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Prostate Biopsy How Easy to Miss Cancer

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Assay of the cause of missed diagnosis in mpMRI/TRUS fusion-guided targeted prostate biopsy

  • Shun Zhang1  na1,
  • Haifeng Huangone,
  • Qing Zhang1,
  • Shengjie Zhangane,
  • Shiwei Zhang1 &
  • Hongqian Guo1

BMC Urology volume 22, Commodity number:74 (2022) Cite this commodity

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Abstract

Objectives

To investigate the causes of missed diagnosis in mpMRI/TRUS fusion-guided targeted prostate biopsy.

Methods

The clinical data of 759 patients who underwent transperineal prostate biopsy from March 2021 to June 2021 at Nanjing DrumTower Infirmary were retrospectively analyzed. Twenty-i patients had MRI contraindications. Ultimately, 738 patients completed mpMRI/TRUS fusion-guided targeted prostate biopsy + 12-core transperineal systematic biopsy subsequently mpMRI and PI-RADS scoring. The pathological diagnoses from targeted and systematic biopsy were compared to evaluate and clarify the reasons for missed diagnoses in targeted biopsy.

Results

A total of 388 prostate cancer patients were identified, including 37 (9%) missed diagnoses with targeted biopsy and 44 (xi.34%) with systematic biopsy. Between the target biopsy missed diagnosis grouping and non missed diagnosis group, there was no significant difference in age (71.08 ± 7.11 vs. 71.lxxx ± seven.94), only PSA (thirteen.63 ± 12.41 vs. 54.54 ± 177.25 ng/ml), prostate volume (61.82 ± forty.64 vs. 44.34 ± 25.07 cm3), PSAD (0.27 ± 0.28 vs. one.07 ± 2.91), and ISUP grade [1(i) vs. 3(2)] were significantly different. The pathological results of the 37 targeted biopsy missed diagnoses were recompared with MRI: 21 prostate cancers were normal on MRI; nine cancer areas were abnormal on MRI; and seven cancer areas on MRI were PI-RADS iii.

Conclusions

Early prostate cancer, large prostate, effect of local anesthesia, doctor–patient cooperation, MRI diagnosis, and operator technology were possible factors for missed diagnosis in targeted biopsy. Improvements imaging technology, greater experience, and personalized biopsy may lead to an accurate pathological diagnosis.

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Introduction

The incidence of prostate cancer is the highest among all male person cancers in the United states [ane] and is increasing in China every year [2]. Prostate biopsy is the main method for diagnosing prostate cancer. The guided types of prostate biopsy include finger guided, transrectal ultrasound (TRUS)-guided, and magnetic resonance prototype (MRI)-guidedbiopsies; the former two types are also used to guide systematic biopsy (SB) [three]. The 2020 European Association of Urology (EAU) guidelines on prostate cancer [4] and 2021 National Comprehensive Cancer Network (NCCN) Guidelines [v] has recommended multiparameter magnetic resonance imaging (mpMRI) as an important imaging method for detecting prostate cancer. mpMRI/TRUS fusion-guided targeted biopsy (TB) has become the main method because of the accurateness of MRI and flexibility of TRUS. In this study, nosotros sought to place the causes of and strategies for avoiding TB missed diagnosis to improve the positive rate of TB by analyzing 759 patients who underwent transperineal prostate biopsy.

Objects and methods

Objects

A total of 759 patients who received transperineal prostate biopsy from March 2021 to June 2021 in Nanjing DrumTower Hospital, anile from 42 to 95 (lxx.18 ± eight.04) years. Inclusion criteria, fulfil one of the post-obit conditions: (1) abnormal digital rectal examination, (2) abnormal imaging exam (including abnormal MRI, ultrasound, PET, CT), (3) prostate specific antigen (PSA) > 10 ng/mL, (4) PSA 4–10 ng/mL and Prostate Imaging and Reporting and Information System (PI-RADS) score ≥ iii according to MRI. Patients with contraindications, including coagulation dysfunction, infection, severe cardiopulmonary insufficiency, etc., were excluded.

Method

mpMRI

Patients were scanned with a Philips Achieva 3.0T MRI scanner and the following scanning sequences: T1-weighted imaging (T1WI), T2-weighted imaging (T2WI), diffusion weighted imaging (DWI, b-value 1500), apparent diffusion coefficient (ADC), and dynamic contrast enhanced (DCE) imaging. All MR images were analyzed by two senior radiologists according to the prostate MRI section of the 2020 European urology guidelines [4] and graded by the PI-RADS version 2.ane [6] for suspected prostate cancer surface area: a score of 1 was considered beneficial, 2 probable benign, three between beneficial and malignant, four likely malignant, and 5 highly suspected malignant.

Biopsy

An Italian ESAOTE MyLabTwice ultrasonic diagnostic system was used to perform the biopsies. A real-time virtual sonography (RVS) image fusion organisation was adopted for mpMRI/TRUS epitome fusion, which tin fuse MRI images with real-time TRUS images and brandish the target lesion from the MRI scan on the TRUS images in existent time. A 18 G × 20 cm automatic biopsy needle by Gallini company in Italy was used to extract a specimen of length 20 mm. With the patient in the lithotomy position, after local perineal anesthesia with 1% lidocaine, one lesion with a PI-RADS score ≥ three on MRI was punctured with 2–four needles, followed by standard 12-core transperineal SB. For patients with lesions with a PI-RADS score ≤ 2 or no lesion on MRI, 12-core SB was performed, which were classified every bit TB negative. Antibiotics were administered to foreclose infection after the operation.

Histopathology

Any prostate cancer diagnosis was considered. Histopathology of prostate cancer was illustrated by International Society of Urological Pathology (ISUP). A 5-tier ISUP Grading System was established on the basis of Gleason grades, with grade i tumors being Gleason score (GS) ≤ 6; grade 2 existence GS 3 + 4 = 7; class 3 being GS 4 + iii = 7; grade 4 being GS 4 + 4 = 8, 3 + 5 = 8 or 5 + 3 = 8; and grade five being GS nine–10. [7].

Statistical methods

The statistical software SPSS 17.0 was used to clarify and process the data. Based on the pathological diagnosis, differences were analyzed between TB and SB. Counted data are indicated past % and were compared with the Χ2, chiselled variable are indicated by median (interquartile range) and were compared with rank sum test, and continuous data are indicated by \({\overline{\text{X}}}\) ± S and were compared with the t test. P < 0.05 was considered statistically significant.

Results

Amongst the 759 patients, prostate cancer was detected in 403 patients, with a positive charge per unit of 53.x%. Twenty-1 of these patients did non undergo MRI due to metal implants or claustrophobia and were not included in the following assay.

A total of 738 patients completed TB + SB afterward mpMRI, and prostate cancer was detected in 388 patients, with a positive charge per unit of 52.57% (Table 1). Co-ordinate to the biopsy pathology, patients were divided into four groups: 37 patients who were TB negative and SB positive (TB− & SB+ group), 44 TB positive and SB negative (TB+ & SB− grouping), 307 TB positive and SB positive (TB+ & SB+ grouping), and 350 TB negative and SB negative (TB− & SB− group). The TB− & SB+ patients were chosen the TB missed diagnosis group (TB-Doctor); the TB+ & SB− patients were chosen the SB missed diagnosis grouping (SB-MD); the TB+ & SB− and TB+ & SB+ patients were grouped into the TB not-missed diagnosis group (TB-NMD), with a total of 351; and the TB− & SB+ and TB+ & SB+ patients were grouped into the SB not-missed diagnosis grouping (SB-NMD), with a total of 344 (Table 2).

Table ane Patient demographics, number of core, and biopsy findings (overall accomplice)

Full size table

Table 2 Missed diagnosis in TB and SB

Full size tabular array

A comparison between the TB-Dr. group and the TB-NMD group is shown in Tabular array 3.

Table iii Differences between TB-MD grouping and TB-NMD group

Full size tabular array

The pathological results of the TB-Dr. group were compared with MR image again: 21 patients' any area of MR images were normal; 9 patients' cancer areas detected past SB were TB areas on MR paradigm; and 7 patients' cancer areas detected by SB were corrected to PI-RADS 3 on MR prototype.

In the TB+ & SB+ grouping, ISUP grade of the TB sample was greater than or equal to that of the SB for 276 patients, accounting for 89.90% of the patients in this group. Analyzing the SB-positive locations on the MR images, 45 patients had SB-positive areas with non-TB-positive areas, which means that TB missed prostate cancer lesions in these cases, bookkeeping for fourteen.66%. 24 patients' cancer lesions missed by TB were normal on MRI; 10 patients' cancer lesions missed by TB were other TB-negative areas; and 11 patients' cancer areas detected by SB were corrected to PI-RADS 3 on MRI. The ISUP grade of the cancer lesions with TB missed diagnoses was 1 (1), and the ISUP grade of cancer lesions with TB diagnoses was iii (two), P = 0.00. The ISUP grade of the TB lesions was greater than or equal to that of the TB missed diagnosis lesions, bookkeeping for 93.33%.

Discussion

Prostate biopsy, as the gold standard for prostate cancer diagnosis, tin be performed in a guided manner, ranging from finger guidance to TRUS guidance. With the development of imaging technology, mpMRI has shown obvious advantages in prostate cancer diagnosis, specially with implementation of the PI-RIDS, allowing a quantified and standardized diagnosis. Quentin et al. [8] reported that MRI can be used to directly guide prostate biopsy; however, every bit MRI cannot be performed on patients with metal implants, involves a long scanning time and cannot provide real-time guidance, and requires an expensive, complex, and long biopsy procedure, this method has not been used widely. The emergence of image fusion technology perfectly combines the convenience, ease of functioning and depression cost of TRUS with the high sensitivity of mpMRI for prostate cancer, addressing the lack of random sampling in systematic puncture biopsy, and has been gradually implemented in clinical practise.

Leveraging TB engineering and the MRI screening of patients with PSA 4–x ng/mL, the positive charge per unit of all 759 patients was 53.10%, higher than that previously reported for SB (positive charge per unit 38.2%) [ix]. Some patients were contraindicated for MRI and thus could not undergo mpMRI-TRUS fusion TB. In this report, local anesthesia, transperineal free-arm biopsy was performed, which can be carried out on a large calibration for outpatient or daytime patients. The operation time is approximately fifteen min and has the advantage of imparting a low risk of haemorrhage and infection. Patients by and large tolerate the process well, and the prostate can be punctured with no bullheaded spot.

In this report, the missed diagnosis rate of TB was slightly lower than that of SB, merely in that location was no significant deviation; both TB and SB missed approximately 10% of prostate cancers, and then TB + SB is currently the all-time way to perform prostate biopsy.

In the TB missed diagnosis grouping, a TB missed diagnosis was non significantly associated with patient age but was significantly associated with lower PSA, larger prostate volume, lower PSAD and lower ISUP grade, so early prostate cancer and big prostate volume were more likely to crusade TB missed diagnosis.

Among the 37 patients with TB missed diagnoses, the MRIs of 21 prostate cancers diagnosed by SB only showed no abnormalities, which is associated with the sensitivity of MRI; previous studies have concluded that MRI had higher sensitivity to high-hazard PCa and tumors longer than five mm in diameter [x]. The PCa areas sampled past SB in 9 patients were TB target areas, suggesting that TB did not hit the MRI target area. The possible reasons for this are equally follows: (i) Fusion error: unlike bladder filling state during MRI examination and biopsy, deformation acquired by insertion of rectal prostate probe, and operator's judgment of the datum plane can all bear upon the fusion of the MR and TRUS images. Consequently, the target lesion region displayed on the TRUS image will exist offset from the actual target lesion region on MRI, causing the actual target lesion to be missed. (2) Involuntary patient motility due to hurting and discomfort during biopsy [eleven], causing displayed target lesion deviation. (iii) The target lesion surface area shown on MRI contained both inflammation and cancer tissue, and merely the inflammation surface area was punctured, which resulted in a missed cancer diagnosis; (4) The target lesion was besides modest to puncture. To reduce the probability of a missed diagnosis for such patients, the following methods could be considered: (1) The patient should empty the float before MRI exam and biopsy. (2) The median sagittal plane (urethral airplane) should be used equally the datum plane for fusion. (three) The local anesthesia should exist improved by fully injecting the anesthetic into the area from the perineal skin to the noon region of the prostate, especially on both sides of the nerve vascular bundle. (4) Greater advice should be conducted with the patient before and during biopsy to ease the patient'due south feet. (5) Larger lesions should be sampled with a greater number of TB needles. (half dozen) The operator should have greater feel in puncturing, in detail, large prostates, small lesions, or lesions in difficult locations (pubic occlusion surface area, anterior urethral area, base of operations and noon), Pepe et al. [12] found that mpMRI increased the diagnosis of PCa located in the anterior zone of the prostate, where were contained in difficult locations. In the other vii patients, the PI-RADS scores were underestimated earlier biopsy, resulting in missed TB of actual PI-RADS 3 areas, which required a careful analysis of the MR images past MRI diagnostic doctors. Khosravi et al. [13] applied artificial intelligence (AI) to the evaluation of MR images and achieved good results. Through full communication between the radiologist and operator and puncturing all suspicious lesions, the positive rate of TB can be farther improved.

The ISUP form of TB and SB samples in the TB+ & SB+ group showed that TB achieved the highest grade in approximately 90% of patients. Prostate cancer is a multifocal tumor, which means there may be several cancer lesions in the prostate. Although every patient was diagnosed with prostate cancer in this group, 45 patients were SB-positive in the non-TB target areas, which means that they experienced missed diagnoses of their prostate cancer lesions. Comparing the missed lesions with the unmissed ones, it was found that the ISUP class of the TB unmissed lesions was significantly higher than that of the TB missed lesions. Baco et al. [14] suggested that the index lesion be divers as the tumor lesion with the highest Gleason score, or if two or more lesions had the same Gleason score, the index lesion should be defined every bit the largest lesion. Liu [15] found that index lesions promoted the progression of prostate cancer; therefore, TB probable missed secondary lesions and instead sampled lesions that dominated the overall affliction process. Comparing TB missed lesions with MRI in this subgroup and analyzing the causes of each lesion, nosotros constitute similar results to the TB missed group.

TB has the advantage of requiring fewer needles, and most of the missed lesions were early prostate cancer or secondary lesions. This is similar to the findings of Zhang et al. [16], who found that TB could increase the detection rate of clinically significant prostate cancer while reducing the number of needles. Missed clinically nonsignificant prostate cancer does not necessarily have serious consequences for patients [17]. However, the affliction will keep to progress, and these missed cases may filibuster the handling of some patients. Pepe et al. [18] reported that 16.2% clinically meaning prostate cancers missed by targeted fusion prostate biopsy and a PI-RADS score of 3 or greater. The aim of many existing prostate biopsy studies [19, 20] was to obtain the closest results to radical pathology, to avoid equally many missed diagnoses of prostate cancer as possible, and to obtain the true ISUP grade and range of lesions. Patients with clinically pregnant prostate cancer require positive treatment; patients with clinically nonsignificant prostate cancer can choose the about appropriate intervention or wait for observation according to his or her actual state of affairs and closely monitor the progress of prostate cancer. If a diagnosis is missed during biopsy for these patients, the best handling opportunity in the progression of the illness may exist lost.

The limitations of the present study include: this is a single-center retrospective written report; primary objective is diagnoses of any prostate cancer rather than clinically significant prostate cancer; RVS epitome fusion system is non organ tracking MRI-TRUS fusion system. The patient and/or prostate move during the biopsy, may significantly influence the precision of targeting. Farther, the registration in 3D prostate volume of each biopsy track is difficult to evaluate, consequently it is hard to confirm the existent location of the biopsy cores. If improved fusion system tin runway organ (prostate) and tape the real location of the biopsy cores, the MRI and biopsy findings could be correlated with pathologic large slice subsequently radical prostatectomy, farther written report volition help reduce missed diagnosis of prostate cancer more.

In summary, early prostate cancer, a large prostate, the result of local anesthesia, patient cooperation, MRI reading, and skill of the operator are possible causes of TB missed diagnoses. Improved imaging engineering, boosted biopsy experience, improved fusion system, and personalized biopsy plans will assistance exploit the advantages of TB and further improve the positive rate to that of existent prostate pathology.

Availability of information and materials

The datasets generated and analysed during the current report are non publicly available due to do not have consent from all patients to publish this data, only are available from the respective author on reasonable request.

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Acknowledgements

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Writer information

Writer notes

  1. Fan Zhang and Shun Zhang have contributed as to this piece of work as co-start authors.

Authors and Affiliations

  1. Department of Urology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, 321 Zhongshan Road, Nanjing, 210008, Jiangsu, China

    Fan Zhang, Shun Zhang, Haifeng Huang, Qing Zhang, Shengjie Zhang, Shiwei Zhang & Hongqian Guo

Contributions

FZ and SZ wrote the main manuscript text. FZ, HH and SZ completed prostate biopsy. FZ and QZ completed information statistics. HG and SZ designed and directed inquiry. All authors reviewed the manuscript. All authors read and approved the final manuscript.

Respective authors

Correspondence to Shiwei Zhang or Hongqian Guo.

Ethics declarations

Ethics blessing and consent to participate

The written report was approved past Nanjing Pulsate Belfry Infirmary, The Affilicated Hospital of Nanjing Academy Medical School Medical Ethics Committee of No. 2019-174. All patients have signed informed consent forms. All methods were performed following the relevant guidelines and regulations.

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Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Zhang, F., Zhang, S., Huang, H. et al. Analysis of the crusade of missed diagnosis in mpMRI/TRUS fusion-guided targeted prostate biopsy. BMC Urol 22, 74 (2022). https://doi.org/10.1186/s12894-022-01021-8

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Keywords

  • Transrectal ultrasound
  • Magnetic resonance
  • Prostate cancer
  • Targeted prostate biopsy
  • Missed diagnosis

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