european urology supplements 5 (2006) 362–368

available at www.sciencedirect.com
journal homepage: www.europeanurology.com

Hormone Therapy for Prostate Cancer: Guidelines versus

Clinical Practice

Antonio Alcaraz a,*, Pierre Teillac b

a
Hospital Clinic, University of Barcelona, Barcelona, Spain
b
Hôpital Saint-Louis, Paris, France

Article info Abstract

Keywords: Objectives: In 2005, the European Association of Urology (EAU) published

Clinical practice an update of the EAU guidelines on prostate cancer. This report evaluates
Guidelines whether these guidelines reflect the current therapy standards in daily
Hormone therapy clinical practice.
Prostate cancer Methods: An interactive meeting was held comparing the current ther-
Radiation therapy apy standards in prostate cancer with the EAU guidelines. This paper
Radical prostatectomy contains a summary of the outcomes of this meeting.
Results: The EAU guidelines recommend curative therapy for patients
diagnosed with localized prostate cancer (T1b–T2c). However, for unfit
patients with a life expectancy of 5–10 yr and poorly differentiated
tumours, the combination of radiotherapy and hormones is recom-
mended. The majority of the delegates (68%) would also recommend
combination therapy in the latter. However, 17% would prescribe luteiniz-
ing hormone releasing hormone (LHRH) agonist monotherapy for this
type of patient. Although radiotherapy in combination with adjuvant
hormone therapy is recommended for patients with advanced prostate
cancer (T3–T4), only 30% of the delegates agreed. Almost half of the uro-
logists (48%) would prescribe LHRH agonist monotherapy. The patient’s
age appears to be a major differentiator for urologists to select the most
appropriate treatment strategy. Approximately half of the urologists
adhered to the guidelines for patients with a biochemical relapse after
radical prostatectomy and would recommend radiotherapy. Around one
third of the urologists would prescribe LHRH agonist monotherapy. The
discussion on defining the moment for initiating LHRH agonist mono-
therapy remained inconclusive. Different practice patterns were noted
for patients with positive nodes and patients with metastatic disease.
Conclusions: The EAU guidelines, although followed by a majority of phy-
sicians, do not give direction for all patients seen in daily clinical practice.
Large variations in practice exist among the participating urologists.
# 2006 Elsevier B.V. All rights reserved.

* Corresponding author. Hospital Clinic, University of Barcelona, Department of Urology,

Villarroel, 170, 08036 Barcelona, Spain. Tel. +34 9322 75545; Fax: +34 9322 75545.
E-mail address: aalcaraz@clinic.ub.es (A. Alcaraz).
1569-9056/$ – see front matter # 2006 Elsevier B.V. All rights reserved. doi:10.1016/j.eursup.2006.01.001
 european urology supplements 5 (2006) 362–368 363

1. Introduction 150 urologists coming from countries throughout

In October 2005, the European Association of
Urology (EAU) published the updated guidelines
on prostate cancer [1,2]. To discuss whether these
guidelines (Table 1) reflect the current therapy
standards in daily clinical practice, an interactive
session was held during the symposium ‘‘New
Horizons in Urology,’’ Malta, 29–30 October 2005.
The symposium was attended by approximately
Europe.
Four specific patient cases were introduced to
the audience (Figs. 1–4), followed by an interactive
voting session where the delegates had to select
their preferred treatment option. The subsequent
debate with the audience and 10 experts was chaired
by Prof. Teillac and Prof. Alcaraz.
The main outcomes from the interactive voting
session and the debate, as well as comparisons with

Table 1 – Summary of the EAU guidelines on primary treatment of prostate cancer [1,2]

Stage Treatment Comment

T1a Watchful waiting Standard treatment for well-, and moderately differentiated tumours and <10-year life expectancy.
In patients with >10-year life expectancy, re-staging with TRUS and biopsy is advised
(grade B recommendation)
Radical prostatectomy Optional in young patients with a long life expectancy, especially for poorly differentiated tumours
(grade B recommendation)
Radiotherapy Optional in younger patients with a long life expectancy, especially for poorly differentiated tumours.
Higher complication risks after TURP, especially with interstitial radiation (grade B recommendation)
Hormonal Not an option (grade A recommendation)
Combination Not an option (grade C recommendation)

T1b-T2b Watchful waiting Asymptomatic patients with well-, and moderately, differentiated tumours and a life expectancy
<10 years. Patients who do not accept treatment-related complications (grade B recommendation)
Radical prostatectomy Standard treatment for patients with life expectancy >10 years who accept treatment-related
complications (grade A recommendation)
Radiotherapy Patients with a life expectancy >10 years who accept treatment-related complications. Patients
with contraindications for surgery. Unfit patients with 5–10 years of life expectancy and poorly
differentiated tumours (combination therapy is recommended; see below) (grade B recommendation)
Hormonal Symptomatic patients who need palliation of symptoms unfit for curative treatment.
(grade C recommendation). Antiandrogens are associated with poorer outcome in comparison
with watchful waiting and are not recommended (grade A recommendation)
Combination Neoadjuvant hormonal therapy (NHT) + radical prostatectomy: no proven benefit
(grade A recommendation) NHT + radiotherapy: better local control. No proven
survival benefit (grade B recommendation). Hormonal (3 years) + radiotherapy:
better than radiotherapy in poorly differentiated tumours (grade A recommendation)

T3-T4 Watchful waiting Option in asymptomatic patients with T3, well-differentiated and moderately differentiated
tumours, and a life expectancy <10 years (grade C recommendation)
Radical prostatectomy Optional for selected patients with T3a and a life expectancy >10 years (grade C recommendation)
Radiotherapy T3 with >5–10 years of life expectancy. Dose escalation >70 Gy seems to be of benefit.
If this is not available, a combination with hormonal therapy could be recommended
(see below) (grade A recommendation)
Hormonal Symptomatic patients, extensive T3-T4, high PSA level (>25 ng/mL), unfit patients.
Better than watchful waiting (grade A recommendation)
Combination Radiotherapy + hormonal seems better than radiotherapy alone (grade A recommendation).
NHT + radical prostatectomy: no proven benefit (grade B recommendation)

N+, M0 Watchful waiting Asymptomatic patients. Patient driven. May have worse survival (grade C recommendation)
Radical prostatectomy No standard option (grade C recommendation)
Radiotherapy No standard option (grade C recommendation)
Hormonal Standard therapy (grade A recommendation)
Combination No standard option. Patient driven (grade B recommendation)

M+ Watchful waiting No standard option. May have worse survival/more complications than with immediate
hormonal therapy (grade B recommendation)
Radical prostatectomy Not an option (grade C recommendation)
Radiotherapy Not an option (given for cure) (grade C recommendation)
Hormonal Standard therapy. Symptomatic patients should not be denied treatment (grade B recommendation)
Combination Not an option (grade C recommendation)

TRUS = transrectal ultrasound; TURP = transurethral resection of the prostate.

Reprinted from Aus G, Abbou CC, Bolla M, et al. EAU guidelines on prostate cancer. Eur Urol 2005;48:546–551, with permission from the European
Association of Urology.
364 european urology supplements 5 (2006) 362–368
Fig. 1 – The majority of the delegates selected the
combination of radiotherapy plus hormone therapy as
preferred treatment option for this patient.
(a) Localized prostate cancer, specific patient case: 70 yr, T2b,
Gleason 7 (4+3) on 6 of 10 cores, PSA level 16 ng/ml, moderate
symptoms, unfit for surgery, life expectancy about 10 yr.
AA = antiandrogen; LHRH = luteinizing hormone releasing
hormone; HT = hormone therapy.
the recommendations from the EAU guidelines are
summarized in this paper.
2. Localized prostate cancer (T1a–T2c)
2.1. EAU guidelines
Overall, the EAU guidelines [1,2] recommend radical
prostatectomy as standard therapy for young
patients (about 55 yr) diagnosed with stage T1b–T2
prostate cancer, a life expectancy of >10 yr, fit for
surgery, and otherwise healthy (Table 1). However, if
the patient does not meet one of the above criteria, he
should be offered different radiotherapy schedules.
For patients with a diagnosis of low-risk disease (T1a–
T2a N0, M0, Gleason score 6, and a prostate specific
antigen [PSA] level <10 ng/mL), external radiotherapy
up to 70–72 Gy is recommended [3]. Intermediate-risk
patients (T2b or PSA 10–20 ng/ml or Gleason score 7),
however, should receive dose escalation with a dose
ranging from 76 to 81 Gy [3–5]. Patients with high-risk
disease (T2c or Gleason score >7 or PSA >20 ng/mL),
or unfit patients with a life expectancy of 5–10 yr
and poorly differentiated tumours, should receive
radiotherapy in combination with short-term neoad-
juvant and concomitant hormone therapy.
Watchful waiting is only recommended in asymp-
tomatic patients with well- and moderately differ-
entiated tumours and a life expectancy of <10 yr.
Also, patients who do not accept treatment-related
complications may be offered deferred therapy [1,2].
Hormone therapy as monotherapy is only recom-
mended for symptomatic patients unfit for curative
therapy who need palliation of symptoms. Antian-
drogen monotherapy has a poorer outcome than
watchful waiting and is not recommended for
patients with localized prostate cancer [1,2].
2.2. Daily clinical practice
Most delegates agreed that radical therapy is the
standard of care for patients diagnosed with localized
disease, with age and physical condition as major
differentiators between radical prostatectomy and
radiation therapy. Most discussion between experts
and delegates was related to whether these patients
should receive additional hormone therapy, either
in a neoadjuvant and/or an adjuvant setting.
The majority of the delegates (68%) agreed that
the addition of hormone therapy to radiation
therapy has proven benefit in localized prostate
cancer patients (Fig. 1). Especially high-risk patients
(high PSA level and high Gleason score) or patients
unfit for surgery will benefit from the addition of
hormones. Moreover, 17% of the delegates indicated
that they would prescribe luteinizing hormone
releasing hormone (LHRH) agonist monotherapy to
these patients (Fig. 1).
Although the benefits of hormone therapy for
high-risk localized prostate cancer have been proven,
some questions remain. First, what is the optimal
duration of hormone therapy? In the experts’
opinion, concomitant and adjuvant hormone therapy
should be administered for as long as 2–3 yr.
Neoadjuvant hormone therapy, on the other hand,
should only be administered as short-term therapy
(2–6 mo). Second, there is no study available that
directly compares the combination of radiotherapy
and hormone therapy with hormone therapy alone.
As such, it is not clear whether the positive effects
achieved by the combination of radiotherapy plus
hormone therapy have been the result of both
therapies or of hormone therapy alone. To address
this question, the Scandinavian Prostate Cancer
Study Group (SPCG) has initiated a randomized
controlled trial (SPCG 7) enrolling about 880 patients
comparing the combination of radiotherapy (at
least 70 Gy) and hormone therapy with hormone
monotherapy. Results are expected early 2006
(personal communication, P.-A. Abrahamsson,
Malmö, Sweden and A. Widmark, Umeå, Sweden).
2.3. EAU guidelines versus daily clinical practice
Although the EAU guidelines recommend curative
therapy as the preferred treatment option for
 european urology supplements 5 (2006) 362–368
patients diagnosed with localized disease, both the
experts and the delegates of the meeting indicated
that they may prefer the additional administration
of hormone therapy in some high-risk cases. The
experts also felt that the total clinical picture of the
patient should be taken into account before deciding
on the most appropriate therapy. Unfortunately, no
systematic decision models exist today to provide
guidance on selecting the most appropriate therapy.
3. Advanced prostate cancer (T3–T4)
3.1. EAU guidelines
Watchful waiting is optional in T3 prostate cancer
patients with well- or moderately differentiated
tumours and a life expectancy <10 yr [1,2].
As radical prostatectomy in locally advanced
prostate cancer often leads to incomplete tumour
excision, surgery is not recommended in these
patients. Nevertheless, good results have been
observed in patients with clinical T3a. However, it
should be noted that the capability to differentiate
T2b-c from T3a tumours is low. If surgery is applied
to these patients, it should be followed by immedi-
ate postoperative radiation (Table 1) [1,2].
Since the combination of radical prostatectomy
and hormone therapy is no longer recommended
for patients with locally advanced prostate cancer,
combining radiotherapy with hormone therapy is
considered to be the standard (Table 1) [6–9].
Short-term neoadjuvant hormone therapy plus
radiotherapy is specifically indicated in patients
with a low Gleason score (Gleason 2–6) [8]. On the
other hand, adjuvant hormone therapy following
radiotherapy with a duration of 2–3 yr is highly
recommended in patients with advanced prostate
cancer with a high Gleason score (Gleason 7–10)
[9].
Hormone therapy, as monotherapy, delays pro-
gression, prevents potentially catastrophic compli-
cations, and effectively palliates symptoms.
However, as hormone therapy does not prolong
survival, it is only recommended in symptomatic
patients, unfit for surgery, with extensive T3–T4 and
a high PSA level (>25 ng/ml; Table 1) [1,2].
3.2. Daily clinical practice
As Fig. 2 indicates, the delegates’ opinions are
divided between LHRH agonist monotherapy (48%)
and the combination of hormone therapy and
radiation therapy (30%). According to the experts,
the major differentiator between both treatment
365
Fig. 2 – LHRH agonists seem to be the preferred treatment
option for this patient.
(b) Advanced prostate cancer, specific patient case: 74 yr, T3b,
N0, M0, Gleason 8 (4+4) on 8/10 cores, PSA level 20 ng/ml,
moderate symptoms, unfit for surgery, life expectancy about
5–10 yr.
AA = antiandrogen; LHRH = luteinizing hormone releasing
hormone; HT = hormone therapy.
options is the patient’s age. Young patients (about
55 yr) have different needs and priorities than older
patients (about 75 yr). Survival is much more
important in younger patients than in older
patients, whereas preserving quality of life (QOL)
is the most important treatment factor for older
patients. Most younger patients will receive radia-
tion therapy in combination with hormone ther-
apy, whereas older patients will receive hormone
monotherapy.
Most experts base their opinion on the study by
Bolla et al. [6] stating that radiotherapy plus at least 3
yr of adjuvant hormone therapy is better than
radiotherapy alone. Overall, the agreed recommen-
dation for young patients with advanced disease is
radiotherapy administered in a high dose (about 78
Gy) plus concomitant and adjuvant addition of
hormone therapy for about 3 yr.
The experts also indicated that radical prosta-
tectomy is the most aggressive (and perhaps the
only) therapy option for young patients diagnosed
with a very aggressive tumour. As those patients
are expected to have positive surgical margins,
postoperative radiation therapy or hormone therapy
in an adjuvant setting is, in their opinion, highly
recommended.
3.3. EAU guidelines versus daily clinical practice
Both the recommendations in the EAU guidelines
and the delegates’ practice patterns matched in the
sense that radiotherapy in combination with at
least 3 yr of adjuvant hormone therapy is the
366 european urology supplements 5 (2006) 362–368
preferred treatment option for advanced disease.
However, although the EAU guidelines do not take
the patient’s age into account, the delegates
indicated that radiotherapy plus adjuvant hormone
therapy is mainly for younger patients. Older
patients should be offered hormone monotherapy.
However, since studies directly comparing the
combination of radiation and hormone therapy
with hormone monotherapy are lacking, no firm
conclusions can be made with regard to standard
of care in these patients.
4. Biochemical failure after radical therapy
4.1. EAU guidelines
About 27–53% of all patients undergoing radical
therapy (radiation therapy or radical prostatectomy)
will develop local or distant recurrence within 10 yr
after initial therapy [10–12]. Following a study by
Pound et al. [13] who demonstrated that no patient
followed for >5 yr developed any recurrence without
a concomitant PSA rise, treatment failure is cur-
rently defined as ‘‘a rising PSA level after radical
therapy’’. The EAU guidelines define recurrent
prostate cancer as follows: ‘‘Following radical prosta-
tectomy, two consecutive PSA values 0.2 ng/ml repre-
sent recurrent cancer. Following radiation therapy, three
consecutive increasing PSA values above a previous nadir
represent recurrent cancer’’ [1,2]. Once recurrent
prostate cancer has been diagnosed, determining
whether the recurrence has developed at local or at
distant sites is of major importance. Local failure
after radical prostatectomy can be predicted with an
80% probability by a PSA increase >3 yr after surgery,
a PSA doubling time (PSA DT) 11 mo, Gleason score
6, stage pT3a pN0, pTxR1. On the opposite,
distant failure after radical prostatectomy is pre-
dicted by a PSA increase <1 yr after surgery, a short
PSA DT (4–6 mo), Gleason score 8–10, stage pT3b,
pTxpN1. After radiation therapy, a late and slowly
rising PSA level is a sign of local failure. A prostate
biopsy demonstrating malignant cells after 18 mo
following initial radiotherapy, and no evidence of
metastatic spread on computer tomography (CT)/
magnetic resonance imaging (MRI) and bone scinti-
graphy should exclude distant failure [1,2].
The recommended therapy for local recurrence
after radical prostatectomy is salvage radiation
therapy (64–66 Gy) before the PSA level has risen
>1.5 ng/ml. Carefully selected patients suffering
from local recurrence after initial radiation therapy
might be candidates for salvage radical prostatect-
omy. However, due to the high risk of complications,
Fig. 3 – The majority of the delegates indicated that
radiotherapy, closely followed by LHRH agonists, is the
preferred treatment option for this patient suffering from
biochemical recurrence after initial prostatectomy.
(c) Second-line therapy, specific patient case: 68 yr, PSA relapse
4 yr after initial radical prostatectomy (pT2a, PSA 7 ng/ml,
Gleason 6), PSA DT of 15 mo.
AA = antiandrogen; LHRH = luteinizing hormone releasing
hormone.
patients might be offered watchful waiting with
possible hormone therapy later on [1,2].
Early hormone therapy might be of benefit in
delaying progression and possibly achieving survi-
val benefit in patients diagnosed with distant failure
after initial curative therapy [1,2].
4.2. Daily clinical practice
The experts unanimously agreed that both PSA
level and PSA DT are the most important predictors
to distinguish between local and distant recurrence.
Overall, when a patient is diagnosed with low
PSA levels after radical prostatectomy and a long
PSA DT (both indicative for local recurrence),
radiation therapy of at least 64 Gy is the preferred
treatment for 49% of the urologists (Fig. 3). As
mentioned in the paper by Klotz [14], PSA DT is the
major predictor of progression. Patients diagnosed
with a PSA DT of >2 yr have a probability of about
1% of dying from prostate cancer without receiving
any treatment [4]. As a consequence, many experts
agreed that if the patient has a long PSA DT, active
surveillance is the best treatment option, espe-
cially with regard to preserving the patient’s QOL.
Currently, the patient’s QOL has gained a lot of
interest. Most studies discussed in the EAU guide-
lines [1,2] are old(er) studies that only focused on
survival outcomes. Nevertheless, QOL is an impor-
tant element in patients with biochemical recur-
rence. Therefore, new studies should investigate
QOL elements together with survival.
 european urology supplements 5 (2006) 362–368
About one third of the delegates (31%; Fig. 3)
preferred to treat patients with biochemical failure
after radical therapy with LHRH agonist monother-
apy to avoid treatment-related side effects of salv-
age radiotherapy and to improve the patient’s QOL.
4.3. EAU guidelines versus daily clinical practice
Both the experts and the delegates follow the EAU
guidelines with respect to salvage radiotherapy after
initial radical prostatectomy. However, they also
stated that the EAU guidelines only discuss the
importance of survival but forget the patient’s QOL.
Because the emphasis of biochemical recurrence
therapy in daily clinical practice is currently not
only on survival but also on QOL, LHRH agonist
monotherapy is increasingly used for patients with
recurrent disease.
5. Positive nodes/metastatic disease (N+/M+)
5.1. EAU guidelines
In case of clinical node positive disease, the guide-
lines recommend hormone therapy to palliate
symptoms, to defer progression to a symptomatic
stage, and to prolong progression-free and overall
survival (Table 1) [1,2]. Also patients diagnosed with
metastatic disease will benefit from early hormone
therapy (Table 1) [1,2].
Watchful waiting is recommended only for
asymptomatic metastatic patients not willing to
suffer from treatment-related side effects.
5.2. Daily clinical practice
As seen in Fig. 4, most delegates would administer
the combination of LHRH agonists with an addi-
tional antiandrogen (combined androgen blockade
[CAB], 44%) or LHRH agonist monotherapy (39%).
However, as combination therapy shows no benefit
and an increased number of side effects compared
to hormone monotherapy, LHRH agonist monother-
apy seems to be the preferred treatment option
[15,16].
5.3. EAU guidelines versus daily clinical practice
Both the EAU guidelines and the attendees indicate
that patients diagnosed with either node-positive
and/or metastatic disease (or both) should receive
hormone therapy. However, the debate remains
inconclusive whether LHRH agonist monotherapy
or CAB is the preferred treatment option.
367
Fig. 4 – Both LHRH agonists and combined androgen
blockade seem to be the preferred treatment options for
this specific patient.
(d) Positive nodes, specific patient case: 74 yr, 7 of 10 cores
positive on biopsy, nodes >2 cm on computed tomography
scan, N+, Mx, Gleason 7 (4+3), PSA 32 ng/ml, mild symptoms.
AA = antiandrogen; LHRH = luteinizing hormone releasing
hormone; CAB = combined androgen blockade.
In conclusion, although there is agreement on the
administration of hormone therapy, there is a high
practice variation related to the type of hormone
therapy.
6. Conclusions
The interactive voting sessions and the subsequent
debate highlighted the differences between the
recommendations in the EAU guidelines and clinical
practice patterns. The recommendations in the EAU
guidelines are largely based on results from rando-
mized, clinical trials, the ‘‘gold standard’’ for
evidence-based medicine. However, there are not
enough randomized, controlled trials in the field of
prostate cancer to answer all clinical questions in
sufficient detail to apply to the wide range of
patients seen in everyday clinical practice. This is
because randomized, controlled clinical trials have
strict inclusion and exclusion criteria and therefore
exclude many patients who are commonly treated
in clinical practice. Although robust evidence-based
medicine about the benefits of many therapies in
specific patients is often lacking, physicians none-
theless make treatment decisions every day based
also on their clinical experience. On the other hand,
an overload of information is currently available on
many aspects of prostate cancer management. It
has become virtually impossible to assimilate all
these data for clinicians in clinical practice.
It can be concluded that the EAU guidelines are a
useful tool to achieve appropriate care in prostate
368 european urology supplements 5 (2006) 362–368
cancer management, but unfortunately, they are
insufficient to provide direction for a number of
patients seen in clinical practice. Continued medical
education by experts remains critical to try to
achieve that goal.
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