Clinical UM Guideline
|Guideline #:||CG-MED-45||Current Effective Date:||06/28/2016|
|Status:||Reviewed||Last Review Date:||05/05/2016|
This document addresses the use of transrectal ultrasonography in the diagnosis, staging, and management of conditions involving the prostate, rectum, and surrounding tissues.
Note: Please see the following related document for additional information:
Transrectal ultrasonography (TRUS) is considered medically necessary for any of the following indications:
Not Medically Necessary:
Transrectal ultrasonography (TRUS) is considered not medically necessary when criteria are not met and for all other indications, including but not limited to use as a primary screening test for prostate cancer.
The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|C19||Malignant neoplasm of rectosigmoid junction|
|C20||Malignant neoplasm of rectum|
|C21.0-C21.8||Malignant neoplasm of anus and anal canal|
|C61||Malignant neoplasm of prostate|
|C7A.026||Malignant carcinoid tumor of the rectum|
|C76.3||Malignant neoplasm of pelvis|
|C78.5||Secondary malignant neoplasm of large intestine and rectum|
|C79.82||Secondary malignant neoplasm of genital organs|
|D01.1-D01.3||Carcinoma in situ of rectosigmoid junction, rectum, anus and anal canal|
|D07.5||Carcinoma in situ of prostate|
|D12.7-D12.9||Benign neoplasm of rectosigmoid junction, rectum, anus and anal canal|
|D29.1||Benign neoplasm of prostate|
|D3A.026||Benign carcinoid tumor of the rectum|
|D37.5||Neoplasm of uncertain behavior of rectum|
|D37.8||Neoplasm of uncertain behavior of other specified digestive organs|
|D40.0||Neoplasm of uncertain behavior of prostate|
|D49.0||Neoplasm of unspecified behavior of digestive system|
|D49.5||Neoplasm of unspecified behavior of other genitourinary organs|
|K60.0-K60.5||Fissure and fistula of anal and rectal regions|
|K61.0-K61.4||Abscess of anal and rectal regions|
|K62.0-K62.9||Other diseases of anus and rectum|
|N41.0-N41.9||Inflammatory diseases of prostate|
|N42.0-N42.9||Other and unspecified disorders of prostate|
|N70.01-N77.1||Inflammatory diseases of female pelvic organs|
|N80.4||Endometriosis of rectovaginal septum and vagina|
|N82.3||Fistula of vagina to large intestine|
|Q42.0-Q42.9||Congenital absence, atresia and stenosis of large intestine|
|Q43.0-Q43.9||Other congenital malformations of intestine|
|Q52.2||Congenital rectovaginal fistula|
|Q55.4||Other congenital malformations of vas deferens, epididymis, seminal vesicles and prostate|
|R19.00-R19.09||Intra-abdominal and pelvic swelling, mass and lump|
|R19.8||Other specified symptoms and signs involving the digestive system and abdomen|
|R97.2||Elevated prostate specific antigen (PSA)|
|Z85.040-Z85.048||Personal history of malignant neoplasm of rectum, rectosigmoid junction, and anus|
|Z85.46||Personal history of malignant neoplasm of prostate|
|Z87.430||Personal history of prostatic dysplasia|
Transrectal ultrasonography (TRUS), also called endorectal ultrasound (ERUS), is an imaging procedure used in the diagnosis, staging, and management of conditions involving the prostate, rectum, and surrounding tissues. TRUS has both diagnostic and therapeutic indications. The brief outpatient procedure involves the use of a small lubricated probe inserted into the rectum that sends out high-energy sound waves. These sound waves bounce off internal tissues or organs, making echoes that form a picture of body tissue called a sonogram. While the probe may be temporarily uncomfortable, TRUS is essentially a painless procedure.
Prostate cancer is the most common cancer found in North American men other than skin cancer and is the second leading cause of male cancer death. The National Cancer Institute (NCI, 2016) estimates new cases and disease-related deaths from prostate cancer in the United States in 2016 to be 180,890 and 26,120, respectively. Imaging procedures suggested as possible screening modalities for prostate cancer include ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI). Each modality has relative merits and disadvantages for distinguishing different features of prostate cancer. Ultrasound has received the most attention, having been examined by several investigators in observational settings (Waterhouse, 1989). The sensitivity of TRUS in these settings ranged from 71% to 92% for prostate cancer and 60% to 85% for subclinical disease. Specificity values ranged from 49% to 79%, and positive predictive values in the 30% range have been reported. The sensitivity and positive predictive value for ultrasound as a single test may be better than for rectal examination. The rate of cancer is extremely low among ultrasound-positive men for whom rectal and PSA examinations are normal (Cooner, 1988). According to the NCI (2016):
TRUS is generally relegated to a role in the diagnostic work-up of an abnormal screening test rather than in the screening algorithm. The cost and poor performance of other imaging modalities have led to their elimination from all early detection algorithms...There is insufficient evidence on which to decide the efficacy of TRUS...for routine screening in asymptomatic men.
The gold standard in the diagnosis of prostate cancer is a prostate biopsy. Contemporary prostate biopsy relies on spring-loaded biopsy devices that are either digitally guided or guided via ultrasound. TRUS guidance is the most frequently used method of directing prostate needle biopsy because there is some suggestion that the yield of biopsy is improved with such guidance (NCI, 2016; Renfer, 1995). With the virtually simultaneous clinical acceptance of TRUS, spring-loaded biopsy devices, and the proliferation of PSA screening in the late 1980s, the number of prostate cores obtained from individuals with either an abnormal DRE or PSA was most commonly six, using a sextant method of sampling the prostate (Hodge, 1989).
The American College of Radiology (ACR) Appropriateness Criteria® for pretreatment detection, staging, and surveillance of prostate cancer recommends a TRUS-guided needle biopsy of the prostate gland if either the DRE or PSA test suggests malignancy (Eberhardt, 2013).
When a definitive diagnosis requires biopsies of the prostate, needle biopsy is usually performed under TRUS guidance. The National Comprehensive Cancer Network® (NCCN) Clinical Practice Guideline (CPG) for early detection of prostate cancer (NCCN, V1.2016) includes the following indications for biopsy (both a cut point as well as the use of multiple variables) while removing the distinction between various PSA levels above the cut point for TRUS-guided biopsy (that is, < 10 ng/mL or > 10 ng/mL).
The Panel recommends that systematic prostate biopsy under TRUS guidance should be considered as initial biopsy for men (for those aged 45 to 75 years) with "a serum PSA level > 3.0 ng/mL" (Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate). This level of PSA correlates with the risk of prostate cancer reported in the Prostate Cancer Prevention Trial (PCPT) results (Thompson, 2005) in which 15% of men with a PSA level of ≤ 4.0 ng/mL, approximately 30% to 35% of men with serum PSA between 4 to 10 ng/mL were found to have cancer, and PSA levels of > 10 ng/mL conferred a greater than 67% likelihood of biopsy-detectable prostate cancer. The NCCN CPG considered randomized controlled trials using PSA thresholds to prompt a biopsy, noting PSA cut points for biopsy varied between centers and trials over time, stating:
Although a serum PSA of 2.5 ng/mL has been used by many, a level of 3 ng/mL is supported by the trials and would more robustly limit the risk of overdetection. However, some panel members did not recommend limiting the option of biopsy to pre-specified PSA thresholds, noting that there are many other factors (eg, age, race, family history, PSA kinetics) that should also inform the decision to perform biopsy (NCCN, V1.2016).
For management of benign biopsy results, the guideline recommends "repeat prostate biopsy, based on risk." For management of high-grade prostatic intraepithelial neoplasia (HGPIN) biopsy (< 2 sites) results, the guideline recommends follow-up with: 1) PSA and DRE at 1-year interval initially; and, 2) repeat TRUS-guided biopsy based on risk, considering "...it is well known that a negative biopsy does not preclude a diagnosis of prostate cancer on subsequent biopsy" (both 2A recommendation). Current tools to calculate risk combine factors including age, family history, ethnicity, DRE and PSA (that is, medical history) to aid in the decision of whom to biopsy. The guideline also recommends a repeat extended pattern rebiopsy (12 cores) within 6 months with increased sampling of the affected site and adjacent areas for individuals with: 1) initial atypia (suspicious for cancer); and, for 2) multifocal HGPIN (> 2 sites) (2A recommendation).
For individuals diagnosed with cancer on prostate biopsy, the NCCN CPG for prostate cancer (treatment) (V2.2016) does not recommend routine repeat biopsy, except in special circumstances, such as the suspicion that the individual harbors more aggressive cancer than was evident on the initial biopsy and the individual is otherwise a candidate for active surveillance. TRUS is also used to guide transrectal biopsies for staging for candidates for local therapy, and can be considered for those individuals with biochemical recurrence after radical prostatectomy and post-irradiation recurrence.
An American Urological Association (AUA) clinical guideline (Carter, 2013) states that early detection of prostate cancer is driven by PSA-based screening followed by TRUS biopsy for diagnostic confirmation; however, PSA testing can generate a significant number of false positive results due to low specificity. The AUA references the use of a 3.0 ng/mL cut off point as used in the multicenter European Randomized Study of Screening for Prostate Cancer (ERSPC), estimating that PSA screening at this level will correctly predict the presence of prostate cancer in about 1 of every 2 (TRUS) biopsies (Schröder, 2009). The guideline recognizes PSA testing as the primary screening test to assist in informed decision-making concerning the need for a (TRUS) prostate biopsy or repeat biopsy. The AUA further recommends that for men ages 70 to 75 with a PSA of < 3.0 ng/mL, further screening may not be needed, based on the estimated lifetime probability of prostate cancer-related death at 7%, with the frequency increasing with age, as reported in an observational study by Schaeffer and colleagues (2009).
Transperineal prostate brachytherapy is considered a treatment option for clinically localized prostate cancer. TRUS is used as an effective guide prior to brachytherapy to determine the number of needles and corresponding radioactive seeds, the isotope, and the isotope strength for the procedure and during the procedure to execute the placement of the radioactive seeds into the prostate (Davis, 2012). A best practice statement of the AUA (2008) recommends assessment of the anatomic region adherent to the prostate gland with TRUS be performed prior to cryoablation for the treatment of localized prostate cancer, and to determine the placement of posterior cryoprobes and the tip of the thermocouple as documented by TRUS with or without cystoscopy (Donnelly, 2005).
The peer-reviewed medical literature does not support the use of TRUS alone as a screening tool for prostate cancer because of its low sensitivity and positive predictive value. An American College of Preventive Medicine (ACPM) (Lim, 2008) position statement states:
The principal screening tests for the detection of asymptomatic prostate cancer are the DRE and serum PSA levels. Transrectal ultrasound (TRUS) is no longer considered a first-line screening test for prostate cancer but does play a role in the investigation of patients with abnormal DRE or PSA when guided biopsies are required.
In 2016, the NCI estimates 134,490 new cases and 49,190 deaths from colorectal (combined) cancer in the United States. Pretreatment local staging evaluation for rectal cancer is mainly accomplished through physical examination, endoscopy, CT scans, MRI, and TRUS.
According to ACR Appropriateness Criteria for pretreatment staging of colorectal cancer, imaging modalities including TRUS, CT, and MRI have all been extensively evaluated in the initial staging of colorectal cancer (Dewhurst, 2012). TRUS has become the standard imaging procedure for staging rectal cancer (Doornebosch, 2008; Rifkin, 1986; Rifkin, 1989). TRUS is useful for locoregional tumor staging and is considered to be more accurate than axial CT scans for assessing the depth of tumor invasion, perirectal spread, and nodal staging. Several studies comparing the accuracy of TRUS to CT and MRI suggest that TRUS is superior to both for primary tumor (T) staging of rectal cancer (Kim, 1999). In one systematic review, the accuracy of TRUS was greatest (95%) in distinguishing whether a tumor was confined to the rectal wall or invaded through it (tumor grades T1-T2 versus T3 or greater). TRUS has also been associated with overstaging of rectal cancer and is not fully accurate in differentiating T2 from T3 lesions (Dewhurst, 2012).
Comparative studies report the accuracy of TRUS for defining the status of the regional lymph nodes (approximately 70% to 75%) as similar to CT (55% to 65%) and MRI (60% to 65%). TRUS, however, has not been shown to be predictive of the histology of the visualized lymph nodes, however, this is a point of concern for other imaging tests as well (Cârţână, 2011; Li, 2015). Many lymph nodes measuring < 5 millimeters in diameter have associated micrometastases, and some early-stage T1 and T2 tumors are likely to have lymph node micrometastases missed by TRUS (Dewhurst, 2012).
Bipat and colleagues (2004) performed a meta-analysis of 90 articles published between 1985 and 2002 comparing the staging accuracy of TRUS, CT, and MRI to histopathologic findings as the reference standard. TRUS and MRI had similar sensitivity for muscularis propria invasion (T1 vs. T2 disease), and specificity of TRUS was significantly higher (86% vs. 69%). The sensitivity of TRUS for perirectal tissue invasion (T3 disease) was significantly higher than either MRI or CT (90% vs. 82% and 79%, respectively). For invasion of adjacent organs (T4 disease) and lymph node involvement, estimates for TRUS, CT, and MRI were comparable. However, Dewhurst and colleagues (2012) state that although reports suggest that TRUS and MRI "may provide better methods than CT for staging rectal cancer, to date they have not been successful enough to be used routinely as the sole imaging modality."
The American Society of Colon and Rectal Surgeons (ASCRS) practice parameters for the treatment of rectal cancer (Tjandra, 2004) recommend that TRUS, CT, or MRI of the abdomen and pelvis should typically be performed in individuals who are potential surgical candidates, stating:
Transrectal ultrasound has emerged as the diagnostic modality of choice for preoperative local staging of mid and distal rectal cancers. TRUS more accurately assesses bowel wall penetration and lymph node involvement. Overall MRI has similar accuracy to TRUS in tumor staging. MRI seems to be more accurate in assessing T4 and T4 lesions, whereas TRUS may be more accurate in defining earlier-stage lesions (T1, T2). Nodal staging seems to be comparable between TRUS and MRI.
TRUS is a clinically useful tool for evaluation of other conditions involving the prostate, rectum, and surrounding tissues and has been used in the evaluation of congenital anomalies. The procedure can be performed quickly and is well-tolerated by individuals with no exposure to radiation. TRUS can identify structural abnormalities of the prostate gland, seminal vesicles, and spermatic cord, and guide biopsies if suspicious abnormalities are identified in those organs. Additional uses of TRUS include assessment of the prostate gland and prostate volume before medical management or minimally invasive surgical procedures for BPH (for example, transurethral microwave thermotherapy [TUMT]) (Wasserman, 2006), and, to evaluate other conditions of the prostate including symptoms of prostatitis, suspected abscess, or prostatic calculi.
In evaluation of infertility, the male partner is involved in approximately one-third of the cases. TRUS, with or without seminal vesicle aspiration and seminal vesiculography, is considered as an initial minimally invasive diagnostic test to identify ejaculatory duct obstruction in azoospermic men with low ejaculate volumes and bilateral palpable vasa (Abdulwahed, 2013; ASRM, 2012; AUA, 2011; Chen, 2014; Gangel, 2002). In men with ejaculatory duct obstruction demonstrated by TRUS, the findings may direct testis biopsy if needed to confirm normal spermatogenesis. TRUS is also used to rule out seminal vesicular cysts, müllerian cysts, or utricular cysts.
Hematospermia (hemospermia), defined as blood in the semen, is a common condition that is rarely associated with significant pathology. Hematospermia may be the result of an infection (prostatitis), prostate cancer, conditions of the urethra (urethritis and other lesions), congenital and acquired seminal vesicle lesions, systemic disorders, or trauma. TRUS is considered the imaging procedure of choice for evaluation of men with persistent hematospermia (lasting more than 1 month) to distinguish idiopathic from secondary hematospermia when the bleeding cause is known or suspected (for example, bladder, prostate or systemic malignant pathology) and an accurate diagnosis dictates the extent of further evaluation and treatment of the condition (Manohar, 2008; Yagci, 2004; Zhao, 2012).
Endometriosis is a condition in which tissue similar to that normally lining the uterus is found outside the uterus, usually on the ovaries, fallopian tubes, and other pelvic structures, and affects 10% to 15% of women of reproductive age. TRUS has been used for assessing the extent of endometriosis and is accurate in the diagnosis and management of endometriosis in the rectovaginal septum. The sensitivity and specificity of preoperative imaging with TRUS in defining the extent of endometrial lesions and predicting rectovaginal septum or rectosigmoid infiltration has been confirmed in prospective and retrospective case series (Abrão, 2004; Delpy, 2005; Doniec, 2003; Fedele, 1998; Kruse, 2012; Ribeiro, 2008).
TRUS and TRUS-guided transrectal biopsy have been used with or without other imaging modalities including pelvic or transvaginal ultrasonography to evaluate the extension of gynecologic-related pelvic masses, including cervical, retroperitoneal, ovarian, or uterine masses, into surrounding tissues and to guide further treatment (such as drainage of deep pelvic and perirectal abscesses) (Giede, 2004; Lorentzen, 2011; Nielsen, 2004; Zaritzky, 1979). When transvaginal scanning is not feasible or contraindicated, TRUS has been used as an alternative to transvaginal ultrasonography to evaluate conditions of the female pelvis (Fleischer, 1995; Timor-Tritsch, 2003). For women with endometrial cancer in the presence of atrophic or post-radiation vaginal stenosis, TRUS has been used to define the extent of the cancer and guide fine-needle aspiration biopsy of recurrent tumors (Squaillaci, 1988).
Structural abnormalities of the anal sphincter, the rectal wall, and the puborectalis muscle can be identified in detail with TRUS. TRUS has been used as an alternative to MRI evaluation of anal, rectal, and perianal abscesses and fistulas, and benign tumors. The vast majority of TRUS studies have focused on individuals without Crohn's disease. The rigid nature of the TRUS probe, however, may prevent good acoustic coupling higher in the rectum, thus preventing the interpretation of higher fistula tracks in the evaluation of these conditions in individuals with or without Crohn's disease. For management of severe Crohn's disease, an American College of Gastroenterology (ACG) (Lichtenstein, 2009) practice guideline recommends evaluation of an abdominal mass/abscesses or perianal complications with serial imaging, including endoscopic ultrasonography, CT, or MRI, prior to consideration of surgical intervention.
TRUS is also useful for establishing a diagnosis in individuals in whom a medical history or manometric findings suggest sphincter dysfunction or occult sphincter injury, and is currently the simplest, most reliable, and least invasive test for defining anatomic defects in the external and internal anal sphincters. For persons with suspected fecal incontinence, an ACG practice guideline (Rao, 2004) recommends imaging with endosonography to assess and define structural defects of the external and internal anal sphincter muscle for the presence of scarring, loss of muscle tissue, and other local pathology.
An American Institute of Ultrasound in Medicine (AIUM, 2012) Practice Guideline for the Performance of an Ultrasound Examination in the Practice of Urology (developed in collaboration with the AUA) states the indications for the transrectal approach to ultrasound of the prostate include, but are not limited to:
Biopsy: The removal of a sample of tissue for examination under a microscope for diagnostic purposes.
Digital rectal examination (DRE): An examination of the lower rectum where the medical practitioner uses a gloved, lubricated finger to check for abnormalities of the prostate.
Prostate: A walnut-shaped gland in men that extends around the urethra at the neck of the urinary bladder and supplies fluid that goes into semen.
Prostate-specific antigen (PSA): A blood test that measures the amount of a specific prostate-related protein in blood, used to screen for prostate cancer and other conditions. A high PSA level in the blood has been linked to having prostate cancer as well as several other benign prostate conditions.
Transrectal ultrasound (TRUS): A procedure in which sound waves produced by a probe inserted into the rectum bounce off internal tissues or organs and make echoes to form a picture of body tissue called a sonogram.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Reviewed||05/05/2016||Medical Policy & Technology Assessment Committee (MPTAC) review.|
|Reviewed||05/04/2016||Hematology/Oncology Subcommittee review. Updated Discussion/General Information, References, and Websites for Additional Information sections. Removed ICD-9 codes from Coding section.|
|Revised||05/06/2015||Hematology/Oncology Subcommittee review. Format change and clarification to the Not Medically Necessary statement. Updated Description, Discussion, References, and Websites for Additional Information sections.|
|Revised||05/14/2014||Hematology/Oncology Subcommittee review. Revised medically necessary criterion addressing the use of TRUS to guide prostate biopsy when prostate cancer is suspected by changing the required PSA level from >10 ng/ml to >3.0 ng/ml. Format change to Description. Updated Discussion, References, and Websites for Additional Information sections.|
|New||05/09/2013||MPTAC review. Initial document development.|