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## Complete Summary

#### GUIDELINE TITLE

Post-treatment follow-up of prostate cancer.

#### BIBLIOGRAPHIC SOURCE(S)

Kawashima A, Francis IR, Baumgarten DA, Bluth EI, Bush WH Jr, Casalino
DD, Curry NS, Israel GM, Jafri SZ, Papanicolaou N, Remer EM, Sandler CM,
Spring DB, Fulgham P, Expert Panel on Urologic Imaging. Post-treatment
follow-up of prostate cancer. \[online publication\]. Reston (VA):
American College of Radiology (ACR); 2007. 8 p. \[60 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Kawashima A, Choyke PL, Bluth
EI, Bush WH Jr, Casalino DD, Francis IR, Jafri SZ, Kronthal AJ, Older
RA, Papanicolaou N, Ramchandani P, Rosenfield AT, Sandler CM, Segal AJ,
Tempany CM, Resnick MI, Expert Panel on Urologic Imaging. Post-treatment
follow-up of prostate cancer. \[online publication\]. Reston (VA):
American College of Radiology (ACR); 2005. 9 p. \[50 references\]

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

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [May 23, 2007, Gadolinium-based Contrast
    Agents](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Gadolinium):
    The addition of a boxed warning and new warnings about the risk of
    nephrogenic systemic fibrosis (NSF) to the full prescribing
    information for all gadolinium-based contrast agents (GBCAs).

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 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)

Prostate cancer

#### GUIDELINE CATEGORY

Evaluation

#### CLINICAL SPECIALTY

Nuclear Medicine\
Oncology\
Radiology\
Urology

#### INTENDED USERS

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

#### GUIDELINE OBJECTIVE(S)

To evaluate the appropriateness of radiologic procedures for
post-treatment follow-up of prostate cancer

#### TARGET POPULATION

Patients treated for prostate cancer

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Nuclear imaging (NUC)

    -   Bone scan whole body

    -   ProstaScint scan

2.  Ultrasound

    -   Prostate, transrectal

    -   Prostate, transabdominal

    -   Invasive ultrasound (US)-guided transrectal biopsy of the
        prostate bed

3.  Magnetic resonance imaging (MRI) of the pelvis

4.  Computed tomography (CT) of the abdomen and pelvis with contrast

5.  Fluorodeoxyglucose positron emission tomography (FDG-PET)/CT of the
    whole body

6.  X-ray

    -   Radiographic survey of the whole body

    -   Intravenous urography

#### MAJOR OUTCOMES CONSIDERED

Utility of radiologic procedures in post-treatment follow-up of prostate
cancer

### 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 recent
peer-reviewed medical journals, and the major applicable articles were
identified and collected.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### 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.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**ACR Appropriateness Criteria®**

**Clinical Condition: Post Treatment Follow-up of Prostate Cancer**

**Variant 1: Status post radical prostatectomy. Rising PSA Level.**

  -----------------------------------------------------------------------------------
  **Radiologic          **Rating**   **Comments**                      **RRL\***
  Procedure**                                                          
  --------------------- ------------ --------------------------------- --------------
  NUC bone scan whole   8            More likely to be helpful if      Med
  body                               PSA\>10. Readily available. Scan  
                                     to include correlative plain      
                                     films. If bone scan is positive,  
                                     no further imaging work-up is     
                                     necessary.                        

  CT abdomen and pelvis 7            For nodal involvement. Not very   High
  with contrast                      useful for local recurrence.      

  INV US-guided biopsy  6            Should be done under ultrasound   IP
  prostate bed                       guidance to confirm recurrence.   
  transrectal                        Local recurrent tumor may be      
                                     visualized on transrectal         
                                     ultrasound in only 30% to 50% of  
                                     cases.                            

  MRI pelvis            6            Endorectal coil MRI may be useful None
                                     for evaluating local extension or 
                                     pelvic nodal involvement. Use of  
                                     Gadolinium injection is promising 
                                     in detecting local recurrence.    
                                     MRI-guided biopsy is not widely   
                                     available. If bone scan is        
                                     inconclusive, MRI would be        
                                     helpful for further               
                                     characterization. See comments    
                                     regarding contrast in text under  
                                     \"Anticipated Expectations.\"     

  US prostate           4            Will not show microscopic         None
  transrectal                        occurrences.                      

  NUC ProstaScint Scan  3            May be more appropriate if        High
                                     decisions regarding local therapy 
                                     are being considered. Fusion      
                                     imaging with CT or MRI has been   
                                     reported.                         

  FDG-PET/CT whole body 3            PET/CT promising, but data        High
                                     insufficient to warrant routine   
                                     use.                              

  US prostate           2                                              None
  transabdominal                                                       

  X-ray radiographic    1                                              Low
  survey whole body                                                    

  X-ray intravenous     1            If bone scan shows obstruction or Low
  urography                          elevated creatinine.              

  **[Rating                                                            **\*Relative
  Scale]{.underline}:                                                  Radiation
  1=Least appropriate,                                                 Level**
  9=Most appropriate**                                                 
  -----------------------------------------------------------------------------------

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

**Variant 2: Status post radiation therapy. Rising PSA level.**

  -----------------------------------------------------------------------------------
  **Radiologic          **Rating**   **Comments**                      **RRL\***
  Procedure**                                                          
  --------------------- ------------ --------------------------------- --------------
  NUC bone scan whole   8            Scan to include correlative plain Med
  body                               films.                            

  CT abdomen and pelvis 7                                              High
  with contrast                                                        

  INV US-guided biopsy  6                                              IP
  prostate bed                                                         
  transrectal                                                          

  MRI pelvis with       6            Use of Gadolinium injection is    None
  contrast                           promising in detecting local      
                                     recurrence. See comments          
                                     regarding contrast in text under  
                                     \"Anticipated Expectations.\"     

  US prostate           3                                              None
  transrectal                                                          

  NUC ProstaScint Scan  3                                              High

  FDG-PET/CT whole body 3                                              High

  US prostate           1                                              None
  transabdominal                                                       

  X-ray radiographic    1                                              Low
  survey whole body                                                    

  X-ray intravenous     1                                              Low
  urography                                                            

  **[Rating                                                            **\*Relative
  Scale]{.underline}:                                                  Radiation
  1=Least appropriate,                                                 Level**
  9=Most appropriate**                                                 
  -----------------------------------------------------------------------------------

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

**Variant 3: Treatment of metastatic prostate cancer by androgen
deprivation therapy (ADT). Rising PSA level.**

  -----------------------------------------------------------------------------------
  **Radiologic          **Rating**   **Comments**                      **RRL\***
  Procedure**                                                          
  --------------------- ------------ --------------------------------- --------------
  NUC bone scan whole   8            Obtain plain films as needed.     Med
  body                                                                 

  CT abdomen and pelvis 7                                              High
  with contrast                                                        

  MRI pelvis            6            See comments regarding contrast   None
                                     in text under \"Anticipated       
                                     Expectations.\"                   

  NUC ProstaScint Scan  2                                              High

  FDG-PET/CT whole body 2                                              High

  US prostate           1                                              None
  transrectal                                                          

  INV US-guided biopsy  1                                              IP
  prostate bed                                                         
  transrectal                                                          

  X-ray intravenous     1            May be indicated if bone scan     Low
  urography                          shows obstruction or elevated     
                                     creatinine.                       

  US prostate           1                                              None
  transabdominal                                                       

  X-ray radiographic    1                                              Low
  survey whole body                                                    

  **[Rating                                                            **\*Relative
  Scale]{.underline}:                                                  Radiation
  1=Least appropriate,                                                 Level**
  9=Most appropriate**                                                 
  -----------------------------------------------------------------------------------

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

**Summary of Literature Review**

In evaluating of patients with recurrent or metastatic prostate cancer,
it is important to define the location, size and the extent of local
and/or distant tumors. Prostate cancer is treated by four standard
methods: radical prostatectomy, radiation therapy, cryosurgical
ablation, or androgen deprivation therapy (ADT). The treatment choice is
based on the stage of the tumor as well as the histology and grade and
is influenced to a certain extent by the preference of the treating
physician and the patient. After treatment, patients are followed at
periodic intervals with measurement of serum prostate-specific antigen
(PSA) levels and digital rectal examination (DRE). However, DRE is
frequently unreliable in evaluating local recurrent disease after
radical prostatectomy.

PSA is produced by the epithelial cells of the prostate gland and is
therefore specific for prostatic tissue. A rise in PSA is detected in
the serum when the prostate gland has been disrupted as with prostate
cancer, benign prostatic hyperplasia (BPH), or acute prostatitis, or
following prostate biopsy. PSA is now widely used as a tumor marker for
prostate cancer, both for detection and for monitoring response to
therapy. No imaging study is necessary after treatment for clinically
localized prostate cancer unless the PSA is elevated, the DRE is
abnormal, or the patient has bone pain.

Although PSA alone does not differentiate local from distant disease
recurrence, the patterns of PSA rise after local therapy can help to
differentiate local from distant failure. Patients with a late
biochemical recurrence (\>24 months after local treatment), low PSA
velocity (change in PSA over time), and/or prolonged PSA doubling time
(\>6 months) most likely have recurrent local disease. Conversely,
patients with a rapid PSA recurrence (\<24 months after local
treatment), high PSA velocity, or short PSA doubling time (\<6 months)
are more likely to have distant disease recurrence.

Bone x-rays are not sensitive for detecting metastasis compared with
radionuclide bone scans, but they may be helpful in identifying
degenerative changes as the cause for a positive bone scan. Chest x-ray
is not necessary because lung metastases are only found in late-stage
disease after other more common sites are involved by tumor.

Whole-body bone scans are frequently performed for detecting skeletal
metastases in patients with rising PSA following treatment. If the bone
scan is positive for metastatic disease, no other imaging is indicated.
One study suggested that bone scans be done annually in patients without
evidence of metastatic disease and in patients with clinical or
biochemical indications of recurrent disease. However, since bone scans
are rarely positive without symptoms or without abnormal PSA levels, the
routine use of this study post treatment is considered unproductive by
some investigators. Another study found three patients with bone
metastases in a series of 59 patients without suspicious serum PSA
levels. A bone scan may be inconclusive since it is a sensitive but not
specific examination. Magnetic resonance imaging (MRI) may be helpful in
the diagnosis of bone metastasis when other examinations are
conflicting, and it can be used to determine response to hormonal
treatment. A comparison of MRI and bone scans showed 818 abnormal
vertebrae detected by MRI versus 499 by bone scan in the same group of
patients.

**Post Radical Prostatectomy**

Following radical prostatectomy, PSA levels are expected to be
undetectable to less than 0.15 ng/ml within several weeks of surgery.
Waiting 6-8 weeks after treatment is advisable before assessing the
serum PSA value since the half-life of serum PSA is relatively long.
Since the PSA is specific for the prostate, detectable PSA levels mean
that there is residual prostate tissue. If there is a rise in a
previously undetectable or stable postoperative PSA level, a prompt
search for persistent, recurrent, or metastatic disease should be
pursued. The major objective of the diagnostic imaging studies is to
assess patients for the presence of distant metastatic disease or local
recurrent disease, each requiring different forms of systemic or local
therapy.

*Radionuclide Bone Scintigraphy*

Radionuclide bone scan is traditionally the first examination obtained.
If the bone scan is positive for metastatic disease, no further imaging
studies are necessary. If the bone scan is inconclusive, further imaging
studies are performed, including conventional radiographs, MRI, or
computed tomography (CT). However, the level of post-treatment PSA that
should prompt a bone scan is uncertain. In a study of patients with
biochemical failure following radical prostatectomy, the probability of
a positive bone scan was less than 5% with PSA levels between 40 to 45
ng/mL. In another study, bone scan was limited until PSA rose above 30
to 40 ng/mL. Men with PSA doubling times less than 6 months after
radical prostatectomy were at increased risk of a positive bone scan
(26% vs. 3%) or positive CT (24% vs. 0%) compared to those with longer
PSA doubling time.

Based on a survey by the American Urology Association (AUA) on current
practice strategies for follow-up after radical prostatectomy, bone
scans are recommended only if the patient had symptoms of bone pain, a
rapid rise in PSA (PSA velocity), or a significantly elevated PSA value.

*Transrectal Ultrasonography*

The use of imaging in the evaluation of local tumor recurrence is
controversial. Transrectal ultrasound (TRUS) with guided biopsy of the
vesicourethral anastomosis (VUA) has been the standard imaging approach
to document local recurrence. A palpable abnormality is not always a
good guide to the location of recurrent or progressive tumor because
postoperative fibrosis may mimic tumor. Negative results of
ultrasound-guided transrectal biopsy of the VUA, regardless of a
palpable mass or indurations, may be inconclusive because of sampling
error. The use of biopsy has been questioned in the face of a rising PSA
level, since the negative results are unreliable and elevated PSA levels
usually precede clinical evidence of local recurrence by one or more
years. Repeat TRUS with VUA needle biopsy may be necessary in one-third
of cases. The yield for detecting local recurrent tumor with TRUS with
needle biopsy rises significantly with serum PSA levels. Only about 25%
of men with prostatectomy PSA levels of less than 1 ng/mL have
histologic confirmation of local recurrence after biopsy of the
prostatic fossa. None of the patients with PSA levels of 0.5 ng/mL or
less who had negative DRE and TRUS have a biopsy-proved local
recurrence.

A staging pelvic lymphadenectomy is sometimes done at the time of a
radical retropubic prostatectomy; therefore, follow-up of the lymph
nodes usually is not necessary in such cases. However, if the biopsy of
the VUA is repeatedly negative in the face of a rising PSA level, then
pelvic imaging looking for adenopathy with CT or MRI may be indicated.

*Computed Tomography*

CT is not effective for detecting recurrent tumor in the surgical bed. A
CT scan can recognize only local recurrences that are greater than or
equal to 2 grams. The mean PSA value associated with a positive CT scan
after radical prostatectomy was 27.4 ng/mL.

In the evaluation of nodal disease, CT has replaced lymphography and
relies on nodal size to detect nodal metastases. Using 1 cm as a cutoff,
studies have reported sensitivity between 27% to 75% and specificity
between 66% to 100%. By decreasing the size cutoff to 0.7 cm and by
sampling suspicious nodes by fine-needle aspiration (FNA), one group of
researchers were able to attain a sensitivity of 78% and specificity of
100%. However, this decreased size criteria with concomitant use of FNA
has not been widely adopted. CT is useful in detecting bone and visceral
metastases, although bone scan and MRI are superior in the diagnosis and
follow-up of bone metastases.

*Magnetic Resonance Imaging*

The use of MRI is evolving and has potential to evaluate both local
recurrence and distant bony and nodal metastases. MRI utilizing an
endorectal coil is used to evaluate local recurrence. In a study by one
group of researchers, MRI was positive in men with cancer recurrence
only with a concomitant rise in PSA level. In the absence of PSA rise,
despite suspicious findings on DRE, the MRI was negative. In another
study of 16 patients with rising PSA after radical prostatectomy and
negative transrectal ultrasound-guided biopsy, gadolinium-enhanced,
dynamic endorectal coil MRI demonstrated nodular enhancing lesions in 13
of 16 patients (84%). In 8 of the 13 patients with positive MRI
findings, PSA levels decreased after radiation therapy. Concurrent
MRI-directed biopsy of suspicious sites is not available, making
histologic correlation and assessment of its true utility difficult.

The accuracy of MRI for staging pelvic lymph nodes by size criteria is
similar to that of CT. MRI can be more sensitive and specific in the
diagnosis of bone metastases with better spatial and contrast resolution
when compared to bone scan. MRI cannot cover the entire skeleton within
a reasonable time at a reasonable cost. Therefore, it is only useful
when other imaging modality findings are indeterminate. Response of bone
metastases to treatment can be more accurately monitored by serial MRI
scans.

**Post Radiation Therapy**

Prostate cancer treated with radiation therapy (RT) is monitored
differently, since the prostate and the lymph nodes are left in place.
Following radiation therapy, the serum PSA level decreases in the
majority of the patients during the first year. Surveillance for tumor
recurrence in patients post radiation therapy should include a DRE and
serial serum PSA levels. The prostate gland becomes atrophic and
fibrotic after radiation treatment, making distinction between local
recurrent disease and benign irradiated prostatic gland difficult by DRE
alone. The American Society of Therapeutic Radiology and Oncology
(ASTRO) has defined recurrence following radiation therapy as three
consecutive rises in serum PSA following a post-RT PSA nadir. An
increasing serum PSA level will prompt radionuclide bone scan. If the
bone scan is positive, no further evaluation is necessary. If the bone
scan is inconclusive, MRI may be helpful. If the bone scan is negative
or inconclusive, TRUS-directed biopsy of the prostate is indicated. MRI
may be indicated to depict local recurrence after radiotherapy. In 22
patients with rising PSA after external beam radiation therapy,
contrast-enhanced dynamic MRI demonstrated areas of recurrent
intraprostatic tumor more accurately and with less interobserver
variability than T2-weighted images did. Evaluation for lymph node
enlargement is done by either CT or MRI. Both imaging tests are
relatively accurate for detecting lymph node enlargement.

**Post Cryosurgery**

Serum PSA should fall to a low level 6 to 8 weeks following cryosurgery
and should not rise on successive occasions. Follow-up after cryosurgery
should be the same as that after radiotherapy, and it seems reasonable
to use similar guidelines to define disease recurrence. It is often
difficult to differentiate recurrent tumor from post-cryosurgery changes
by means of DRE, TRUS, and MRI.

**Post Androgen Deprivation Therapy**

ADT---using bilateral orchiectomy, luteinizing hormone-releasing hormone
analogue, diethylstilbestrol, bilateral orchiectomy and flutamide, and
luteinizing hormone-releasing hormone analogue and flutamide---may
control prostate cancer for long periods by decreasing the size of the
tumor, thus relieving pain and other symptoms in patients with advanced
disease. ADT may be added to definitive therapy (radical prostatectomy,
radiation therapy, and cryosurgery) in patients with early-stage disease
as adjuvant therapy (after definitive therapy) or neoadjuvant therapy
(prior to definitive therapy). ADT may have a direct suppressive effect
on serum PSA level that is independent of tumor activity. PSA production
is under hormonal control, and ADT reduces the cell\'s ability to
produce and secrete PSA. Therefore, serum PSA is not always a reliable
marker of disease status in these patients.

In a study by one group of researchers, serial serum PSA measurements
after ADT were able to predict response to the treatment. Patients whose
serum PSA levels remained elevated for more than three months after
treatment had a high risk of disease progression within two years.
Serial PSA determinations in combination with radionuclide bone scanning
are clinically warranted in these patients with advanced disease as
follow-up. In patients with an increasing serum PSA level, the
investigation can end if the bone scan is conclusive. CT is also useful
in assessing nodal or visceral metastatic disease. If the bone scan and
CT are negative or inconclusive, further investigation for metastasis
may be pursued using MRI.

**Summary**

All patients treated for prostate cancer are monitored with serial PSA
measurements and DRE. A radionuclide bone scan has traditionally been
obtained at one year after treatment regardless of PSA level. This
tradition is now being challenged, but bone scans are still commonly
obtained after ADT.

A rising PSA level usually prompts a bone scan. If it is positive, no
other imaging is indicated. An equivocal bone scan may lead to more
refined imaging such as MRI or CT. A negative bone scan requires further
investigation such as TRUS-guided biopsy (post local therapy, including
prostatectomy, radiation therapy, and cryosurgery) and lymph node
evaluation with CT or MRI. Endorectal coil MRI is evolving and provides
useful information regarding local recurrence as well as pelvic nodal
and bone metastases. Chest x-ray is not necessary because prostatic lung
metastasis is only found in late stage disease after other metastatic
sites are well established. Bone x-rays are only used to help in
identifying degenerative bone changes as a cause for abnormal foci on
radionuclide bone scans.

**New Techniques**

*ProstaScint Scan (111 Indium capromab pendetide)*

ProstaScint is a murine monoclonal antibody that targets
prostate-specific membrane antigen (PSMA). ProstaScint imaging in the
detection of metastases and local recurrence has been reported to have a
sensitivity of 49% to 94%, a specificity of 65% to 72%, and an overall
accuracy of 63% to 80%. However, there are still questions remaining
regarding its optimal use. Further, the scans are challenging to
interpret and expensive to perform. It has been reported that the
likelihood of a positive scan outcome is enhanced when patients with
high PSA levels and high Gleason grade tumors are felt to have a
recurrence. Fused SPECT/CT or MRI will improve the specificity of
ProstaScint examination in detecting recurrent prostate cancer.

*Positron Emission Tomography with 2-deoxy-2- \[F-18\] fluoro-D-glucose*

Many foci of metastatic prostate cancer demonstrate increased FDG
accumulation, though this uptake is generally low compared to the other
cancers. FDG-PET is relatively insensitive in detecting osseous
metastases compared to standard bone scintigraphy. Helical CT and
FDG-PET scanning may be more helpful than ProstaScint imaging in
detecting nodal disease in men with high PSA level after radical
prostatectomy. PET/CT can provide information about anatomy and
metabolism of the recurrent and metastatic disease.

*Positron Emission Tomography with Newer Radiotracers including
\[11-C\]-acetate, \[11-C or 18-F\]-choline, and \[11-C\]-methionine*

PET with 11C acetate and PET with 11C and 18F choline have been reported
to detect recurrent disease in patients with high PSA after local
treatment. PET with 11C methionine has been reported to be more
sensitive than FDG-PET in detecting bone metastases. The efficacy and
clinical utility of PET with these new agents are under investigation.

*Magnetic Resonance Spectroscopic Imaging*

MR spectroscopic imaging (MRSI) provides metabolic information from
3-dimensional multiple contiguous volumes (voxels) within the prostate
gland. Addition of the metabolic information provided by MRSI to the
morphologic information provided by endorectal coil MRI can help
discriminate regions of residual tumor from other prostatic tissues and
necrosis following radiation therapy, cryosurgery, and hormone therapy.
Time-dependent effects of hormone therapy on prostate metabolism are
detected on MRSI. However, prostate metabolic profiles associated with
prostate cancer can be identifiable on MRSI in patients with PSA levels
exceeding 0.20 ng/mL and with 3 months or less of neoadjuvant hormone
therapy for locally confined prostate cancer.

*Newer Lymph Nodal Magnetic Resonance Contrast Agent*

MRI following IV administration of lymphotropic superparamagnetic iron
oxide nanoparticles has been reported to improve detection of positive
lymph nodal metastases from prostate cancer when compared to unenhanced
MRI. This MRI contrast agent is investigational and is not commercially
available at this time.

**Anticipated Exceptions**

Nephrogenic systemic fibrosis (NSF, also known as nephrogenic fibrosing
dermopathy) was first identified in 1997 and has recently generated
substantial concern among radiologists, referring doctors and lay
people. Until the last few years, gadolinium-based MR contrast agents
were widely believed to be almost universally well tolerated, extremely
safe and non-nephrotoxic, even when used in patients with impaired renal
function. All available experience suggests that these agents remain
generally very safe, but recently some patients with renal failure who
have been exposed to gadolinium contrast agents (the percentage is
unclear) have developed NSF, a syndrome that can be fatal. Further
studies are necessary to determine what the exact relationships are
between gadolinium-containing contrast agents, their specific components
and stoichiometry, patient renal function and NSF. Current theory links
the development of NSF to the administration of relatively high doses
(e.g., \>0.2 mM/kg) and to agents in which the gadolinium is least
strongly chelated. The FDA has recently issued a \"black box\" warning
concerning these contrast agents
(<http://www.fda.gov/cder/drug/InfoSheets/HCP/gcca_200705HCP.pdf>).

This warning recommends that, until further information is available,
gadolinium contrast agents should not be administered to patients with
either acute or significant chronic kidney disease (estimated GFR \<30
mL/min/1.73m^2^), recent liver or kidney transplant or hepato-renal
syndrome, unless a risk-benefit assessment suggests that the benefit of
administration in the particular patient clearly outweighs the potential
risk(s).

**Abbreviations**

-   CT, computed tomography

-   FDG-PET, fluorodeoxyglucose positron emission tomography

-   INV, invasive

-   IP, in progress

-   Med, medium

-   MRI, magnetic resonance imaging

-   NUC, nuclear medicine

-   PSA, prostate-specific antigen

-   US, ultrasound

#### CLINICAL ALGORITHM(S)

None available

### 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 imaging procedures for post
treatment follow-up of prostate cancer

#### POTENTIAL HARMS

-   The relative radiation level is high for computed tomography (CT) of
    the abdomen and pelvis with contrast, nuclear medicine (NUC)
    ProstaScint scan, fluorodeoxyglucose positron emission tomography
    (FDG-PET/CT) whole body; medium for NUC bone scan whole body; and
    low for X-ray radiographic survey of the whole body, and X-ray
    intravenous urography.

-   Some patients with renal failure who have been exposed to gadolinium
    contrast agents (the percentage is unclear) have developed
    nephrogenic systemic fibrosis, a syndrome that can be fatal. Until
    further information is available, gadolinium contrast agents should
    not be administered to patients with either acute or significant
    chronic kidney disease (estimated GFR \<30 mL/min/1.73m^2^), recent
    liver or kidney transplant or hepato-renal syndrome, unless a
    risk-benefit assessment suggests that the benefit of administration
    in the particular patient clearly outweighs the potential risk(s).

### 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)

Kawashima A, Francis IR, Baumgarten DA, Bluth EI, Bush WH Jr, Casalino
DD, Curry NS, Israel GM, Jafri SZ, Papanicolaou N, Remer EM, Sandler CM,
Spring DB, Fulgham P, Expert Panel on Urologic Imaging. Post-treatment
follow-up of prostate cancer. \[online publication\]. Reston (VA):
American College of Radiology (ACR); 2007. 8 p. \[60 references\]

#### ADAPTATION

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

#### DATE RELEASED

1996 (revised 2007)

#### 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 Urologic Imaging

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Panel Members*: Akira Kawashima, MD; Isaac R. Francis, MD; Deborah A.
Baumgarten, MD, MPH; Edward I. Bluth, MD; William H. Bush, Jr., MD;
David D. Casalino, MD; Nancy S. Curry, MD; Gary M. Israel, MD; S. Zafar
H. Jafri, MD; Nicholas Papanicolaou, MD; Erick M. Remer, MD; Carl M.
Sandler, MD; David B. Spring, MD; Pat Fulgham, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Kawashima A, Choyke PL, Bluth
EI, Bush WH Jr, Casalino DD, Francis IR, Jafri SZ, Kronthal AJ, Older
RA, Papanicolaou N, Ramchandani P, Rosenfield AT, Sandler CM, Segal AJ,
Tempany CM, Resnick MI, Expert Panel on Urologic Imaging. Post-treatment
follow-up of prostate cancer. \[online publication\]. Reston (VA):
American College of Radiology (ACR); 2005. 9 p. \[50 references\]

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/ExpertPanelonUrologicImaging/PostTreatmentFollowUpofProstateCancerDoc10.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 are 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.aspx).

-   ACR Appropriateness Criteria®. Relative radiation level information.
    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/RRLInformation.aspx).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on February 9, 2006. This summary
was updated by ECRI Institute on May 17, 2007 following the U.S. Food
and Drug Administration (FDA) advisory on Gadolinium-based contrast
agents. This summary was updated by ECRI Institute on June 20, 2007
following the U.S. Food and Drug Administration (FDA) advisory on
gadolinium-based contrast agents. This NGC summary was updated by ECRI
Institute on November 26, 2007.

#### 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.

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008