|Subject:||Prostate Saturation Biopsy|
|Policy #:||SURG.00107||Current Effective Date:||04/16/2013|
|Status:||Reviewed||Last Review Date:||02/14/2013|
Prostate saturation biopsy, also called prostate saturation needle biopsy, involves taking numerous samples of prostate tissue, typically 20 to 40 cores, in order to increase the likelihood of detecting prostate cancer in a subgroup of high-risk individuals in whom previous conventional prostate biopsies have been negative.
Note: Please see the following related document for additional information:
Investigational and Not Medically Necessary:
Transrectal ultrasound-guided prostate saturation biopsy, consisting of at least 20 core samples taken at the same time, is considered investigational and not medically necessary for all indications.
Transperineal stereotactic template-guided prostate saturation biopsy is considered investigational and not medically necessary.
Prostate biopsy commonly occurs based on detection of elevated prostate-specific antigen (PSA) performed as part of prostate cancer screening. Typically, the initial biopsy consists of a small number of core specimens taken of the prostate. Individuals with an elevated PSA level but with a normal initial biopsy often undergo repeat biopsy evaluation. In addition, some advocate more extensive biopsy procedures in an individual with low grade prostate cancer to verify the result. Based on concerns about false-negative biopsies and misclassification as low grade, prostate saturation biopsy, an approach with an increase in the total number of biopsy specimens, was developed.
A best practice statement of the American Urological Association (AUA, 2009) suggests a standard prostate biopsy scheme consists of at least 8 to 12 cores of tissue targeting the peripheral zone at the apex, mid-gland, and base, as well as laterally directed cores on each side of the prostate. A standard prostate biopsy is usually performed after a positive (elevated) PSA test utilizing a transrectal, ultrasound-guided prostate biopsy (TRUS) approach in the outpatient setting with local anesthesia. The AUA, however, does not recommend a single threshold value that would prompt a prostate biopsy. The AUA states the decision to proceed to prostate biopsy should be based primarily on PSA and digital rectal examination (DRE) results but should take into account multiple factors, including free and total PSA, age of the individual, PSA velocity, PSA density, family history, ethnicity, prior biopsy history and comorbidities.
According to the National Comprehensive Cancer Network® (NCCN®, 2012) clinical practice guideline for early detection of prostate cancer, a systematic prostate biopsy approach performed under TRUS guidance is the recommended technique for prostate biopsy. A commonly used scheme for prostate biopsy is the 12-core extended-pattern biopsy scheme that includes a standard sextant as well as a lateral sextant scheme. Another approach to increase the number of prostate biopsy tissue cores is use of a saturation biopsy. In general, saturation biopsy is considered as a minimum of 20 cores taken from the prostate (AUA, 2009). The current NCCN (2012) clinical practice guideline does not specify the number of cores taken in a saturation biopsy scheme.
The use of saturation biopsy protocols has been evaluated as an initial biopsy technique, in individuals with repeated/prior negative biopsies or high-grade prostatic intraepithelial neoplasia, and in individuals prior to or being followed on active surveillance protocols.
Initial Prostate Biopsy
Standard prostate biopsy schemes have been proven to identify more cancer at initial biopsy compared to sextant biopsies, decreasing the false negative rate from 20% to 5% (Presti, 2000). An extended-pattern biopsy strategy is currently recommended by the NCCN clinical practice guideline panel for individuals undergoing initial prostate biopsy (NCCN, 2012). A number of studies have compared the diagnostic yield of finding prostate cancer and have not found that use of saturation biopsy improves cancer detection rates compared with extended biopsy strategies (Jones, 2006; Sur, 2004). Authors suggest that large, easy-to-identify tumors in the general population are usually identified without a need for saturation biopsy. Ashley and colleagues (2008) performed a nonrandomized cohort study (n=469) of a consecutive series of prostate biopsies to determine whether saturation biopsy (greater than or equal to 24 cores) detects more prostate cancer than a standard 12-18 core office biopsy technique. The primary outcome assessed was the detection of prostate cancer. After adjustments for covariates, saturation biopsy did not detect more prostate cancer than the control group (odds ratio [OR]: 1.2; p=0.339). The investigators concluded that saturation biopsy did not appear to detect more abnormal prostate pathology than standard office biopsy of the prostate, and the procedure may be associated with increased cost and morbidity.
Lane and colleagues (2008) studied the use of prostate saturation biopsy as an initial biopsy strategy in 257 men between January 2002 and April 2006. Prostate cancer was initially detected in 43% of the participants who underwent saturation biopsy. In the 147 men with negative initial saturation biopsy, follow-up including DRE and repeat PSA measurement was recommended at least annually. Persistently increased PSA or an increase in PSA was seen as an indication for repeat saturation biopsy. During the median follow-up of 3.2 years after negative initial saturation biopsy, 121 men (82%) underwent subsequent evaluation with PSA and DRE. Median PSA remained 4.0 ng/ml or greater in 57% of the men and it increased by 1 ng/ml or greater in 23%. Prostate cancer was detected in 14 of 59 men (24%) undergoing repeat prostate biopsy for persistent clinical suspicion of prostate cancer. No significant association was demonstrated between prostate cancer detection and initial or follow-up PSA, or findings of atypia and high grade prostatic intraepithelial neoplasia on initial saturation biopsy. Cancers detected on repeat prostate biopsy were more likely to be Gleason 6 and organ confined at prostatectomy than were those diagnosed on initial saturation biopsy. The investigators concluded that while office based saturation prostate biopsy may improve cancer detection in men who have previously undergone a negative prostate biopsy; it does not improve cancer detection as an initial biopsy technique.
Chun and colleagues (2011) conducted a systematic review of the current peer-reviewed literature regarding the performance and interpretation of initial prostate biopsy strategies. The authors stated the evidence demonstrates that a minimum of 10 but not greater than 18 systematic cores, with 14 to 18 cores taken in glands greater than or equal to 50 cm3, is recommended on initial prostate biopsy.
While the data suggests an increase in the rate of diagnosis of prostate cancer using saturation techniques, there is no peer-reviewed literature which conclusively demonstrates that this approach results in reduced mortality or other clinically significant outcomes when compared to standard biopsy protocols.
Repeat Prostate Biopsy
The peer-reviewed literature evaluating repeat prostate biopsy strategies consists of a systematic review and prospective and retrospective studies. Some studies compare extended-biopsy to saturation biopsy schemes, while others compare saturation biopsy as a primary or repeat prostate biopsy technique (Pepe and Aragona, 2007).
Stewart and colleagues (2001) conducted a retrospective, comparative study suggesting that markedly increasing the number of cores obtained during prostate needle biopsy may improve the cancer detection rate in men with persistent indications for repeat biopsy. An average of 23 saturation biopsy cores (range 14 to 45) were distributed throughout the entire prostate, including the peripheral, medial and anterior regions. The investigators reported that cancer was detected in 34% (77 of 224) of the participants. The overall complication rate for saturation biopsy was 12%; hematuria requiring hospital admission was the most common adverse event. The investigators reported the evidence suggests that the sensitivity of needle biopsy could improve by 30% to 35% when increasing the number of biopsy cores beyond six (e.g., 14-45 cores). The extent to which an increase in detection rate would reduce morbidity and mortality from prostate cancer or increase the percentage of men treated unnecessarily was unknown.
Eichler and colleagues (2006) systematically reviewed and compared the cancer detection rates and complications of different extended prostate biopsy methods. The reviewers included studies that compared different systematic prostate biopsy methods using sequential sampling or a randomized design in men scheduled for biopsy due to suspected prostate cancer. Pooled data from 68 studies compared a total of 94 extended schemes with the standard sextant scheme; 87 studies were analyzed with a total of 20,698 participants. The studies included participants of all age groups with suspected prostate cancer scheduled for prostate biopsy with increased PSA, a positive DRE, or both. The authors concluded that prostate biopsy schemes consisting of 12 cores that add laterally directed cores to the standard sextant scheme "strike the balance" between the cancer detection rate and adverse events; taking more than 12 cores added no significant benefit.
Simon and colleagues (2008) reported on the results using an extensive saturation biopsy in 40 men with a clinical suspicion of prostate cancer after previous negative prostate biopsies. The median (range) number of cores taken was 64 (39-139) and was adjusted to the size of the prostate. Of the 40 men, 18 (45%) had cancer in at least one core. Sixteen men had marked hematuria after the biopsy procedure. The investigators concluded there was no significant increase in the cancer detection rate in an extensive saturation biopsy regimen compared to published series with fewer cores, but there was an increased morbidity.
Stav and colleagues (2008) evaluated the diagnostic value of prostate saturation biopsy in men (n=27) with a PSA greater than 10 ng/mL, PSA velocity greater than 0.75 ng/mL/year, free PSA ratio less than 0.2, and at least three sets of negative biopsy specimens. According to the investigators' findings, prostate saturation biopsy has a low diagnostic yield in men who previously had at least three sets of negative traditional biopsy specimens. In all the cases where prostate cancer was found, the histologic features were consistent with biologically insignificant disease.
A non-randomized, prospective comparative study of extended biopsy versus office-based transrectal saturation biopsy in a repeat biopsy population was conducted by Zaytoun and colleagues (2011). After an initially negative biopsy, 1,056 men underwent either a repeat 12- to 14-core biopsy (n=393) or a 20- to 24-core repeat biopsy (n=663) at the discretion of the attending urologist's practice pattern. Indications for second biopsy included a previous suspicious pathologic finding and/or clinical indications such as abnormal digital rectal examination, persistently increased PSA, and PSA (increasing) greater than 0.75 ng/mL annually. Prostate cancer was detected in 29.8% (n=315) of repeat biopsies. The saturation biopsy group had a detection rate of 32.7% versus 24.9% in the extended biopsy group (p=0.0075). Of the 315 positive biopsies, 119 (37.8%) revealed clinically insignificant cancer (defined as Gleason sum greater than 7, a total of three fewer positive cores, and a maximum of 50% or less of cancer in any positive core). There was a trend toward increased detection of clinically insignificant cancer detection in the saturation versus the extended biopsy cases, 40.1% versus 32.6%, respectively (p=0.02).
Giulianelli and colleagues (2011) evaluated whether or not the saturation biopsy technique increased the cancer detection rate in men with a PSA less than 10 ng/mL, after a first negative biopsy. From January 2004 to January 2006, 780 men underwent TRUS-guided prostate biopsies. Of these men, 186 (23.8%) were diagnosed with prostate cancer, while 594 (76.2%) had negative biopsies. For one year, all of the men with no evidence of cancer were observed according to a follow-up schedule including PSA every three months and DRE every six months. During this period, 140 men showed an increase of PSA (less than10 ng/mL) or a low PSA free/total. This group underwent a second TRUS-guided prostate biopsy with the saturation technique under general anesthesia. Of the 140 men, 50 (35.7%) had prostate cancer showing a Gleason score of 4 or 5 in 26%, 6 or 7 in 75%, and 8 to 10 in 9%, respectively. Apical biopsies carried out in the anterior horn of peripheral zone tissue showed cancer in 35 men (70% of those rebiopsied), versus 24% in lateral zones, and 5% for parasagittal. Cancer in the men who underwent the saturation biopsy was considered clinically significant (defined as Gleason score of greater than and tumor volume greater than 0.5 cc) in 47 men (94%). Forty-eight of 50 men underwent a radical prostatectomy and two underwent external beam radiation therapy. The authors concluded that the saturation biopsy technique increased the cancer detection rate by 36% in men with a PSA less than 10 ng/mL, after a first negative biopsy, and showed a higher positivity (70% prostate cancer detection rate) if the saturation biopsy included the anterior horn of peripheral zone tissue. It is important to note however, that the size of the prostate may help to explain why the cancer detection rate was increased on repeat biopsy using the saturation technique. As in an earlier study, the authors observed a higher cancer detection rate on rebiopsy in men with larger prostate volumes (63.3 plus/minus 15.2 cc) when utilizing the saturation technique.
The current AUA best practice statement states that a saturation biopsy may be considered in individuals with persistently elevated PSA levels and multiple previous negative prostate biopsies (AUA, 2009). Similarly, the NCCN clinical practice guideline states that for high risk men with multiple (two) negative extended TRUS-guided biopsies, in the presence of persistently rising PSA values, consideration may be give to a saturation biopsy strategy (NCCN, 2012). The level of evidence provided to support this recommendation is the retrospective, comparative study by Stewart and colleagues (2001).
While the data suggests an increase in the rate of diagnosis of prostate cancer using saturation techniques in individuals undergoing repeat prostate biopsy, there is no peer-reviewed literature which conclusively demonstrates that this approach results in reduced mortality or other clinically significant outcomes when compared to standard biopsy protocols.
High-grade Prostatic Intraepithelial Neoplasia (HGPIN) and Atypical Small Acinar Proliferation (ASAP)
HGPIN and ASAP are non-malignant but pathologically atypical findings on a prostate biopsy. In the non-randomized cohort study by Ashley and colleagues (2008), the authors evaluated whether saturation biopsy (n=168) detected more HGPIN and ASAP than a standard 12-18 core office biopsy technique (n=301). Subjects in the saturation biopsy cohort carried a more frequent diagnosis of HGPIN or ASAP. After adjusting for covariates, saturation biopsy did not detect more abnormal pathology than a standard office prostate biopsy technique (HGPIN [OR, 1.4; p=0.368], or ASAP [OR, 2.2; p=0.201].
Lee and colleagues (2011) evaluated the role of transrectal saturation biopsy for cancer detection in men with HGPIN diagnosed by extended biopsy. From 1999 to 2009, 314 men had at least one or more repeat biopsies due to the presence of exclusive HGPIN (without any other pathologic finding) in a previous extended biopsy. They were divided into two groups according to the initial follow-up biopsy scheme; 178 men were followed using a second standard extended biopsy scheme and 136 men were followed up using the saturation biopsy scheme. In the standard repeat biopsy group, 35 of 178 (19.7%) men had cancer on initial repeat biopsy. In the saturation biopsy group, 42 of 136 (30.9%) had cancer on initial repeat biopsy (overall, p=0.04). Multivariate analysis demonstrated that the biopsy scheme on repeat biopsy was an independent predictor of prostate cancer detection (OR: 1.85, (95% confidence interval [CI]: 1.03, 3.29), exclusive of age, PSA level, days from initial biopsy, DRE status, and multifocal prostatic epithelial neoplasia (PIN). Pathologic findings on repeat biopsies demonstrated similar Gleason grades, regardless of biopsy technique: Gleason 6 was present in 74.3% and 73.1% of specimens in the standard and saturation schemes, respectively. The presence of a Gleason score of 8 or higher was 8.6% and 9.5%, respectively. Some of the limitations of this study include its retrospective design, exclusion of family history information for multivariate analysis (as it is a known risk factor), and that the diagnoses of HGPIN was not retrospectively reviewed and confirmed by a single, blinded pathologist. Additional prospective studies of men with multifocal HGPIN alone and randomly designed saturation versus standard biopsy is needed to determine if saturation biopsy enhances the detection of clinically significant prostate cancer in men initially diagnosed with HGPIN.
The current NCCN clinical practice guideline recommends a repeat biopsy using an extended pattern including transition zone if non-focal HGPIN is found on a sextant biopsy; however, a delayed strategy (re-biopsy one year after initial biopsy) may be considered if extended biopsies were used on initial biopsy. A repeat extended biopsy scheme within 3-6 months is indicated with additional cores being obtained from the prior region demonstrating atypia. The NCCN guideline does not consider a saturation biopsy strategy in the management of HGPIN or ASAP (NCCN, 2012).
A saturation biopsy protocol has been suggested as a part of active surveillance in individuals with clinically localized prostate cancer, in terms of being able to more accurately assess tumor volume, tumor grade, or both. The peer-reviewed literature is limited in studies that evaluate the use of a saturation biopsy protocol for active surveillance (Ayres, 2012).
According to the AUA's guidelines for the management of clinically localized prostate cancer, an ideal regimen for active surveillance has not been defined but could include periodic repeat prostate biopsies to assess for sampling error of the initial biopsy as well as for subsequent progression of tumor grade and/or volume (AUA, 2011). The current NCCN clinical practice guideline for prostate cancer includes a recommendation for repeat biopsy at specified intervals, however, a saturation biopsy scheme was not included as part of an active surveillance protocol (NCCN, 2012).
Transperineal Saturation and Three-Dimensional Mapping Biopsy Techniques
An alternative to a transrectal saturation biopsy is a transperineal prostate biopsy technique performed under local, regional, or general anesthesia using a brachytherapy grid and transrectal ultrasound guidance. Similar to transrectal saturation biopsy, the AUA suggests this technique is reserved for individuals with elevated and/or rising PSA values and prior negative transrectal prostate biopsies (AUA, 2009).
Merrick and colleagues (2007) established the incidence of prostate cancer, anatomic distribution, Gleason score profile, and tumor burden in men (n=102) diagnosed by a transperineal template-guided saturation biopsy (TTSB) technique. All but one participant in this study had a minimum of one prior negative TRUS biopsy. In multivariate analysis, prostate volume was the best predictor for prostate cancer diagnosis. The authors concluded that TTSB diagnosed prostate cancer in 42.2% of participants; however, considerable anatomic variability in prostate cancer distribution was documented in the study results. Additional study is required to determine appropriate candidates for TTSB and the number of biopsy cores and regions to be sampled.
Barqawi and colleagues (2011) prospectively studied the use of a 3-dimensional mapping biopsy (3DMB) technique (n=215) on 180 men with early stage, organ confined prostate cancer based on TRUS guided 10 to 12 core biopsies, and on 35 men with prior negative TRUS biopsies. The purpose of the study was to determine the impact of this grid-based 3DMB technique on decision making for primary management of early stage prostate cancer. Eligible participants presented with a histological diagnosis of prostate cancer (Gleason 7 or less) on prior TRUS guided biopsy and were considering active surveillance or targeted focal therapy. At presentation the median PSA was 4.8 ng/ml (range: 0.5 to 72.4) and median prostate volume was 35 cc (range: 9 to 95). The 35 participants with prior negative TRUS guided biopsies were also offered 3DMB and analyzed separately. The median number of cores acquired by 3DMB was 56 (range: 8 to 124), and the median number of positive cores was two (range: 0 to 19). Of men with positive TRUS biopsies, 144 (80%) had positive 3DMB. Of the 180 participants, Gleason score upgrade was documented in 49 (27.2%) of the participants with up-stage occurring in 82 (45.6%) of the participants; 36 (20.0%) of the participants had negative 3DMB. Comparison of Gleason grades between
3DMB and previous TRUS guided biopsy showed that 48.9% remained unchanged. Only 16.1% of 3DMB results, based on Gleason grade and stage, matched positive TRUS guided biopsy results. The incidence of urinary retention catheter requirement of greater than 48 hours was 3.2% and the incidence of transient orthostatic hypotension was 5%. There were no documented urinary tract infections. After 3DMB, 38 participants elected radical prostatectomy, 11 received radiation therapy, 45 underwent whole gland cryotherapy, 60 were enrolled in a targeted focal cryotherapy clinical study and 44 elected active surveillance. One participant elected high intensity focused ultrasound as part of another investigational study and four underwent targeted focal interstitial laser therapy. Post mapping data including treatment choices after 3DMB were not available for analysis on 12 participants. The investigators concluded that for select individuals, these results demonstrate the potential for 3DMB to supplement available data when making a decision on treatment options for men with previously diagnosed prostate cancer; however, further study is warranted to determine the treatment effect of 5a-reductase inhibitors to decrease the rate of upgrade/upstage from TRUS guided biopsy, and the impact this has on the sensitivity of 3DMB to detect prostate cancer. Limitations of this study include the potential for interobserver bias, as the TRUS biopsies were read by various community pathologists. Clinician preference and referral patterns along with the anxiety level or those individuals with a negative TRUS biopsy may have influenced those men who subsequently underwent a 3DMB procedure. There was also no correlation with whole mount pathological specimens to determine whether the additional lesions detected were significant or insignificant and whether these findings truly reflected overall pathological findings. Finally, this study did not determine the effect of further disease staging on clinical outcome.
Addollah and colleagues (2011) compared a transrectal to transperineal approach using a saturation biopsy technique. A total of 472 men were evaluated; 70% (332) underwent a transrectal biopsy and 30% (140) underwent a transperineal biopsy with a 24-core prostate rebiopsy technique. Matching 280 participants with homogeneous characteristics representing the final study cohort, the authors reported an overall prostate cancer detection rate of 28.6%. There was no statistically significant difference in the prostate cancer detection rate between the transrectal and transperineal approach (31.4% vs 25.7%, respectively; p=0.3). The type of approach was not an independent predictor of prostate cancer detection rate at multivariable analyses (OR, 0.61; p=0.1).
Mabjeesh and colleagues (2012) reported on a cohort of high-risk men with at least two previous negative transrectal biopsies who then underwent a multiple-core prostate TTSB. Prostate cancer was detected in 26% of the 92 men, predominantly in the anterior zones. A median of 30 cores was taken in the saturation biopsies. Gleason score of equal to or greater than 7 was detected in 46% of the diagnosed men. Most of the tumors (83.3%) were found in the anterior zones of the gland, with a significantly higher number of positive cores versus the posterior zones (mean 4.9 vs. 1.5, p= 0.015). Limitations of this study include the lack of any randomization and comparison with other biopsy approaches; therefore, the study contains biases regarding participant selection data (e.g., prostate volume and age of participants). In addition, the size of the cohort studied limits extrapolating the results to the general population.
Ayres and colleagues (2012) evaluated the role of transperineal template prostate biopsies in 101 men on active surveillance for prostate cancer. The criteria for active surveillance included men ages 75 years or younger, Gleason score of less than or equal to 3+3, PSA less than or equal to 15 ng/mL, clinical stage T1-2a, and less than or equal to 50% TRUS-guided biopsy cores positive for cancer, with less than or equal to 10 mm of disease in a single core. The number of men with an increase in disease volume or Gleason grade on transperineal template biopsy and the number of men who later underwent radical treatment were assessed. The role of PSA and PSA kinetics were studied. In all, 34% of men had more significant prostate cancer on restaging transperineal template biopsies compared with their transrectal biopsies. Of these men, 44% had disease predominantly in the anterior part of the gland, an area often under-sampled by transrectal biopsies. In the group of men who had their restaging transperineal template biopsies within six months of commencing active surveillance, 38% had more significant disease. There was no correlation with PSA velocity or PSA doubling time. In total, 33% of men stopped active surveillance and had radical treatment. The study concluded that around one-third of men have more significant prostate cancer on transperineal template biopsies, however, this probably reflects under-sampling by initial transrectal biopsies rather than disease progression within six months of starting active surveillance.
The National Institute for Health and Clinical Excellence (NICE, 2010) interventional procedure guidance on transperineal template biopsy and mapping of the prostate states "…current evidence on the efficacy of transperineal template biopsy of the prostate shows an increase in diagnostic yield in patients with suspected prostate cancer who have had negative or equivocal results from other biopsy methods." "Evidence was not found to support the use of transperineal template biopsy of the prostate as a mapping technique to determine the exact location and extent of prostate cancer in order to guide focal therapy, nor as part of an active surveillance regime."
The role of prostate saturation biopsy in the detection of prostate cancer requires further study. The evidence in the peer-reviewed published literature indicates that as an initial biopsy technique, the greater number of cores taken during a saturation biopsy does not improve initial cancer detection. There is also insufficient evidence in the peer-reviewed published literature in the form of randomized controlled trials to determine the clinical utility of prostate saturation biopsy, or that it improves health outcomes as a more effective biopsy technique when compared to an extended prostate biopsy for the detection of clinically significant prostate cancer. Despite the conclusions by some investigators that prostate saturation biopsy may provide increased accuracy in the predictability of prostate tumor volume and grade to select suitable candidates for active surveillance, it is unclear whether early detection and subsequent earlier treatment leads to any change in the natural history and outcome of individuals with prostate cancer. The evidenced-based guidelines for the evaluation of high-risk individuals in whom prior conventional prostate biopsies have been negative lacks consensus regarding which zones of the prostate to sample during the saturation biopsy and how many cores to obtain. The lack of specific algorithms for use of the prostate saturation biopsy technique may increase the risk of detecting clinically insignificant cancers which may lead to unnecessary treatment.
Prostate cancer is the most common diagnosed cancer, other than skin cancers, in North American men. Estimated new cases and disease-related deaths from prostate cancer in the United States in 2012 is 241,740 and 28,170 respectively. Prostate cancer is the second leading cause of cancer death in American men, exceeded only by lung cancer. Men in the United States have about one chance in six of eventually being diagnosed with this malignancy and about one man in 36 will eventually die of the disease (ACS, 2012; NCCN, 2012; NCI, 2012).
The gold standard for diagnosis of prostate cancer is a prostate biopsy. According to the National Cancer Institute (2012),
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. 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 patients with either an abnormal DRE or PSA was most commonly six, using a sextant method of sampling the prostate. There is evidence that the predictable increase in cancer detection rates that would be expected by increasing the number of biopsy cores beyond six does occur; e.g., biopsies with 12 or 15 cores would increase the proportion of biopsied men having cancer detected by 30% to 35%. The extent to which such increased detection will reduce morbidity and mortality from the disease or increase the fraction of men treated unnecessarily is unknown.
The prostate saturation biopsy procedure is based on the assumption that the cancer is small or located in one of the deeper reaches of the prostate gland. The whole gland is sampled without following any particular zonal pattern. It is theorized that the larger the number of evenly distributed samples increases the probability of detecting an underlying cancer, regardless of the tumor size or location. Saturation sampling typically involves 20 to 40 core biopsies, with additional cores taken for larger prostates. Saturation biopsy technique is similar to the sextant or the extended biopsy performed during the TRUS-guided biopsy procedures. A template or grid identifies the exact location of each biopsy core so the exact location and size of the tumor can be mapped. Either regional or general anesthesia or intravenous sedation is typically used. Another method of performing saturation biopsy involves utilizing a transperineal template or grid-based method, known as transperineal template-guided saturation biopsy, or TPSB, using a brachytherapy template. This method has been proposed to be more systematic and allows for improved sampling of the area immediately anterior to the urethra (Raja, 2006).
Proposed indications for TPSB include mapping to determine the location and extent of prostate cancer as a guide to focal treatment (such as ablation); as part of active surveillance of low-risk localized prostate cancer with the aim of reducing the number of biopsies; and as a reference test for evaluation of new methods of imaging the prostate. This procedure is carried out with the individual under local or general anesthesia, requires intravenous prophylactic antibiotics, and involves the placement of a temporary urinary catheter (NICE, 2010). The grid template placed on the perineum during the TPSB procedure contains multiple holes at approximately five millimeter (mm) increments. In order to render a 3-dimensional (3D) reconstruction, biopsies are obtained using a standard 18 gauge biopsy gun to include a cross-section of the prostate from the apex to the base at the five mm intervals. A larger number of samples are obtained from different parts of the prostate in this procedure referred to as 3D mapping biopsy. This biopsy technique is proposed to improve detection of small cancers compared to other biopsy methods and thereby assist in decision making for primary management of early stage prostate cancer.
Adverse events and complications have been associated with repeat prostate sampling biopsies, including fever, pain, hematospermia/hematuria, positive urine cultures, and rarely sepsis. Sepsis occurs in approximately 0.4% of cases (NCI, 2012). Klein and colleagues (2010) evaluated the effect of multiple core prostate biopsy and periprostatic nerve block on voiding and erectile function. A total of 198 individuals in whom prostate cancer was suspected, were randomly assigned to undergo 10-core prostate biopsy with (71) or without (74) periprostatic nerve block. The 53 men with a history of negative prostate biopsy underwent 20-core saturation prostate biopsy with periprostatic nerve block. The International Prostate Symptom Score (IPSS) and International Index of Erectile Function were completed before, and 1, 4 and 12 weeks after biopsy to measure changes in voiding and erectile function, and quality of life. The IPSS was significantly increased in all men at week 1, which persisted at weeks 4 and 12 after saturation biopsy (p=0.007 and 0.035, respectively). Quality of life was significantly affected at all times after saturation prostate biopsy (p=0.001, 0.003 and 0.010, respectively). International Index of Erectile Function scores decreased significantly in all groups at week 1 (p <0.05). The authors concluded that: 1) prostate biopsy causes impaired voiding; 2) saturation prostate biopsy and periprostatic nerve block appear to have a lasting impact on voiding function; and 3) erectile function is transiently affected by prostate biopsy regardless of periprostatic nerve block and the number of cores.
Active surveillance: Treatment approach, also referred to as expectant management or watchful waiting, where tests such as PSA and a DRE are assessed and prostate biopsies are performed on a regular basis.
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.
Gleason Grading System: A prostate cancer grading system based on a number range from one to five; the lower the number, the lower the grade, and the slower the cancer growth.
Gleason score: Represents the sum of the two most common Gleason grades observed by the pathologist on a specimen, the first number is the most frequent grade seen.
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 mapping: A procedure involving a combination of multi-sequence magnetic resonance imaging (MRI) techniques and a template guided biopsy system used to diagnosis prostate cancer.
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 an increased chance of having prostate cancer.
Radical prostatectomy: Surgical procedure for the removal of the prostate.
Transrectal ultrasound (TRUS): An ultrasound test in which the sound waves are produced by a probe inserted into the rectum. In men, the structures most commonly examined with this test are the prostate, bladder, seminal vesicles and ejaculatory ducts.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference. 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.
When services are Investigational and Not Medically Necessary:
|55706||Biopsies, prostate, needle, transperineal, stereotactic template guided saturation sampling, including imaging guidance|
|55899||Unlisted procedure, male genital system [when specified as transrectal stereotactic template guided saturation biopsy of the prostate]|
|G0416||Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, 10-20 specimens [when specified as transperineal biopsy specimens or 20 transrectal biopsy specimens]|
|G0417||Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, 21-40 specimens|
|G0418||Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, 41-60 specimens|
|G0419||Surgical pathology, gross and microscopic examination for prostate needle saturation biopsy sampling, greater than 60 specimens|
|ICD-10 Diagnosis||ICD-10-CM draft codes; effective 10/01/2014:|
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Web Sites for Additional Information|
3D Mapping Biopsy
Transperineal Stereotactic Template-guided Saturation Prostate Biopsy
Transperineal Template-guided Saturation Biopsy (TTSB)
Transrectal Ultrasound-guided (TRUS) Prostate Biopsy
|02/14/2013||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale, Background, References, Web Sites for Additional Information, and Index.|
|02/16/2012||MPTAC review. Revised investigational and not medically necessary statement, separately addressing transrectal and transperineal saturation biopsy techniques. Reformatted and updated the Rationale, Coding, References, and Web Sites for Additional Information.|
|11/16/2011||Hematology/Oncology Subcommittee review. Updated Rationale, Background, References, and Web Sites for Additional Information.|
|11/17/2010||Hematology/Oncology Subcommittee review. Updated Description, Rationale, Background, Definitions, References, Web Sites for Additional Information and Index.|
|11/18/2009||Hematology/Oncology Subcommittee review. Updated Rationale, Background, and References.|
|11/19/2008||Hematology/Oncology Subcommittee review. Initial document development.|