![](media/image1.png){width="5.96875in" height="0.41944444444444445in"}

Top of Form

## Complete Summary

#### GUIDELINE TITLE

Node-positive prostate cancer.

#### BIBLIOGRAPHIC SOURCE(S)

Lawton CA, Roach M III, Anscher MS, Beyer DC, Lee WR, Merrick G,
Michalski JM, Pollack A, Vijayakumar S, Carroll PR, Higano CS, Mauch PM,
Expert Panel on Radiation Oncology-Prostate Work Group. Node-positive
prostate cancer. \[online publication\]. Reston (VA): American College
of Radiology (ACR); 2006. 6 p. \[41 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: McCormick B, Mendenhall NP,
Shank BM, Haffty BG, Halberg FE, Martinez AA, McNeese MD, Mitchell SE,
Rabinovitch RA, Solin LJ, Taylor ME, Singletary SE, Leibel S. Local
regional recurrence and salvage surgery. American College of Radiology.
ACR Appropriateness Criteria. Radiology 2000 Jun;215(Suppl):1181-92.

The appropriateness criteria are reviewed annually and updated by the
panels as needed, depending on introduction of new and highly
significant scientific evidence.

### COMPLETE SUMMARY CONTENT

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

### SCOPE

#### DISEASE/CONDITION(S)

Node-positive prostate cancer

#### GUIDELINE CATEGORY

Treatment

#### CLINICAL SPECIALTY

Internal Medicine\
Oncology\
Radiation Oncology\
Radiology\
Surgery

#### INTENDED USERS

Health Plans\
Hospitals\
Managed Care Organizations\
Physicians\
Utilization Management

#### GUIDELINE OBJECTIVE(S)

To evaluate the appropriateness of radiologic treatment procedures for
patients with node-positive prostate cancer

#### TARGET POPULATION

Patients with node-positive prostate cancer

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Radiation therapy with hormonal treatment

2.  Hormonal treatment alone

3.  Radiation to pelvis and prostate

4.  Radical prostatectomy with hormonal treatment

5.  Radical prostatectomy alone

6.  Radiation to prostate only

7.  Consideration of radiation dose, treatment plan, and blocking

#### MAJOR OUTCOMES CONSIDERED

-   Disease-free, cause-specific, and overall survival rates

-   Local and distant control rates

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

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

The guideline developer performed literature searches of peer-reviewed
medical journals and the major applicable articles were identified and
collected.

#### NUMBER OF SOURCE DOCUMENTS

The total number of source documents identified as the result of the
literature search is not known.

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

Weighting According to a Rating Scheme (Scheme Not Given)

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

Not stated

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

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

One or two topic leaders within a panel assume the responsibility of
developing an evidence table for each clinical condition, based on
analysis of the current literature. These tables serve as a basis for
developing a narrative specific to each clinical condition.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus (Delphi)

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

Since data available from existing scientific studies are usually
insufficient for meta-analysis, broad-based consensus techniques are
needed for reaching agreement in the formulation of the appropriateness
criteria. The American College of Radiology (ACR) Appropriateness
Criteria panels use a modified Delphi technique to arrive at consensus.
Serial surveys are conducted by distributing questionnaires to
consolidate expert opinions within each panel. These questionnaires are
distributed to the participants along with the evidence table and
narrative as developed by the topic leader(s). Questionnaires are
completed by participants in their own professional setting without
influence of the other members. Voting is conducted using a scoring
system from 1-9, indicating the least to the most appropriate imaging
examination or therapeutic procedure. The survey results are collected,
tabulated in anonymous fashion, and redistributed after each round. A
maximum of three rounds is conducted and opinions are unified to the
highest degree possible. Eighty percent agreement is considered a
consensus. This modified Delphi technique enables individual, unbiased
expression, is economical, easy to understand, and relatively simple to
conduct.

If consensus cannot be reached by the Delphi technique, the panel is
convened and group consensus techniques are utilized. The strengths and
weaknesses of each test or procedure are discussed and consensus reached
whenever possible. If \"No consensus\" appears in the rating column,
reasons for this decision are added to the comment sections.

#### 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

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Criteria developed by the Expert Panels are reviewed by the American
College of Radiology (ACR) Committee on Appropriateness Criteria.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**ACR Appropriateness Criteria®**

**Clinical Condition: Node-Positive Prostate Cancer**

**Variant 1: 72-year-old male. Microscopic metastasis in a single lymph
node following radical prostatectomy. Negative margins.**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  Radiation therapy    7                    
  with hormonal                            
  treatment                                

  Hormonal treatment   6                    
  alone                                    

  Radiation to pelvis  5                    
  and prostate bed                         

  Radiation to         2                    
  prostate bed only                        

  **Pelvic Radiation                       
  Dose**                                   

  4500/25 fractions    6                    

  5040/28 fractions    7                    

  5400/30 fractions    2                    

  **Prostate Bed                           
  Dose**                                   

  4500/25 fractions    2                    

  5940/33 fractions    6                    

  6660/37 fractions    7                    

  **Treatment Plan**                       

  3D CT-based plan     7                    

  IMRT                 7                    

  2D CT-based plan     6                    

  Non-CT based         5                    
  computerized plan                        

  **Blocking**                             

  Complex block        6                    

  Hand block           5                    

  Open field           3                    

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 2: 55-year-old male. Grossly involved pelvic lymph nodes
before planned prostatectomy.**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  Radiation therapy    7                    
  with hormonal                            
  treatment                                

  Hormonal treatment   6                    
  alone                                    

  Radiation to pelvis  6                    
  and prostate                             

  Radical              3                    
  prostatectomy with                       
  hormonal treatment                       

  Radical              2                    
  prostatectomy alone                      

  Radiation to         2                    
  prostate only                            

  **Pelvic Radiation                       
  Dose**                                   

  4500/25 fractions    6                    

  5040/28 fractions    7                    

  5400/30 fractions    2                   Additional radiation boost to the
                                           area of the involved lymph nodes
                                           is acceptable

  **Prostate Dose**                        

  7020/39 fractions    7                    

  7560/42 fractions    7                    

  5940/33 fractions    2                    

  6660/37 fractions    6                    

  **Treatment Plan**                       

  IMRT                 7                    

  2D CT-based plan     6                    

  3D CT-based plan     5                    

  Non-CT based         4                    
  computerized plan                        

  **Blocking**                             

  Complex block        6                    

  Hand block           5                    

  Open field           2                    

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 3: 67-year-old male. PSA of 30. CT-guided fine needle biopsy
of pelvic lymph node reveals metastatic adenocarcinoma.**

  ---------------------------------------------------------------------------
  **Treatment**        **Appropriateness   **Comments**
                       Rating**            
  -------------------- ------------------- ----------------------------------
  Radiation therapy    8                    
  with hormonal                            
  treatment                                

  Radiation to pelvis  7                    
  and prostate                             

  Hormonal treatment   6                    
  alone                                    

  Radical              3                    
  prostatectomy with                       
  hormonal treatment                       

  Radical              2                    
  prostatectomy alone                      

  Radiation to         2                    
  prostate only                            

  **Pelvic Radiation                       
  Dose**                                   

  4500/25 fractions    6                    

  5040/28 fractions    7                    

  5400/30 fractions    2                   Additional radiation boost to the
                                           area of the involved lymph nodes
                                           is acceptable.

  **Prostate Dose**                        

  5940/33 fractions    2                    

  6660/37 fractions    6                    

  7020/39 fractions    7                    

  7560/42 fractions    7                   Still needs local control, could
                                           give higher dose.

  **Treatment Plan**                       

  3D CT-based plan     7                    

  IMRT                 7                    

  2D CT-based plan     6                    

  Non-CT based         4                    
  computerized plan                        

  **Blocking**                             

  Complex block        8                    

  Hand block           6                    

  Open field           2                    

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

Histologically proven lymph node metastasis from adenocarcinoma of the
prostate portends a poor prognosis. With the widespread use of PSA
screening, 90% of all prostate cancers are discovered in the local and
regional stages. Thus approximately 10%-20% of patients present with
locally advanced disease, many of whom have positive regional lymph
nodes. The optimal treatment of these node-positive patients remains
controversial; recommendations range from immediate hormonal treatment
to aggressive combined modality approaches.

Given the variable natural history of prostate cancer, several
investigators have examined histologic variables that can predict
ultimate prognosis. Recent investigations have examined
immunohistochemical variables (p53 alterations, human glandular
kallikrein 2) that are detectable in metastatic lymph nodes as potential
prognostic factors. The available data indicate that both the number of
involved nodes and the extent of metastatic involvement are predictive
of subsequent disease progression. The few series with long follow-up,
however, indicate that even patients with minimal microscopic lymphatic
metastases have poor long-term disease-free survival with most patients
developing metastatic disease by 10 years following treatment.

In the absence of some form of adjuvant hormonal therapy, radical local
or locoregional therapy (radical prostatectomy plus lymph node
dissection or radiotherapy) has resulted in ten-year survivals of only
20%-30% with nearly all patients developing evidence of distant
metastasis within ten years of diagnosis. Series of patients treated
with early androgen ablation show similar results. The best results
reported in node-positive patients are from series that combined a local
or locoregional modality (surgery or radiation) with early adjuvant
hormonal therapy.

Many of the series reported above include patients treated before the
widespread availability of PSA to monitor patients following treatment.
The few series for which post-treatment PSA levels are available show
much lower rates of disease-free survival if PSA is used to define the
absence of disease.

A randomized trial found an overall survival benefit for immediate
androgen deprivation following prostatectomy for men with node-positive
disease. This study was rather small (98 men), never achieved its
projected goal of 240 men, and did not require central pathologic
review. Furthermore, disease-free survival in the control arm was lower
than that reported in several single-institution series of radical
prostatectomy alone. Although this study suggests an advantage for early
androgen-deprivation, further studies with larger numbers of patients
will be required. Two other prospective randomized series of
node-positive prostate cancer patients have been reported recently. In
the first study, the subset of pathologically positive lymph node
patients showed a clear overall survival advantage with the addition of
hormone therapy to definitive radiation therapy. In the data from the
first study, the subset of pathologically positive lymph node patients
showed a clear overall survival advantage with the addition of hormone
therapy to definitive radiation therapy. Each endpoint from PSA---local
control, distant disease, cause specific, and overall survival was
positively impacted by the use of hormone therapy over radiation alone
for the node---positive patients in that trial. In addition, the second
study, for which patients were randomized between whole pelvic and
prostate only irradiation in addition to neoadjuvant vs adjuvant
therapy, showed an advantage to patients with whole pelvis radiation
therapy and neoadjuvant hormonal manipulation in terms of
progression-free survival for patients who had a risk of lymph node
involvement \>15%.

The natural history of treated patients with node-positive prostate
cancer indicates that a large proportion of men will develop distant
metastases by within ten years of treatment. Recent molecular staging
methods suggest that a majority of patients with node-positive prostate
cancer harbor occult distant metastatic disease at the time of
diagnosis. One author has published his experience in 55 men with
prostate cancer in whom bone aspirates were examined by reverse
transcriptase polymerase chain reaction (RTPCR) and immunohistochemical
techniques to identify metastatic prostate cancer cells. It was reported
that more than 70% of men with lymphatic metastases and a negative bone
scan had evidence of metastatic cancer cells in the bone marrow.

If these node-positive patients do in fact have micrometastatic distant
disease, any local modality is doomed to failure. Treatment strategies
designed to cure patients with node-positive prostate cancer should
include a systemic component in addition to aggressive locoregional
therapy.

Recent studies suggest that comprehensive pelvic nodal radiotherapy may
be best accomplished by using IMRT. This approach results in better
coverage of nodal areas and less dose to adjacent tissues such as the
bladder, rectum, and penis.

**Abbreviations**

-   2D-CT two-dimensional computed tomography based plan

-   3D-CT, three-dimensional computed tomography based plan

-   CT, computed tomography

-   IMRT, intensity modulated radiotherapy

-   PSA, prostate-specific antigen

#### CLINICAL ALGORITHM(S)

Algorithms were not developed from criteria guidelines.

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are based on analysis of the current literature and
expert panel consensus.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Selection of appropriate radiologic procedures for management of
patients with node-positive prostate cancer

#### POTENTIAL HARMS

Not stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

An American College of Radiology (ACR) Committee on Appropriateness
Criteria and its expert panels have developed criteria for determining
appropriate imaging examinations for diagnosis and treatment of
specified medical condition(s). These criteria are intended to guide
radiologists, radiation oncologists, and referring physicians in making
decisions regarding radiologic imaging and treatment. Generally, the
complexity and severity of a patient\'s clinical condition should
dictate the selection of appropriate imaging procedures or treatments.
Only those exams generally used for evaluation of the patient\'s
condition are ranked. Other imaging studies necessary to evaluate other
co-existent diseases or other medical consequences of this condition are
not considered in this document. The availability of equipment or
personnel may influence the selection of appropriate imaging procedures
or treatments. Imaging techniques classified as investigational by the
U.S. Food and Drug Administration (FDA) have not been considered in
developing these criteria; however, study of new equipment and
applications should be encouraged. The ultimate decision regarding the
appropriateness of any specific radiologic examination or treatment must
be made by the referring physician and radiologist in light of all the
circumstances presented in an individual examination.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

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

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Lawton CA, Roach M III, Anscher MS, Beyer DC, Lee WR, Merrick G,
Michalski JM, Pollack A, Vijayakumar S, Carroll PR, Higano CS, Mauch PM,
Expert Panel on Radiation Oncology-Prostate Work Group. Node-positive
prostate cancer. \[online publication\]. Reston (VA): American College
of Radiology (ACR); 2006. 6 p. \[41 references\]

#### ADAPTATION

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

#### DATE RELEASED

1996 (revised 2006)

#### GUIDELINE DEVELOPER(S)

American College of Radiology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

The American College of Radiology (ACR) provided the funding and the
resources for these ACR Appropriateness Criteria®.

#### GUIDELINE COMMITTEE

Committee on Appropriateness Criteria, Expert Panel on Radiation
Oncology--Prostate Work Group

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Panel Members*: Colleen A. Lawton, MD; Mack Roach III, MD; Mitchell S.
Anscher, MD; David C. Beyer, MD; W. Robert Lee, MD; Gregory Merrick, MD;
Jeff M. Michalski, MD, MBA; Alan Pollack, MD, PhD; Srinivasan
Vijayakumar, MD; Peter R. Carroll, MD; Celestia S. Higano, MD; Peter M.
Mauch, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: McCormick B, Mendenhall NP,
Shank BM, Haffty BG, Halberg FE, Martinez AA, McNeese MD, Mitchell SE,
Rabinovitch RA, Solin LJ, Taylor ME, Singletary SE, Leibel S. Local
regional recurrence and salvage surgery. American College of Radiology.
ACR Appropriateness Criteria. Radiology 2000 Jun;215(Suppl):1181-92.

The appropriateness criteria are reviewed annually and updated by the
panels as needed, depending on introduction of new and highly
significant scientific evidence.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[American College of Radiology (ACR) Web
site](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/pdf/ExpertPanelonRadiationOncologyProstateWorkGroup/NodePositiveProstateCancerDoc4.aspx).

ACR Appropriateness Criteria® *Anytime*, *Anywhere*™ (PDA application).
Available from the [ACR Web
site](http://www.acr.org/SecondaryMainMenuCategories/ACRStore/FeaturedCategories/QualityandSafety/ac_pda.aspx).

Print copies: Available from the American College of Radiology, 1891
Preston White Drive, Reston, VA 20191. Telephone: (703) 648-8900.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   ACR Appropriateness Criteria®. Background and development. Reston
    (VA): American College of Radiology; 2 p. Electronic copies:
    Available in Portable Document Format (PDF) from the [American
    College of Radiology (ACR) Web
    site](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/pdf/background_dev.aspx).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on September 5, 2006.

#### COPYRIGHT STATEMENT

Instructions for downloading, use, and reproduction of the American
College of Radiology (ACR) Appropriateness Criteria® may be found on the
[ACR Web
site.](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/ACRAppropriatenessCriteriaTermsandConditionsDoc1.aspx)

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
associations, public or private organizations, other government
agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline
developers, and are screened solely to determine that they meet the NGC
Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

NGC, AHRQ, and its contractor ECRI Institute make no warranties
concerning the content or clinical efficacy or effectiveness of the
clinical practice guidelines and related materials represented on this
site. Moreover, the views and opinions of developers or authors of
guidelines represented on this site do not necessarily state or reflect
those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or
hosting of guidelines in NGC may not be used for advertising or
commercial endorsement purposes.

Readers with questions regarding guideline content are directed to
contact the guideline developer.

Bottom of Form

© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008