This is the current release of the guideline.

This guideline updates a previous version: Israel GM, Francis IR, Roach M III, Anscher MS, Bluth EI, Kawashima A, Lee WR, Merrick G, Sandler CM, Fulgham P, Expert Panel on Urologic Imaging and Radiation Oncology–Prostate. Pretreatment staging prostate cancer. [online publication]. Reston (VA): American College of Radiology (ACR); 2007. 12 p. [104 references]

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

Prostate cancer

To evaluate the appropriateness of initial radiologic examinations for pretreatment staging of patients with prostate cancer

Patients with prostate cancer

Accuracy, sensitivity, specificity, and positive and negative predictive value of radiologic procedures for pretreatment staging of prostate cancer

Literature Search Procedure

The Medline literature search is based on keywords provided by the topic author. The two general classes of keywords are those related to the condition (e.g., ankle pain, fever) and those that describe the diagnostic or therapeutic intervention of interest (e.g., mammography, MRI).

The search terms and parameters are manipulated to produce the most relevant, current evidence to address the American College of Radiology Appropriateness Criteria (ACR AC) topic being reviewed or developed. Combining the clinical conditions and diagnostic modalities or therapeutic procedures narrows the search to be relevant to the topic. Exploding the term "diagnostic imaging" captures relevant results for diagnostic topics.

The following criteria/limits are used in the searches.

1. Articles that have abstracts available and are concerned with humans.
2. Restrict the search to the year prior to the last topic update or in some cases the author of the topic may specify which year range to use in the search. For new topics, the year range is restricted to the last 5 years unless the topic author provides other instructions.
3. May restrict the search to Adults only or Pediatrics only.
4. Articles consisting of only summaries or case reports are often excluded from final results.

The search strategy may be revised to improve the output as needed.

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

Strength of Evidence Key

Category 1 - The conclusions of the study are valid and strongly supported by study design, analysis, and results.

Category 2 - The conclusions of the study are likely valid, but study design does not permit certainty.

Category 3 - The conclusions of the study may be valid, but the evidence supporting the conclusions is inconclusive or equivocal.

Category 4 - The conclusions of the study may not be valid because the evidence may not be reliable given the study design or analysis.

The topic author drafts or revises the narrative text summarizing the evidence found in the literature. American College of Radiology (ACR) staff draft an evidence table based on the analysis of the selected literature. These tables rate the strength of the evidence for all articles included in the narrative text.

The expert panel reviews the narrative text, evidence table, and the supporting literature for each of the topic-variant combinations and assigns an appropriateness rating for each procedure listed in the table. Each individual panel member forms his/her own opinion based on his/her interpretation of the available evidence.

More information about the evidence table development process can be found in the ACR Appropriateness Criteria® Evidence Table Development document (see the "Availability of Companion Documents" field).

Modified Delphi Technique

When the data available from existing scientific studies are insufficient, the American College of Radiology Appropriateness Criteria (ACR AC) employs systematic consensus techniques to determine appropriateness. The ACR AC panels use a modified Delphi technique to determine the rating for a specific procedure. A series of surveys are conducted to elicit each individual panelist's expert opinion of the appropriateness of an imaging or therapeutic procedure for a specific clinical scenario based on the available data. ACR staff distributes surveys to the panelists along with the evidence table and narrative. Each panelist interprets the available evidence and rates each procedure. Voting surveys are completed by panelists without consulting other panelists. The ratings are integers on a scale between 1 and 9, where 1 means the panel member feels the procedure is "least appropriate" and 9 means the panel member feels the procedure is "most appropriate." Each panel member has one vote per round to assign a rating. The surveys are collected and de-identified and the results are tabulated and redistributed after each round. A maximum of three rounds are conducted. The modified Delphi technique enables each panelist to express individual interpretations of the evidence and his or her expert opinion without excessive bias from fellow panelists in a simple, standardized, and economical process.

Consensus among the panel members must be achieved to determine the final rating for each procedure. If eighty percent (80%) of the panel members agree on a single rating or one of two consecutive ratings, the final rating is determined by the rating that is closest to the median of all the ratings. Up to three voting rounds are conducted to achieve consensus.

If consensus is not reached through the modified Delphi technique, the panel is convened by conference call. The strengths and weaknesses of each imaging examination or procedure are discussed and a final rating is proposed. If the panelists on the call agree, the rating is accepted as the panel's consensus. The document is circulated to all the panelists to make the final determination. If consensus cannot be reached, "No consensus" appears in the rating column and the reasons for this decision are added to the comment sections.

Not applicable

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

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

Note from the American College of Radiology (ACR) and the National Guideline Clearinghouse (NGC): ACR has updated its Relative Radiation Level categories and Rating Scale. The Rating Scale now includes categories (1,2,3 = Usually not appropriate; 4,5,6 = May be appropriate; 7,8,9 = Usually appropriate). See the original guideline document for details.

ACR Appropriateness Criteria®

Clinical Condition: Pretreatment Staging Prostate Cancer

Variant 1: T1–2 and Gleason score (GS) ≤6 and PSA <10 and <50% biopsy cores positive.

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

Variant 2: T1–2 and GS ≤6 and PSA <10 and ≥50% biopsy cores positive.

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

Variant 3: T1–2 and GS ≤6 and PSA 10 to <20 and <50% biopsy cores positive.

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

Variant 4: T1–2 and GS ≤6 and PSA 10 to <20 and ≥50% biopsy cores positive.

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

Variant 5: T1–2 and GS = 7 and PSA <20 and <50% biopsy cores positive.

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

Variant 6: (T1–2 and GS ≤6 and PSA >20) or T1–2 and GS = 8–10 and PSA <20 and <50% biopsy cores positive.

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

Variant 7: T1–2 and GS >7 and PSA ≥20 or ≥50% biopsy cores positive.

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

Variant 8: Clinical T3, seminal vesicle or bladder neck invasion.

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

Summary of Literature Review

Prostate cancer is the most common noncutaneous malignancy of men in the United States and is the second leading cause of cancer death in American men. The American Cancer Society recommends that men over the age of 50 have an annual digital rectal examination (DRE) and a serum prostate-specific antigen (PSA) test, and that men with a family history of prostate cancer or who are of African-American descent begin annual screening at age 45.

If either the DRE or PSA test suggests neoplasm, a transrectal ultrasound-guided needle biopsy of the prostate gland is usually performed. Alternatively, prostate cancer may be found in the tissue obtained during a transurethral resection of the prostate (TURP), although this procedure is becoming less common. Pretreatment staging is important, because clinically localized disease (stage T1 or T2) is generally amenable to local therapy, while more advanced disease may require multimodal therapy (e.g., androgen deprivation therapy and radiation therapy). The staging system developed by the American Joint Committee on Cancer (AJCC) encompasses the status of the primary tumor (T), the lymph nodes (N), and any metastasis (M) (see Appendix 1 in the original guideline document).

Clinical Staging Methods

Digital Rectal Examination

The DRE is considered insensitive for detecting extracapsular tumor extension. At least 40% of patients with cancers judged to be clinically confined (T1 or T2) by DRE are found to have extraprostatic extension at surgery. Thus, DRE alone has proven unsatisfactory for determining stage.

Prostate-specific Antigen

Serum PSA is used as a biomarker not only in identifying men with prostatic cancer but also in predicting pathologic stage, especially when combined with a patient's Gleason score, and for monitoring treatment response. In general, the higher the PSA, the more advanced the disease; moreover, the likelihood of having organ-confined disease is inversely proportional to the level of the PSA. Despite its utility, it is clear that as many as 15% of men with a normal PSA will have prostate cancer on one or more biopsy specimens. Recent data also suggest that the correlation with extent of disease is poor for men with relatively low PSA levels (e.g., <9 ng/mL).

The initial PSA value correlates with the likelihood of being free of biochemical evidence of persistent disease and surviving prostate cancer. PSA measurements are evaluated alone or by comparison with a prior measurement (PSA velocity and PSA doubling time [PSADT]), or in the context of the patient's gland volume (PSA density). There are also age-specific PSA levels available. The density and age specificity help to separate the elevations in PSA due to benign prostatic hyperplasia (BPH) from those due to cancer; however, these methods provide guidance only on the likelihood of cancer versus benign disease. The capability of PSA level alone to accurately predict final pathologic stage in an individual has a prohibitively high false-positive rate. The bound and free components of PSA have been measured; the proportion of free PSA (i.e., not bound to plasma proteins) was found to be lower in patients with cancer than in those with BPH. For instance, free PSA values <15% were associated with more aggressive tumors, whereas free PSA values >25% generally had low-risk tumors.

Prostate Acid Phosphatase

With the introduction of PSA in the 1980s, prostate acid phosphatase (PAP) fell into disfavor because PSA performed significantly better in terms of screening and monitoring response to treatment. However, recent radical prostatectomy, external-beam radiation therapy, and brachytherapy series have demonstrated that PAP is a statistically significant predictor for biochemical progression-free survival and/or cause-specific survival in patients with intermediate- and high-risk prostate cancer. PAP appears to be particularly valuable in predicting distant failure in higher-risk patients for whom high levels of local control are achieved with aggressive local treatment. If PAP is to be introduced as a standard component of the initial diagnostic workup of prostate cancer, additional clinical studies are necessary to corroborate the currently published data.

Gleason Score

The Gleason scoring system has been shown to correlate well with the extent of disease and prognosis. It is the single best predictor of the biological activity, and therefore the stage, of the tumor. The scoring ranges from 2 (well differentiated, minimally aggressive) to 10 (anaplastic, highly aggressive). The probability of seminal vesicle and lymph node involvement (LN+) increases with the Gleason score, and some investigators have found a combination of the Gleason score and serum PSA level to give the greatest prognostic information.

Nomograms and Risk Group Stratification

Work by several groups of investigators has led to the development of nomograms that predict the probability of extracapsular extension (ECE), seminal vesicle involvement (SV+), and (LN+). This work was subsequently validated by others and led to attempts to correlate nomograms with prognosis. Most nomograms use combinations of clinically available prognostic factors such as PSA level, grade, and clinical T stage to estimate the risk. Estimates of the probability of LN positivity derived from such nomograms have subsequently been shown to be of use in determining the utility of staging studies and in guiding therapy.

Clinicians have widely adopted a simplified approach to predicting outcome based on the same pretreatment parameters used in the nomograms. Using such an approach, patients with similar risk of biochemical recurrence can be divided into risk groups that, with additional follow-up, have been correlated with mortality:

• Low risk: AJCC clinical stage T1c or 2a and PSA ≤10 ng/mL and biopsy Gleason score ≤6~80, 10-year PSA failure-free survival rate.
• Intermediate risk: AJCC clinical stage T2b or PSA >10 and ≤20 ng/mL or biopsy Gleason score 7~50, 10-year PSA failure-free survival rate.
• High risk: AJCC stage T2c disease or PSA >20 ng/mL or biopsy Gleason score ≥8~33, 10-year PSA failure-free survival rate.

Alternative risk stratification schemes have also been described, and despite their differences they support the notion that Gleason score, clinical T stage, and PSA can be used to predict survival and direct therapy. More recently, the number of positive biopsies (e.g., >5) and the percentage of each core that is positive for biopsy (e.g., >50%) have been associated with increased risk of recurrent disease.

Summary of Nonimaging Methods of Staging

While DRE, PSA, or Gleason score individually predict stage, they are less accurate than when they are combined into nomograms that provide estimates of risk. Patients can be stratified by their risk for extraprostatic, nodal, and disseminated disease.

Imaging potentially improves these general estimates of risk by specifically identifying lesions with anatomic abnormalities. However, interpretation of imaging findings should be made in the context of the nonimaging findings. Due in part to the limitations of clinical staging, efforts have been made to use imaging modalities to better predict the extent of disease and outcome.

Imaging Methods

Ultrasound

Gray-scale ultrasound (US) has not proven satisfactory for local staging of prostate cancer. The ability of transrectal US to predict ECE varies widely from 37% to 83% in different settings and populations; however, it is generally acknowledged that US is of limited value due to limitations of its spatial resolution. The addition of color Doppler and power Doppler has been reported to improve the detection of prostate cancer by identifying increased vascularity but has not yet been shown to improve staging accuracy. Failure to identify a neurovascular bundle near the site of a tumor is suggestive of ECE, but there is not yet consensus that its use is mandatory for staging. Contrast-enhanced US has the potential to substantially improve the staging of prostate cancer but has not yet been tested in a multi-institutional trial. Similarly, three-dimensional (3D) US is under investigation to improve the delineation of the cancer and prostate capsule.

Magnetic Resonance Imaging

Endorectal coil magnetic resonance imaging (erMRI) provides the highest spatial resolution among the imaging modalities currently available. Three major techniques that have been used to stage prostate cancer with erMRI: T2-weighted MRI, magnetic resonance spectroscopic imaging (MRSI), and dynamic contrast-enhanced MRI (DCE-MRI). It is generally accepted that an endorectal coil is required to achieve sufficient signal-to-noise ratios to allow small field-of-view (12 to 16 cm) imaging, which, in turn, allows images to be acquired with high resolution (~0.5 mm). Additionally, 3-Tesla (3T) erMRI may be beneficial by providing higher signal, thus further improving spatial (or temporal, in the case of DCE-MRI) resolution. One group of researchers has shown that 3T erMRI imaging is accurate for staging of prostate cancer, that there is moderate to substantial interobserver agreement, and that minimal capsular invasion could be detected. However, there are insufficient data in the literature to support the routine use of 3T erMRI.

T2-weighted Magnetic Resonance Imaging

Over 15 years of clinical experience exists with T2-weighted erMRI. Improvements in coil design (dual endorectal coil and torso coil arrays), pulse sequences, and image intensity correction have led to improvements in the performance of T2-weighted imaging, but some inherent limitations remain. Low-signal lesions on T2-weighted imaging can be due to cancer or can be caused by benign processes such as prostatitis. erMRI remains limited in its ability to identify microscopic or early macroscopic capsular penetration due to restrictions on spatial resolution and motion artifacts. Moreover, individual radiologist expertise is an important determinant of staging accuracy. In one study, one reader achieved an accuracy of 91%, while the other had an accuracy of only 56%.

Early studies from the 1990s reported accuracies from 51% to 82% in distinguishing T2 and T3 disease. More recently, erMRI has been shown to improve the prediction of neurovascular bundle invasion prior to radical prostatectomy. One study demonstrated that the differences between "expert" readers and less experienced readers could be reduced by incorporating other clinical data (e.g., PSA value, tumor grade) and using strict imaging criteria. Another study has shown that using DCE-MRI rather than T2-weighted images can improve staging performance by less experienced readers, when compared to more experienced readers. Endorectal MRI has also been shown to be accurate in demonstrating seminal vesicle invasion. The combination of a tumor at the base of the prostate that extends beyond the capsule combined with low signal in the seminal vesicles that have lost normal architecture is highly predictive of seminal vesicle invasion.

More recently, similar strategies to include erMRI in a neural network have resulted in overall accuracies of 88% to 91% depending on the exact implementation. These results are superior to conventional results with Partin's tables. In this study, Gleason score was the most influential predictive factor, followed by erMRI results and then PSA levels. Several studies have documented that erMRI is most successful in men with intermediate-risk prostate cancer based on Partin's tables. In these men, erMRI staging was highly predictive of PSA recurrence. In a study involving 344 patients, one group of investigators demonstrated that erMRI added statistically meaningful staging data regarding ECE. Endorectal MRI has also proven helpful in directing 3D conformal radiotherapy and improving outcomes.

Magnetic Resonance Spectroscopy

One group of investigators demonstrated that prostate cancers have a characteristic loss of the citrate peak and gain in the choline/creatine peak on MRSI. Moreover, the ratio of choline to citrate is related to the Gleason score, suggesting that MRSI may provide information about tumor aggressiveness. Improvements in diagnostic accuracy and staging have been reported. However, a recent clinical trial under the auspices of the American College of Radiology Imaging Network (ACRIN®) showed no benefit of MR spectroscopy for localizing prostate cancer over standard MRI alone. Thus, MRSI cannot yet be considered a routine diagnostic tool.

Dynamic Contrast-enhanced Magnetic Resonance Imaging

Prostate cancers, like many tumors, demonstrate angiogenesis that can be detected on DCE-MRI. DCE-MRI demonstrates earlier and more intense enhancement in sites of tumor compared with the normal peripheral zone. One group of investigators found minimal improvements in diagnostic accuracy over conventional T2-weighted scans using DCE-MRI. Another group showed that tumors could be distinguished from noncancerous prostate with high reliability, although the study did not specifically address staging. DCE-MRI can improve staging performance when used in conjunction with T2-weighted images for less experienced readers when compared to more experienced readers. One study has demonstrated that the combination of high-spatial-resolution DCE-MRI and T2-weighted images improved assessment of extracapsular extension and yielded better results for prostate cancer staging compared with either technique independently. However, this method still suffers from a lack of a uniformly accepted analytic method and has not been tested in multi-institutional trials. Thus, it is still of unproven benefit.

Nodal Staging with Magnetic Resonance Imaging

MRI has been shown to be at least equivalent to computed tomography (CT) for detecting abnormal lymph nodes in men with prostate cancer. Neither MRI nor CT scans are as accurate as laparoscopic node dissection. Unfortunately, metastatic lymph nodes in prostate cancer are often small, so that conventional size criteria underestimate the extent of nodal disease. Thus, low sensitivities are observed, even in high-risk patients. Ultrasmall particles of iron oxide (USPIO) have been shown to dramatically improve sensitivity of MRI for nodal metastasis; however, the iron-based contrast agent ferumoxtran (trade name Combidex) is not yet approved by the FDA. The role of MRI for nodal staging will need to be reassessed if the FDA approves Combidex.

Computed Tomography

CT of the abdomen and pelvis suffers from poor sensitivity in detecting capsular penetration, SV+, and lymph node extension and should be reserved for use in patients with a high probability of LN+. Overall accuracy in staging was reported as 65% by one group of investigators and as 67% by another group. For locoregional staging, such as extracapsular penetration, the accuracy has been reported as low as 24%. Even with refined techniques in performing CT (3-mm slice thickness and 5-mm table increments with both IV and oral contrast), it is generally felt that CT is of little value in staging the local extent of prostatic carcinoma. However, one study reports 93.7% accuracy for CT in detecting positive lymph nodes, which increases to 96.5% if CT-guided fine-needle aspiration biopsy is added. This degree of accuracy was only achieved by using a threshold of 6 mm or larger as pathologic. Thus, CT of the abdomen and pelvis is of limited value in local staging and nodal staging and should be reserved for intermediate- and high-risk patients.

ProstaScint (Indium Capromab)

The reliability and usefulness of ProstaScint scan based on indium-111 radiolabeled capromab pendetide (a first-generation monoclonal antibody against prostate-specific membrane antigen [PSMA]) as a method to help initial staging in prostate cancer remain unproven at this time. Initial studies suggested that this technology may improve the detection of metastatic lymph nodes when applied to patients estimated to have a risk of LN+ of >20%. Studies are needed with a sufficient number of patients with histopathological correlation to document sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. One group of investigators conducted histopathological correlation in lymph nodes after ProstaScint scan in 31 patients (43 samples). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy value were 94%, 42%, 53%, 92%, and 65%, respectively. Its limitations appear to be due to the intracellular binding site of the antibody as well as nonprostatic expression of PSMA. Routine ProstaScint scanning as an initial staging procedure is not justified based on evidence at this time. However, many studies show its utility in postoperative failure settings, especially to guide radiotherapeutic decisions. New methods to suppress normal uptake as well as coregistration and fusion with CT or MRI seem to improve its utility in defining target volumes in radiotherapeutic settings.

Bone Scan

The radionuclide bone scan is a standard component of the evaluation for many patients diagnosed with prostate cancer. However, original work by one group of investigators has shown that in patients with low PSA level (<10 ng/mL) who have no pain, the yield of a staging bone scan is too low to warrant its routine use. In their experience, no patient with a PSA ≤ 10 ng/mL had a positive bone scan, and only one patient in 300 with a PSA level ≤20 ng/mL had a positive radionuclide bone scan. Such observations have been confirmed by more recent studies as well. These studies suggest that for patients with no skeletal symptoms and a serum PSA level of 10 ng/mL or less, a staging radionuclide bone scan is not necessary; however, this recommendation has to be modified under specific circumstances such as T3 or T4 disease or a high Gleason score.

The rate of positive bone scans depends on the PSA value and Gleason score. Patients with PSA ≤20 ng/mL and Gleason Score <8 have a 1% to 13% rate of positive bone scans. For this reason only patients with a PSA ≥20 ng/mL (with any T stage or Gleason score), locally advanced disease (T3 or T4 with any PSA or Gleason score), or Gleason score ≥8 or greater (with any PSA or T stage) should be considered for a radionuclide bone scan. Patients with skeletal symptoms or advanced stage disease should also be considered candidates for bone scans.

Positron Emission Tomography

The role of positron emission tomography (PET) in the staging workup of newly diagnosed and recurrent prostate cancer is still being evaluated. It has the potential to play an important role in detecting early metastatic spread and monitoring post-therapy response. PET using the most commonly available tracer, fluorine-18-2-fluoro-2-deoxy-D-glucose (FDG), has proved disappointing in the initial staging of prostate cancer. In that study, 23 of 24 primary prostate cancer lesions were not detected by FDG-PET. FDG-PET can play a role in the detection of local recurrence and/or distant metastases with increasing PSA after initial treatment failure. Several additional radiotracers have been extensively studied, including C11 or F18 choline and acetate, C11 methionine, F18 fluoride, gallium-68–labeled peptides, and fluorodihydrotestosterone. PET scans using these radiotracers can have advantages over traditional agents and may help in the clinical decision-making process, especially in patients with high-risk primary disease. For instance, the use of C11 choline or acetate PET appears to be promising for detecting nodal metastases. But these agents remain experimental or are not widely available, and so PET scanning has a limited role in the staging of prostate cancer at present.

Chest Radiography

There are no data in the literature documenting the yield of a chest radiograph. Therefore, it should be performed as part of the initial staging only with suspected metastatic disease (e.g., PSA >100 ng/mL) or in patients who are heavy smokers with clinically localized disease.

Summary

• Pretreatment staging of prostate cancer should be individualized based on consideration of the clinical parameters that are predictive of the likelihood of ECE, SV+, and LN+. These clinical parameters should include the pretreatment PSA level and the rate of rise or doubling time, the Gleason score, the palpation T stage, the number of positive biopsies, and the percentage of the specimen involved.
• Imaging in low-risk patients is controversial.
• In intermediate-risk and high-risk individuals, imaging may play a role in staging and thus in directing therapy. MRI using endorectal coil techniques appears to be the most accurate imaging test available for local staging of the prostate, providing both locoregional and nodal evaluation. The accuracy of the technique appears related to the experience of the radiologists. MR spectroscopy and dynamic contrast-enhanced MRI may be useful adjuncts in the future but are, as yet, unproven in multi-institutional trials.
• In truly high-risk patients (clinical T3, very high PSA levels, and Gleason score ≥8), radionuclide bone scans and CT may be useful for detecting bony metastases and lymph nodes, respectively. ProstaScint scans may also play a role in detecting nodal metastases in selected high-risk patients, but the modest accuracy of this test has led most experts to consider its value dubious. PET scans with FDG are of limited value in initial staging but may be more useful in recurrent and metastatic disease.

Anticipated Exceptions

Nephrogenic systemic fibrosis (NSF) is a disorder with a scleroderma-like presentation and a spectrum of manifestations that can range from limited clinical sequelae to fatality. It appears to be related to both underlying severe renal dysfunction and the administration of gadolinium-based contrast agents. It has occurred primarily in patients on dialysis, rarely in patients with very limited glomerular filtration rate (GFR) (i.e., <30 mL/min/1.73 m²), and almost never in other patients. There is growing literature regarding NSF. Although some controversy and lack of clarity remain, there is a consensus that it is advisable to avoid all gadolinium-based contrast agents in dialysis-dependent patients unless the possible benefits clearly outweigh the risk, and to limit the type and amount in patients with estimated GFR rates <30 mL/min/1.73 m². For more information, please see the American College of Radiology (ACR) Manual on Contrast Media (see the "Availability of Companion Documents" field).

Abbreviations

• CT, computed tomography
• Med, medium
• MRI, magnetic resonance imaging
• NS, not specified
• PSA, prostate-specific antigen
• T, tumor
• Tc, technetium

None provided

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

Appropriate selection of radiologic imaging procedures for pretreatment staging of patients with prostate cancer

Gadolinium-based Contrast Agents

Nephrogenic systemic fibrosis (NSF) is a disorder with a scleroderma-like presentation and a spectrum of manifestations that can range from limited clinical sequelae to fatality. It appears to be related to both underlying severe renal dysfunction and the administration of gadolinium-based contrast agents. It has occurred primarily in patients on dialysis, rarely in patients with very limited glomerular filtration rate (GFR) (i.e., <30 mL/min/1.73 m²), and almost never in other patients. Although some controversy and lack of clarity remain, there is a consensus that it is advisable to avoid all gadolinium-based contrast agents in dialysis-dependent patients unless the possible benefits clearly outweigh the risk, and to limit the type and amount in patients with estimated GFR rates <30 mL/min/1.73 m². For more information, please see the American College of Radiology (ACR) Manual on Contrast Media (see the "Availability of Companion Documents" field).

Relative Radiation Level (RRL)

Potential adverse health effects associated with radiation exposure are an important factor to consider when selecting the appropriate imaging procedure. Because there is a wide range of radiation exposures associated with different diagnostic procedures, an RRL indication has been included for each imaging examination. The RRLs are based on effective dose, which is a radiation dose quantity that is used to estimate population total radiation risk associated with an imaging procedure. Additional information regarding radiation dose assessment for imaging examinations can be found in the ACR Appropriateness Criteria® Radiation Dose Assessment Introduction document (see the "Availability of Companion Documents" field).

The 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.

An implementation strategy was not provided.

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

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

Committee on Appropriateness Criteria, Expert Panels on Urologic Imaging and Radiation Oncology–Prostate

Panel Members: Gary M. Israel, MD (Principal Author); Isaac R. Francis, MD (Co-Chair); Mack Roach III, MD (Co-Chair); May Abdel-Wahab, MD, PhD; David D. Casalino, MD; Jay P. Ciezki, MD; Pat Fulgham, MD; John R. Leyendecker, MD; Gregory Merrick, MD; James Lloyd Mohler, MD; Sheila Sheth, MD

Not stated

This is the current release of the guideline.

This guideline updates a previous version: Israel GM, Francis IR, Roach M III, Anscher MS, Bluth EI, Kawashima A, Lee WR, Merrick G, Sandler CM, Fulgham P, Expert Panel on Urologic Imaging and Radiation Oncology–Prostate. Pretreatment staging prostate cancer. [online publication]. Reston (VA): American College of Radiology (ACR); 2007. 12 p. [104 references]

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

Electronic copies: Available in Portable Document Format (PDF) from the American College of Radiology (ACR) Web site.

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

The following are available:

• ACR Appropriateness Criteria®. Overview. 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.
• ACR Appropriateness Criteria®. Literature search process. Reston (VA): American College of Radiology; 1 p. Electronic copies: Available in Portable Document Format (PDF) from the ACR Web site.
• ACR Appropriateness Criteria®. Evidence table development. Reston (VA): American College of Radiology; 4 p. Electronic copies: Available in Portable Document Format (PDF) from the ACR Web site.
• ACR Appropriateness Criteria®. Radiation dose assessment introduction. Reston (VA): American College of Radiology; 2 p. Electronic copies: Available in Portable Document Format (PDF) from the ACR Web site.
• ACR Appropriateness Criteria® Manual on contrast media. Reston (VA): American College of Radiology; 90 p. Electronic copies: Available in PDF from the ACR Web site.

None available

This NGC summary was completed by ECRI on November 15, 2004. The information was verified by the guideline developer on December 21, 2004. This summary was updated by ECRI on March 23, 2006. This NGC summary was updated by ECRI Institute on December 4, 2007. This NGC summary was updated by ECRI Institute on June 17, 2010. This summary was updated by ECRI Institute on January 13, 2011 following the U.S. Food and Drug Administration (FDA) advisory on gadolinium-based contrast agents.

Instructions for downloading, use, and reproduction of the American College of Radiology (ACR) Appropriateness Criteria® may be found on the ACR Web site .