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ORIGINAL ARTICLE
Year : 2020  |  Volume : 16  |  Issue : 7  |  Page : 1698-1702

Is targeted magnetic resonance imaging/transrectal ultrasound fusion prostate biopsy enough for the detection of prostate cancer in patients with PI-RADS ≥3: Results of a prospective, randomized clinical trial


1 Department of Nephrology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China
2 Department of Urology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China

Date of Submission11-Oct-2020
Date of Decision22-Nov-2020
Date of Acceptance19-Jan-2021
Date of Web Publication9-Feb-2021

Correspondence Address:
Keqin Zhang
Department of Urology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong
China
Qiang Fu
Department of Urology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jcrt.JCRT_1495_20

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 > Abstract 


Objective: To evaluate targeted magnetic resonance imaging/transrectal ultrasound (MRI/TRUS) fusion prostate biopsy versus systematic prostate biopsy and the two approaches combined for the detection of prostate cancer (PCa) and clinically significant PCa (csPCa) in our center.
Patients and Methods: From September 2018 to June 2020, a total of 161 patients with PI-RADS ≥3 were enrolled in this study. They were randomly to undergo either systematic prostate biopsy (systematic group) or targeted MRI/TRUS fusion prostate biopsy + systematic prostate biopsy (combined group). The clinical data and pathological results of biopsies were analyzed.
Results: The detection rate of PCa by targeted MRI/TRUS fusion prostate biopsy was higher than systematic prostate biopsy (38/81 vs. 33/81) in combinated group, but there was no significantly difference. The PCa detection rate in combinated group was significantly higher than systematic group (47/81 vs. 34/80, P = 0.049). There were 40 patients in combinated group and 22 patients in systematic group diagnosed as csPCa, respectively. The ratio of detected csPCa was much higher in combinated group (P = 0.032). In Gleason score no more than 6, the detected ratio of targeted MRI/TRUS fusion prostate biopsy was significantly lower than systematic biopsies in combinated group (P = 0.044). While, in Gleason score higher than 6, the detected ratios of targeted MRI/TRUS fusion prostate biopsy were all higher than systematic biopsies.
Conclusions: Among patients with PI-RADS ≥ 3, targeted MRI/TRUS fusion prostate biopsy is superior to systematic prostate biopsy in the detection rate of PCa and csPCa, but it still misses some PCa patients, including csPCa. Combining targeted MRI/TRUS fusion prostate biopsy and systematic prostate biopsy can led to more detection of all PCas, especially csPCa.

Keywords: Fusion image, magnetic resonance imaging, prostate biopsy, prostate cancer, transperineal


How to cite this article:
Zhang J, Zhu A, Sun D, Guo S, Zhang H, Liu S, Fu Q, Zhang K. Is targeted magnetic resonance imaging/transrectal ultrasound fusion prostate biopsy enough for the detection of prostate cancer in patients with PI-RADS ≥3: Results of a prospective, randomized clinical trial. J Can Res Ther 2020;16:1698-702

How to cite this URL:
Zhang J, Zhu A, Sun D, Guo S, Zhang H, Liu S, Fu Q, Zhang K. Is targeted magnetic resonance imaging/transrectal ultrasound fusion prostate biopsy enough for the detection of prostate cancer in patients with PI-RADS ≥3: Results of a prospective, randomized clinical trial. J Can Res Ther [serial online] 2020 [cited 2021 Feb 28];16:1698-702. Available from: https://www.cancerjournal.net/text.asp?2020/16/7/1698/308762

Zhang Jing and Zhu Aiyun contributed equal to the paper.





 > Introduction Top


Prostate cancer (PCa) ranks as the second most frequently diagnosed cancer in men worldwide, and its incidence in China is increasing year by year.[1] The mortality rate of PCa is decreasing in developed countries while is rising in China. Because of lack of advanced diagnostic technology, the majority of PCa patients in China are diagnosed at an advanced stage.[2] Many PCa patients lost the chance of radical prostatectomy. Early diagnosis is the key to improve PCa patients' survival in China.

Pathologic diagnosis is the gold standard for PCa. At present, transrectal ultrasound (TRUS)-guided prostate biopsy, as a most used systematic prostate biopsy, is the routine method for the initial diagnosis of PCa in China. TRUS-guide prostate biopsy can miss 40%–50% of prostate cases, with a relevant number of significant tumors, especially in large glands.[3] Despite the continuous development of ultrasound technology, the sensitivity of ultrasound to PCa is still low. The misdiagnosis of clinically significant PCa (csPCa) and overdetection of clinically insignificant PCa are the major drawbacks of TRUS-guided prostate biopsy.[4],[5]

Multiparametric magnetic resonance imaging (MRI) is regarded as the best imaging modality in detecting PCa, which has sensitivity 58%–96% and negative predictive value of 63%–98% with specificity 23%–87%.[6] Currently, targeted MRI/TRUS fusion prostate biopsy has been widely performed in developed countries due to its high accuracy and ease of operation, but it is in still rare in China because of professional equipment and high cost. Most studies found that targeted MRI/TRUS fusion prostate biopsy could improve the rate of PCa detection compared to TRUS-guided prostate biopsy, especially in csPCa detection. Is systematic prostate biopsy no longer to be needed? There is controversy about whether to combine the systematic prostate biopsy or not.[7],[8] Based on these findings, we conducted a prospective randomized study to assess the value of targeted MRI/TRUS fusion prostate biopsy versus systematic prostate biopsy and the two approaches combined for the detection of PCa and csPCa in patients with PI-RADSsn.


 > Patients and Methods Top


Patients

We conducted a prospective, randomized study between September 2018 and June 2020. Patients were recruited in outpatient clinics, among patients referred for suspicion of PCa on the basis of increased prostate-specific antigen (PSA) concentration, abnormal digital rectal examination (DRE), or abnormal TRUS examination. Eligible men had no history of prostate biopsy, were aged between 18 and 75 years, had a PSA concentration of 50 ng/ml or less, had a DRE that did not suggest extracapsular (T3) disease (i.e., all patients had PCa stage eT2c), were suitable candidates for biopsy of the prostate and for multiparametric MRI, and had no history of hip prosthesis, androgen deprivation therapy, pelvic radiotherapy, or PCa diagnosed after transurethral resection of the prostate.

All patients underwent MRI on a 3.0-T MRI in the radiology department of our hospital. Three experienced radiologists interpreting prostate MRI performed independent review based on PI–RADS v2 score and formed consensus reads of all studies in this series. Of these patients, a total of 161 patients with PI-RADSs were enrolled in this study. These patients were randomized in a 1:1 ratio to undergo either systematic prostate biopsy (systematic group) or targeted MRI/TRUS fusion prostate biopsy + systematic prostate biopsy (combined group) by means of a random number table. A total of 80 patients with a mean age of 64.44±5.40 years were randomized to undergo systematic prostate biopsy (SG) and 81 with a mean age of 65.15±5.80 years underwent combining prostate biopsies group (CG) (P=0.423). This study was approved by our hospital ethics committee. Informed consent of all patients was obtained.

Biopsy protocol

The patients were placed in the lithotomy position under spinal or general anesthesia. A Foley catheter was left in situ overnight because spinal or general anesthesia was used. All biopsies were performed with TRUS guidance system (BK-3000, Herlev, Denmark). All procedures were performed by two experienced urologists (K Zhang and D Sun). In combined group, suspect lesions were previously contoured and recorded by our radiologists. Two core targeted MRI/TRUS fusion prostate biopsies were taken from every suspect lesion performed by K Zhang. Second, 12 core transperineal free-hand systematic prostate biopsies[9] were performed by D Sun who remained blinded to the MRI images and report. With this approach, 8 biopsy specimens were obtained systematically from the peripheral zone, including the apex and four from the transition zone. In systematic group, 12 core transperineal free-hand systematic prostate biopsies were performed by D Sun who still remained blinded to the MRI images and report. An 18G needle with a cutting length of 22 mm was used to obtain specimens. All biopsies were analyzed by two experienced pathologists. Significant cancer was defined as those with at least one core with a Gleason score of 3 + 4, or a score of 6 with a maximum cancer core length 4 mm.[10]

Statistical analysis

All relevant data were depicted and statistically analyzed. Statistical analysis was performed using the SPSS 17 statistical software package (SPSS Statistics 17.0.1, Chicago, USA). The measurement data were expressed as mean and standard deviation. The measurement data were compared with the two-sample t-test for independent samples between the two groups. Categorical data were compared with the Chi-square test or Fisher's exact probability test. P < 0.05 was considered statistically significant.


 > Results Top


[Table 1] summarizes the characteristics of the two groups. None of the baseline parameters was significantly different between the two groups; these parameters include age, body mass index, PSA level, prostate volume, PSA density, and the rate of anomaly in DRE and TRUS.
Table 1: Patient characteristics

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Comparison of the positive (detected PCa) and negative (undetected PCa) results of CG and SG is shown in [Table 2]. The detection rate of PCa by targeted MRI/TRUS fusion prostate biopsy was higher than systematic prostate biopsy (38/81 vs. 33/81) in combinated group, but there was no significantly difference. The PCa detection rate in combinated group was significantly higher than systematic group (47/81 vs. 34/80, P = 0.049).
Table 2: Comparison the detection of the positive and negative results of systematic prostate biopsy and combining prostate biopsies group

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Comparison of the detected rate of csPCa between two groups is shown in [Figure 1]. There were 40 patients in combined group and 22 patients in systematic group diagnosed as csPCa, respectively. The ratio of detected csPCa was much higher in combinated group (P = 0.004).
Figure 1: Comparison of the detected rate of csPCa between two groups. There were 40 patients in combinated group and 22 patients in systematic group diagnosed as csPCa, respectively. The ratio of detected csPCa was much higher in combined group (P = 0.004, Chi-square test)

Click here to view


[Table 3] shown pathologic results between different biopsy approaches in combinated group. In Gleason score no more than 6, the detected ratio of targeted MRI/TRUS fusion prostate biopsy was significantly lower than systematic prostate biopsy (P = 0.044). While, in Gleason score higher than 6, the detected ratios of targeted MRI/TRUS fusion prostate biopsy were all higher than systematic prostate biopsy.
Table 3: The pathologic results between different biopsy approaches in combining prostate biopsies group

Click here to view



 > Discussion Top


In this study, all the patients underwent MRI, not only patients with targeted MRI/TRUS fusion prostate biopsy, which was different from most previous studies. This can better ensure the consistency of the two groups of patients, and the results are more convicting. Meanwhile, we not only compared the results of combined group and systematic group, but also compared the difference between targeted MRI/TRUS fusion prostate biopsy and systematic prostate biopsy in combined group. The major findings of the present study are as follows: (1) The PCa detection rate of combined group was significantly higher than systematic group, (2) The csPCa detection rate was significantly higher in combined group compared with systematic group, and (3) the targeted MRI/TRUS fusion prostate biopsy is superior to systematic prostate biopsy in the detection rate of PCa and csPCa, but it still misses some PCa patients, including csPCa.

Our study found that the PCa detection rate of combined group was significantly higher than systematic group. TRUS prostate biopsy has become a widely accepted, routinely performed technique for PCa detection, which is simple and does not require additional equipment. However, this procedure has limitations related to the low detection rate described in the literature, which can miss 40%–50% of PCa cases.[3] TRUS prostate biopsy includes transrectal and transperineal approaches. Although several studies have demonstrated that the transrectal prostate biopsy is a faster and convenient approach, it has been reported to cause severe complications such as fever, sepsis, rectal bleeding or other complications requiring admission compared with the transperineal biopsy.[11] More importantly, an increasing risk of septic shock was reported in the transrectal biopsy, which might be life-threatening.[12] Furthermore, transrectal prostate biopsy can miss more PCa located at the anterior zone of the prostate.[13] Recently, transperineal prostate biopsy has been becoming an increasingly popular approach for detecting PCa because of its safety. Previous study found that the detection rate of PCa by targeted MRI/TRUS fusion prostate biopsy was similar with systematic prostate biopsy. Other studies thought combinated both techniques could improve the detection of PCa and systematic biopsy was still needed.[14],[15] In this study, the detection rate of PCa by targeted MRI/TRUS fusion prostate biopsy was higher than systematic prostate biopsy (38/81 vs. 33/81) in combined group, but there was no significantly difference. The detection rate of combined group was significantly higher than that of systematic group (47/81 vs. 34/80, P = 0.049). What is the reason? PCa is multifocal, and multiparametric MRI could not detect all lesions. We think systematic prostate biopsy is indispensable and important for the detection of PCa, especially transperineal biopsy, whose complications are rare and mild.

Our study showed that the csPCa detection rate of combined group was significantly higher than systematic group and could miss some cases at the same time. Not all PCa needs to be treated. It is proved that men with clinical insignificant cancer do not benefit from the treatment. Only men with csPCa are in urgent need of treatment. Hence, how to improve the detection of csPCa is the focus of prostate biopsy. Increasing evidences showed that the multiparametric MRI had the most favorable diagnostic accuracy in csPCa detection and increased the number of significant cancer detected while reducing the number of insignificant cancer diagnosed compared to systematic prostate biopsy.[16],[17] Some studies found that targeted MRI/TRUS fusion prostate biopsy has shown similar or higher rates of detection of csPCa and lower rates of detection of clinically insignificant cancer compared with systematic prostate biopsy.[18],[19],[20] Our results showed that the detection rate of csPCa by targeted MRI/TRUS fusion prostate biopsy was higher than systematic prostate biopsy (37/81 vs. 27/81) and the detection rate of clinically insignificant PCa by targeted prostate biopsy was lower than systematic prostate biopsy (1/81 vs. 6/81) in combined group, but there was no significantly difference (P = 0.108, 0.053 respectively). Is systematic prostate biopsy useless in detecting csPCa? Is targeted MRI/TRUS fusion prostate biopsy enough for the detection of csPCa? Our results disagreed with these. Three patients with csPCa were undetected by targeted MRI/TRUS fusion prostate biopsy while detected by systematic prostate biopsy. Meanwhile, our study found that the detection rate of csPCa in combined group was significantly higher than in systematic group (40/81 vs. 22/80, P = 0.004). The detection rate of clinically insignificant PCa in combined group was lower than that in systematic group (7/81 vs. 12/80 P = 0.211). Hence, we think combined both techniques can improve the detection of csPCa, which was agreed with the previous studies.[21],[22]

The limitations of this study are the single-center sample size, the small sample size, and lack of power calculation. Multicentre large sample studies are required to validate these results.


 > Conclusions Top


Among patients with PI-RADSsO, targeted MRI/TRUS fusion prostate biopsy is superior to systematic prostate biopsy in the detection rate of PCa and csPCa, but it still misses some PCa patients, including csPCa. Systematic prostate biopsy is indispensable and important. Combining targeted MRI/TRUS fusion prostate biopsy and systematic prostate biopsy can led to more detection of all PCa s, especially csPCa.

Financial support and sponsorship

This work was supported by the Jinan Science and Technology Plan (201907062).

Conflicts of interest

There are no conflicts of interest.



 
 > References Top

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  [Table 1], [Table 2], [Table 3]



 

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