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=== <span style="color:#ff00ff">PLCO</span> === * '''<span style="color:#ff0000">Population: 76,685 US men aged 55-74</span>''' from 10 centers * '''<span style="color:#ff0000">Randomized to annual screening</span> (PSA annually x 6 years, DRE annually x 4 years) <span style="color:#ff0000">vs. standard care</span>''' ** '''Biopsy recommended If PSA >4.0 or suspicious DRE''' * Primary outcome: cancer-specific mortality * '''<span style="color:#ff0000">Results:</span>''' ** '''<span style="color:#ff0000">No difference in PC mortality</span>''' (Rate ratio (RR) 0.93 (95% CI 0.81β1.08) 17-year follow-up) ** '''Increased incidence of prostate cancer in screening group''' (RR 1.05 (95% CI 1.01β1.09) 17-year follow-up) ** '''No difference in disease stage''' ** '''No difference in metastasis''' (RR 0.85 (95% CI 0.67 β 1.06)) ** '''Higher proportion Gleason 2-6 in screening arm; higher proportion Gleason β₯ 8 in control arm''' *** Gleason 2β6: RR 1.17 (95% CI 1.11β1.23) *** Gleason 7 disease RR 1.00 *** Gleason 8β10 disease RR 0.89 (95% CI 0.80β0.99) * '''<span style="color:#ff0000">Criticisms (4)</span>''': *# '''<span style="color:#ff0000">High rates of contamination</span>''' (77% as per 2018 AUA early detection prostate cancer guidelines) *# '''<span style="color:#ff0000">High rates of pre-screening</span>''' *#* In control group at baseline, 34.3% had PSA test once within past 3 years, 9.8% had PSA tests two or more times within past 3 years; 31.9% had DRE once within past 3 years, 22.0% had DRE two or more times within past 3 years *#* After 1995, trial implemented exclusion criteria of more than one PSA test within last 3 years[https://pubmed.ncbi.nlm.nih.gov/11189684/ Β§] *# '''<span style="color:#ff0000">High rates of l</span><span style="color:#ff0000">Lack of adherence to diagnostic biopsies</span>''' among patients with abnormal screening results in the screening arm *# '''<span style="color:#ff0000">Underpowered to detect mortality benefit</span>''' * [https://pubmed.ncbi.nlm.nih.gov/19297565/ Andriole, Gerald L., et al.] "Mortality results from a randomized prostate-cancer screening trial." New England Journal of Medicine 360.13 (2009): 1310-1319. * [https://pubmed.ncbi.nlm.nih.gov/30288918/ Pinsky, Paul F., et al.] "Extended followβup for prostate cancer incidence and mortality among participants in the Prostate, Lung, Colorectal and Ovarian randomized cancer screening trial." BJU international 123.5 (2019): 854-860.
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