📃 Paper Title: Mortality Results from a Randomised Prostate-Cancer Screening Trial (Prostate, Lung, Colorectal and Ovarian ((PLCO)) Cancer Screening Trial)
🧍 Author: Andriole
🕒 Year: 2009
📚 Journal: The New England Journal of Medicine (NEJM)
🌎 Country: USA
ㅤContext to the study:
Which large multicentre trial in the USA compared annual PSA and DRE surveillance to a control group?
ㅤ✅ Take-home message of study:
The PLCO trial assessed the effect of screening with annual PSA and digital rectal examination on mortality from prostate cancer in over 70,000 patients across 10 centres in the USA. No significant improvement in prostate cancer mortality at 7 years (rate ratio 1.13) or 10 years (rate ratio 1.11) was seen when comparing the screened group to the control (usual care) group. Screening led to a relative increase of 22% in the rate of prostate cancer diagnosis compared to the control group.
ㅤ Multi-centre, randomised trial
Recruitment period: 1993 to 2001
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Study participants:
76,693 patients included
Two arms: screening group (n=38,343) vs. usual care group (n=38,350)
Screening intervention: patients offered annual PSA for 6 years and annual digital rectal examination for 4 years
10 centres in USA
Inclusion criteria: aged 55 to 74 years
Exclusion criteria
History of a PLCO cancer
Current cancer treatment
1 PSA blood test performed in previous 3 years (starting in 1995)
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Key study outcomes:
Primary outcome: prostate cancer mortality (death from prostate cancer)
At 7 years follow-up, there was no significant difference between groups
Incidence of prostate cancer mortality at 7 years:
2.0 per 10,000 person years (screening group)
1.7 per 10,000 person years (control group)
Overall rate ratio (rate of death in screening group divided by control group): 1.13
Incidence of prostate cancer mortality at 10 years:
At 10 years follow-up rate ratio: 1.11
Selected secondary outcomes:
Incidence of prostate cancer
At 7 years follow-up the incidence of prostate cancer in the screened group was higher than control group (rate ratio: 1.22) (i.e. relative increase in 22%)
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Study Limitations:
Follow-up data at 10 years was only 67% complete
A significant proportion of men in the usual care group also underwent screening (e.g. 40% underwent PSA screening in the first year)
Follow-up period may have not been long enough to detect benefit in early detection
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