Transrectal versus transperineal prostate biopsy in detection of prostate cancer: a retrospective study based on 452 patients

doi:10.21203/rs.3.rs-2220141/v1

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Transrectal versus transperineal prostate biopsy in detection of prostate cancer: a retrospective study based on 452 patients

https://doi.org/10.21203/rs.3.rs-2220141/v1

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Journal Publication

published 28 Jan, 2023

Read the published version in BMC Urology →

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Background Transrectal (TR) ultrasound guided prostate biopsy and transperineal (TP) ultrasound guided prostate biopsy are the two most commonly used methods to detect prostate cancer, the detection rate of the two biopsy approaches may differ in patients with different clinical characteristics. Here we aimed to compare the prostate cancer detection rate and positive rate of biopsy cores between TR and TP prostate biopsy in patients with different clinical characteristics.

Methods We retrospectively analyzed and compared the clinical data of 452 patients underwent TR or TP prostate biopsy in our hospital from June 2017 to September 2021. And patients were stratified according to several clinical characteristic (serum PSA level, prostate volume, PSA density, PI-RADS score, T stage and ISUP grade), cancer detection rate and positive rate of biopsy cores were compared in different stratified groups.

Results There was no significant difference in age, PSA level, prostate volume, and PSA density between the TR and TP groups. TR group had a higher overall cancer detection rate and positive rate of biopsy cores than TP group. Further subgroup analysis showed that TR group had a higher cancer detection rate in patients with PI-RADS score of > 3, prostate volumes > 30 mL, and that the TR group had a higher positive rate of biopsy cores among the patients with T3-T4 stages, while TP group had a higher positive rates of biopsy cores among the patients with T1-T2 stages.

Conclusions TR approach may have advantage in patients with PI-RADS score of > 3, prostate volumes > 30 mL and T3-T4 stages, while TP approach may have advantage in patients with T1-T2 stages.

Transrectal biopsy

Transperineal biopsy

Prostate cancer

Cancer detection rate

Positive rate of biopsy cores

Prostate cancer diagnosis rate is increasing year by year¹. In 2021, prostate cancer is the first most common malignancy diagnosed in men worldwide². When prostate cancer is suspected, prostate biopsy remains the standard method of diagnosis³. Transrectal (TR) ultrasound guided biopsy was first reported by Cooner et al. in 1988, and further refined by Hodge et al. in 1989^{4, 5}. Transperineal (TP) prostate biopsy offered an alternative approach, and after decades of being described, TP prostate biopsy becomes more and more widely adopted for its lower risk of infectious complications and higher diagnosis rate for anterior cancers^{6, 7}.

Several studies were performed to compare the detection rates and complications of TR and TP approaches. Firstly, TP biopsy significantly reduces infectious complications compared to TR biopsy^8–10, as well as improves the detection rate of anterior zone cancers^{11, 12}. Moreover, there were no significant differences in both cancer detection rate and cancer core rate between TR and TP approaches for prostatic biopsy in most studies^13–16. However, the detection rate of the two biopsy approaches may differ in patients of different ages, PSA values, and prostate volumes^{17, 18}.

12 cores biopsy was recommended to achieve the balance between the cancer detection rate and adverse events¹⁹. In our center, almost all prostate biopsies are performed by using 12 cores systematic biopsies plus 1 core in suspicious area. And our center started performing free-hand TP ultrasound guided prostate biopsy in May 2020. Until now, we have completely replaced TR prostate biopsy with TP prostate biopsy. In this study, the clinical data of 452 patients in our hospital who underwent prostate biopsy were retrospectively analyzed, to compare the detection rates between TP and TR approaches. In addition, by comparing detection rates of patients with different clinical characteristics, we aimed to find out the optimal biopsy approach in patients with different clinical characteristics.

Patient Cohort

This study collected 452 patients underwent TR or TP prostate biopsy at the Department of Urology, Zhongnan Hospital of Wuhan University from June 2017 to September 2021, Patients with PSA ≥ 100 ng/mL were excluded because their prostate cancer detection rate was close to 100%. All methods used for analysis in this study were carried out in accordance with the approved regulations of the Medical Ethics Committee, Zhongnan Hospital of Wuhan University. The indications for prostate biopsy are based on ‘Chinese diagnosis and treatment of urological diseases Guide’, including patients with: (1) suspicious lesions detected by digital rectal examination (DRE); (2) suspicious lesions on imaging; (3) PSA > 10 ng/mL; (4) 10 ng/mL ≥ PSA > 4 ng/mL and abnormal free/total PSA ratio or PSA density.

Biopsy procedure

Almost all prostate biopsies (both TR and TP approaches) in our hospital are performed by using 12 cores systematic biopsies plus 1 core in suspicious area. Biopsies were accomplished in a “fan-like” pattern²⁰, an 18-gauge disposable core biopsy instrument (Bard Healthcare Science, Shanghai, CO, LTD.) was used to obtain specimens. Each core was marked and packed site-specifically, and assigned a separate Gleason score.

In accordance with the same steps reported in the literature²¹, the patient who underwent transrectal procedure was placed in the left lateral decubitus position. No anesthesia was administered. A transrectal ultrasound (TRUS) probe was used for needle placement and guidance. A standard biopsy procedure sampled parasagittal midline and lateral apical, medial, and basal regions bilaterally for a total of 12 cores as well as the additional cores from areas of suspicion (Fig. 1a). The patient who underwent transperineal procedure was positioned in lithotomy and general anesthesia was administered. Excessive hair was shaved and the perineum was prepared using 1% povidone-iodine. An indwelling Foley catheter was used to visualize the urethra on ultrasound images. The scrotum was elevated anteriorly using surgical incise drape to expose the perineum. A curvilinear ultrasound probe (transperineal ultrasound, TPUS) was pressed vertically against the lower part of the perineum and visualized the gland. The needle was inserted from the upper edge of the probe in plane with the ultrasound beam. The prostate was divided into left and right lobes. For each lobe, six cores were taken from anterior, middle and posterior zones of the lateral and medial area, additional cores were taken from areas of suspicion (Fig. 1b).

Data collection

The following clinical data was acquired by retrospective review of medical records and compared between the two groups: age, serum PSA level (ng/mL), prostate volume (mL), prostate cancer diagnosis rate and positive rate of biopsy cores, the prostate volume was calculated using the formula: height × width × length × 0.52 (in cm). Furtherly, patients were stratified according to several clinical characteristic, including: serum PSA level, prostate volume, PSA density, PI-RADS (prostate imaging reporting and data system) score, T stage and ISUP (international society for urological pathology) grade, cancer detection rate and positive rate of biopsy cores were compared in different stratified groups.

Statistical analyses

Continuous variables were described as averages, ranges and medians. Age was compared by independent t test, while PSA level, prostate volume and PSA density were compared by Mann-Whitney U test as they did not conform to normal distribution. The normal distribution of each dataset was checked by Kolmogorov-Smirnov test. Chi-square test was performed to compare the prostate cancer diagnosis rate and positive rate of biopsy cores among different groups. Cochran-Mantel-Haenszel (CMH) test was performed to compare the cancer detection rate after controlling for confounding variables according to PSA level and PSA density. The results were expressed as odds ratios (ORs) with 95% confidence intervals (CIs). SPSS 22.0 was used to perform all statistical analyses and p value < 0.05 was considered significant.

Out of the 452 patients underwent prostate biopsy (Table 1), 230 (50.9%) cases were diagnosed with prostate cancer, the overall positive rate of biopsy cores was 24.6% (1416 of 5759 cores). Average age was 70.1 years, average PSA level was 22.0 ng/mL, average prostate volume was 57.0 mL, and average PSA density was 0.51 ng/mL². There was no significant difference in age, PSA level, prostate volume, and PSA density between two groups. The overall detection rate in TR group appeared to be higher than in TP group in our study (56.1% vs 44.4%, OR: 1.612, 95% CI: 1.111–2.340, p = 0.012). To minimize confounding factors of PSA level and PSA density in two groups, CMH test was performed, showing that the cancer detection rate in TR group was still higher than in TP group both when adjusting with PSA level (OR: 1.529, 95% CI: 1.036–2.255, p = 0.032), or when adjusting with PSA density (OR: 1.514, 95% CI: 1.030–2.226, p = 0.035). Similarly, the positive rate of biopsy cores was higher in the TR group than in the TP group (27.5% vs 21.0%, OR: 1.429, 95% CI: 1.264–1.616, p < 0.001).

Table 1

Clinical characteristics of patients underwent transrectal or transperineal prostate biopsy.
Variables	All patients (n = 452)	Transrectal biopsy (n = 245)	Transperineal biopsy (n = 207)	p value
Age at biopsy (years)
Average/Median	70.1 ± 8.4/70	70.0 ± 8.7/70	70.3 ± 8.1/70	0.769
Range	45–88	45–88	51–88	0.769
PSA (ng/mL)
Average/Median	22.0 ± 20.6/13.8	23.2 ± 21.8/14.1	20.6 ± 19.0/13.7	0.634
Range	0.3–99.2	0.3–99.2	0.8–97.6	0.634
Prostate volume (mL)
Average/Median	57.0 ± 36.0/49	54.4 ± 31.6/46	60.0 ± 40.3/52	0.151
Range	10–334	11–204	10–334	0.151
PSA density (ng/mL²)
Average/Median	0.51 ± 0.59/0.27	0.55 ± 0.64/0.29	0.47 ± 0.51/0.26	0.181
Range	0.01–3.63	0.01–3.63	0.02–2.40	0.181
Prostate cancer diagnosis rate (n, %)	230/452 (50.9%)	138/245 (56.1%)	92/207 (44.4%)	0.012
Positive rate of biopsy cores (n, %)	1416/5759 (24.6%)	876/3185 (27.5%)	540/2574 (21.0%)	< 0.001

Furthermore, to compare the prostate cancer detection rate of two biopsy approaches in patients with different clinical characteristics, subgroup analysis was performed according to serum PSA level, prostate volume, PSA density and PI-RADS (prostate imaging reporting and data system) score. As shown in Table 2, In subgroup analysis stratified by PSA level, there were no significant differences in cancer detection rate between the TR and TP groups for each subgroup. When stratified by prostate volume, the TR group have a higher cancer detection rate than the TP group among the patients with 30–80 mL prostate volume (56.3% vs 40.5%, OR: 1.892, 95% CI: 1.165–3.073, p = 0.010), as well as in the subgroup with > 80 mL prostate volume (36.6% vs 16.3%, OR: 2.967, 95% CI: 1.060–8.305, p = 0.034). However, there was no significant difference between two biopsy approaches in cancer detection rate among the patients with ≤ 30 mL prostate volume. Similarly, cancer detection rates did not significantly differ between TR and TP group according to different PSA density. In addition, PI-RADS score can be assessed in 235 patients (130/245 in TR group, 105/207 in TP group) by MRI, when stratified by PI-RADS score (≤ 3, > 3), TR group had a higher cancer detection rate than TP group (83.9% vs 65.7%, OR: 2.734, 95% CI: 1.255–5.957, p = 0.010) in patients with PI-RADS score of > 3, however, did not significantly differ with TP group on cancer detection rate in patients with PI-RADS score of ≤ 3.

Table 2

Comparison of prostate cancer detection rate according to PSA level, prostate volume and PSA density between transrectal and transperineal prostate biopsy.
Variables	All patients (n, %)	Transrectal biopsy (n, %)	Transperineal biopsy (n, %)	p value
PSA (ng/mL)
≤ 10	63/152 (41.4)	40/87 (46.0)	23/65 (35.4)	0.190
10–20	56/140 (40.0)	29/63 (46.0)	27/77 (35.1)	0.188
20–100	111/160 (69.4)	69/95 (72.6)	42/65 (64.6)	0.280
Prostate volume (mL)
≤ 30	74/96 (77.1)	38/53 (71.7)	36/43 (83.7)	0.163
30–80	134/272 (49.3)	85/151 (56.3)	49/121 (40.5)	0.010
> 80	22/84 (26.2)	15/41 (36.6)	7/43 (16.3)	0.034
PSA density (ng/mL²)
≤ 0.15	23/92 (25.0)	14/42 (33.3)	9/50 (18.0)	0.091
> 0.15	207/360 (57.5)	124/203(61.1)	83/157 (52.8)	0.118
PI-RADS score
≤ 3	27/87 (31.0)	14/49 (28.6)	13/38 (34.2)	0.573
> 3	112/148 (75.7)	68/81 (83.9)	44/67 (65.7)	0.010

Table 3

Comparison of positive rate of biopsy cores according to T stage and ISUP grade between transrectal and transperineal prostate biopsy.
Variables	All patients (n, %)	Transrectal biopsy (n, %)	Transperineal biopsy (n, %)	p value
T stage
T1 + T2	381/1160 (32.8)	231/754 (30.6)	150/406 (36.9)	0.029
T3 + T4	725/1065 (68.1)	433/598 (72.4)	292/467 (62.5)	0.001
ISUP grade
1	79/542 (14.6)	49/351 (14.0)	30/191 (15.7)	0.582
2–3	369/853 (42.3)	192/455 (42.2)	177/398 (44.5)	0.504
4–5	955/1520 (62.8)	622/975 (63.8)	333/545 (61.1)	0.297

Among 230 patients diagnosed with prostate cancer by biopsy, T stages were assessable in 175 patients (104/138 in TR group, 71/92 in TP group). We further analyzed the difference in the positive rates of biopsy cores between the two biopsy approaches in patients with different T stages. As shown in Table 3, the TR group have a higher positive rates of biopsy cores among the patients with T3 and T4 stages (72.4% vs 62.5%, OR: 1.573, 95% CI: 1.213–2.038, p = 0.001), while TP group have a higher rate among the patients with T1 and T2 stages (30.6% vs 36.9%, OR:0.754, 95% CI: 0.585–0.972, p = 0.029). Additionally, except for 1 patient in TR group diagnosed with neuroendocrine carcinoma, ISUP (international society for urological pathology) grades were obtained according to the highest pathology score core for each individual patient. When stratified by ISUP grade, there were no significant differences in positive rates of biopsy cores between the TR and TP groups for each subgroup.

Since TR ultrasound guided biopsy was introduced by Hodge et al.⁵, it has gradually become the main approach for the diagnosis of prostate cancer worldwide. Despite the routine use of antimicrobial prophylaxis, approximately 3%-5% of TP approach biopsy patients are readmitted for infection^{22, 23}. TP ultrasound guided biopsy has been recommended as a safer alternative for its lower infection rate^{9, 10}. Over the past decades, with the improvement of multiparametric MRI (magnetic resonance imaging) diagnosis, MRI has become more and more sensitive for the detection of prostate cancer²⁴. Multiparametric MRI-targeted biopsies (MRI-TBx) appeared to significantly improve the diagnosis of clinically significant prostate cancer (a single biopsy core indicating disease of Gleason score 3 + 4 or greater) compared with TRUS-guided systematic biopsy²⁵. However, because of the high cost of MRI-TBx, TRUS-guided systematic biopsy is still the primary method of prostate biopsy for its easy promotion.

Several previous studies were performed to compare the prostate cancer detection rates of TR and TP approaches, indicating no significant difference in overall cancer detection rates between the two approaches^{13, 14, 26–28}. Jiang et al. reported that the detection rates of TR approach were higher than TP approach for patients with PSA level 20.1–100.0 ng/mL (80.8% vs 69.1%, p = 0.040)¹⁷. In our study, the overall detection rate in TR group appeared to be higher than in TP group (56.1% vs 44.4%, OR: 1.612, p = 0.012). However, when stratified by PSA level, there were no significant differences in cancer detection rate between the TR and TP groups for patients with 20–100 ng/mL PSA level (72.6 vs 64.6%, p = 0.280) in our study, which may be caused by the small sample size in the subgroup.

In China, the proportion of newly diagnosed prostate cancer patients with high-risk and advanced-stage prostate cancer is higher than in Europe and the United States, which is more prevalent in poorer areas²⁹. Among 410 patients diagnosed with prostate cancer in our hospital (180 patients whose prostate volume was not available, or with PSA ≥ 100 ng/mL were excluded from the study), patients with PSA levels > 20 ng/mL accounted for 68.3% (280/410), patients with ISUP grade 4–5 accounted for 66.3% (272/410), and patients with T3 and T4 stages accounted for 67.2% (197/293). Consistent with the higher diagnostic rate of TR approach in patients with PSA > 20 ng/mL reported in the literature¹⁷, the TR group had a higher positive rate of biopsy cores among the patients with T3 and T4 stages (72.4% vs 62.5%, OR: 1.573, p = 0.001) in our study, which suggested that TR approach may have advantage in patients with a probable diagnosis of high-risk prostate cancer (PSA levels > 20 ng/mL, cT3-T4 stage tumor on imaging or digital rectal examination). In addition, TR group had a higher cancer detection rate than TP group (83.9% vs 65.7%, OR: 2.734, p = 0.010) in patients with PI-RADS score of > 3, and patients with large prostate volumes (30–80 mL: 56.3% vs 40.5%, OR: 1.892, p = 0.010; > 80 mL: 36.6% vs 16.3%, OR: 2.967, p = 0.034). In contrast, TP group seems to have a higher positive rates of biopsy cores among the patients with T1 and T2 stages (30.6% vs 36.9%, OR:0.754, p = 0.029), and the literature also reported the advantage of the TP approach in patients with PSA levels of 4.01-10.00 ng/mL^{6, 27}, indicating that TP approach may have advantage in patients with low- and intermediate-risk prostate cancer.

Our study had some limitations. Firstly, this is a single-center retrospective study with a low level of evidence. Additionally, partial information was missing for some patients in this study, such as PI-RADS score and T-stage. More research is needed to further verify these opinions.

Based on 452 patients underwent prostate biopsy in our hospital, TR group had a higher overall cancer detection rate and positive rate of biopsy cores than TP group. Further subgroup analysis showed that TR group had a higher cancer detection rate in patients with PI-RADS score of > 3, prostate volumes > 30 mL, and that the TR group had a higher positive rate of biopsy cores among the patients with T3-T4 stages, while TP group had a higher positive rates of biopsy cores among the patients with T1-T2 stages.

transrectal

transperineal

PSA

prostate-specific antigen

DRE

digital rectal examination

TRUS

transrectal ultrasound

TPUS

transperineal ultrasound

PI-RADS

prostate imaging reporting and data system

ISUP

international society for urological pathology

CMH

Cochran-Mantel-Haenszel

odds ratio

confidence interval

MRI

magnetic resonance imaging

Ethical approval and consent to participation

The Medical Ethics Committee, Zhongnan Hospital of Wuhan University approved the study (Ethical Approval No. 2020102). Informed consent was obtained from each participant. The study was carried out in accordance with the Helsinki Declaration.

Consent to publication

Not applicable.

Availability of data and material

The datasets used or analysed during the current study are available from the corresponding author on reasonable request.

Competing interest

The authors declare that they have no competing interests.

Funding

This study was supported by Program of Excellent Doctoral (Postdoctoral) of Zhongnan Hospital of Wuhan University (Grant No. ZNYB2019006) and Natural Science Foundation of Hubei Province (Grant No. 2019CFB505).

Acknowledgement

The authors would like to thank all the patients who participated in the study.

Author contribution

ZHY and HZ conceived the idea and its design. MXL, YL and JTY collected the data and performed data analyses. MXL and YL drafted the manuscript. MXL, ZHY and YZW reviewed and corrected the manuscript. All authors contributed to the article and approved the submitted version.

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No competing interests reported.

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You are reading this latest preprint version

Transrectal versus transperineal prostate biopsy in detection of prostate cancer: a retrospective study based on 452 patients

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Material And Methods

Patient Cohort

Biopsy procedure

Data collection

Statistical analyses

Results

Discussion

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