■前列腺特异性抗原(PSA)筛查具有降低前列腺癌死亡率的潜力,但经常发现临床上不重要的前列腺癌。
为了描述被邀请参加由PSA测试组成的前列腺癌筛查方案的男性中确定的低级别(1级)和高级别(2-5级)前列腺癌的发生率,一个4-kallikrein面板,和磁共振成像(MRI)扫描。
■ProScreen试验是在赫尔辛基和坦佩雷进行的临床试验,芬兰,在2018年2月至2020年7月期间,以1:3的比例对61193名年龄在50岁至63岁之间无前列腺癌的男性进行了随机分组,邀请或不邀请他们接受前列腺癌筛查.
■随机参加干预的男性接受PSA测试。PSA水平为3.0ng/mL或更高的患者接受了4-激肽释放酶组风险评分的高级别前列腺癌的额外测试。激肽释放酶组评分为7.5%或更高的患者接受了前列腺MRI检查,然后对前列腺MRI异常的患者进行有针对性的活检。最终数据收集进行到2023年6月31日。
■在描述性探索性分析中,我们比较了接受前列腺癌筛查的组和对照组在第一轮筛查后低级别和高级别前列腺癌的累积发病率.
■60745名符合条件的男性(平均[SD]年龄,57.2[4.0]年),15201被随机邀请接受前列腺癌筛查,45544被随机不邀请接受前列腺癌筛查。在被邀请接受筛查的15201名合格男性中,7744(51%)参加。其中,32例低级别前列腺癌(累积发病率,0.41%)和128例高级别前列腺癌(累积发病率,1.65%)被检测到,1个癌症等级组结果缺失。在拒绝参加的7457名受邀男子(49%)中,7种低度前列腺癌(累积发病率,0.1%)和44例高级别前列腺癌(累积发病率,0.6%)被检测到,缺少7个癌症等级组。对于整个受邀筛选小组来说,39例低级别前列腺癌(累积发病率,0.26%)和172例高级别前列腺癌(累积发病率,1.13%)被检出。在平均3.2年的随访中,在未被邀请接受筛查的小组中,65例低级别前列腺癌(累积发病率,0.14%)和282例高级别前列腺癌(累积发病率,0.62%)被检出。随机分配到筛选邀请组的整个组与对照组的风险差异对于低级别癌症为0.11%(95%CI,0.03%-0.20%),对于高级别癌症为0.51%(95%CI,0.33%-0.70%)。
■在这项正在进行的随机临床试验的初步描述性报告中,在随机邀请接受单一前列腺癌筛查干预的人群中,每196名男性中检测到1名高级别癌症,每909名男性中检测到1名低级别癌症。这些单轮筛查的初步结果应该谨慎解释,研究主要死亡率结局的待定结果。
■ClinicalTrials.gov标识符:NCT03423303。
Prostate-specific antigen (PSA) screening has potential to reduce prostate cancer mortality but frequently detects prostate cancer that is not clinically important.
To describe rates of low-grade (grade group 1) and high-grade (grade groups 2-5) prostate cancer identified among men invited to participate in a prostate cancer screening protocol consisting of a PSA test, a 4-kallikrein panel, and a magnetic resonance imaging (MRI) scan.
The ProScreen trial is a clinical trial conducted in Helsinki and Tampere, Finland, that randomized 61 193 men aged 50 through 63 years who were free of prostate cancer in a 1:3 ratio to either be invited or not be invited to undergo screening for prostate cancer between February 2018 and July 2020.
Participating men randomized to the intervention underwent PSA testing. Those with a PSA level of 3.0 ng/mL or higher underwent additional testing for high-grade prostate cancer with a 4-kallikrein panel risk score. Those with a kallikrein panel score of 7.5% or higher underwent an MRI of the prostate gland, followed by targeted biopsies for those with abnormal prostate gland MRI findings. Final data collection occurred through June 31, 2023.
In descriptive exploratory analyses, the cumulative incidence of low-grade and high-grade prostate cancer after the first screening round were compared between the group invited to undergo prostate cancer screening and the control group.
Of 60 745 eligible men (mean [SD] age, 57.2 [4.0] years), 15 201 were randomized to be invited and 45 544 were randomized not to be invited to undergo prostate cancer screening. Of 15 201 eligible males invited to undergo screening, 7744 (51%) participated. Among them, 32 low-grade prostate cancers (cumulative incidence, 0.41%) and 128 high-grade prostate cancers (cumulative incidence, 1.65%) were detected, with 1 cancer grade group result missing. Among the 7457 invited men (49%) who refused participation, 7 low-grade prostate cancers (cumulative incidence, 0.1%) and 44 high-grade prostate cancers (cumulative incidence, 0.6%) were detected, with 7 cancer grade groups missing. For the entire invited screening group, 39 low-grade prostate cancers (cumulative incidence, 0.26%) and 172 high-grade prostate cancers (cumulative incidence, 1.13%) were detected. During a median follow-up of 3.2 years, in the group not invited to undergo screening, 65 low-grade prostate cancers (cumulative incidence, 0.14%) and 282 high-grade prostate cancers (cumulative incidence, 0.62%) were detected. The risk difference for the entire group randomized to the screening invitation vs the control group was 0.11% (95% CI, 0.03%-0.20%) for low-grade and 0.51% (95% CI, 0.33%-0.70%) for high-grade cancer.
In this preliminary descriptive report from an ongoing randomized clinical trial, 1 additional high-grade cancer per 196 men and 1 low-grade cancer per 909 men were detected among those randomized to be invited to undergo a single prostate cancer screening intervention compared with those not invited to undergo screening. These preliminary findings from a single round of screening should be interpreted cautiously, pending results of the study\'s primary mortality outcome.
ClinicalTrials.gov Identifier: NCT03423303.