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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.4011

摘要内容如下：

重要性

前列腺癌PSA检测的集群随机试验（CAP）报道，在中位10年随访（主要结果）中，前列腺特异性抗原（PSA）筛查对前列腺癌死亡率没有影响，但PSA筛查对前列腺癌死亡率的长期影响尚不清楚。

目的

在中位随访15年时，评估单次邀请PSA筛查与未邀请筛查相比对前列腺癌特异性死亡率的影响。

设计、设置和参与者

CAP随机临床试验的二次分析纳入了英格兰和威尔士573家初级保健诊所中50至69岁的男性。在2001年9月25日至2007年8月24日期间，对初级保健实践进行随机分组，并在2002年1月8日至2009年1月20日期间招募男性。随访于2021年3月31日完成。

干预

如果PSA水平为3.0 ng/mL或更高，男性只需接受一次PSA筛查测试，随后进行诊断测试。对照组接受标准做法（无邀请）。

主要成果和措施

主要结果已有报道。在8个预先指定的次要结果中，有4个结果是以前报告的。在15年的随访中，剩下的4个预先指定的次要结果是前列腺癌特异性死亡率、全因死亡率、诊断时的前列腺癌分期和Gleason分级。

结果

在415357名符合条件的男性（平均[SD]年龄为59.0[5.6]岁）中，98%被纳入这些分析。总体而言，干预组和对照组分别有12013名和12958名诊断为前列腺癌的男性（15年累积风险分别为7.08%[95%CI，6.95%-7.21%]和6.94%[95%CI，6.82%-7.06%]）。在中位数为15年的随访中，干预组有1199名男性（0.69%[95%CI，0.65%-0.73%]）和对照组有1451名男性（0.78%[95%CI，0.73%-0.82%]）死于前列腺癌（比率[RR]，0.92[95%CI，0.85-0.99]；P=.03）。与对照组相比，PSA筛查干预增加了低级别（Gleason评分[GS]≤6分:2.2%vs 1.6%；P<.001）和局部（T1/T2:3.6%vs 3.1%；P<.001），但不包括中度（GS 7）、高度（GS≥8）、局部晚期（T3）或远端晚期（T4/N1/M1）肿瘤。干预组全因死亡45084例（23.2%[95%CI，23.0%-23.4%]），对照组全因死亡50336例（23.3%[95%CI，23.1%-23.5%]）（RR，0.97[95%CI，0.94-1.01]；P=.11）。干预组的8例前列腺癌死亡（0.7%）和对照组的7例死亡（0.5%）与诊断性活检或前列腺癌治疗有关。

结论和相关性

在这项随机临床试验的二次分析中，在中位随访时间为15年时，与没有常规筛查的标准实践相比，单次邀请PSA筛查降低了前列腺癌死亡率。然而，死亡人数的绝对下降幅度很小。

试用注册

ISRCTN.org标识符：ISRCTN92187251。

英文原文如下：

Abstracts

Importance  The Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP) reported no effect of prostate-specific antigen (PSA) screening on prostate cancer mortality at a median 10-year follow-up (primary outcome), but the long-term effects of PSA screening on prostate cancer mortality remain unclear.

Objective  To evaluate the effect of a single invitation for PSA screening on prostate cancer-specific mortality at a median 15-year follow-up compared with no invitation for screening.

Design, Setting, and Participants  This secondary analysis of the CAP randomized clinical trial included men aged 50 to 69 years identified at 573 primary care practices in England and Wales. Primary care practices were randomized between September 25, 2001, and August 24, 2007, and men were enrolled between January 8, 2002, and January 20, 2009. Follow-up was completed on March 31, 2021.

Intervention  Men received a single invitation for a PSA screening test with subsequent diagnostic tests if the PSA level was 3.0 ng/mL or higher. The control group received standard practice (no invitation).

Main Outcomes and Measures  The primary outcome was reported previously. Of 8 prespecified secondary outcomes, results of 4 were reported previously. The 4 remaining prespecified secondary outcomes at 15-year follow-up were prostate cancer-specific mortality, all-cause mortality, and prostate cancer stage and Gleason grade at diagnosis.

Results  Of 415 357 eligible men (mean [SD] age, 59.0 [5.6] years), 98% were included in these analyses. Overall, 12 013 and 12 958 men with a prostate cancer diagnosis were in the intervention and control groups, respectively (15-year cumulative risk, 7.08% [95% CI, 6.95%-7.21%] and 6.94% [95% CI, 6.82%-7.06%], respectively). At a median 15-year follow-up, 1199 men in the intervention group (0.69% [95% CI, 0.65%-0.73%]) and 1451 men in the control group (0.78% [95% CI, 0.73%-0.82%]) died of prostate cancer (rate ratio [RR], 0.92 [95% CI, 0.85-0.99]; P = .03). Compared with the control, the PSA screening intervention increased detection of low-grade (Gleason score [GS] ≤6: 2.2% vs 1.6%; P < .001) and localized (T1/T2: 3.6% vs 3.1%; P < .001) disease but not intermediate (GS of 7), high-grade (GS ≥8), locally advanced (T3), or distally advanced (T4/N1/M1) tumors. There were 45 084 all-cause deaths in the intervention group (23.2% [95% CI, 23.0%-23.4%]) and 50 336 deaths in the control group (23.3% [95% CI, 23.1%-23.5%]) (RR, 0.97 [95% CI, 0.94-1.01]; P = .11). Eight of the prostate cancer deaths in the intervention group (0.7%) and 7 deaths in the control group (0.5%) were related to a diagnostic biopsy or prostate cancer treatment.

Conclusions and Relevance  In this secondary analysis of a randomized clinical trial, a single invitation for PSA screening compared with standard practice without routine screening reduced prostate cancer deaths at a median follow-up of 15 years. However, the absolute reduction in deaths was small.

Trial Registration  isrctn.org Identifier: ISRCTN92187251.

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