RAPID COMMUNICATION

CME ARTICLE

SERUM PROSTATE-SPECIFIC ANTIGEN CONCENTRATION IS

A POWERFUL PREDICTOR OF ACUTE URINARY RETENTION
AND NEED FOR SURGERY IN MEN WITH CLINICAL
BENIGN PROSTATIC HYPERPLASIA
CLAUS G. ROEHRBORN, JOHN D. MCCONNELL, MICHAEL LIEBER, STEVEN KAPLAN,
JACK GELLER, GHOLEM H. MALEK, RONALD CASTELLANOS, SCOTT COFFIELD,
BRIAN SALTZMAN, MARTIN RESNICK, THOMAS J. COOK, AND JOANNE WALDSTREICHER,
FOR THE PLESS STUDY GROUP

ABSTRACT
Objectives. Prostate-specific antigen (PSA) is produced exclusively in the prostate gland and is currently the
most useful clinical marker for the detection of prostate cancer. In this report, we examine whether serum
PSA is also a predictor of important benign prostatic hyperplasia (BPH)-related outcomes, acute urinary
retention (AUR), and the need for BPH-related surgery.
Methods. Three thousand forty men were treated with either placebo or finasteride in a double-blind,
randomized study of 4-year duration. Serum PSA was measured at baseline, and baseline prostate volume
was measured in a 10% subset of 312 men. Probabilities and cumulative incidences of AUR and BPH-related
surgery, as well as reduction in risk of events with finasteride, were calculated for the entire patient
population, stratified by treatment assignment, baseline serum PSA, and prostate volume.
Results. The risk of either needing BPH-related surgery or developing AUR ranged from 8.9% to 22.0%
during the 4 years in placebo-treated patients stratified by increasing prostate volume and from 7.8% to
19.9% when stratified by increasing serum PSA. In comparison with symptom scores, flow rates, and
residual urine volume, receiver operating characteristic curve analyses showed that serum PSA and prostate
volume were the most powerful predictors of spontaneous AUR in placebo-treated patients (area under the
curve 0.70 and 0.81, respectively). Finasteride treatment reduced the relative risk of needing surgery or
developing AUR by 50% to 74% and by 43% to 60% when stratified by increasing prostate volume and
serum PSA, respectively.
Conclusions. Serum PSA and prostate volume are powerful predictors of the risk of AUR and the need for
BPH-related surgery in men with BPH. Knowledge of baseline serum PSA and/or prostate volume are useful
tools to aid physicians and decision makers in predicting the risk of BPH-related outcomes and choosing
therapy for BPH. UROLOGY 53: 473–480, 1999. © 1999, Elsevier Science Inc. All rights reserved.

B enign prostatic hyperplasia (BPH) is a very

common condition in elderly men. Histologic
evidence in the form of both stromal and glandu-
lar-epithelial hyperplasia can be found in approxi-
mately 60% of men in their 60s, and 80% of men in
their 80s. Although not all these men require treat-

A complete list of the members of the PLESS Study Group is given
in the Appendix.
Dr. Waldstreicher and Thomas J. Cook are employees of Merck
& Co., Inc., the sponsor of the study.
From the Departments of Urology, University of Texas South-
western Medical Center at Dallas, Dallas, Texas; Mayo Clinic,
Rochester, Minnesota; Columbia Presbyterian College of Physicians
and Surgeons, New York, New York; Jackson Foundation, Madison,
Wisconsin; Ft. Myers Study Center, Fort Myers, Florida; Scott &
White Memorial Hospital, Temple, Texas; Beth Israel Deaconess
Medical Center, Boston, Massachusetts; Case Western Reserve Uni-
versity, Cleveland, Ohio; Department of Medicine, Mercy Hospital
and Medical Center, San Diego, California; and Departments of Bio-
statistics and Clinical Research, Endocrinology and Metabolism,
Merck Research Laboratories, Rahway, New Jersey
Reprint requests: Claus G. Roehrborn, M.D., Department of Urol-
ogy, University of Texas Southwestern Medical Center at Dallas,
5323 Harry Hines Boulevard, J8-130, Dallas, TX 75235-9110
Submitted: October 13, 1998, accepted (with revisions): No-
vember 10, 1998

© 1999, ELSEVIER SCIENCE INC. 0090-4295/99/$20.00

ALL RIGHTS RESERVED PII S0090-4295(98)00654-2 473
ment, in many it will cause bothersome symptoms
that may interfere with activities of daily living and
reduce their quality of life.1 Long-term conse-
quences of the disease may include acute urinary
retention (AUR) and the need for surgery, as well
as urinary tract infection, bladder function deteri-
oration, and rarely renal failure due to obstruc-
tion.2– 4 Although limited clinical data are available
regarding the incidence of AUR and the need for
surgery in men followed up longitudinally, it is
worthwhile to review the evidence at hand.
Among 50-year-old men, the lifetime incidence
of surgical or medical intervention for BPH is esti-
mated to be 35%.5 In a 3-year study comparing
watchful waiting to transurethral resection of the
prostate (TURP), 24% of men with moderate
symptoms assigned to watchful waiting underwent
surgery.6
AUR is a painful condition characterized by the
inability to initiate voiding and empty the bladder.
It may occur spontaneously in men with BPH or be
precipitated by surgery, anesthesia, or ingestion of
medications such as alpha-sympathomimetics and
anticholinergics. AUR occurred in 3% of patients
with moderate symptoms of BPH in the watchful
waiting versus TURP study.6 In a cohort study of
500 men with BPH who were candidates for pros-
tate surgery and followed up for 4 years, the inci-
dence of AUR was 25 per 1000 (40 per 1574) per-
son-years.2 In the community-based longitudinal
Olmsted County Study, the incidence of AUR in
2115 men followed up for 4 years was 6.8 per 1000
(57 per 8344) person-years.3
Although not very common, both AUR and the
need for surgery present a dramatic event in the
natural history of BPH for the patients affected by
them. It would therefore be advantageous to be
able to predict in some form whether a given pa-
tient is at higher or lower risk of experiencing ei-
ther one of these outcomes.
Recent evidence suggests that prostate volume
correlates with the risk of AUR in the Olmsted
County community-based study.3 Prostate volume
is also a powerful predictor of symptom and flow
rate improvement in men with BPH treated with
the 5-alpha-reductase inhibitor finasteride, which
decreases conversion of testosterone to the more
potent androgen dihydrotestosterone, and de-
creases prostate volume by approximately 20%.7
Treatment with finasteride also decrases the risk of
developing AUR and needing BPH-related sur-
gery.8 Although it would be intuitively reasonable
to select patients at risk of therapy with finasteride
on the basis of prostate volume, the digital rectal
examination (DRE) tends to underestimate pros-
tate size considerably.9 However, a strong positive
correlation between prostate volume and serum
474
PSA has been described,10 suggesting that PSA may
be useful as a proxy for prostate volume.
In the present analysis, we sought to determine
whether serum PSA, as a proxy for prostate vol-
ume, is a useful predictor of long-term outcomes of
BPH, such as AUR and BPH-related surgery, in pa-
tients followed up longitudinally with and without
therapy with finasteride.
MATERIAL AND METHODS
SUBJECTS
Three thousand forty men with clinical BPH diagnosed on
the basis of moderate-to-severe symptoms, a decreased peak
urinary flow rate (less than 15 mL/s with a voided volume of
150 mL or more; Urodyn 1000, Dantec, Mahway, NJ), and an
enlarged prostate gland by DRE were enrolled in a 4-year
study comparing finasteride with placebo. Men receiving al-
pha-blocking agents or antiandrogens and men with a history
of chronic prostatitis, recurrent urinary tract infections, pros-
tate or bladder cancer or surgery, or a serum PSA greater than
10 ng/mL were excluded. Men with serum PSA concentrations
between 4.0 and 9.9 ng/mL had to have a negative prostate
biopsy before enrollment.
STUDY DESIGN
The study was approved by the institutional review boards
at all 95 participating centers, and all men gave written in-
formed consent. After a 1-month single-blind placebo lead-in,
men were randomly assigned to receive placebo or 5 mg of
finasteride (Proscar, Merck and Co., Inc., West Point, Pa)
daily. Symptoms, bothersomeness, adverse events, and uri-
nary flow rates were assessed every 4 months.8 Serum PSA was
measured every 4 months in the first year and then every 8
months at a central laboratory. Physical examination and rou-
tine hematologic and serum chemistry tests were performed
yearly. Magnetic resonance imaging was performed at baseline
and then yearly in a subset of participants at 13 centers (n 5
312). All magnetic resonance images were read by a central
radiologist unaware of the treatment allocation and time of
imaging (ie, base line or follow-up). Additional details on
study design have previously been described.8
AUR and surgery for BPH were predefined secondary end
points. An Endpoint Committee, whose members were un-
aware of the treatment assignment, reviewed all documenta-
tion relating to episodes of AUR and all prostate surgeries for
BPH, excluding surgery for prostate cancer. The Endpoint
Committee classified episodes of AUR as spontaneous versus
precipitated (when contributing factors such as a cerebrovas-
cular accident, urinary tract infection, surgery, anesthesia, and
ingestion of alpha-sympathomimetic drugs or anticholin-
ergics were identified).
Complete data on outcomes, including 4-year follow-up
information for men who had discontinued treatment, were
available for 92% of the men randomized. In the other 8%,
complete information was available until discontinuation of
the medication or up to the 6-month follow-up assessment
after discontinuation.
STATISTICAL ANALYSIS
The effect of baseline prostate volume and serum PSA on the
risk of a BPH-related outcome (developing AUR and need for
BPH-related surgery) were assessed by dividing patients into
tertiles of baseline prostate volume and baseline serum PSA
and calculating the risk of developing an outcome by life-
table, time-to-first event analysis, and Fisher’s exact test for
UROLOGY 53 (3), 1999
 TABLE I. Baseline characteristics of men in the finasteride and placebo groups
Placebo Finasteride
Parameter Mean 6 SD n Mean 6 SD n
Age (yr) 64 6 7 1503 64 6 6 1513
Quasi-AUA symptom score* 15 6 6 1503 15 6 6 1513
Peak flow rate (mL/s) 11 6 4 1196 11 6 4 1208
Prostate volume (mL)† 55 6 26 155 54 6 25 157
First tertile (14–41) 32 6 6 45 33 6 6 59
Second tertile (42–57) 49 6 5 60 47 6 5 44
Third tertile (58–150‡) 81 6 29 50 82 6 22 54
Serum PSA (ng/mL) 2.8 6 2.1 1498 2.8 6 2.1 1512
First tertile (0.2–1.3) 0.9 6 0.3 511 0.8 6 0.3 472
Second tertile (1.4–3.2) 2.2 6 0.6 514 2.2 6 0.6 536
Third tertile (3.3–12.0) 5.4 6 1.7 473 5.4 6 1.7 504
None of the differences was significant.
* Quasi-AUA symptom score based on an adaptation of the American Urological Association (AUA) symptom score, also known as the IPSS (International Prostate Symptom
Score).
†
Prostate volume was only measured in approximately 10% of patients in 13 of the participating centers.
‡
One additional patient had a prostate volume of 222 mL.

cumulative incidence. The finasteride-related reduction in

risk during 4 years was calculated using log-rank analyses.
Comparisons among tertiles in event rates and treatment by
tertile interactions were assessed using the Cox proportional
hazard test. All statistical tests were two-sided with an alpha of
0.05 and a P value of less than 0.05 accepted as significant.
The measurement characteristics of baseline PSA and pros-
tate volume in the prediction of BPH-related outcomes were
evaluated using receiver operating characteristic (ROC)
curves. The area under the ROC curve (AUC) for a given
population is given by the probability that a randomly chosen
individual in the affected population has a higher value of the
index (in this case PSA or prostate volume) than a randomly
chosen individual in the nonaffected population. The AUCs
were computed using the method of Hanley and McNeil.11
Differences between AUCs in the finasteride and placebo
group were tested using normal statistics with standard devi-
ations computed by the same method.

RESULTS
At baseline, men assigned to finasteride and pla-
cebo were similar in terms of age, demographics,
symptom severity, peak flow rate, prostate volume,
and serum PSA (Table I). Baseline characteristics
of the subset with prostate volume measurements
were similar to those in the entire study group.
The overall incidence of AUR was 7% with pla-
cebo and 4% with finasteride (spontaneous AUR FIGURE 1. Four-year incidences of either AUR or BPH-
related surgery in patients treated with placebo or fin-
4% with placebo and 1% with finasteride; precipi-
asteride, stratified in tertiles by (A) baseline prostate
tated AUR 3% with placebo and 2% with finas- volume (subset of 10% of patients) or (B) baseline se-
teride) and of BPH-related surgery, 10% in men rum PSA. Arrows denote reduction in risk by the log-
taking placebo and 5% in men taking finasteride.8 rank test. †One placebo patient had a prostate volume
The incidence of AUR or surgery increased from of 222.
8.9% to 22.0% from the first to the third tertile of
baseline prostate volume for placebo-treated pa- baseline serum PSA, the risk increased from 7.8%
tients; it remained relatively stable between 5.1% to 19.9% for the placebo group (P , 0.001) and
and 5.6% for finasteride-treated patients (Fig. 1A). from 4.4% to 8.3% for the finasteride group (P 5
As a result, the risk reduction with finasteride in- 0.035), resulting in a finasteride-related reduction
creased from 50% in the smallest to 74% in the of risk from 43% in the lowest to 60% in the highest
largest prostate volume tertile. When stratified by tertile of serum PSA (Fig. 1B).

UROLOGY 53 (3), 1999 475


FIGURE 2. Kaplan-Meier curves for the risk of all AUR
or BPH-related surgery for patients treated with placebo
or finasteride by baseline serum PSA stratified in tertiles.
(A) Risk for the lowest tertile of serum PSA (0.2 to 1.3
ng/mL), (B) risk for the second or middle tertile (1.4 to
3.2 ng/mL), and (C) risk for the third or highest serum
PSA tertile (3.3 to 12.0 ng/mL).
Figure 2 displays Kaplan-Meier curves for the in-
cidence of AUR or surgery for patients treated with
placebo or finasteride, stratified by baseline PSA.
Patients in the lowest tertile of serum PSA (0.0 to
1.3 ng/mL) had the lowest risk of either one of the
events, and the benefit of finasteride over placebo is
minimal for the first 2 years. In this tertile, the over-
all 4-year relative risk for finasteride- versus place-
bo-treated patients is 0.57 (95% confidence interval
[CI] 0.35 to 0.95), with a 43% risk reduction (P 5
0.030; Fig. 2A). For patients in the second tertile
(serum PSA between 1.4 and 3.2 ng/mL), the 4-year
476
risk for finasteride- versus placebo-treated patients
is 0.54 (95% CI 0.37 to 0.80), with a 46% risk
reduction with finasteride treatment (P 5 0.002;
Fig. 2B). Finally, the relative risk for finasteride-
versus placebo-treated patients in the third tertile
is 0.40 (95% CI 0.29 to 0.56), with a 60% risk
reduction with finasteride (P , 0.001; Fig. 2C).
The cumulative incidences for spontaneous
AUR, all AUR (spontaneous and precipitated com-
bined), and BPH-related surgery for 4 years by in-
crements of baseline serum PSA thresholds are
shown in Figure 3. Although in the placebo group
the cumulative incidence for spontaneous (Fig.
3A) and all AUR (Fig. 3B) increases with increasing
serum PSA values (P , 0.001), in the finasteride-
treated patients this effect is nearly absent. The
cumulative incidence of BPH-related surgery in-
creases linearly across PSA values in placebo-
treated patients from 10% to 24% (P , 0.001),
whereas in finasteride-treated patients it increases
only in men with a baseline PSA greater than 5.0
ng/mL (P 5 NS) (Fig. 3C).
ROC curve analyses evaluating the performance
of baseline serum PSA in predicting outcomes in
comparison to the more traditional baseline pa-
rameters of BPH, including symptom severity,
bothersomeness, peak urinary flow rate, residual
urine volume, and age, are shown in Table II.
Within the placebo group, serum PSA and prostate
volume were the best predictors for all AUR (AUCs
0.68 and 0.69, respectively), as well as for sponta-
neous AUR (AUC 0.70 and 0.81, respectively). In-
terestingly, serum PSA, prostate volume, and peak
flow rate had higher AUC values in the placebo
group for AUR than for BPH-related surgery.
Symptom severity, bothersomeness scores, and re-
sidual urine had higher AUC values in the placebo
group for BPH-related surgery than for AUR. Age
had similar AUC values in the placebo group for
both AUR and BPH-related surgery. In general, the
AUCs were numerically higher for the placebo
group than for the finasteride group, suggesting
that finasteride treatment weakens the relationship
between baseline values and the occurrence of
BPH-related outcomes (Fig. 4). Neither symptom
severity nor bothersomeness of symptoms had any
predictive value (AUCs 0.49 and 0.47, respec-
tively) for the development of AUR in finasteride-
treated patients (Table II).
COMMENT
Serum PSA is currently the most widely used
marker for prostate cancer detection, and a yearly
measurement is recommended in men older than
50 years to aid in the early detection of prostate
cancer. The observation that there is a strong log-
linear relationship between serum PSA and pros-
UROLOGY 53 (3), 1999

FIGURE 3. Incidences of (A) spontaneous AUR, (B)
both spontaneous and precipitated AUR, and (C) BPH-
related surgery in placebo- and finasteride-treated pa-
tients during 4 years by incremental baseline serum
PSA thresholds.
tate volume in men with BPH10 has led us to con-
sider that PSA may also predict those men at
increased risk of developing AUR or needing BPH-
related surgery.
In the longitudinal community-based Olmsted
County study,3 it had been shown that men with
prostate volumes greater than 30 mL by transrectal
ultrasound had almost four times the odds of ex-
UROLOGY 53 (3), 1999
periencing AUR compared with those with pros-
tate volumes less than 30 mL. The tertile analysis
(Fig. 1) presented here demonstrates a very strong
relationship between baseline prostate volume and
serum PSA in predicting the incidence of BPH-re-
lated surgery or AUR during 4 years. The significant
increase in the risk of experiencing these compli-
cations with placebo treatment is nearly com-
pletely obliterated with finasteride treatment. This
phenomenon leads to a greater benefit of finas-
teride over placebo in men with either larger pros-
tate volumes or higher baseline PSA in avoiding
these complications. About 1 of 5 patients in the
highest tertiles are likely to experience either AUR
or surgery for BPH, and the risk reduction with
finasteride treatment is 74% (based on prostate
volume) and 60% (based on serum PSA).
A second important question for clinicians is
whether the risk increases over time of observa-
tion. In fact, in placebo-treated patients, the cumu-
lative risk increases in a linear fashion for all three
serum PSA tertiles (Fig. 2). With the exception of
the lowest PSA tertile, where there is no apparent
benefit of finasteride over placebo in the first 2
years (Fig. 2A), the difference in risk between
treatment groups in the two higher tertiles (greater
than 1.3 ng/mL) becomes evident as early as the
first follow-up visit at 4 months (Figs. 2B and C).
Physicians may have different thresholds regard-
ing their use of preventive healthcare measures.
Figure 3 provides a graphic assessment to aid in
this decision. The cumulative incidence of sponta-
neous AUR for placebo-treated patients increases
dramatically with serum PSA levels above approx-
imately 1.3 ng/mL. In fact, although the cumula-
tive risk for all patients is approximately 4% or 1 in
25 men in 4 years, it reaches 9% or nearly 1 in 10
patients for those with a PSA greater than 4.0
ng/mL at baseline (Fig. 3A). At the same time, the
risk remains unchanged for the entire serum PSA
spectrum for finasteride-treated patients. Similar
observations hold true for the cumulative risk of
both spontaneous and precipitated AUR and BPH-
related surgery (Figs. 3B and C).
The ROC curve analyses show a trend toward a
reduction in the predictive power of many baseline
parameters with finasteride therapy when com-
pared with placebo. This is not unexpected as ther-
apy with finasteride significantly interferes with
the natural history of the disease process. For
spontaneous AUR, the purest outcome in terms of
being the least likely to be influenced by either the
patient or physician, both prostate volume (AUC
0.81) and serum PSA (AUC 0.70) are the most
powerful predictors in the placebo-treated patients
(Fig. 4C). That serum PSA and prostate volume are
both similarly significant predictors of outcomes is
477
 TABLE II. Area under the curve 6 standard error values for ROC
curves for several baseline parameters for spontaneous acute
urinary retention and prostate-related surgery
Parameter Finasteride Placebo P Value*
Spontaneous AUR
Serum PSA 0.53 6 0.06 0.70 6 0.03 0.012
Prostate volume 0.67 6 0.04 0.81 6 0.11 0.665
Peak flow rate 0.67 6 0.06 0.62 6 0.04 0.510
Residual urine volume 0.46 6 0.07 0.56 6 0.04 0.224
Quasi-AUA symptom score 0.49 6 0.06 0.55 6 0.04 0.440
Bothersomeness score 0.47 6 0.07 0.58 6 0.04 0.168
Age 0.57 6 0.06 0.53 6 0.04 0.562
Surgery
Serum PSA 0.59 6 0.03 0.62 6 0.02 0.461
Prostate volume 0.49 6 0.09 0.63 6 0.08 0.213
Peak flow rate 0.59 6 0.04 0.57 6 0.03 0.692
Residual urine volume 0.52 6 0.03 0.60 6 0.02 0.046
Quasi-AUA symptom score 0.60 6 0.03 0.59 6 0.02 0.761
Bothersomeness score 0.55 6 0.03 0.60 6 0.02 0.197
Age 0.60 6 0.03 0.57 6 0.03 0.507
KEY: ROC 5 receiver operating characteristic; AUR 5 acute urinary retention; PSA 5 prostate-specific antigen; Quasi-
AUA 5 adaptation of American Urological Association symptom score.
* Represents the between-group P value.

likely a reflection of the strong correlation between
the two parameters.10
It is interesting to speculate why the symptom
severity and bothersomeness scores are better pre-
dictors of BPH-related surgery than of AUR. Spon-
taneous AUR is an event that cannot be influenced
by the patient, the physician, or by their interac-
tion. A placebo effect is most unlikely in such setting.
Precipitated AUR, triggered by surgery, ingestion
of drugs such as alpha-adrenergics or anticholin-
ergics, is clearly a less reliable end point in the
natural evolution of BPH. The incidence of BPH-
related surgery, on the other hand, can be substan-
tially influenced by the interaction between patient
and physician. It is likely that this patient-physi-
cian interaction, the discussion of perceived pro-
gression and improvement of the condition based
on scores, may have an influence on the need for
surgery. It is intuitively obvious that in the face of
rising symptom scores or decreasing peak flow
rates, the physician may suggest that the patient
consider a surgical procedure. This subjective ele-
ment is probably less prevalent in a clinical trial
setting, where both patients and physicians feel
compelled to continue the study until it ends.
However, when the trial is scheduled for 4 years,
clinical judgment may lead the physician to at least
discuss with the patient possible surgery, as other-
wise the patient would have to live with worsening
symptoms for a considerable period.
That finasteride attenuates the predictive power
of prostate volume and serum PSA regarding sur-
gery and AUR was anticipated, as it has been
clearly shown to change the natural history of the
disease by shrinking the prostate gland and pre-
venting further measurable growth. In fact, to
make predictions about the risk of surgery and/or
AUR once treatment is initiated is less important
than to be able to give patients and healthcare pro-
viders information before a treatment decision re-
garding possible future BPH-related outcomes.
Several limitations of our study need to be recog-
nized. First, even though it is the longest BPH trial
ever conducted, in the lifespan of a patient with
BPH it still covers only a fraction of the entire du-
ration during which the patient is at risk. Extrapo-
lations of the data over extended periods have to be
undertaken with great caution. Second, all patients
in this study had to have an enlarged prostate by
DRE at baseline to be eligible for participation. De-
spite the stratification by PSA levels and the strong
clinical correlation between serum PSA and pros-
tate volume, we cannot state with certainty that
similar results would be obtained in a cohort of
men not selected for enlarged prostate glands.
Prostate volume and serum PSA are good candi-
date parameters to aid in the individualized discus-
sion that takes place between patients and physicians
before initiation of therapy for BPH. Finasteride
decreases the risk of developing a BPH-related out-
come by approximately half in all subgroups exam-
ined. However, the absolute risk of having an out-
come is substantially different across the different
levels of PSA and prostate volume. Risk is viewed
differently by patients, physicians, and administra-
tors. The data provided in this report should be
helpful to all parties involved in the decision of

478 UROLOGY 53 (3), 1999


FIGURE 4. ROC curve analyses for the ability of base-
line serum PSA to predict (A) the need for BPH-related
surgery, (B) both spontaneous or precipitated AUR, and
(C) spontaneous AUR only for patients treated with
placebo or finasteride.
whether to treat BPH based on predictable risks
and predictable reductions in risk with finasteride.
CONCLUSIONS
Serum PSA strongly correlates with prostate vol-
ume in men with BPH, and both parameters predict
equally well the risk of AUR and the need for BPH-
related surgery. The incidence of both untoward
outcomes increases nearly linearly with increasing
serum PSA and prostate volume in men treated
UROLOGY 53 (3), 1999
with placebo— or watched conservatively—and it
is reduced by 50% or more in men on finasteride
independent of baseline serum PSA and prostate
volume. The predictable risk of retention and need
for surgery, and the reduction of risk with finas-
teride, should help all parties involved in decision
making (patients, physicians, and administrators)
to decide whether and how to treat symptomatic
BPH.
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APPENDIX
The PLESS Study Group includes (in alphabetical order):
A. Aigen, P. Albertsen, R. Anderson, G. Andriole, S. Auerbach,
M. Bamberger, J. Bannow, W. Barzell, D. Bergner, J. Bonilla,
R. B. Bracken, W. Brannan, W. Bremner, T. Brown, R. Bruske-
witz, R. Castellanos, S. Childs, K. S. Coffield, T. Cook, C. Cox,
E. D. Crawford, B. Dalkin, R. W. deVere White, G. Drach,
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