Abstract
INTRODUCTION
ExactVu micro-ultrasound generates high-resolution images and promises to improve prostate biopsy performance, while transperineal prostate biopsy (TPB) has gained popularity due to its sterile technique. The aim of this study was to compare TPB using ExactVu to transrectal biopsy (TRB).
METHODS
A retrospective analysis of patients who underwent TPB (n=306) using ExactVu or TRB (n=392) from 2019–2023 was performed. Clinical parameters were compared between the groups using Chi-squared test. Putative predictors of cancer on biopsy and upgrading on radical prostatectomy were investigated using logistic regression.
RESULTS
More transperineal than transrectal biopsy patients had a Prostate Imaging-Reporting and Data System (PI-RADS) 5 lesion (40% vs. 28%, p=0.001) and were biopsynaive (53% vs. 39%, p<0.001). In patients with no previous diagnosis of prostate cancer, the clinically significant prostate cancer detection rate was higher in the TPB group (53% vs. 42%, p=0.01). Transperineal patients required fewer cores to obtain equal cancer detection rates (11±5 vs. 15±4 cores, p<0.01). Upgrading from grade group 1 to grade group ≥2 on radical prostatectomy was more common with TRB (9.1% vs. 2.1%, p=0.04). Urinary retention rate did not differ by biopsy type and two transrectal but no transperineal patients developed urosepsis.
CONCLUSIONS
TPB required fewer cores to obtain a similar clinically significant prostate cancer detection rate when compared to TRB. TPB had fewer complications and a low upgrade rate. This suggests that cognitive fusion TPB using ExactVu is an excellent alternative to software fusion TRB.
KEY MESSAGES
■ Micro-ultrasound transperineal biopsy (TPB) has a superior clinically significant prostate cancer (csPCa) detection rate in patients with no prior prostate cancer when compared to transrectal software fusion biopsy.
■ Few patients undergoing TPB were upgraded to csPCa on radical prostatectomy.
■ Complication rates after TPB were low, with no episodes of sepsis.
INTRODUCTION
Magnetic resonance imaging (MRI)-targeted prostate biopsy has been widely adopted, as it increases the detection of clinically significant prostate cancer (csPCa, grade group [GG] ≥2) while reducing identification of clinically indolent PCa (GG1) when compared to systematic biopsy. 1,2 Cognitive- and software-guided MRI-ultrasound (US) fusion prostate biopsy techniques have been shown to be equivalent;3 however, both are still often accompanied by systematic biopsies to minimize missed csPCa, and access can be limiting.3 New technologies are being evaluated to further improve the accuracy of MRI-targeted biopsy and increase accessibility.
ExactVu micro-ultrasound (ExactVu Imaging Inc, Markham, ON, Canada) is being evaluated as such a technology, as it provides high-resolution images of the prostate.4 Socarrás et al assessed 194 patients who underwent ExactVu targeted transperineal biopsy (TPB) under spinal anesthetic followed by MRI-US fusion and systematic biopsy.4 The csPCa detection rate was not statistically different between ExactVu and software-guided MRI-US fusion TPB (24% vs. 28%), suggesting that ExactVu could be a promising alternative to MRI-US fusion biopsy. Similar findings have been reported by multiple small, observational studies comparing ExactVu and MRI-US fusion transrectal biopsies (TRBs).5,6
In addition to improving the detection rate of csPCa with prostate biopsy, there is an increasing focus on reducing associated complications. The TPB sterile technique likely decreases the risk of sepsis while maintaining a comparable, if not superior, PCa detection rate, with improved sampling of the anterior and apical zones.7,8 Thus, interest in TPB under local anesthetic is becoming a popular alternative to TRB.
While ExactVu guided cognitive TPB may be a valuable office-based tool to improve csPCa detection rates and decrease sepsis rates, evidence for this is lacking. Therefore, the objective of this study was to compare PCa detection rate, upgrade rates, and complication rates between office-based TPB using ExactVu and TRB. We hypothesized that office-based TPB using ExactVu would perform similarly to software fusion TRB.
METHODS
Population and variables
After obtaining institutional review board approval (H24-03139), a retrospective review of all patients at our tertiary center who underwent TPB and a consecutive cohort of patients who underwent TRB from 2019–2023 was performed. This included both patients on active surveillance and those without a previous diagnosis of PCa. Patients without a pre-biopsy prostate MRI were excluded (Supplementary Figure 1; available at cuaj.ca).
Demographic, clinicopathologic, and outcome data were collected from electronic medical records. Biopsy findings were categorized by the presence of any PCa or csPCa (defined as International Society of Urological Pathology (ISUP) GG ≥2) and using the National Comprehensive Cancer Network risk groups.
Multiparametric MRI was used at our center. TPBs were performed by one of two urologists (MG, MM) under local anesthetic in-office using cognitive fusion with the ExactVu microultrasound (Exact Imaging, Markum, ON, Canada). A sample ExactVu image from our center can be seen in Figure 2 of Vassallo et al’s 2025 review.9
TPB patients received three days of twice daily oral ciprofloxacin prophylaxis until 2022, at which time our center switched to a single dose 500 mg oral cephalexin. TRBs were performed by radiologists under local anesthetic using an 8–9 MHz endorectal US and the UroNav© (Philips) system software for MRI-US fusion in the hospital radiology department. Three days of either 500 mg twice daily oral ciprofloxacin or 3 g once daily oral fosfomycin antibiotic prophylaxis were used for TRB.
Statistical analysis
Patients were grouped based on biopsy technique (TRB or TPB). Clinical parameters, including previous biopsy status, prostate volume, prostate MRI findings (Prostate Imaging-Reporting and Data System [PI-RADS] score, number, and location of lesions), and prostate biopsy results, were compared using the Mann-Whitney U test for continuous variables and the Chi-squared or Fisher’s exact test for categorical variables. Prostate-specific antigen (PSA) was presented as a median due to significant outliers and compared using the median test. These methods were also used to compare post-biopsy complications, PCa treatment, and rate of grade upgrade between TPB and TRB. If a patient underwent radical prostatectomy (RP), the pathologic findings of the prostatectomy specimen were compared to those of the prostate biopsy to calculate the upgrade rate.
Multivariable analysis using logistic regression was performed to identify risk factors for PCa or csPCa on biopsy and upgrade at time of RP. Variables included biopsy approach (TPB vs. TRB), PSA, prostate size, PI-RADs score, and previous biopsy. Subgroup analyses were also performed, excluding patients on active surveillance and assessing anterior vs. posterior MRI lesions. Patients with missing data were excluded from multivariable analyses. A p-value of <0.05 was considered significant, and all statistical analysis was conducted with SPSS-v.25 (IBM Corp. Armock, NY, U.S.).
RESULTS
A total of 698 patients were included in the analysis, of which 392 underwent TRB and 306 TPB. Mean followup was 18±13 months. As shown in Table 1, the sample’s median PSA was 8.0 ng/ml, with a mean prostate volume of 57 cc, and 36% of men were on active surveillance. A larger proportion of the TPB than TRB cohort had PI-RADs 5 (40% vs. 28%, respectively) and peripheral zone lesions (79% vs. 64%, respectively). Most patients in the TPB group had a targeted biopsy only (73% TPB vs. 5.7% TRB), while TRB patients were more likely to have a combined targeted and systematic prostate biopsy (88% TRB vs. 25% TPB, p<0.001). This corresponded to a mean of 11±5 biopsy cores taken during TPB and 15±4 cores for TRB (p<0.001).
Table 1.
Basic clinical parameters
| TRB (n, %) | TPB (n, %) | Total (n, %) | p | ||
|---|---|---|---|---|---|
|
| |||||
| Previous biopsy | None | 153 (39%) | 161 (53%) | 314 (45%) | <0.001 |
| Negative | 93 (24%) | 41 (13%) | 134 (19%) | ||
| Positive | 144 (37%) | 103 (34%) | 247 (36%) | ||
|
| |||||
| cT stage | T1 | 53 (75%) | 162 (67%) | 215 (69%) | 0.629 |
| T2 | 14 (20%) | 65 (27%) | 79 (25%) | ||
| T3 | 3 (4.2%) | 10 (4.1%) | 13 (4.1%) | ||
| T4 | 1 (1.4%) | 6 (2.5%) | 7 (2.2%) | ||
|
| |||||
| PSA (median ± IQR) | 8.0±6 | 8.8±7 | 8.4±6 | 0.125 | |
|
| |||||
| Prostate volume (mean ± SD) | 57±31 | 53±26 | 55±29 | 0.188 | |
|
| |||||
| Number of lesions on MRI (mean ± SD) | 1.4±0.7 | 1.5±0.8 | 1.4±0.7 | 0.800 | |
|
| |||||
| PI-RADS (maximum) | 2 | 6 (1.6%) | 10 (3.7%) | 16 (2.4%) | 0.001 |
| 3 | 88 (23%) | 40 (15%) | 128 (20%) | ||
| 4 | 186 (48%) | 113 (42%) | 299 (46%) | ||
| 5 | 106 (28%) | 107 (40%) | 213 (33%) | ||
|
| |||||
| Lesion location | Transition zone | 126 (33%) | 53 (20%) | 179 (28%) | <0.001 |
| Peripheral zone | 246 (64%) | 211 (79%) | 457 (71%) | ||
| Central zone | 10 (2.6%) | 2 (0.8%) | 12 (1.9%) | ||
|
| |||||
| Lesion location 2 | Anterior | 38 (63%) | 52 (37%) | 90 (45%) | 0.001 |
| Posterior | 22 (37%) | 88 (63%) | 107 (55%) | ||
|
| |||||
| Lesion location 3 | Apex | 116 (34%) | 85 (33%) | 201 (34%) | 0.085 |
| Apex to mid | 34 (10%) | 21 (8.1%) | 55 (9.2%) | ||
| Mid | 119 (35%) | 93 (36%) | 212 (36%) | ||
| Mid to base | 15 (4.5%) | 26 (10%) | 41 (6.9%) | ||
| Base | 53 (16%) | 33 (13%) | 86 (15%) | ||
|
| |||||
| Maximum lesion size (mean ± SD) | 1.6±0.8 | 1.6±0.8 | 1.6±0.8 | 0.812 | |
|
| |||||
| Biopsy type | Systematic only | 15 (6.1%) | 9 (2.9%) | 24 (4.4%) | <0.001 |
| Targeted only | 14 (5.7%) | 222 (73%) | 236 (43%) | ||
| Both | 216 (88%) | 75 (25%) | 291 (53%) | ||
|
| |||||
| Number of cores taken (mean ± SD) | 15±4.3 | 11±4.6 | 13±5.0 | <0.001 | |
IQR: interquartile range; MRI: magnetic resonance imaging; PI-RADS: Prostate Imaging-Reporting and Data System; PSA: prostate-specific antigen; SD: standard deviation; TRB: transrectal biopsy; TPB: transperineal biopsy.
Table 2 demonstrates that overall PCa and csPCa detection rates were 72% and 48%, respectively. In a subgroup analysis of biopsy-naive patients, the TPB cohort had a significantly higher csPCa detection rate than the TRB (59 vs. 48%, p<0.05). The same was true when patients on active surveillance were excluded (csPCa detection rate 53 vs. 42%, p<0.05). Although not statistically significant, TRB detected more GG1 PCa (28% vs. 21%) and fewer GG5 cancers (9.2% vs. 14%). PCa detection rates by biopsy approach are stratified by PI-RADs score in Figure 1. Complications were uncommon, but two patients undergoing TRB developed urosepsis requiring hospitalization and IV antibiotics (Clavien Dindo grade 2). Emergency room visits occurred in four TPB and 12 TRB patients, while four TPB and six TRB patients went into urinary retention (Clavien Dindo grade 1–2).
Table 2.
Prostate biopsy results
| TRB (n, %) | TPB (n, %) | Total | p | |||
|---|---|---|---|---|---|---|
|
| ||||||
| ISUP grade group | Negative biopsy | 103 (27%) | 81 (27%) | 184 (27%) | 0.158 | |
| 1 | 105 (28%) | 62 (21%) | 167 (25%) | |||
| 2 | 81 (21%) | 64 (21%) | 145 (21%) | |||
| 3 | 39 (10%) | 30 (10%) | 69 (10%) | |||
| 4 | 19 (5.0%) | 20 (6.7%) | 39 (5.7%) | |||
| 5 | 35 (9.2%) | 43 (14%) | 78 (11%) | |||
|
| ||||||
| NCCN risk group | Low | 69 (25%) | 50 (22%) | 119 (24%) | 0.165 | |
| Intermediate | 147 (52%) | 106 (47%) | 253 (50%) | |||
| High | 65 (23%) | 69 (31%) | 134 (27%) | |||
|
| ||||||
| PCa detection rate | All patients | 281 (72%) | 219 (72%) | 500 (72%) | 1.000 | |
| AS excluded | 159 (64%) | 134 (66%) | 293 (65%) | 0.623 | ||
| Biopsy naïve | 104 (68%) | 118 (74%) | 222 (71%) | 0.266 | ||
| AS only | 50 (100%) | 39 (100%) | 89 (100%) | 1.000 | ||
|
| ||||||
| csPCa detection rate | All patients | 175 (45%) | 157 (51%) | 332 (48%) | 0.093 | |
| AS excluded | 103 (42%) | 108 (53%) | 211 (47%) | 0.013 | ||
| Biopsy naïve | 73 (48%) | 95 (59%) | 168 (54%) | 0.045 | ||
| AS only | 47 (86%) | 37(97%) | 84 (97%) | 1.000 | ||
|
| ||||||
| Complications | ER visit | 12 (3.2%) | 4 (1.3%) | 16 (2.3%) | 0.132 | |
| Sepsis | 2 (0.5%) | 0 (0%) | 2 (0.3%) | 0.505 | ||
| Retention | 6 (1.6%) | 4 (1.3%) | 10 (1.5%) | 1.000 | ||
|
| ||||||
| Management | GG1 | Active surveillance | 80 (80%) | 57 (93%) | 137 (85%) | 0.113 |
| Radical prostatectomy | 12 (12%) | 3 (4.9%) | 15 (9.3%) | |||
| Radiation | 4 (4.0%) | 1 (1.6%) | 5 (3.1%) | |||
| Other* | 4 (4.0%) | 0 (0%) | 4 (2.5%) | |||
| ≥GG2 | Active surveillance | 17 (9.8%) | 9 (5.9%) | 26 (8.0%) | 0.002 | |
| Radical prostatectomy | 103 (60%) | 112 (73%) | 215 (66%) | |||
| Radiation | 47 (27%) | 20 (13%) | 67 (21%) | |||
| Other* | 6 (3.5%) | 12 (7.8%) | 18 (5.5%) | |||
Included systemic therapy, focal therapy, and clinical trials.
AS: active surveillance; csPCa: clinically significant prostate cancer; ER: emergency room; GG: grade group; ISUP: International Society of Urological Pathology; NCCN: National Comprehensive Cancer Network; PCa: prostate cancer; TRB: transrectal biopsy; TPB: transperineal biopsy.
Figure 1.
Detection of prostate cancer on transrectal vs. transperineal biopsy stratified by PI-RADs lesion. Black bars represent transrectal biopsy patients, while grey bars represent transperineal biopsy patients. PI-RADs 3–5 lesions are shown separately and then combined. (A) The detection rate of any prostate cancer; (B) includes only clinically significant prostate cancer (GG2+); and (C) includes only GG1 prostate cancer. GG: grade group; PI-RADS: Prostate Imaging-Reporting and Data System.
Of the patients who underwent RP (Table 3), 96% had csPCa on RP pathology. GG5 cancers were more common in the TPB than in the TRB group (30% vs. 12%). Upgrade to ≥GG2 occurred in 9.1% of TRB patients compared to only 2.1% of TPB patients (p=0.04).
Table 3.
Pathologic outcomes of patients who underwent radical prostatectomy
| TRB (n, %) | TPB (n, %) | Total | p | ||
|---|---|---|---|---|---|
|
| |||||
| GG | 1 | 4 (3.5%) | 1 (1.0%) | 5 (2.3%) | 0.003 |
| 2 | 52 (46%) | 48 (46%) | 100 (46%) | ||
| 3 | 32 (28%) | 19 (18%) | 51 (24%) | ||
| 4 | 9 (8.0%) | 5 (4.8%) | 14 (6.5%) | ||
| 5 | 13 (12%) | 31 (30%) | 44 (20%) | ||
|
| |||||
| NCCN risk group | Low | 1 (0.9%) | 1 (0.9%) | 2 (0.9%) | 0.703 |
| Intermediate | 68 (61%) | 60 (55%) | 128 (58%) | ||
| High | 42 (38%) | 48 (44%) | 90 (41%) | ||
|
| |||||
| Clinically significant PCa | 106 (94%) | 103 (99%) | 209 (96%) | 0.067 | |
|
| |||||
| Concordance between biopsy and RP | Same GG | 62 (55%) | 58 (56%) | 120 (55%) | 0.394 |
| Downgraded | 27 (24%) | 18 (17%) | 46 (21%) | ||
| Upgraded | 24 (21%) | 28 (27%) | 52 (24%) | ||
|
| |||||
| Upgrade to ≥GG3 | All patients | 10 (8.8%) | 14 (14%) | 24 (11%) | 0.285 |
| AS excluded | 5 (7.8%) | 12 (18%) | 17 (13%) | 0.080 | |
| Biopsy naive | 2 (4.7%) | 10 (17%) | 12 (12%) | 0.053 | |
|
| |||||
| % of GG1–2 biopsies upgraded to ≥GG3 | All patients | 17% | 29% | 23% | 0.387 |
| AS excluded | 22% | 48% | 35% | 0.057 | |
| Biopsy naive | 18% | 48% | 38% | 0.139 | |
|
| |||||
| Upgrade to csPCa (≥GG2) | All patients | 10 (9.1%) | 2 (2.1%) | 12 (5.8%) | 0.038 |
| AS excluded | 3 (4.9%) | 1 (1.6%) | 4 (3.3%) | 0.619 | |
| Biopsy naïve | 2 (5.0%) | 1 (1.9%) | 3 (3.2%) | 0.575 | |
|
| |||||
| % of GG1 biopsies upgraded to ≥GG2 | All patients | 92% | 67% | 87% | 0.371 |
| AS excluded | 75% | 100% | 80% | 1.000 | |
| Biopsy naïve | 100% | 100% | 100% | 1.000 | |
AS: active surveillance; GG: grade group; NCCN: National Comprehensive Cancer Network; PCa: prostate cancer; RP: radical prostatectomy; TRB: transrectal biopsy; TPB: transperineal biopsy.
Biopsy method was not a risk factor for PCa or csPCa in a multivariable analysis (p=0.9, n=639), even when patients on active surveillance or with a previous biopsy were excluded (p=0.5, n=404 and p=0.4, n=275, respectively). Additionally, biopsy method was not a risk factor for upgrading at time of RP. This remained true in subgroup analyses looking at anterior vs. posterior MRI lesions, although only 139 patients with PCa/csPCa and 68 patients who underwent RP were included due to missing data. A further subgroup analysis was done looking at only patients with targeted or combined systematic and targeted biopsies with no difference in outcomes (p=0.7, n=478).
DISCUSSION
MRI-targeted TPB improves PCa diagnosis while limiting associated sepsis risk, but access is limited and systematic biopsies are often added to avoid missing csPCa.7 Micro-US allows clinicians to correlate real-time high-resolution US images with MRI regions of interest, possibly enhancing cognitive fusion-targeted biopsies and even identifying PCa missed on MRI review.6 In fact, a recent randomized control trial by Kinnaird et al showed that micro-US guidance alone is non-inferior to software fusion MRI-guided biopsy.10
Our results support the utility of micro-US by demonstrating high detection rates for csPCa with ExactVu cognitive TPB. Additionally, there were no episodes of urosepsis with TPB and an equally low rate of urinary retention compared to TRB.11
Our study found a PCa detection rate of 72% and csPCa detection rate of 51% for PI-RADs 3–5 lesions, which is on the higher end of published literature.12–14 There were no significant differences in PCa detection rates between TPB and TRB groups in our study, which was mirrored in Uleri et al’s 2023 systematic review comparing MRI-targeted TPB and TRB.14 Uleri et al demonstrated a significantly higher csPCa detection rate for TPB, which was congruent with the trend seen in our biopsy-naive patients and those not on active surveillance, although not statistically significant on multivariable analysis. Through subgroup analyses, Uleri et al attributed the difference to a higher detection rate of anterior and apical lesions with TPB.14 Unfortunately, our study had missing data with regard to lesion location, so subgroup analyses were limited.
Overall, our population had a low rate of post-biopsy complications. Previous literature, including the PREVENT trial, has suggested that TPB decreases the risk of urosepsis compared to TRB.8,15,16 In fact, Castellani et al’s meta-analysis demonstrated that TPBs can be done without prophylactic antibiotics after it demonstrated no difference in infectious complications in 3662 men undergoing TPB with or without antibiotic prophylaxis.17
The ProBE-PC trial, on the other hand, failed to show a difference in the infection rate in 718 men randomized to TRB with antibiotics or TPB without antibiotics, with a letter to the editor stating that an adequately powered comparative trial would require 3938 patients in each arm to identify a difference in urosepsis rates.15,18
Our study was also underpowered to demonstrate a difference, but did identify two cases of urosepsis in men undergoing TRB and none in the TPB cohort. All patients in our study received antibiotic prophylaxis, but as this evidence evolved, TPB patients were stepped down to a single dose of cephalexin, while TRB patients remained on ciprofloxacin or fosfomycin.
TPB has been associated with a higher rate of urinary retention, which was not seen in our study, where retention rates were equal between groups;11 however, previous studies assessing TPB have used general anesthesia and/or performed saturation biopsies with a greater number of cores retrieved, both of which elevate the risk of urinary retention.19 TPBs in our study were done under local anesthetic and had fewer cores taken, likely reducing morbidity.
Upgrade rates to csPCa on RP were low in all patients. Given that very few patients in our study underwent RP for GG1 PCa, a second analysis was done assessing upgrading to GG3 with no significant differences between groups. Our results were comparable to Ahdoot et al’s study comparing transrectal MRI-targeted, systematic, and combined biopsies in 2103 men.20 They found that 6.7% of combined biopsies were upgraded to GG3 on RP, corresponding to our TRB upgrade rate of 8.8%. Our TPB group underwent primarily targeted biopsy with an upgrade rate of 14%, again mirroring Ahdoot et al’s targeted biopsy upgrade rate of 18.3%. This suggests that TPB using ExactVu cognitive fusion is an accurate diagnostic technique.
Limitations
Our study is limited by its retrospective nature and cohort size that is not large enough to compare rare events such as post-biopsy urosepsis. Our cohorts were heterogenous due to referral patterns, with a higher rate of previous negative biopsy in the TRB group; however, subgroup analyses were done assessing biopsy-naive patients with similar results. The TPB group also had more PI-RADs 5 lesions than the TRB group. Therefore, detection rates were displayed stratified by PI-RADS score. Furthermore, our broad inclusion criteria and wide catchment area as a tertiary referral center make our results more generalizable, with the caveat that the specialized care available at our center likely enhances outcomes.
Our study is limited in that it compares two different biopsy approaches and two different imaging techniques, as all TPBs at our center are done with ExactVu, which is not available for use for TRBs.
We were further limited by missing data, such that we were unable to perform accurate subgroup analyses looking specifically at apical or anterior tumors.
Finally, we did not account for improvement in PCa detection rate with operator experience, as ExactVu was new to our center in 2019.
CONCLUSIONS
The csPCa detection rate with cognitive fusion TPB using ExactVu was not statistically different than that with TRB, even though 73% of TPB were targeted while 88% of TRB were combined targeted and systematic. Few patients undergoing TPB were upgraded to csPCa on RP, and complication rates were low, with no episodes of sepsis after TPB. This suggests that TPB using ExactVu is a safe and effective alternative to software fusion TRB, which can be used to improve accessibility. Further research is warranted to validate these findings.
Supplementary Information
Footnotes
Appendix available at cuaj.ca
See related commentary on page 21
COMPETING INTERESTS: The authors do not report any competing personal or financial interests related to this work.
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