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The purpose of prostate cancer screening is early detection, early diagnosis, and early treatment of prostate cancer in order to improve the curative effect and improve the prognosis
.
The current domestic screening strategy is to regularly detect prostate-specific antigen (PSA), and those with elevated PSA are referred to a qualified hospital for diagnosis, treatment and follow-up [1]
.
Different from the domestic prostate cancer screening program, the foreign structured prostate cancer screening (organized prostate cancer screening) adopts PSA detection followed by standard transrectal ultrasound-guided prostate biopsy, but this screening method can lead to excessive Biopsy and overdiagnosis
.
On September 2, 2021, the New England Journal of Medicine (NEJM) published a study on structured prostate cancer screening.
The results confirmed that in population screening, magnetic resonance imaging (MRI) is compared with standard biopsy.
Targeted biopsy combined with standard biopsy is not inferior to standard biopsy in detecting clinically significant prostate cancer, and the detection rate of clinically insignificant prostate cancer has decreased [2]
.
"NEJM Frontiers in Medicine" invites Professor Huang Xiaobo from Peking University People's Hospital to comment on this research in depth
.
To read the full translation of NEJM, please visit the official website, APP or WeChat applet of NEJM Medical Frontier
.
Huang Xiaobo, Peking University People’s Hospital Urology and Lithotripsy Center; Peking University Applied Lithotripsy Research Institute It is estimated that approximately 1.
4 million men are diagnosed with prostate cancer each year and 375,000 die from the disease
.
Prostate cancer is the second most common cancer in men and the fifth leading cause of cancer death in 2020 [3]
.
In the early 1990s, PSA was widely used in prostate cancer screening, and the number of diagnosed prostate cancer patients increased rapidly, and the mortality rate was reduced by 50% in the next 25 years [4]
.
However, the use of PSA testing combined with traditional biopsy screening may lead to over-diagnosis, thereby increasing unnecessary biopsies
.
Therefore, how to avoid over-diagnosis is a key issue in prostate cancer screening for large-scale populations
.
MRI combined with targeted biopsy has shown the potential to solve this problem [5], but its application in large-scale prostate cancer screening populations is still unclear
.
Study introduction: Non-inferiority trial based on large-scale population.
This study is a population-based non-inferiority trial for prostate cancer screening.
Men between the ages of 50 and 74 in the general population are invited to participate by e-mail, and the PSA level Subjects with ≥3 ng/mL were randomly divided into groups at a ratio of 2:3 and received standard biopsy (standard biopsy group) or MRI
.
If the MRI results suggest prostate cancer, perform targeted and standard biopsy (test biopsy group)
.
The main outcome of the trial was the detection rate of clinically significant prostate cancer (Gleason score ≥ 7) in the intention-to-treat population, and the secondary outcome was the detection rate of clinically non-significant prostate cancer (Gleason score 6)
.
Among 12,750 men, 1532 had a PSA level ≥3 ng/mL, of which 603 were assigned to the standard biopsy group and 929 were assigned to the experimental biopsy group
.
In the intention-to-treat population analysis, 192 men (21%) in the trial biopsy group were diagnosed with clinically significant prostate cancer, while 106 men (18%) in the standard biopsy group were diagnosed with clinically significant prostate cancer (two groups difference 3 percentage points; 95% CI, −1~7, non-inferiority P<0.
001; the non-inferiority threshold jointly established by urologists, oncologists and statisticians in this study is −4%)
.
In the experimental biopsy group, 41 men were diagnosed with clinically insignificant prostate cancer (4%), which was significantly lower than the standard biopsy group (12%); the difference between the two groups was −8 percentage points (95% CI, −11~− 5)
.
The proportion of benign biopsy results in the experimental biopsy group and standard biopsy group was 11% and 43%, respectively (a difference of −32 percentage points; 95% CI, −36 to −27)
.
The results of this study indicate that in a population-based screening test, patients with elevated PSA levels and MRI results suggesting that prostate cancer undergoes targeted and standard biopsy are not inferior to standard biopsy in detecting clinically significant prostate cancer.
And it reduces the detection rate of clinically insignificant prostate cancer
.
In addition, the author believes that, on the whole, the medical cost savings brought about by the reduction of excessive treatment can offset the additional cost of MRI examinations in the population
.
Thinking and extending Most MRI targeted biopsy studies have shown that compared with standard biopsy, the sensitivity of detecting clinically significant prostate cancer is higher [5]
.
These study populations were limited to men who underwent a biopsy for clinically suspected prostate cancer
.
This study is the largest prostate cancer screening test based on the general population so far; it is worth noting that the selected population in the study has a PSA ≥ 3 ng/mL, and then they are divided into standard biopsy group and experimental biopsy group
.
This is quite different from the indications of prostate puncture in our domestic clinical practice, and may be one of the reasons why this study led to the higher proportion of clinically insignificant prostate cancer in the standard biopsy group
.
Due to the limitations of domestic medical conditions, MRI fusion targeted puncture cannot be carried out on a large scale.
Most medical units still use systematic puncture or saturation puncture
.
Based on the above research results, the proportion of clinically insignificant prostate cancer diagnosed will be higher
.
This is mainly related to the Chinese people's awareness of panic about cancer
.
Most clinicians in China do not fully realize the significance of distinguishing between "clinically significant prostate cancer" and "clinically non-significant prostate cancer".
The awareness of active monitoring of clinically non-significant prostate cancer is weak, and patients and their families panic Awareness has further accelerated the overtreatment of clinically insignificant prostate cancer
.
The way to solve this problem is, on the one hand, to accelerate the application of clinical research to clinical practice
.
In recent years, studies on early localized prostate cancer found that during the 20-year follow-up period, there was no significant difference in the low-risk prostate cancer mortality between the radical prostatectomy group and the non-surgical observation group [6]
.
On the other hand, China should carry out multiple rounds of screening, strictly in accordance with the guidelines of the prostate puncture guidelines for screening
.
However, when the patient meets the indications for prostate puncture, whether to perform a 12-needle systemic puncture directly, or a systemic puncture combined with MRI targeted puncture, the ASIST study provides clinicians with a good answer: it should be necessary before confirming the puncture In MRI examination, for the lesions containing the prostate imaging report and data system (Prostate Imaging Reporting and Data System, PI-RADS) ≥ 3, systematic puncture combined with MRI targeted puncture is used to confirm the diagnosis [7]
.
China has not yet widely implemented MRI image fusion targeted puncture, but cognitive fusion targeted puncture does not require special equipment or software, which meets the basic domestic conditions and can be actively promoted
.
In summary, given the benefits of screening in clinical practice, patients, physicians, and policy makers need to weigh the benefits and harms of screening
.
The biggest harm of prostate cancer screening may be "over-detection" and subsequent long-term adverse effects related to treatment
.
References 1.
Prostate Cancer Group, Professional Committee of Urinary and Male Reproductive System Tumors, Chinese Anti-Cancer Association.
Chinese Expert Consensus on Prostate Cancer Screening (2021 Edition).
Chinese Journal of Cancer 2021;31:435-40.
2.
Eklund M, Jaderling F, Discacciati D et al.
MRI-targeted or standard biopsy in prostate cancer screening.
N Engl J Med 2021;385:908-20.
3.
Sung H, Ferlay J, Siegel RL, et al.
Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.
CA Cancer J Clin 2021;71:209-49.
4.
Hugosson J, Roobol MJ, Månsson M, et al.
A 16-yr follow-up of the European randomized study of screening for prostate cancer.
Eur Urol 2019;76:43-51.
5.
Kasivisvanathan V, Stabile A, Neves JB, et al.
Magnetic resonance imaging targeted biopsy versus systematic biopsy in the detection of prostate cancer: a systematic review and meta-analysis.
Eur Urol 2019;76:284-303.
6.
Wilt TJ, Jones KM, Barry MJ, et al.
Follow-up of prostatectomy versus observation for early prostate cancer.
N Engl J Med 2017;377:132-42.
7.
Klotz L, Pond G, Loblaw A, et al.
Randomized study of systematic biopsy versus magnetic resonance imaging and targeted and systematic biopsy in men on active surveillance (ASIST): 2-year post biopsy follow-up.
Eur Urol 2020;77:311-7.
Author introduction Huang Xiaobo, Professor, Doctoral Supervisor, Director of Urology and Lithotripsy Center, Peking University People’s Hospital, Beijing Director of the University Applied Crushed Stone Research Institute
.
Member of the Urology Branch of the Beijing Medical Association, member of the Standing Committee of the Urological Oncology Committee of the Beijing Oncology Society, member of the Evaluation Committee of Intermediate and Senior Professional Titles of the Ministry of Health, member of the Medical Malpractice Appraisal Committee of the Chinese Medical Association, and member of the Beijing Medical Malpractice Appraisal Committee
.
He has successively published more than 70 papers on clinical and related basic research on urinary calculi, kidney cancer and bladder cancer in core journals at home and abroad
.
At present, he leads the team to focus on the comprehensive development of clinical treatment of urinary stones and tumors, related clinical and basic research, and medical equipment research and development
.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by the Jiahui Medical Research and Education Group (J-Med) and the "New England Journal of Medicine" (NEJM)
.
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group
.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn
.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities
.
.
The current domestic screening strategy is to regularly detect prostate-specific antigen (PSA), and those with elevated PSA are referred to a qualified hospital for diagnosis, treatment and follow-up [1]
.
Different from the domestic prostate cancer screening program, the foreign structured prostate cancer screening (organized prostate cancer screening) adopts PSA detection followed by standard transrectal ultrasound-guided prostate biopsy, but this screening method can lead to excessive Biopsy and overdiagnosis
.
On September 2, 2021, the New England Journal of Medicine (NEJM) published a study on structured prostate cancer screening.
The results confirmed that in population screening, magnetic resonance imaging (MRI) is compared with standard biopsy.
Targeted biopsy combined with standard biopsy is not inferior to standard biopsy in detecting clinically significant prostate cancer, and the detection rate of clinically insignificant prostate cancer has decreased [2]
.
"NEJM Frontiers in Medicine" invites Professor Huang Xiaobo from Peking University People's Hospital to comment on this research in depth
.
To read the full translation of NEJM, please visit the official website, APP or WeChat applet of NEJM Medical Frontier
.
Huang Xiaobo, Peking University People’s Hospital Urology and Lithotripsy Center; Peking University Applied Lithotripsy Research Institute It is estimated that approximately 1.
4 million men are diagnosed with prostate cancer each year and 375,000 die from the disease
.
Prostate cancer is the second most common cancer in men and the fifth leading cause of cancer death in 2020 [3]
.
In the early 1990s, PSA was widely used in prostate cancer screening, and the number of diagnosed prostate cancer patients increased rapidly, and the mortality rate was reduced by 50% in the next 25 years [4]
.
However, the use of PSA testing combined with traditional biopsy screening may lead to over-diagnosis, thereby increasing unnecessary biopsies
.
Therefore, how to avoid over-diagnosis is a key issue in prostate cancer screening for large-scale populations
.
MRI combined with targeted biopsy has shown the potential to solve this problem [5], but its application in large-scale prostate cancer screening populations is still unclear
.
Study introduction: Non-inferiority trial based on large-scale population.
This study is a population-based non-inferiority trial for prostate cancer screening.
Men between the ages of 50 and 74 in the general population are invited to participate by e-mail, and the PSA level Subjects with ≥3 ng/mL were randomly divided into groups at a ratio of 2:3 and received standard biopsy (standard biopsy group) or MRI
.
If the MRI results suggest prostate cancer, perform targeted and standard biopsy (test biopsy group)
.
The main outcome of the trial was the detection rate of clinically significant prostate cancer (Gleason score ≥ 7) in the intention-to-treat population, and the secondary outcome was the detection rate of clinically non-significant prostate cancer (Gleason score 6)
.
Among 12,750 men, 1532 had a PSA level ≥3 ng/mL, of which 603 were assigned to the standard biopsy group and 929 were assigned to the experimental biopsy group
.
In the intention-to-treat population analysis, 192 men (21%) in the trial biopsy group were diagnosed with clinically significant prostate cancer, while 106 men (18%) in the standard biopsy group were diagnosed with clinically significant prostate cancer (two groups difference 3 percentage points; 95% CI, −1~7, non-inferiority P<0.
001; the non-inferiority threshold jointly established by urologists, oncologists and statisticians in this study is −4%)
.
In the experimental biopsy group, 41 men were diagnosed with clinically insignificant prostate cancer (4%), which was significantly lower than the standard biopsy group (12%); the difference between the two groups was −8 percentage points (95% CI, −11~− 5)
.
The proportion of benign biopsy results in the experimental biopsy group and standard biopsy group was 11% and 43%, respectively (a difference of −32 percentage points; 95% CI, −36 to −27)
.
The results of this study indicate that in a population-based screening test, patients with elevated PSA levels and MRI results suggesting that prostate cancer undergoes targeted and standard biopsy are not inferior to standard biopsy in detecting clinically significant prostate cancer.
And it reduces the detection rate of clinically insignificant prostate cancer
.
In addition, the author believes that, on the whole, the medical cost savings brought about by the reduction of excessive treatment can offset the additional cost of MRI examinations in the population
.
Thinking and extending Most MRI targeted biopsy studies have shown that compared with standard biopsy, the sensitivity of detecting clinically significant prostate cancer is higher [5]
.
These study populations were limited to men who underwent a biopsy for clinically suspected prostate cancer
.
This study is the largest prostate cancer screening test based on the general population so far; it is worth noting that the selected population in the study has a PSA ≥ 3 ng/mL, and then they are divided into standard biopsy group and experimental biopsy group
.
This is quite different from the indications of prostate puncture in our domestic clinical practice, and may be one of the reasons why this study led to the higher proportion of clinically insignificant prostate cancer in the standard biopsy group
.
Due to the limitations of domestic medical conditions, MRI fusion targeted puncture cannot be carried out on a large scale.
Most medical units still use systematic puncture or saturation puncture
.
Based on the above research results, the proportion of clinically insignificant prostate cancer diagnosed will be higher
.
This is mainly related to the Chinese people's awareness of panic about cancer
.
Most clinicians in China do not fully realize the significance of distinguishing between "clinically significant prostate cancer" and "clinically non-significant prostate cancer".
The awareness of active monitoring of clinically non-significant prostate cancer is weak, and patients and their families panic Awareness has further accelerated the overtreatment of clinically insignificant prostate cancer
.
The way to solve this problem is, on the one hand, to accelerate the application of clinical research to clinical practice
.
In recent years, studies on early localized prostate cancer found that during the 20-year follow-up period, there was no significant difference in the low-risk prostate cancer mortality between the radical prostatectomy group and the non-surgical observation group [6]
.
On the other hand, China should carry out multiple rounds of screening, strictly in accordance with the guidelines of the prostate puncture guidelines for screening
.
However, when the patient meets the indications for prostate puncture, whether to perform a 12-needle systemic puncture directly, or a systemic puncture combined with MRI targeted puncture, the ASIST study provides clinicians with a good answer: it should be necessary before confirming the puncture In MRI examination, for the lesions containing the prostate imaging report and data system (Prostate Imaging Reporting and Data System, PI-RADS) ≥ 3, systematic puncture combined with MRI targeted puncture is used to confirm the diagnosis [7]
.
China has not yet widely implemented MRI image fusion targeted puncture, but cognitive fusion targeted puncture does not require special equipment or software, which meets the basic domestic conditions and can be actively promoted
.
In summary, given the benefits of screening in clinical practice, patients, physicians, and policy makers need to weigh the benefits and harms of screening
.
The biggest harm of prostate cancer screening may be "over-detection" and subsequent long-term adverse effects related to treatment
.
References 1.
Prostate Cancer Group, Professional Committee of Urinary and Male Reproductive System Tumors, Chinese Anti-Cancer Association.
Chinese Expert Consensus on Prostate Cancer Screening (2021 Edition).
Chinese Journal of Cancer 2021;31:435-40.
2.
Eklund M, Jaderling F, Discacciati D et al.
MRI-targeted or standard biopsy in prostate cancer screening.
N Engl J Med 2021;385:908-20.
3.
Sung H, Ferlay J, Siegel RL, et al.
Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.
CA Cancer J Clin 2021;71:209-49.
4.
Hugosson J, Roobol MJ, Månsson M, et al.
A 16-yr follow-up of the European randomized study of screening for prostate cancer.
Eur Urol 2019;76:43-51.
5.
Kasivisvanathan V, Stabile A, Neves JB, et al.
Magnetic resonance imaging targeted biopsy versus systematic biopsy in the detection of prostate cancer: a systematic review and meta-analysis.
Eur Urol 2019;76:284-303.
6.
Wilt TJ, Jones KM, Barry MJ, et al.
Follow-up of prostatectomy versus observation for early prostate cancer.
N Engl J Med 2017;377:132-42.
7.
Klotz L, Pond G, Loblaw A, et al.
Randomized study of systematic biopsy versus magnetic resonance imaging and targeted and systematic biopsy in men on active surveillance (ASIST): 2-year post biopsy follow-up.
Eur Urol 2020;77:311-7.
Author introduction Huang Xiaobo, Professor, Doctoral Supervisor, Director of Urology and Lithotripsy Center, Peking University People’s Hospital, Beijing Director of the University Applied Crushed Stone Research Institute
.
Member of the Urology Branch of the Beijing Medical Association, member of the Standing Committee of the Urological Oncology Committee of the Beijing Oncology Society, member of the Evaluation Committee of Intermediate and Senior Professional Titles of the Ministry of Health, member of the Medical Malpractice Appraisal Committee of the Chinese Medical Association, and member of the Beijing Medical Malpractice Appraisal Committee
.
He has successively published more than 70 papers on clinical and related basic research on urinary calculi, kidney cancer and bladder cancer in core journals at home and abroad
.
At present, he leads the team to focus on the comprehensive development of clinical treatment of urinary stones and tumors, related clinical and basic research, and medical equipment research and development
.
Copyright information This article was translated, written or commissioned by the "NEJM Frontiers of Medicine" jointly created by the Jiahui Medical Research and Education Group (J-Med) and the "New England Journal of Medicine" (NEJM)
.
The Chinese translation of the full text and the included diagrams are exclusively authorized by the NEJM Group
.
If you need to reprint, please leave a message or contact nejmqianyan@nejmqianyan.
cn
.
Unauthorized translation is an infringement, and the copyright owner reserves the right to pursue legal liabilities
.
