| Coverage Policy Manual | |
| Policy #: | 2015032 |
| Category: | Radiology |
| Initiated: | August 2017 |
| Last Review: | March 2024 |
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| Magnetic Resonance Imaging (MRI) Targeted Biopsy and Multiparametric MRI (mpMRI) of the Prostate | |
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| Description: |
Before a transrectal ultrasound-guided biopsy, a magnetic resonance imaging (MRI) scan can be used to pinpoint the location of suspicious lesions in the prostate. MRI permits a targeted biopsy (as opposed to a blind biopsy, which is the current standard of care). The use of an MRI-guided prostate biopsy serves two functions: (1) to identify areas in the prostate that could harbor a high-grade tumor; and (2) to divert attention from any clinically insignificant cancers not needing treatment. In accomplishing the secondary function, patients are placed into one of two categories: those only needing active surveillance; and those needing definitive intervention.
PROSTATE CANCER
Prostate cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among men in the United States, (Seigel, 2022). Diagnosis and grading of prostate cancer are performed by taking a biopsy of the prostate gland. A prostate biopsy typically is performed in men who have an elevated prostate-specific antigen (PSA) level, or who present with symptoms. The purpose of the biopsy is to determine whether cancer is present and to determine tumor grade. Tumor grade (Gleason score) is a major determinate in whether a patient is eligible for active surveillance (AS) (lower grade tumors) or whether definitive intervention is warranted (higher grade tumors). Patients in active surveillance undergo periodic follow-up prostate biopsies to assess cancer progression (upgrading of Gleason score).
Prostate biopsies are commonly performed using transrectal ultrasound (TRUS) guidance with a 12-core sampling strategy. Use of TRUS was introduced in the late 1980s; with this technique, tissue cores are obtained under US guidance systematically throughout the whole prostate, although, this still represents blind biopsy of the prostate as to the location of possible cancer. Prior to the 12-core sampling, 6 core (sextant) sampling was thought to miss too many cases of cancer, however, the current 12-core sampling method may over-diagnose clinically insignificant disease and miss diagnosis of clinically significant disease. Compared with subsequent prostatectomy, TRUS underestimates tumor grade up to 40% of the time and too often detects clinically insignificant disease.
Therefore, the ideal biopsy strategy would only identify men with PCa of clinical significance to direct interventional therapy, and to minimize the detection of clinically insignificant PCa and the risk of consequent overtreatment.
For men undergoing an initial biopsy for an elevated PSA, systematic 12-core TRUS biopsy detection rate for prostate cancer is approximately 40-45%. If an initial 12-core biopsy is negative, and there is still a clinical suspicion of cancer, subsequent serial 12-core biopsies may detect cancer, or other biopsy techniques such as transperineal template-guided saturation biopsy (in which 30-80 cores are typically obtained) may be used. Saturation biopsy allows for anterior and apical sampling and may detect significant cancer, but also results in oversampling of insignificant cancers. In addition, transperineal biopsy requires general anesthesia and is associated with increased morbidity.
Multiparametric MRI (mpMRI) includes anatomic T2-weighted imaging for localization of the normal gland and cancer foci and two functional imaging techniques, diffusion weighted and perfusion imaging. mpMRI evaluation allows for the possibility of identifying tumor location and extent, over sampling of the areas of interest and under sampling or no sampling of the non-target areas, and for sampling of clinically significant disease (higher grade tumor). T2 weighted images reflect water content of tissues and can define the zonal anatomy of the prostate and the presence of PCa as focal areas of low signal intensities. Degree of intensity decrease differs with Gleason score; higher Gleason score PCa shows lower signal intensities.1 False positive findings can occur with benign abnormalities, including prostatitis, atrophy, fibrosis, gland hyperplasia or irradiation or hormonal treatment effects. Diffusion weighted images measure the random motion of water molecules. Low diffusion coefficients are associated with PCa, and there is an inverse correlation between these values and Gleason score; however, confidence intervals overlap. Perfusion imaging allows the assessment of contrast kinetics in focal lesions; PCa typically enhances faster and to a greater extent than the surrounding prostate; however, nonspecificity of patterns limits the usefulness of this in isolation.
Several methods of MRI guidance are available for performance of prostate biopsy: cognitive (or visual), direct (“in-bore”) and MRI-US fusion (visual targeted or software based targeted). Image fusion is the process of combining information from more than one image into a single image, which may be more informative than any of the images separately. To date, no prospective comparison of the three methods has been studied. Based on MRI, suspicious areas are identified (referred to as “regions of interest”) and subjected to targeted biopsy.
With the visual method, the US operator simply aims the biopsy needle at the area of the prostate where the reviewed prior MRI demonstrated the lesion. This method requires no additional equipment beyond the MRI and a conventional TRUS facility and no additional training beyond TRUS biopsy for the US operator. The disadvantage is the potential for human error in the extrapolation from MRI to TRUS without an overlay of the images.
Direct (in-bore) MRI targeted biopsy is performed in the MRI tube, with fusion of a prior MRI demonstrating a lesion with a contemporaneous MRI to confirm biopsy needle location, and needles are introduced into areas of interest. Serial MRI scans are performed to confirm biopsy needle placement. Studies have demonstrated that in-bore MRI targeted biopsies have a median cancer detection rate significantly higher than random biopsies; however, it is time-consuming and costly, including the in-bore time and the two MRI sessions necessary. In addition, only suspicious lesions are sampled, as tissues with a “normal” appearance on MRI are not obtained.
MRI-TRUS fusion biopsy, either done visually or using software, superimposes pre-procedure (stored) MRI with an intra-procedure (real-time) US to direct the biopsy needle to an US region of interest defined by the mpMRI.
Techniques for MRI-Guided Prostate Biopsy:
Proposed clinical indications for use of MRI-targeted prostate biopsy include: (1) as initial biopsy, (2) re-biopsy after a first negative standard biopsy in men with persistent suspicion of disease, including those with persistently increased prostate-specific antigen (PSA) levels, suspicious digital rectal exam (DRE), previous biopsy with an atypical focus on histology, or extensive high-grade prostatic intraepithelial neoplasia (PIN), (3) follow-up for active surveillance to determine initial eligibility for active surveillance and assessing progression of disease over time, and (4) for local recurrence after radical prostatectomy, after external-beam radiotherapy, or after high-intensity focused ultrasound (HIFU).
Regulatory Status
MRI-targeted or MRI-TRUS fusion biopsy is a medical procedure that uses MRI and ultrasound devices previously approved by the U.S. Food and Drug Administration (FDA). Prostate biopsy is a surgical procedure and, as such, is not subject to regulation by the FDA.
FDA product code, ultrasound devices: IYN, ITX, IYO. FDA product code, MRI devices: LNH, LNI, MOS.
Several MRI-US fusion software-based targeted prostate biopsy platform specifications have been cleared for marketing by FDA through the 510(k) process. Fusion software include Artemis™ (Eigen, Grass Valley, CA), BioJet™ (D&K Technologies, Gurajat, India), BiopSee® (MedCom, Columbia, SC), Real-time Visual Sonography (Hitachi, Tokyo, Japan), UroNav™ (Invivo/Philips, Gainesville, FL), Urostation® (Koelis, Auburndale, MA), and Virtual Navigator (Esaote, Genoa, Italy).
Coding
There is no specific CPT code for MRI-guided prostate biopsy. It would likely be reported with a prostate biopsy code (55700-55706) and the MRI guidance code 77021.
Multiparametric MRI (mpMRI) of the Prostate is performed in conjunction with MRI of the prostate. MRI of the prostate including mpMRI if performed, should be billed with 72197 - Magnetic resonance (eg, proton) imaging, pelvis; without contrast material(s), followed by contrast material(s) and further sequences. The mpMRI portion is an integral part of the MRI prostate and is not separately reimbursable.
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Policy/ Coverage: |
Effective March 01, 2023
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Magnetic Resonance Imaging (MRI) Targeted Biopsy of the Prostate
Magnetic resonance imaging (MRI) targeted biopsy of the prostate does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered.
For members with contracts without primary coverage criteria, magnetic resonance imaging (MRI) targeted biopsy of the prostate is considered investigational and is not covered. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Multiparametric MRI (mpMRI) for Prostate Cancer
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
MRI pelvis (including/inclusive of multiparametric technique) meets member benefit certificate primary coverage criteria and is covered for diagnosis or management of prostate cancer when the below criteria are met:
Diagnostic workup:
Indicated in ANY of the following scenarios:
OR
Management:
Indicated in ANY of the following scenarios:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
MRI pelvis (including/inclusive of multiparametric technique) for prostate cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered for any indication or any circumstance other than those listed above.
For members with contracts without primary coverage, MRI pelvis (including/inclusive of multiparametric technique) for prostate cancer is considered investigational and is not covered for any indication or any circumstance other than those listed above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective November 2017 through February 2023
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Magnetic resonance imaging (MRI) targeted biopsy of the prostate does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, Magnetic resonance imaging (MRI) targeted biopsy of the prostate is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
This policy was created in 2015 and is based on a search of the MEDLINE database through August 4, 2015.
The literature consists of numerous prospective and retrospective studies of paired cohorts and systematic reviews and meta-analyses of these studies.
MRI Targeted Biopsy Compared to Standard Biopsy for the Detection of Prostate Cancer (PCa)
A 2015 systematic review and meta-analysis by Schoots and colleagues assessed the diagnostic differences between MRI-targeted biopsy (MRI-TBx) and transrectal ultrasound-guided biopsy (TRUS-Bx) in detecting overall PCa (primary objective) and clinically significant and insignificant PCa (secondary objective) (Bjurlin, 2014). The literature search was through May 2014, and included studies of men with suspected PCa scheduled for transrectal biopsy because of increased PSA and/or positive digital rectal exam. Overall, according to QUADAS criteria, the methodological quality of the studies was deemed to be fair. Only studies that included both MRI-TBx and conventional TRUS-Bx in each patient were included in order to compare the two tests. Therefore, all men had a positive MRI, defined as a suspicious lesion on prostate MRI scan. Reports on transperineal or saturation biopsy were excluded. Relative sensitivity was the sensitivity ratio between MRI-TBx and TRUS-Bx. A relative sensitivity of >1 indicated that MRI-TBx detected more cancers than TRUS-Bx, and a relative sensitivity <1 indicated that MRI-TBx detected fewer cancers than TRUS-Bx. Analyses were performed for two predefined subgroup categories: patient population was categorized as men undergoing initial biopsy, men with a previous negative biopsy and reports in which results were mixed for initial versus subsequent biopsy; navigational system for MRI as direct versus fusion biopsy with visual or software registration. Sixteen studies with 1926 men were eligible. MRI-TBx and TRUS-Bx did not differ significantly in overall PCa detection (sensitivity 0.85, 95% confidence interval [CI] 0.80–0.89, and 0.81, 95% CI 0.70–0.88, respectively). Ten studies presented data on the detection of significant versus insignificant PCa detection. Of the ten studies, five reported results for initial biopsy, two for a previous negative biopsy and three with a mixed population. MRI-TBx had a higher rate of detection of significant PCa compared to TRUS-Bx (sensitivity 0.91, 95% CI 0.87–0.94 vs 0.76, 95% CI 0.64–0.84) and a lower rate of detection of insignificant PCa (sensitivity 0.44, 95% CI 0.26– 0.64 vs 0.83, 95% CI 0.77–0.87). The improvement in significant PCa detection by MRI-TBx was in men with previous negative biopsy, but was not seen in men undergoing initial biopsy (relative sensitivity 1.54, 95% CI 1.05–2.57 vs 1.10, 95% CI 1.00–1.22). Two out of sixteen studies reported mixed data on MRIvisual- TBx and MRI-fusion-TBx. Therefore, fourteen studies were available to compare outcomes of one navigational system versus another, of which, only eight presented data on the detection of significant and insignificant PCa: two studies with MRI-visual-TBx, five with MRI-fusion-TBx, and one with MRI-inbore- TBx. MRI-fusion-TBx and MRI-in-bore-TBx significantly improved PCa detection compared to TRUSBx (relative sensitivity 1.29, 95% CI 1.16-1.43, and 1.26, 95% CI 1.08-1.46, respectively). MRI-visual-TBx did not show much improvement compared to TRUS-Bx (relative sensitivity 1.03, 95% CI 0.91-1.16).
In summary, the study found that MRI-TBx had a 20% better detection rate for clinically significant PCa compared with TRUS-Bx. A relative sensitivity of 0.56 was found for detection of insignificant PCa, in that MRI-TBx showed an almost twofold better performance in avoiding detection of insignificant PCa compared to TRUS-Bx. Strengths to this meta-analysis included the focus on reports that included comparison of biopsies performed by both MRI-guidance and TRUS biopsy in the same patient. Limitations to the study included the inclusion of small studies and publication bias, as the studies only included patients with a positive MRI.
A 2015 systematic review by Valerio and colleagues through December 2013 compared the detection rate of clinically significant cancer with software-based MRI-US fusion biopsy versus standard TRUS biopsy (Valerio, 2015). Secondary outcomes were detection rate of all cancer, sampling efficiency and utility and rate of serious adverse events. Fourteen papers were included in the final analysis. Most studies were considered to have a low risk of bias and low concern for applicability with respect to patient selection. Two of the studies were scored as potentially biased; one had a small sample size (n=13) and significant patient heterogeneity, and the other had a retrospective design and patient heterogeneity. All but one study were paired cohort design. Thirteen studies used 10-12 core TRUS biopsy as the reference test; one study used transperineal biopsy, however, systematic transperineal template cores were not taken from areas previously mapped using MRI-TRUS fusion biopsies, and therefore, the detection rate of clinically significant disease could not be compared. A total of 2293 men were included in the review, with sample sizes ranging from 13 to 582. Three of the studies were conducted in men undergoing first biopsy, three in men with a previous negative TRUS biopsy, eight studies reported on a mixed cohort who were either undergoing first biopsy or had had a previous biopsy, and one study included men with recurrent disease post radiation. The median detection of clinically significant cancer was 23.6% (range 4.8-52%) for standard biopsy and 33.3% (range 13.2-50%) for MRI-TRUS image fusion targeted biopsy. Only one study did not report the criteria for defining clinically significant disease. In the remaining studies, the presence of Gleason pattern 4 was considered to be clinically significant disease. For secondary outcomes, the median detection rate of any cancer was 43.4% (range 14.3-59%) and 50.5% (range 23.7- 82.1%) in the standard biopsy versus MRI-TRUS image fusion biopsy, respectively. The median number of cores needed to detect clinically significant cancer was 37.1 and 9.2 for standard and MRI-TRUS image fusion targeted biopsy. Utility, defined as the number of clinically significant cancers detected by one strategy but missed by the other, was an absolute difference of 9.1% (range 5-16.2%) (additional clinically significant cancers that were missed by standard biopsy alone).
Limitations of the review included heterogeneity in study design and patient population, and variability across studies in terms of MRI characteristics and interpretation, threshold for biopsy, targeted biopsy conduct, and number of cores per target.
MRI Guided Biopsy in the Setting of Active Surveillance (AS)
Schoots and colleagues conducted a systematic review on the use of MRI in men on As for PCa (Schoots, 2015). The literature search was conducted through April 2014. The review assessed evidence for the use of MRI in men with low- or intermediate risk prostate cancer diagnosed with transrectal ultrasound-guided biopsy and were therefore deemed suitable for active surveillance. The reviewers sought to address two main clinical questions: 1) can MRI detect clinically significant disease in men on active surveillance (thereby prompting treatment intervention rather than having them remain on AS), and, 2) can MRI be used in place of repeat standard TRUS biopsy to detect disease progression over time? The studies included reports on three distinct populations of men: group 1): men with histological suitability for active surveillance who chose to have radical prostatectomy, and had an MRI performed preoperatively (n=10 studies); group 2): men on AS who had an MRI before a confirmatory biopsy (n=7 studies); and group 3): men on AS who were assessed for disease progression on further MRI scans after an initial baseline scan (n=2 studies). The accuracy of MRI findings was assessed using whole-mount histology from postprostatectomy specimens (group 1), repeat standard biopsy (groups 2 and 3), or biopsies targeted to any suspicious lesions on MRI (groups 2 and 3). The MRI-guided targeted approach included in-bore targeting, visual registration, and software-assisted registration.
Ten publications assessed radical prostatectomy data from men who were on AS and had undergone preoperative MRI. Of the men that chose surgery, 152/1070 (14%) were upstaged to >T3 disease, and 163/353 (43%) were upgraded to a Gleason score of >6. The likelihood of a positive MRI preoperatively was 73% (963/1326). Upgrading occurred in 43% (291/677) of cases with a positive preoperative MRI, versus 27% (78/293) of patients with a negative MRI preoperatively. (The denominators for these data differ because not all of the groups that were included reported data for upgrading). Upstaging occurred in 10% (54/557) of positive MRI cases and 8% (16/194) in patients with a negative MRI.
There were seven studies that assessed repeat biopsy data for men on AS who had undergone a prior MRI (group 2). Four studies performed MRI-guided targeted biopsies together with transrectal ultrasound (TRUS)-guided biopsies and three studies only performed repeat standard (TRUS) biopsy following MRI. MRI-targeted biopsies were performed using software-registered MRI/US fusion in two of the four studies, visual registered (cognitive) MRI/US fusion in one study and direct in-bore in one study. The likelihood of a positive MRI in men undergoing AS and an MRI and repeat standard (TRUS) biopsy was 70% (340/488). Following a positive MRI, reclassification occurred in 39% (115/298) including all 7 seven studies (those who underwent MRI-guided repeat biopsy with TRUS and those that only underwent TRUS for repeat biopsy), versus 17% (18/107) reclassification in patients with a negative MRI before repeat biopsy. In the cases with a positive MRI and MRI-targeted and TRUS biopsy, reclassification occurred in 47% (84/179) of cases.
Two studies were included in the review which assessed whether men on AS can be followed for disease progression over time by MRI in place of repeat standard biopsy. The studies defined progression differently and the criteria by which patients underwent repeat biopsy varied among study groups, making conclusions difficult.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed below:
Ongoing
(NCT02138760) Comparison of MRI Fusion Biopsy Techniques in Men with Elevated PSA and Prior Negative Prostate Biopsy; planned enrollment 400; completion date December 2015.
(NCT00775866) MRI - Guided Biopsy for Suspicion of Locally Recurrent Prostate Cancer After External Beam Radiotherapy; planned enrollment 90; completion date October 2016.
(NCT01883128) An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer; planned enrollment 177; Completion date January 2016.
(NCT02242773) MRI-Guided Biopsy Selection of Prostate Cancer Patients for Active Surveillance Versus Treatment: The Miami MAST Trial; planned enrollment 165; completion date October 2017.
Summary of Evidence
The evidence for the use of MRI targeted diagnostic or surveillance biopsy of the prostate consists of numerous prospective and retrospective studies of paired cohorts and systematic reviews and meta-analyses of these studies. Relevant outcomes are overall survival, disease-specific survival, morbid events and quality of life. Systematic reviews of the use of MRI-guided prostate biopsy have shown that the technology may diagnose more high-grade cancers than TRUS biopsy and fewer low-grade cancers, which may stratify patients for treatment versus surveillance. In surveillance, it has not been shown that this technique can detect those patients who have progressed and need definitive intervention. It is unknown whether use of this technique will translate into positive clinically meaningful outcomes in terms of survival or quality of life. Further prospective evaluation of MRI-guided techniques is needed to determine whether this approach results in improved health outcomes, and whether this approach would replace the standard existing biopsy protocol or would be performed in addition to TRUS guided biopsy. The evidence is insufficient to determine the effects of the technology on health outcomes.
2018 Update
A literature search was conducted through October 2018. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
DETECTION OF PROSTATE CANCER
Systematic Reviews
Tang et al published a systematic review and meta-analysis of 13 cohorts (12 studies; total N=3225 patients) of men undergoing a biopsy after previous negative biopsy or initial biopsy for suspected prostate cancer (Tang, 2018) The primary outcome was prostate cancer detection rate of MRI-TRUS fusion-guided targeted biopsy compared with the detection rate of TRUS-guided biopsy. The MRI-TRUS fusion biopsy detected prostate cancer in 52.7% (n=1698) of the entire cohort, significantly more than the 42.6% (n=1375) detected by the TRUS biopsy alone (p<0.05). Reviewers also took into account whether cohorts included patients with initial biopsy (5 cohorts; n=1823 patients), a previous negative biopsy (3 cohorts; n=528 patients), or either (5 cohorts; n=874 patients). In patients with initial biopsy, MRI-TRUS fusion biopsy had a detection rate of 56.1% (n=1023 patients), and TRUS biopsy alone had a detection rate of 48.1% (n=877 patients). In patients with a previous negative biopsy, detection rates were higher for the MRI-TRUS fusion biopsy (32.8%) than for TRUS biopsy alone p<0.05). Direct comparison of the 2 biopsy methods did not identify significantly different detection rates for the entire cohort; however, subgroup analysis of higher Gleason score disease and lower Gleason score disease revealed that MRITRUS fusion biopsy was significantly superior at detecting higher Gleason score disease in patients with previous negative biopsy (p<0.05). The subgroup analyses (10 studies; n=2573 patients) also found that MRI-TRUS fusion biopsy identified fewer cases of lower Gleason score disease (12.9%) than was identified by TRUS biopsy (45.58%; p<0.05). Reviewers noted that, while there was no evidence of publication bias or significant selection bias, some of the studies inconsistently reported blinding, and 10 studies came from the same center.
Randomized Controlled Trials
Kasivisvanathan et al published a multicenter non-inferiority trial of 500 men with suspicion of prostate cancer who were randomized to MRI-targeted biopsy (n=252) or standard TRUS-guided biopsy (n=248) (Kasivisvanathan, 2018). Those whose MRI results did not suggest prostate cancer (71 [28%] patients) did not receive a biopsy. A greater proportion of patients in the MRI-targeted biopsy group were diagnosed with clinically significant disease (95 [38%] patients) than in the standard biopsy group (64 [26%] patients): the adjusted difference between groups was 12 percentage points (95% CI, 4% to 20%; p=0.005). There were also fewer diagnoses of clinically insignificant cancer in the MRI-targeted biopsy group (23 [9%] patients) than in the standard biopsy group (55 [22%] patients), which may indicate a reduction in overtreatment. While there were some limitations, including the level of agreement between the multiparametric MRI (mpMRI) site and central radiologist reading (78%), overall MRI-targeted biopsy proved to be not only non-inferior to standard TRUS-guided biopsy but superior for men who suspected prostate cancer but not had a previous biopsy.
Observational Studies
Maxeiner et al retrospectively analyzed results from 318 biopsy-naive consecutive patients who underwent mpMRI and subsequent MRI-TRUS fusion-guided targeted biopsy and TRUS biopsy (Maxeiner, 2018). Results from targeted biopsy alone detected cancer in 67% (n=213) patients, and TRUS biopsy alone detected cancer in 70% (n=222) of patients. According to the Prostate Imaging Reporting and Data System (PI-RADS), 55 patients had a score of 3, of whom 21 (38%) had detectable cancer; 154 had a score of 4, of whom 120 (78%) had cancer; and 109 had a score of 5, of whom 104 (95%) had cancer detected by 1 or both biopsy methods. Of the cancerous lesions detected by MRI-TRUS fusion targeted biopsy and TRUS biopsy, the prostate tumors were deemed to be clinically significant (Gleason score ≥4+3=7) in 195 (61%) of the entire cohort. Diagnoses of insignificant cancer were identical for MRI-TRUS fusion plus TRUS (16%), but the combination of targeted biopsy and TRUS biopsy showed an improvement in detection of 10% over that detected by targeted biopsy alone, which only detected significant cancer in 163 (51%) of patients. Study limitations included the single-center, nonrandomized design, and a different definition of clinically significant prostate disease in relation to previous studies. Based on their observations of the biopsy-naive cohort, authors concluded that targeted biopsy combined with systematic biopsy improved diagnostic accuracy considerably compared with targeted biopsy alone.
DISEASE PROGRESSION DURING ACTIVE SURVEILLANCE
Gordetsky et al retrospectively compared management decisions in patients who had prostate cancer and received TRUS-guided biopsy with or without fusion MRI-targeted biopsy (Gordetsky, 2018). There were a number of significant baseline differences between the standard cohort (n=215 patients) who received TRUS biopsy alone and the target cohort (n=133 patients) who received an additional targeted biopsy of suspicious areas identified by MRI-TRUS fusion. Most patients had the disease of grade 1 or 2. A significantly higher proportion of patients in the target cohort elected active surveillance (49.6%) than in the standard cohort (24.2%; p<0.001). When given a choice between radiotherapy and prostatectomy, fewer patients in the target cohort (24.4%) chose the former, compared with the standard cohort (47.2%; p<0.001). Those who underwent MRI-guided biopsy were more likely to have had a previous positive biopsy (multivariate analysis, p=0.013), but no between-group difference was observed in PSA level prior to the biopsy (p=0.11). Multivariate analysis indicated that race was a predictive factor in disease management, with fewer African American men electing active surveillance than non-African American patients (p=0.013). Limitations included baseline differences between cohorts and a lack of analysis of socioeconomic status as a predictive factor in management choices. Overall, active surveillance was more likely to be chosen by patients who had MRI-targeted biopsy than by men who received TRUS biopsy alone.
PRACTICE GUIDELINES AND POSITION STATEMENTS
American Urological Association
The American Urological Association published a position statement on multi-parametric MRI for diagnosis, staging, and management of prostate cancer (AUA, 2017). While noting that multi-parametric MRI is used increasingly to guide initial biopsy in biopsy-naive men, to confirm presumed localized prostate cancer, and to select a definitive therapy, the Association concluded that the evidence was insufficient to recommend MRI for screening, staging, or surveillance of prostate cancer. Indications for population based screening using MRI were deemed investigational, and the Association recommended that individual patients review risks and benefits with their caregivers to make a shared decision.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Practice Guidelines and Position Statements
National Comprehensive Cancer Network
National Comprehensive Cancer Network (v.2.2019) on prostate cancer makes the following statements on the use of multiparametric magnetic resonance imaging (MRI) in the staging of prostate cancer:[31] “Multiparametric MRI (mpMRI) can be used in the staging and characterization of prostate cancer.” “mpMRI may be used to better risk stratify men who are considering active surveillance. Additionally, mpMRI may detect large and poorly differentiated prostate cancer (Grade Group ≥2) and detect extracapsular extension (T staging). mpMRI has been shown to be equivalent to CT scan for pelvic lymph node evaluation.”
National Institute for Health and Care Excellence
The National for Health and Care Excellence published guidelines on the diagnosis and management of prostate cancer with the following recommendations: (NICE, 2019)
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Several systematic reviews have been published that have compared the diagnostic performance of MRI-targeted biopsy, TRUS-guided biopsy, and/or their combination in detecting prostate cancer (Tang, 2018; Wegelin, 2017; Wu, 2015; Schoots, 2015; Elwenspoek, 2019; Drost, 2020; and Tu, 2020). Despite variation in scope in terms of study designs and populations, definition of clinically significant prostate cancer, and analysis methods, these reviews have generally consistently reported significantly improvements with the MRI-targeted biopsy techniques in detecting clinically significant prostate cancer compared with TRUS-guided biopsy. A sampling of several of the most recent reviews are discussed below.
The largest systematic review is a Cochrane review reported by Drost et al which compared the diagnostic accuracy of MRI only, MRI-targeted biopsy, MRI pathway (MRI with or without MRI-targeted biopsy), and systematic biopsy in detecting clinically significant prostate cancer as compared with a reference standard of template-guided biopsy (Drost, 2020). Based on a search of several electronic databases through July 2018, this review included 43 studies of a total of 6,871 men. Of the 43 studies, 18 conducted diagnostic test accuracy analyses and 25 were agreement analyses. The majority of study participants were biopsy-naïve (77%, n=5,353). Clinically significant prostate cancer was defined as International Society of Urological Pathology grade 2 or higher. In the diagnostic test accuracy studies, the sensitivity rates to detect clinically significant prostate cancer using MRI-targeted biopsy, MRI pathway, and systematic biopsy were 80%, 72%, and 63%, respectively. Specificity rates using MRI-targeted biopsy, MRI pathway, and systematic biopsy were 94%, 96%, and 100%, respectively. In the studies that reported agreement analyses, pooled detection ratios were significantly greater overall for the MRI pathway compared with systematic biopsy (1.12; 95% CI, 1.02-1.23). However, the improved detection ratio for the MRI pathway was primarily driven by findings in studies of men with prior negative biopsies (detection ratio 1.44; 95% CI, 1.19-1.75). The improvement with the MRI pathway in the biopsy-naïve studies did not reach statistical significance (detection ratio 1.05; 95% CI, 0.95-1.16). The authors noted that the certainty in their findings was generally low, however, as a considerable number of studies had a high or unclear risk of bias.
Results also consistently demonstrated improved detection of clinically significant prostate cancer for MRI-targeted biopsy techniques in 2 concurrently conducted systematic reviews that focused only on biopsy-naïve men. Elwenspoek et al conducted a systematic review (literature search through December 2018) of 7 randomized controlled trials [RCTs] published from 2011 to 2018 (total N=2582, n range, 103-1140) that evaluated the diagnostic performance of 2 MRI pathways (MRI plus targeted and systematic biopsy and MRI plus targeted biopsy alone) compared to systematic biopsy alone in biopsy-naïve men (Elwenspoek, 2019). These include the RCTs summarized below. All RCTs were conducted outside of the United States. The review evaluated the rate of patients diagnosed with clinically significant or insignificant prostate cancer as defined by the individual studies. Definitions of clinically significant prostate cancer varied across studies, but all involved a Gleason score of 6 or greater. Some examples include “Gleason score ≥6 and histologically confirmed with adenocarcinoma," “presence of a single biopsy core indicating disease of GS ≥7,” “any Gleason score ≥7 or CCL ≥5 mm” and more. Risk of bias was assessed using the revised Cochrane tool and the majority of RCTs were judged to have a low overall risk of bias. Compared with systematic biopsy alone, MRI with or without targeted biopsy was associated with significant improvement in the detection of clinically significant prostate cancer (+57%; 95% CI, 2%-141%). However, compared with systematic biopsy alone, the MRI plus targeted and systematic biopsy pathway did not significantly improve the rate of clinically significant prostate cancer detection (risk ratio, 1.36; 95% CI, 0.79-2.34). Additionally, comparison between the 2 prebiopsy MRI pathways showed mixed results. Results were similar in another systematic review by Tu et al that included 6 RCTs and 25 own-control cohorts (Tu, 2020). Searches for the review by Tu et al were also through December 2018 and the addition of the own-control cohort studies resulted in a total of 4,020 biopsy-naïve men (Tu, 2020). Although the thresholds for clinically significant prostate cancer (Gleason score of 3 or 4) were generally lower than in the systematic review by Elwenspoek et al, this review by Tu el al also found a significant increase in detection rate for MRI-targeted biopsy compared with systematic biopsy (risk ratio, 1.20; 95% CI, 1.07-1.34) (Elwenspoek, 2019 and Tu, 2020).
Ahdoot et al reported on a prospective cohort study of 2103 men with MRI-visible prostate lesions who underwent both MRI-targeted and systematic biopsies at the National Cancer Institute between June 2007 through January 2019 (Ahdoot, 2020). Prior to study enrollment, the majority of participants (79.3%) had undergone at least 1 previous biopsy. Cancer detection rates for all Gleason Grade groups were 52.5% (n=1104) for the systematic biopsy method, 51.5% (n=1084) for the MRI-targeted method, and 62.4% (n=1312) for the combined method. When detection rates were analyzed according to separate Grade groups, systematic biopsy alone was found to detect significantly more Grade 1 cancers than MRI-targeted biopsy alone (21.6% [n=454] versus 13.7% [n=289]; P<.001) and similar rates compared with the combined method (18.7%, n=394). For Grade 2 cancers, there were no significant differences between the systematic-alone method (17.1%; n=359), the MRI-targeted method alone (17.6%; n=370), and the combined method (21.5%; n=452). But, for Grades 3-5, MRI-targeted biopsy led to the detection of significantly more cancers than systematic biopsy. Differences in cancer detection rates for the MRI-targeted method alone compared with the systematic method alone (95% confidence intervals; percentages of patients) were 1.7% (0.2% to 3.1%; 5.1% versus 3.5%) for Grade 3, 3.7% (2.2% to 5.2%; 10.2% versus 6.5%) for Grade 4, and 1% (0.2% to 1.8%; 4.9% versus 3.9%) for Grade 5. Compared with MRI-targeted biopsy alone, although there were small additional gains with the combined method for Grades 3, (5.9%, n=124), 4 (10.8%, n=228) and 5 (5.4%, n=114), these were not statistically significant. The primary limitations of this study are related to relevance of its population (ie, only MRI-visible lesions), setting (ie, single-center) and delivery methods (ie, use of a single experienced physician to perform the systematic biopsy and another to perform the MRI-directed biopsy). These factors have the potential to limit the generalizability of its findings to practice patterns in community institutions with less experienced practitioners and a broader range of patients.
One randomized controlled trial was identified that compared MRI-targeted biopsy with TRUS-guided biopsy in men on active surveillance for prostate cancer. Klotz et al reported on the ASIST trial (Active Surveillance Magnetic Resonance Imaging Study), a randomized, multicenter, open-label trial in Canada that evaluated 273 men recently diagnosed with grade group 1 prostate cancer (Klotz, 2019 and Klotz, 2020). The primary end point of ASIST was the proportion of patients upgraded to prostate cancer Grade Group 2 or greater and the power calculation was based on a 1-sided Fisher’s exact test and required 266 total patients. The initial results at the time of the confirmatory biopsy did not show a significant benefit for MRI-targeted biopsy. However, at the 2-year biopsy, use of MRI led to significantly less disease progression than no MRI. However, interpretation of findings from this study may be limited by the presence of the design, conduct, and relevance limitations.
National Comprehensive Cancer Network (v.2.2020 ) on prostate cancer makes the following statements on the use of multiparametric magnetic resonance imaging (MRI) in the staging of prostate cancer (NCCN, 2020):
“Multiparametric MRI (mpMRI) can be used in the staging and characterization of prostate cancer.”
“mpMRI may be used to better risk stratify men who are considering active surveillance. Additionally, mpMRI may detect large and poorly differentiated prostate cancer (Grade Group ≥2) and detect extracapsular extension (T staging) and is preferred over CT for abdominal/pelvic staging. mpMRI has been shown to be equivalent to CT scan for pelvic lymph node evaluation.”
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Many RCTs have been incorporated into systematic reviews and meta-analysis to date, with the exception of the following recent RCT. Klotz et al published a multicenter, phase 3, randomized, noninferiority trial of 453 biopsy-naïve men with suspicion of prostate cancer advised to undergo biopsy (Klotz, 2021). Patients were randomized to TRUS-guided biopsy (n=226; 225 evaluated) or MRI-targeted biopsy (n=227; 221 evaluated). A total of 83 (37%) patients in the MRI-targeted biopsy group had a negative MRI and did not receive a biopsy. A grade group 2 or greater prostate cancer was identified in 30% of patients in the TRUS-guided biopsy groups compared with 35% in the MRI-targeted biopsy group, which met the predefined threshold for noninferiority (absolute difference, 5%; 97.5% 1-sided CI, -3.4% to infinity; noninferiority margin, -5%). Diagnosis of clinically insignificant cancers was lower in the MRI-targeted therapy arm compared with the TRUS-guided biopsy arm (10.1% vs 21.7%; absolute difference, 11.6%; 95% CI, -18.2% to -4.9%; p<.001). One limitation of this trial is the potential for undiagnosed cancer in patients that did not receive a biopsy. Patients with no diagnosis of prostate cancer or diagnosis of a grade group 1 tumor are being followed for 2 years, and follow-up data will be evaluated when all patients complete the 2-year follow up. All MRIs were interpreted by experienced radiologists, and generalizability to less experienced practitioners is limited.
In 2017, the American College of Radiology issued appropriateness criteria for post-treatment follow-up of prostate cancer, noting that MRI-targeted biopsy may be appropriate for follow-up status post radical prostatectomy when there is clinical concern for residual disease (ACR, 2017). For follow-up in patients with clinical concern for residual or recurrent disease following nonsurgical local and pelvic treatments, MRI-targeted biopsy is usually appropriate.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A couple of additional systematic reviews by Haider et al and Bass et al have been published that have compared the diagnostic performance of MRI-targeted biopsy, TRUS-guided biopsy, and/or their combination in detecting prostate cancer (Haider, 2021; Bass, 2022).
Eklund et al conducted a prospective, population-based, noninferiority trial involving 1532 men (50 to 74 years of age) with PSA levels ≥3 ng/mL who were randomly assigned in a 2:3 ratio to undergo a standard biopsy (n=603) or MRI with targeted and standard biopsy if the MRI results suggested prostate cancer (the experimental arm; n=929) (Eklund, 2021). The primary outcome was the probability of detection of clinically significant prostate cancer, defined as the percentage of individuals in each group who received a cancer diagnosis with a Gleason score of 3+4 or greater. A key secondary outcome was the detection of clinically insignificant cancers (Gleason score 6). Of patients in the experimental arm, 338 (36%) underwent biopsies. In the standard biopsy group, 438 (73%) underwent biopsy. In the intention-to-treat analysis, clinically significant prostate cancer (Gleason score ≥7) was diagnosed in 192 (21%) patients in the experimental biopsy group versus 106 (18%) patients in the standard biopsy group, a 3% difference (95% CI, -1 to 7; p<.001 for noninferiority). The experimental biopsy group also experienced a lower percentage of clinically insignificant cancers than the standard biopsy group (4% vs. 12%; difference, -8% [95% CI, -11 to -5]). This study was performed in Sweden, with centralized radiologic and pathological assessment, which may limit its generalizability to other settings. Additionally, the researchers completed only a single round of screening; therefore, whether the reduction in overdiagnosis will be retained through multiple screening rounds is unknown.
Schiavina et al conducted an RCT that evaluated 124 men diagnosed with prostate cancer after random biopsy (Schiavina, 2021). The primary endpoint of the trial was the reclassification rate at 12 month random biopsy in the experimental versus control groups. Reclassification was defined as a biopsy ISUP-grade group grade 1 in >2 biopsy cores or biopsy ISUP-grade group grade ≥2. The early use of multiparametric MRI for active surveillance in men with low-risk prostate cancer after random biopsy significantly reduces reclassifications at a 12 month random biopsy. The RCT took place in Italy at 3 different sites between 2015-2018. Participants included men between 35 to 75 years of age diagnosed with prostate cancer after random biopsy fulfilling PRIAS criteria. Group 1 (62 participants) was managed according to PRIAS schedule and 12-core random biopsy at 12 months. Group 2 (62 participants) had a multiparametric MRI at 3 months and fusion-targeted biopsy with positive findings. Due to the study design, the timeline of reclassification was asymmetrical, as the control group was reclassified only at 12 months. The enrolled population was relatively small. Study designed in 2015 when random biopsy was the gold standard in naive patients and the evidence regarding the role of multiparametric MRI was not as robust as the current time period. Results included: Reclassification rate at 12 month random biopsy (6.5% vs. 29%; p<.001) and Rate of adverse pathological features at 12 months (0% vs. 55.6%; p=.04).
In 2020, the American Urological Association published an update of the standard operating procedure on the use of multiparametric MIRI for the diagnosis, staging, and management of prostate cancer (Bjurlin, 2020). The statement concluded that "data support prostate MRI use in men with a previous negative biopsy and ongoing concerns about increased risk of prostate cancer. Sufficient data now exist to support the recommendation of MRI before prostate biopsy in all men who have no history of biopsy. Currently, the evidence is insufficient to recommend MRI for screening, staging, or surveillance of prostate cancer."
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2023. The key identified literature is summarized below.
Multiparametric MRI (mpMRI) For Prostate Cancer
Diagnostic Workup
Prostate cancer is staged using the American Joint Committee on Cancer TNM system. Advanced imaging is not indicated for very low and low-risk groups. Multiparametric MRI (mpMRI, referring to prostate MRI protocol within this guideline) can be used in the staging and characterization of prostate cancer. CT is generally not sufficient to evaluate the prostate gland, but can be used for initial evaluation of nodal and/or visceral metastatic disease.
The prospective multicenter, randomized Phase III PRECISION (PRostate Evaluation for Clinically Important Disease: Sampling Using Image-guidance Or Not?) trial compared mpMRI-targeted biopsy to standard transrectal ultrasound guided biopsy in 500 men with clinical suspicion of prostate cancer (elevated PSA, abnormal digital rectal exam, or both) who had not undergone biopsy previously. The mpMRI-targeted evaluation was able to detect prostate cancer in 38% of men compared with 26% in the standard biopsy group (P = 0.005). Fewer men in the mpMRI group were diagnosed with clinically insignificant cancers (defined as Gleason 6)(Kasivisvanathan et al, 2018).
In a meta-analysis of 75 studies comparing CT to MRI for initial staging, the pooled data for extracapsular extension and T3 detection showed sensitivity and specificity of 57% and 91% for CT vs 61% and 88% for MRI (de Rooij et al, 2016). For detection of lymph node metastases, the differences in performance of CT and MRI were not statistically significant (Hovels et al, 2008). Findings from another prospective study confirmed the equivalency of CT and MRI for lymph node staging (Heck et al, 2014). For intermediate risk or above, abdominal imaging with contrast should be performed if the risk of pelvic lymph node metastases is greater than 10%. FDG-PET is not indicated, as physiologic activity in the bladder obscures tumor detection (Jadvar et al, 2016). Additionally, there is limited evidence to support 11C-choline and 18F fluciclovine PET for initial staging of prostate cancer.
Management
For active surveillance, the NCCN recommends mpMRI be considered for suspected anterior and/or aggressive cancers when PSA increases and prostate biopsies are negative (NCCN, 2022).
Although there are some studies showing a correlation between MRI stability and Gleason stability, the
American Urological Association/American Society for Radiation Oncology/Society of Urologic Oncology 2017 Guidelines for Clinically Localized Prostate Cancer do not currently recommend serial MRI for surveillance (Felker et al, 2016; Lai et al, 2017; Rais-Bahrami et al, 2014; Sandra et al, 2018).
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The results of a prospective cohort were reported of 17,980 men aged 50 to 60 years with a screening PSA ≥3ng/mL who underwent MRI followed by MRI-targeted biopsy and/or systematic biopsy (Hugosson, 2022). The experimental group (n=11,986)received either systematic biopsy or MRI-guided biopsy. The reference group (n=5994) received both systemic and MRI-targeted biopsy. In the intent to treat analysis, clinically insignificant prostate cancer (Gleason score 3+3) was found in 1.2% of patients inthe systematic biopsy group compared to 0.6% of patients in the MRI-targeted biopsy group (relative risk [RR], 0.46; 95% CI, 0.33 to 0.64; p<.001). Clinically significant prostate cancer (Gleason score 3+4) was found in 1.1% of the systematic biopsy group compared to 0.9% of the MRI-targeted biopsy group (RR, 0.81; 95% CI, 0.60 to 1.1). Ten patients had clinically significant cancer that was only detected by systematic biopsy. The authors concluded that overdiagnosis was reduced by half and few clinically significant cancers were missed with MRI-targeted biopsy among patients with elevated screening PSA levels.
A multicenter RCT was published that compared TRUS-guided systematic biopsy (12 cores), MRI-guided biopsy(12 cores), and artificial intelligence ultrasound-guided biopsy (6 cores) in 400 patients with suspected prostate cancer (Wang, 2023). The prostate cancer detection rate for the 3 biopsy strategies was 34.6%, 35.8%, and 49.6%, respectively (p=.036 for artificial intelligence-guided biopsy vs. TRUS-guided biopsy; p=.052 for artificial intelligence-guided biopsy vs. MRI-guided biopsy).Clinically significant prostate cancer detection rates were 26.3%, 23.1%, and 32.3%, respectively. The authors concluded that biopsy guided by artificial intelligence may become an alternative to systematic biopsy.
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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