancer detection improvements of the extended
strategies were still very high. However, this proportion in
our Chinese patients was up to 38.9% (86/221) and it
made the overall cancer detection improvement drop to
6.67%. Further investigations showed that the number
of positive biopsy cores increased significantly with
increasing PSA levels in cancer patients (Table 4). All of
our Chinese prostate cancer patients with PSA levels
> 50 ng/mL had at least four positive cores. In these
patients, cancer tissues had invaded at least half of the
prostate glands. This detailed data could explain why
the sextant and the extended 10-core biopsy strategies
detected the same proportion of cancer cases from our
Chinese patients with their PSA > 50 ng/mL.
The aforementioned differences between our Chinese and developed-world patients at the time of biopsy
must be considered in our clinical practice. For patients
with high PSA and metastatic diseases, the prostate core
needle biopsy can only establish the pathological
diagnosis of prostate cancer. However, for patients with low
PSA levels and localized diseases, the biopsy should not
only establish the diagnosis but also provide more vital
information for guiding treatment [14]. Previous studies
demonstrate that compared with the sextant strategy, the
extended strategies could increase the cancer detection
rate and predict the Gleason score, the extraprostatic
extension and the total tumor volume more accurately in
organ-confined prostate cancer patients [15_17]. These
advantages of the extended strategies are particularly
important for those who can be treated with radical
prostatectomy. For example, the cancer involvement of
base biopsies might influence bladder neck sparing
radical prostatectomy and extensive cancer in one lobe, which
correlates with ipsilateral extraprostatic extension, and
might influence nerve sparing radical prostatectomy [14].
According to our data, the proportion of organ-confined
prostate cancer decreased significantly with increasing
patient PSA levels (Table 4). Therefore, it is of no use to
provide such information for cancer patients with PSA
levles > 50 ng/mL.
As compared with the sextant strategy, the extended
biopsy strategies increase the rate of some complications,
the duration of pain and discomfort during biopsy
procedures and the expense of tissue sampling and
pathological diagnosis. Previous studies demonstrate that there
is no statistically significantly difference between the rate
of major complications of the extended strategies with
10_12 cores and that of the sextant strategy; however,
the rate of minor complications, such as bleeding, was
higher in the extended strategies [5, 18_20]. Our data
also show that hematuria and rectal bleeding rates were
not very low, although they were not higher than those
in previous developed world studies [18_20]. Compared
with the extended 10-core strategy, the sextant strategy
reduces 40% of the expense of tissue sampling and
pathological diagnosis. Because china is still a developing
country, reducing costs is an important issue in our
medical practice. By using the sextant strategy in Chinese
patients, we can obtain the aforementioned advantages
without decreasing the cancer detection rate.
Table 5 shows the individualized prostate biopsy
strategies we recommended for our Chinese patients who
undergoing their first prostate biopsy. Because of the
reasons listed in Table 5, the extended 10-core biopsy
strategy is strongly recommended for Chinese patient
with PSA levels ¡Ü 20 ng/mL and the conventional
sextant strategy is strongly recommended for those with
PSA levels > 50 ng/mL. For Chinese patient with PSA
levels ranging from 20.1 ng/mL to 50 ng/mL, the
extended 10-core strategy only increased cancer detection
by 6.25% over the sextant strategy and only 12.5% or
these prostate cancer patients had organ-confined cancers. Therefore, it is not necessary to use the
extended 10-core strategy for every patient. We
recommend that the 10-core strategy should be applied in
patients with life expectancy longer than 10 years and the
sextant strategy should be applied in those with life
expectancy less than 10 years.
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