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Prostate Cancer Screening (PDQ®): Screening - Health Professional Information [NCI] - Evidence of Benefit

Summary of First Four Prostate, Lung, Colorectal, and Ovarian Screening Roundsa

DRE = digital rectal exam; PSA = prostate-specific antigen; T = tumor.
a Adapted from Grubb et al.[46]
 T0 (Baseline)T1T2T3
Number Tested (PSA or DRE)34,26232,69631,69730,544
PSA positive (>4 ng/mL) (%)7.97.78.28.8
DRE positive (%)7.26.87.37.6
Either test positive (%)14.013.514.415.1
Biopsies and Cancers    
PSA >4 ng/mL2,7182,5022,5932,676
Cancers487308270281
Cancers/1,000 screened14.29.48.59.3
DRE abnormal and PSA ≤4 ng/mL2,0831,9231,9731,943
Cancers62677157
Cancers/1,000 screened1.82.12.31.9
PSA >4 ng/mL or DRE abnormal4,8014,4254,5664,619
Cancers549375341338
Cancers/1,000 screened16.011.510.811.1

After 7 years of follow-up, with vital status known for 98% of men, the incidence of prostate cancer per 10,000 person-years was 116 (2,820 cancers) in the screening group and 95 (2,322 cancers) in the control group (rate ratio, 1.22; 95% CI, 1.16–1.29). The incidence of death per 10,000 person-years was 2.0 (50 deaths) in the screening group and 1.7 (44 deaths) in the control group (rate ratio, 1.13; 95% CI, 0.75–1.70). The data at 10 years were 67% complete and consistent with these overall findings (incidence rate ratio, 1.17; 95% CI, 1.11–1.22 and mortality rate ratio, 1.11; 95% CI, 0.83–1.50). Thus, after 7 to 10 years of follow-up, the rate of death from prostate cancer was very low and did not differ significantly between the two study groups.

At 7 years, the total numbers of deaths (excluding those from prostate, lung, or colorectal cancers) were 2,544 in the screening group and 2,596 in the control group (rate ratio, 0.98; 95% CI, 0.92–1.03); at 10 years, the numbers of such deaths were 3,953 and 4,058, respectively (rate ratio, 0.97; 95% CI, 0.93–1.01). The distribution of the causes of death was similar in the two groups.

The following are several possible explanations for the lack of a reduction in mortality so far in this trial:

  • Annual screening with the PSA test using the standard U.S. threshold of 4 ng per mL and DRE to trigger diagnostic evaluation may not be effective.
  • The level of screening in the control group could have been substantial enough to dilute any modest effect of annual screening in the screening group.
  • Approximately 44% of the men in each study group had undergone one or more PSA tests at baseline, which would have eliminated some cancers detectable on screening from the randomly assigned population; thus, the cumulative death rate from prostate cancer at 10 years in the two groups combined was 25% lower in those who had undergone two or more PSA tests at baseline than in those who had not been tested.
  • Potentially, the most important explanation is that improvement in therapy for prostate cancer during the course of the trial probably resulted in fewer prostate-cancer deaths in the two study groups, which blunted any potential benefits of screening.
  • The follow-up may not be long enough for benefit from the earlier detection of an increased number of prostate cancers in the screening group to emerge.[47]
  • After a PSA finding greater than 4.0 ng/mL, within 1 year only 41% of men underwent prostate biopsy; within 3 years of this finding, only 64% of men underwent prostate biopsy. Such lower biopsy rates, associated with lower prostate cancer detection rates, may have blunted the impact of screening on mortality.[48]
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WebMD Public Information from the National Cancer Institute

Last Updated: February 25, 2014
This information is not intended to replace the advice of a doctor. Healthwise disclaims any liability for the decisions you make based on this information.
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