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## Complete Summary

#### GUIDELINE TITLE

Prostate cancer.

#### BIBLIOGRAPHIC SOURCE(S)

Dutch Urological Association. Prostate cancer. Utrecht, The Netherlands:
Association of Comprehensive Cancer Centres; 2007 Jul 23. 142 p. \[529
references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Prostate cancer

#### GUIDELINE CATEGORY

Counseling\
Diagnosis\
Management\
Treatment

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Nuclear Medicine\
Nursing\
Oncology\
Pathology\
Psychology\
Radiation Oncology\
Radiology\
Urology

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Nurses\
Patients\
Physicians\
Psychologists/Non-physician Behavioral Health Clinicians\
Social Workers

#### GUIDELINE OBJECTIVE(S)

To provide guidance for daily practice that is applicable to all
patients with prostate cancer, irrespective of stage

#### TARGET POPULATION

Patients with prostate cancer

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis**

1.  Patient history

2.  Physical examination for diagnosis and staging

    -   Digital rectal examination

    -   Gleason score

3.  Diagnostic tests

    -   Prostate specific antigen (PSA)

    -   Transrectal grey-scale ultrasound

    -   Contrast-enhanced transrectal ultrasound, color Doppler, power
        Doppler (considered but not recommended)

    -   Computed tomography

    -   Magnetic resonance imaging

    -   Skeletal scintigraphy (bone scan)

    -   Pathological assessment of biopsies, transurethral resection of
        the prostate (TURP) material, and prostatectomy specimens

**Counseling and Supportive Care**

1.  Provision of information on results and consequences of treatment
    options

2.  Structured multidisciplinary review

3.  Lifestyle modification (diet, exercise, smoking cessation)

4.  Psychosocial care for disease- or treatment-related sexual
    dysfunction, urinary symptoms, gastrointestinal symptoms, and course
    of the disease

**Management/Treatment**

1.  Treatment of localized prostate cancer

    -   Active monitoring

    -   Surgery

    -   External beam radiotherapy

    -   Brachytherapy

2.  Treatment of locally advanced prostate cancer

    -   Lymph node dissection

    -   Radical prostatectomy

    -   Adjuvant radiotherapy after radical prostatectomy

    -   Adjuvant hormone therapy after radical prostatectomy

    -   External radiotherapy

    -   Adjuvant or neoadjuvant hormone therapy with radiotherapy

    -   Hormone therapy

    -   Follow-up (duration, PSA assessment)

3.  Treatment of local recurrence of prostate cancer

    -   PSA measurement to determine recurrence after radical
        prostatectomy

    -   External beam radiation therapy (EBRT)

    -   Radical salvage prostatectomy after EBRT

    -   Salvage brachytherapy after EBRT

4.  Treatment of metastatic prostate cancer

    -   Hormone therapy

    -   Intravenous bisphosphonates

    -   Radiotherapy

    -   Chemotherapy (docetaxel + prednisone)

    -   Palliative therapy

The use of contrast-enhanced transrectal ultrasound, color Doppler,
power Doppler ultrasound, for diagnosis, treatment of localized prostate
cancer with adjuvant or neoadjuvant hormone therapy and treatment of
local recurrence of prostate cancer with hormone therapy were considered
but not recommended.

#### MAJOR OUTCOMES CONSIDERED

-   Gleason score

-   Incidence and prevalence of localized prostate cancer, locally
    advanced prostate cancer, recurrence of prostate cancer, and
    metastatic prostate cancer

-   Tumor grade and stage

-   Adverse effects and complications of treatments

-   Recurrence rate

-   Disease- and treatment-related psychosocial issues

-   Mortality

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Relevant articles were found by performing systematic searches in the
Cochrane Library, Medline, and Embase. Manual searches were also
performed. Articles were extracted from the reference lists of the
articles retrieved, and articles already in the possession of working
group members were included. Other guidelines on prostate cancer were
also consulted. For most chapters, the searches covered the last 15
years; in some cases earlier articles were searched. Articles were
selected based on the following criteria: (a) articles published
predominantly in English or Dutch and (b) use of full published articles
whenever possible.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Levels of Evidence**

  ---------------- -------------------------------------------------------------------
  **For articles   
  regarding        
  intervention**   

  **A1**           Systematic reviews covering at least some A2-level studies in which
                   the results of the individual studies are consistent

  **A2**           Randomised comparative clinical studies of good quality
                   (double-blind, controlled), sufficient size and consistency

  **B**            Randomised clinical trials of moderate quality or insufficient
                   size, or other comparative studies (non-randomised, comparative
                   cohort studies, patient-control studies)

  **C**            Non-comparative studies

  **D**            Expert opinion from, for example, working group members

  **For articles   
  regarding        
  diagnosis**      

  **A1**           Studies on the effects of diagnosis on clinical outcomes in a
                   prospectively followed, well-defined patient population with a
                   predefined protocol based on the results of the study test, or
                   decision theory studies on the effects of diagnosis on clinical
                   outcomes based on the results of A2-level studies with sufficient
                   consideration given to the interaction between diagnostic tests

  **A2**           Studies that include a reference test with predefined criteria for
                   the study test and the reference test and a good description of the
                   test and the clinical population studied; a sufficiently large
                   series of consecutive patients must be included, predefined cut-off
                   values must be used and the results of the test and the gold
                   standard must be evaluated independently. For situations in which
                   multiple diagnostic tests are involved, there is in principle
                   interaction and the analysis should take this into account by
                   using, for example, logistical regression

  **B**            Comparison with a reference test and description of the study test
                   and population, but lacking the other characteristics of A-level
                   studies

  **C**            Non-comparative studies

  **D**            Expert opinion from, for example, working group members

  **Level of       
  evidence for     
  conclusions**    

  **1**            At least 1 systematic review (A1) or 2 independently conducted A1-
                   or A2-level studies

  **2**            At least 2 independently conducted B-level studies

  **3**            At least 1 A2-, B- or C-level study

  **4**            Expert opinion from, for example, working group members
  ---------------- -------------------------------------------------------------------

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Systematic literature searches were performed and the quality and
content of the articles retrieved was judged by working group members
using the evidence-based guideline evaluation form
(www.cbo.nl/product/richtlijnen/handleiding_ebro). Articles of mediocre
or poor quality were excluded. After this selection process, the
remaining articles were then used as the basis for the various
conclusions stated in the guideline. The selected articles were then
graded according to the level of evidence using the classification in
\"Rating Scheme for the Strength of Evidence\" field.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The working group formulated basic questions for each chapter. To
develop each chapter, subgroups were formed with representatives from
relevant disciplines. These subgroups worked on developing a draft text
for a specific part of the guideline for 2 years beginning in January
2003. Working group members then wrote a section or chapter of the draft
guideline, which incorporated the literature found. During plenary
meetings, subgroups justified their own text and commented on other
chapters. The editorial team collected the texts developed by the
subgroups and made any necessary changes for consistency to ultimately
create one document: the draft guideline.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The draft guideline was disseminated for commentary among the relevant
professional organisations and regional working groups on urological
tumours. It was presented at a national guideline conference on 18
October 2006. All members of relevant professional societies were
invited to this conference either personally or via an announcement in a
trade journal. The comments made at this conference were incorporated
into the draft to create the definitive guideline.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**Diagnosis**

**1.1.1 Which patient history factors are relevant for the diagnosis of
prostate cancer?**

A family history should be taken for every patient suspected of having
prostate cancer. Patients with a family history indicative of hereditary
prostate cancer should undergo periodic evaluation according to the
recommendations formulated by the Netherlands Foundation for the
Detection of Hereditary Tumours (\"Stichting Opsporing Erfelijke
Tumoren\").

**1.1.2 Which physical examination factors are relevant for diagnosis
and staging?**

Digital rectal examination (DRE) should be performed in men suspected of
having prostate cancer as one component of a targeted physical
examination. Consideration should be given to the low sensitivity and
limited predictive value of DRE in the detection of prostate cancer,
particularly in an unselected population (screening).

**1.2.1 Can digital rectal examination be performed prior to PSA
assessment?**

Given that DRE has little effect on total serum prostate specific
antigen (PSA) level, the DRE can be performed prior to blood collection.

**1.3.1.1 What is the additional diagnostic value of transrectal
grey-scale ultrasound (TRUS) in the diagnosis and staging of prostate
cancer?**

Transrectal grey-scale ultrasound must be used to guide prostate
biopsies.

**1.3.1.2 What is the additional diagnostic value of colour Doppler,
power Doppler, and contrast-enhanced transrectal ultrasound in the
diagnosis and staging of prostate cancer?**

Use of contrast-enhanced ultrasound to direct biopsies of hypervascular
regions cannot yet be recommended for general practice for the diagnosis
and staging of prostate cancer.

**1.3.2 For which patients should a computed tomography (CT) scan be
made in the diagnosis and staging of prostate cancer?**

Use of a CT scan is not recommended for the diagnosis of prostate cancer
or for tumour and lymph node staging.

A CT scan can be useful in guiding lymph node biopsy for nodes suspected
of containing metastases.

**1.3.3.1 For which patients should magnetic resonance imaging (MRI) be
used in the diagnosis and staging of prostate cancer?**

If the biopsy result is negative but a clinical suspicion of prostate
cancer remains, endorectal MRI with a field strength of 1.5 tesla can be
used (if available) before performing a second biopsy.

Patients with an intermediate-to-high risk of tumour invasion beyond the
prostate may undergo endorectal MRI with a field strength of at least
1.5 tesla (if available) prior to therapy. If available, the use of a
3-tesla MRI may also be considered for low-risk patients, given its
higher sensitivity and comparable specificity.

Conventional MRI for lymph node staging should only be used in patients
with an a priori risk greater than 40%.

Localisation of the carcinoma within the prostate for therapeutic
purposes is preferably determined by MRI.

**1.3.4 For which patients should a bone scan be made in the diagnosis
and staging of prostate cancer?**

Routine use of skeletal scintigraphy in the primary diagnosis of
prostate cancer is not advisable. Skeletal scintigraphy is only
recommended to confirm or exclude the presence of bone metastases in
patients with a PSA level of 20 ng/mL or more, a locally advanced
tumour, Gleason score of 8 or more, or symptomatic bone pain.

**1.4.2 When is a repeat biopsy indicated?**

Extension of the sextant biopsy to include two extra bilateral biopsies,
preferably of the anterolateral peripheral zone, is recommended.

If malignancy is clinically suspected, the serial biopsy should be
repeated at least once. Performing additional repeat biopsies depends on
the degree of suspicion.

Reporting the presence of high-grade prostatic intra-epithelial
neoplasia (HGPIN) in a prostate needle biopsy without prostate cancer is
recommended. Repeat biopsy following a diagnosis of multifocal HGPIN is
recommended. For a pathologic diagnosis of \'suspected malignancy\', the
serial biopsy should be repeated at least once with extra biopsies from
the suspected region.

The location of the prostate needle biopsy should be reported not only
as left or right, but also in regard to the segment (apex, mid-prostate,
base).

**1.4.2.1 Gleason score**

The Gleason score and its components are used to grade prostate cancer
and assess the prostate needle biopsy.

**1.4.2.2 Other histopathological prognostic factors**

The pathology report should include the number of biopsies containing
tumour and the amount of tumour (expressed as length in mm or percentage
of volume) for the left and right sides.

**1.4.2.3 Assessment of biopsies, transurethral resection of the
prostate (TURP) samples, and prostatectomy specimens**

Sectioning occurs at a minimum of three levels. From each level, blank
bands and/or sections are saved for immunohistochemistry.

TURP samples are first embedded in 8 cassettes. Embedding the remaining
tissue is advisable for a diagnosis of pT1a - but not pT1b - tumours.

If feasible, the entire prostate should be assessed histologically.

The Gleason score is used to grade prostate cancer in radical
prostatectomy samples. It is recommended to provide a Gleason score for
each individual tumour and to separately report the presence of a higher
grade (4 or 5) as a tertiary component.

Calculating tumour volume is not recommended. To provide an indication
of tumour size, the pathology report should contain the maximum diameter
of the tumour(s).

Prostate cancer is staged according to the most recent version of TNM
staging (2002 or later). It is also recommended to report the extent of
extracapsular invasion.

The presence, location, and extent of positive resection margins
following radical prostatectomy for prostate cancer should be reported.

A positive resection margin without the capsule is not staged as pT3a
but as pT2X or pT2+ to indicate that it is unclear whether there has
been invasion beyond the prostate.

**1.5 Nursing, supportive care, and counseling**

To support the treatment decision-making process, patient counselling
must include quantitative data on the results and consequences of
various treatment options specific to the treating clinic.

In addition to the treating physician, the nurse specialist plays an
important role in counselling and educating men with prostate cancer.

It is advisable to report in the patient\'s medical record who provided
counselling and which treatment options and expected adverse events were
discussed.

A structured multidisciplinary review is desirable for the management of
patients with prostate cancer.

**Treatment of Localised Prostate Cancer**

**2.1.1 What are the expected outcomes of active monitoring in patients
with localised prostate cancer?**

Active monitoring is preferred for patients with low risk (T1c-2a,
Gleason \<7, PSA \<10 ng/mL) with advanced age (\>75 years). With this
approach, the patient should be informed that life expectancy is not
determined by the prostate cancer and that each treatment is associated
with a risk of adverse effects. Active monitoring may also be considered
for patients with moderate or high risk disease if they have obvious
comorbidity and advanced age, which negatively influences life
expectancy.

**2.1.2.1 Relationship between volume and quality for prostatectomy**

To determine the role of radical prostatectomy as a treatment option for
patients with localised prostate cancer, the advantages and
disadvantages of the various treatment options, including external
radiotherapy and brachytherapy, must be weighed against active
monitoring.

Radical prostatectomy is performed preferably in institutions that
perform this procedure routinely.

The laparoscopic procedure should be performed routinely by an
established team in order to obtain and maintain good results.

**2.1.3 What are the expected outcomes of external radiotherapy in
patients with localised prostate cancer?**

To determine the role of external radiotherapy as a treatment option in
patients with localised prostate cancer, the advantages and
disadvantages of various treatment options, including radical
prostatectomy and brachytherapy, must be weighed against active
monitoring.

The working group cannot make any recommendations regarding the minimum
number of patients who must undergo external radiotherapy for localised
prostate cancer annually.

**2.1.4 What are the expected outcomes of brachytherapy in patients with
localised prostate cancer?**

To determine the role of brachytherapy as a treatment option for
patients with localised prostate cancer, the advantages and
disadvantages of various treatment options, including radical
prostatectomy and external radiotherapy, must be weighed against active
monitoring.

**2.1.4.1 Relationship between volume and quality for brachytherapy**

The working group advises that brachytherapy is performed routinely to
maintain sufficient experience and to be able to manage possible
complications following treatment.

**2.1.5 What are the expected outcomes of adjuvant or neoadjuvant
hormone therapy in patients with localised prostate cancer?**

Adjuvant or neoadjuvant hormone therapy is not recommended for patients
with low- or moderate-risk localised prostate cancer.

**2.3 What is the optimal treatment for patients with T1-2 localised
prostate cancer, accounting for level of risk and the risk of
treatment-related harm?**

Based on the available evidence on the treatment of patients with
localised prostate cancer, the working group cannot make any
recommendations regarding which treatment is preferred. The working
group also cannot recommend a specific treatment based on the reported
adverse events and complications.

The choice of treatment is determined after consultation with the
patient whom the physician should inform thoroughly and as objectively
as possible regarding the efficacy and toxicity of each treatment
modality. The patient\'s age and general condition are taken into
account in the decision, particularly when considering the option of
withholding treatment.

**2.4 Nursing, supportive care, counselling, and communication**

Counselling and education after treatment for localised prostate cancer
should be tailored to the individual preferences and needs of the
patient.

Specific attention should be given to the presence of postoperative
pain, urinary symptoms, catheter care, incontinence, and erectile
dysfunction.

The patient\'s medical record should include who has provided
counselling and what was discussed. The treatment options and expected
adverse events that were discussed should also be documented.

**Treatment of Locally Advanced Prostate Cancer**

**3.1 When is lymph node dissection indicated?**

Lymph node dissection is indicated if the results may affect treatment
decisions. Risk estimation for the presence of positive lymph nodes is
made using nomograms, such as the Kattan nomograms.

**3.2.1 What are the results of radical prostatectomy for cT3 tumours?**

In general, radical prostatectomy is not an option for patients with cT3
tumours. Surgery should be performed only for specific cases.

**3.2.2 Neoadjuvant hormone therapy before radical prostatectomy for cT3
prostate cancer**

Neoadjuvant hormone therapy prior to radical prostatectomy should not be
given to patients with cT3 prostate cancer.

**3.2.3 Which patients with pT3 tumours will benefit from adjuvant
radiotherapy after radical prostatectomy?**

Adjuvant radiotherapy is an option for patients with pT3 prostate
cancer.

**3.2.4 Adjuvant hormone therapy after radical prostatectomy for pT3
prostate cancer**

Adjuvant hormone therapy is not recommended for pT3 tumours.

**3.3.1 What are the results of external radiotherapy for cT3 tumours?**

Patients with locally advanced prostate cancer should be offered
radiotherapy.

Patients with locally advanced prostate cancer should undergo external
radiotherapy, whereby at least 70 Gy are delivered to the prostate.

**3.3.2 Which patients with locally advanced prostate cancer will
benefit from adjuvant or neoadjuvant hormone therapy with
radiotherapy?**

The addition of hormone therapy to radiotherapy should be offered
primarily to patients with a Gleason score of 7-10.

Determining the best timing and duration of adjuvant hormone therapy
should be made in consultation with the patient, who should be well
informed. It should be communicated to the patient that the optimal
approach is unknown, and an approach that is most acceptable to the
patient will be chosen.

**3.4 Hormone therapy**

Hormone therapy is a treatment option for patients with cT3 prostate
cancer who refuse external radiotherapy or for whom external
radiotherapy is contraindicated. Given the risk of adverse events
associated with hormone therapy, delayed initiation of therapy is
preferred.

**What are the results of active monitoring without treatment in cT3
tumours?**

Active monitoring and initiation of hormone therapy when symptoms or
metastases arise can be considered for patients with limited life
expectancy (\<10 years).

**Follow-up**

**4.1.2 Duration of follow-up**

After treatment for prostate cancer, a general follow-up schema is
recommended consisting of check-ups after 6 weeks; 3, 6, 9, and 12
months; and semi-annually or annually thereafter for 5 to 10 years.
During the first check-up after 6 weeks, the clinician should inquire
about symptoms and provide additional education on the disease and
possible consequences of treatment.

For patients with demonstrated recurrence, the follow-up schema should
be tailored to the individual patient based on symptoms, prognosis, and
the type of treatment used.

Comparison of the efficacy and safety of different treatment modalities
for localised prostate cancer requires a follow-up of at least 10 years
after the PSA nadir has been reached.

**4.2.1** **PSA assessment**

Men with prostate cancer should undergo PSA assessment at each follow-up
visit.

**4.2.2 Other follow-up tests**

For patients with decreasing or low, stable PSA, DRE and other
additional tests are not necessary. Additional imaging may be of value
as indicated based on symptoms.

Biopsy of the prostate or prostate bed should be performed only if a
positive result would influence the decision to initiate salvage
therapy.

**4.3 Which nursing, supportive care, and lifestyle advice should be
provided?**

Men with prostate cancer should be advised to follow a healthy and
varied diet, get sufficient physical activity, and not smoke.

**4.4 What are the requirements for organisation, cooperation, and
communication?**

Follow-up may involve various disciplines, such as oncology nurses,
urology nurses, radiotherapy nurses, dieticians, physiotherapists,
psychologists, and sexologists, depending on the specific problems,
symptoms, and needs of the individual patient.

If the PSA level is stable (or increasing only very slightly), a general
practitioner and/or specialised nurse may be asked to perform the annual
PSA assessment after the PSA nadir has been reached.

At the beginning of the follow-up period, the goal, frequency, and
duration of follow-up visits should be determined, as well as who will
conduct the follow-up (e.g., urologist, radiation oncologist, others).

The patient must know what types of specific adverse event may occur,
and to which care provider he should report them.

**Treatment of Local Recurrence of Prostate Cancer**

**5.1.1 How is PSA recurrence diagnosed after radical prostatectomy?**

To diagnose PSA recurrence after radical prostatectomy requires two PSA
tests of \>0.2 ng/mL with an interval of 2 to 3 months.

If the PSA doubling time is less than 10 months, it is likely that
metastases or micrometastases are present.

**5.1.2 Which additional tests are indicated for PSA recurrence after
radical prostatectomy?**

Biopsy of the prostate bed, ultrasound of the prostatic region, and DRE
are not required to diagnose local recurrence after radical
prostatectomy if the PSA level is low (\<2.0 ng/mL).

Requesting a bone scan is not necessary for asymptomatic patients with
PSA recurrence after radical prostatectomy and PSA \<20 ng/mL.

Given its low sensitivity for detecting local recurrence in patients
with PSA recurrence after radical prostatectomy, CT scan of the lower
abdomen is not recommended.

MRI is not recommended for detecting local recurrence.

**5.1.3 What is the optimal treatment of patients with PSA recurrence
after radical prostatectomy?**

External radiotherapy may be considered for patients with PSA recurrence
after radical prostatectomy suspected of having local recurrence,
provided that the PSA value is \<1.0 ng/mL.

Hormone therapy is not recommended for the treatment of PSA recurrence.

**5.2.1 How is PSA recurrence diagnosed after external radiotherapy?**

PSA dynamics after external beam radiation therapy (EBRT) must be
interpreted with caution given the phenomenon of PSA bounce. Increased
PSA must be seen in three consecutive measurements made at least 3
months apart before PSA recurrence after EBRT can be diagnosed.

**5.2.2 Which additional tests are indicated for PSA recurrence after
EBRT?**

DRE, prostate ultrasound, or CT scan are not recommended for PSA
recurrence after EBRT.

Bone scan is not useful in patients with PSA recurrence after EBRT and
no specific symptoms and PSA \< 20 ng/mL.

Prostate biopsy after EBRT is indicated if treatment, such as salvage
prostatectomy, is considered.

**5.2.3.2 Radical salvage prostatectomy for local recurrence following
EBRT**

The decision to perform salvage prostatectomy is made on an individual
basis, considering the patient\'s life expectancy, comorbidity, and
tumour characteristics as well as the patient\'s assessment of the
benefits and risks of this intervention. Centralisation of this
intervention is preferred.

**5.2.3.3 Salvage brachytherapy following recurrence after EBRT**

The decision to perform salvage brachytherapy is made on an individual
basis, considering the patient\'s life expectancy, comorbidity, and
tumour characteristics as well as the patient\'s assessment of the
benefits and risks of this intervention. Centralisation of this
intervention is preferred.

**5.2.3.4 Hormone therapy**

Hormone therapy is not recommended for patients with PSA recurrence. If
the patient wishes to receive hormone therapy, the benefits and risks of
adjuvant hormone therapy must be weighed against active monitoring.

**5.3.1 How is PSA recurrence diagnosed after brachytherapy?**

PSA dynamics after brachytherapy should be interpreted with caution due
to the phenomenon of PSA bounce. Increased PSA must be seen in three
consecutive measurements made at least 3 months apart before PSA
recurrence after brachytherapy can be diagnosed.

**5.3.2 What is the optimal treatment of patients with local recurrence
after brachytherapy?**

Salvage treatment after brachytherapy may be considered only after a
long interval (4-5 years).

The choice of therapy for patients with local recurrence following
brachytherapy is made on an individual basis, considering the patient\'s
life expectancy, comorbidity, and tumour characteristics. The benefits
and risks of treatment should be weighed against active monitoring.

**Treatment of Metastatic Prostate Cancer**

**6.1.1 What is the optimal type of hormone therapy?**

Hormone therapy is the treatment of choice for patients with metastatic
prostate cancer. The preferred methods are bilateral orchiectomy,
luteinising hormone releasing hormone (LHRH) analogue, or parenteral
oestrogen.

Maximal androgen blockade is not recommended as first-line therapy.

**6.1.2 What is the optimal timing of hormone therapy?**

The time to start hormone therapy is determined on an individual basis.

**6.1.3 What is the optimal schedule of hormone therapy?**

Intermittent hormone therapy for patients with metastatic prostate
cancer is an experimental approach that is preferably given in the
context of a clinical trial only.

**6.2.1 Should hormone therapy be continued in patients who develop
hormone-resistant metastatic prostate cancer (HRPC)?**

Hormone therapy should be continued in patients with HRPC.

**6.2.2. Is secondary hormone therapy beneficial in patients with
HRPC?**

Treatment with prednisone 5 mg twice daily should be considered for
patients with symptomatic, advanced stage HRPC.

**6.2.3. Is radiotherapy beneficial in patients with HRPC?**

A single dose of 8 Gy is recommended for patients with a limited number
(1-3) of painful bone metastases.

Use of radionuclides may be considered for patients with multiple
painful bone metastases for whom conventional analgesics are
insufficient, local radiotherapy is not possible, and chemotherapy is no
longer an option.

**6.2.4. Is chemotherapy beneficial for patients with HRPC?**

Patients with HRPC may be offered treatment with docetaxel given at a
dose of 75 mg/m^2^ every 3 weeks combined with prednisone given at a
dose of 5 mg twice daily. The combination of docetaxel and estramustine
is not recommended given the increased risk of adverse events.

Asymptomatic patients with HRPC who refuse docetaxel/prednisone are
preferably treated with watchful waiting and symptom management.

**6.2.5 Is treatment with bisphosphonates beneficial in patients with
HRPC?**

Intravenous nitrogen-containing bisphosphonates may be used for patients
with HRPC and bone pain due to skeletal metastases.

**Psychosocial Care**

It is advisable to assume that men with prostate cancer have specific
psychosocial issues arising from disease- or treatment-related sexual
dysfunction, urinary symptoms, gastrointestinal symptoms, and the slow
course of the disease.

Men with prostate cancer should be provided with sufficient counselling
regarding the disease, treatment options, and the possible side effects
of treatment.

Men and their partners should be made aware of the educational materials
available, the time and location of educational meetings, the services
provided by patient organisations, and the contact information for
discussion groups.

Involving men and their partners in treatment decisions is recommended.

Specialised (oncology or urology) nurses can play an important role in
the detection of psychosocial issues and in counselling men and their
partners on the disease and treatment.

The emotional processing and functioning of the partner of a man with
prostate cancer warrants explicit attention in the management of the
disease.

Participation in group meetings or support groups may be offered to men
with prostate cancer to gain more social support and enhance emotional
processing of the disease and the consequences of therapy.

**Implementation and Indicators**

The working group recommends that all relevant societies develop an
implementation plan that is compatible with the aforementioned
initiatives, and subsequently initiate an evaluation of implementation.

The working group recommends converting parts of the guideline into
protocols where appropriate, while taking local conditions into account.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The scientific evidence and the level of the most relevant evidence is
summarized in the \"conclusions\" section following each recommendation
in the original guideline document.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Early detection and appropriate management of prostate cancer

#### POTENTIAL HARMS

Adverse effects and complications of treatment, including incontinence,
erectile dysfunction, anastomotic stenosis (with surgery), urinary
symptoms, proctitis, and acute urinary retention

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Contraindications for brachytherapy are recent transurethral resection
of the prostate, high International Prostate Symptom Score, poor
flowmetry and large prostate volume, because this increases the risk of
adverse events considerably.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

Guidelines are not legal prescriptions, but rather scientifically
founded and widely accepted views and recommendations to which
healthcare providers would have to adhere to provide quality of care.
Given that guidelines are based on \'average\' patients, healthcare
providers can deviate from the recommendations in the guidelines as
necessary in individual cases. Deviation from the guidelines is in fact
sometimes necessary if the patient\'s situation requires it. When there
is deviation from the guideline, however, it must be justified,
documented, and when necessary, discussed with the patient.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

Implementation was considered throughout the various phases of the
development of the draft guideline. Draft versions of the guideline were
presented to regional urological working groups to assess their
feasibility and appropriateness. The guideline was submitted to
participating scientific organisations for endorsement and distributed
among hospitals, scientific societies, and members of regional working
groups of the comprehensive cancer centres. An electronic version of the
guideline is available on Oncoline.nl. A summary of the guidelines will
also be published in the Dutch Journal of Medicine (\"Nederlands
Tijdschrift voor Geneeskunde\").

The working group recommends that all relevant societies develop an
implementation plan that is compatible with the aforementioned
initiatives, and subsequently initiate an evaluation of implementation.

The working group recommends converting portions of the guideline into
protocols where appropriate, while taking local conditions into account.

#### IMPLEMENTATION TOOLS

Foreign Language Translations\
Personal Digital Assistant (PDA) Downloads

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

End of Life Care\
Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Dutch Urological Association. Prostate cancer. Utrecht, The Netherlands:
Association of Comprehensive Cancer Centres; 2007 Jul 23. 142 p. \[529
references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2007 Jul 23

#### GUIDELINE DEVELOPER(S)

Association of Comprehensive Cancer Centres - Disease Specific Society

#### SOURCE(S) OF FUNDING

This guideline was made possible with financial support from the Dutch
Society of Medical Specialists (Orde van Medisch Specialisten) as part
of the programme \'Evidence-Based Guideline Development (Evidence-Based
Richtlijnontwikkeling, EBRO).

#### GUIDELINE COMMITTEE

Not stated

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Primary editors and subgroup chairs*: Dr. Th.M. de Reijke, urologist,
Academisch Medisch Centrum, Amsterdam, vice-chair until September 2004;
chair since September 2004; Prof. Dr. J.J. Battermann, radiation
oncologist, Universitair Medisch Centrum Utrecht, vice-chair since
September 2004; Prof.dr. S. Horenblas, urologist, Antoni van Leeuwenhoek
ziekenhuis, Amsterdam, chair until September 2004; Dr. I.J. de Jong,
urologist, Universitair Medisch Centrum Groningen; Dr. R.J.A. van
Moorselaar, urologist, VU Medisch Centrum Amsterdam; Dr. G.O.N.
Oosterhof, urologist, Academisch Ziekenhuis Maastricht; W. IJzerman,
urologist, Gelre Ziekenhuis, Apeldoorn; Dr. P.F.W.M. Rosier, physician,
Kwaliteitsinstituut voor de Gezondheidszorg CBO, Utrecht, advisor until
January 2005; Dr. J.S. Burgers, programme director, Kwaliteitsinstituut
voor de Gezondheidszorg CBO, Utrecht, advisor since January 2005; Mw.
Dr. P.J.J. Wauben-Penris, director of patient care, Integraal
Kankercentrum Limburg, Maastricht, project manager on behalf of the
VIKC; Mw. H.W.G. Hamelers-Paulus, secretary, Integraal Kankercentrum
Limburg, Maastricht on behalf of the VIKC

*Working group members*: Dr. G. van Andel, urologist, Onze Lieve Vrouwe
Gasthuis Amsterdam; Mw. J. Arnts, radiation oncology nurse, Universitair
Medisch Centrum St. Radboud Nijmegen; Prof.dr. J.O. Barentsz,
radiologist, Universitair Medisch Centrum St. Radboud Nijmegen; Dr.
A.C.M. van de Bergh, radiation oncologist, Universitair Medisch Centrum
Groningen; Dr. R.F.M. Bevers, urologist, Leids Universitair Medisch
Centrum Leiden; Prof.dr. M.A. Blankenstein, director of clinical
chemistry, VU Medisch Centrum Amsterdam Mw; Dr. F.C.J.M. van Gils,
radiation oncologist, Maastro Clinic, Heerlen; Dr. A.J.M. Hendrikx,
urologist, Catharina ziekenhuis Eindhoven; Drs. S.W.T.P.J. Heijmink,
radiologist in training, Universitair Medisch Centrum St. Radboud,
Nijmegen; Mw. Dr. C.A. Hulsbergen-van de Kaa, pathologist, Universitair
Medisch Centrum St. Radboud, Nijmegen; Mw. Drs. H.K. de Jager-Nowak,
radiation oncologist, Haga ziekenhuis, Den Haag; Dr. P.C.M. Koper,
radiation oncologist, Daniel den Hoed Kliniek, Rotterdam (until June
2005); Prof.dr. Th. van der Kwast, pathologist, University Toronto,
Canada (until October 2004); Dr. R.C.M. Pelger, urologist, Leids
Universitair Medisch Centrum, Leiden; J.A. van Spil, nurse practitioner,
Universitair Medisch Centrum Groningen; Drs. Th. Twerda, contact person
for Stichting Contactgroep Prostaatkanker Utrecht (since September
2005); Dr. A.P. Visser, psychologist, on behalf of the NVPO, Helen
Dowling Instituut, Utrecht; Mw. Drs. E.M. de Wit, radiation oncologist,
Ziekenhuis Medisch Spectrum, Enschede; Dr. R. de Wit, medical
oncologist, Daniel den Hoed kliniek, Rotterdam

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Working group members acted independently of their associations and
divulged any conflicts of interest.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in English and Dutch from the [Association
of Comprehensive Cancer Centres Web
site](http://www.oncoline.nl/index.php?pagina=/richtlijn/item/pagina.php&richtlijn_id=575).

Print copies: Available from the Association of Comprehensive Cancer
Centres PO Box 19001, 3501 DA Utrecht, The Netherlands

#### AVAILABILITY OF COMPANION DOCUMENTS

A version of the guideline for Personal Digital Assistants (PDAs) is
also available at the [Association of Comprehensive Cancer Centres Web
site](http://www.oncoline.nl/index.php?pagina=/richtlijn/item/pagina.php&richtlijn_id=549).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on June 12, 2008. The
information was verified by the guideline developer on July 11, 2008.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

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approve, or endorse the guidelines represented on this site.

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Guidelines represented on the NGC Web site are submitted by guideline
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<http://www.guideline.gov/about/inclusion.aspx> .

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Date Modified: 11/3/2008