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PLCO Trial: Study Design

The Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial Fifth Annual African-American Prostate Cancer Disparity Summit September 24, 2009 Christine D. Berg, M.D. Project Officer, PLCO Chief, Early Detection Research Group Division of Cancer Prevention. PLCO Trial: Study Design.

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PLCO Trial: Study Design

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  1. The Prostate, Lung, Colorectal and Ovarian Cancer Screening TrialFifth Annual African-American Prostate Cancer Disparity SummitSeptember 24, 2009Christine D. Berg, M.D.Project Officer, PLCOChief, Early Detection Research GroupDivision of Cancer Prevention

  2. PLCO Trial: Study Design • Screening Centers: 10 • Participants: 154,935 • Gender: 50:50 • Age: 55-74 years • Recruitment: 1993-2001 • Screening: 1993-2006 • Prostate – Annual DRE x 4 and PSA x 6 • Follow-up for 14 years (T0 – T13) • Annual surveys: active • Monitoring and QA: active • Mortality searches: active and NDI, passive • Annual interim analysis

  3. PLCO Screening Centers

  4. PLCO: Selected Characteristics

  5. Prostate Cancer Detectedby 10 years

  6. Comparison of Gleason Scores

  7. Compliance and Contamination • Screening before entry (screening/control) • PSA test DRE • Once: 34.6/34.3 32.8/31/9 • Two or more: 9.4/9.8 22.2/22.0 • Compliance • PSA 85%; DRE 86% • Testing in the control group • PSA: 40% in first year to 52% in sixth year • DRE: Range from 41 to 46%

  8. Number of Diagnoses of All Prostate Cancers and Number of Prostate-Cancer Deaths Andriole GL et al. N Engl J Med 2009;360:1310-1319

  9. PLCO Trial Results • Annual screening with DRE and PSA results in more prostate cancer compared to community screening practices • Seven years: 2820 versus 2322 • Ten years: 3452 versus 2974 • Few Prostate cancer related deaths in either group • 50 screening and 44 controls at 7 years • 92 screening and 82 control at 10 years • Continued follow-up to be done

  10. Serum S T0, T1, T2, T3, T4, T5 2 ml Serum T0 (2), T1, T2, T4, T5 S S 2 ml X 2 Plasma, Buffy Coat, RBC P B R P T0, T3 2 ml X 4 Serum T0 S 2 ml W Plasma, Buffy Coat, RBC W W W T3, T4, T5 (2) 2 ml X 4 2 ml X 6 P B R P Blood Collection Protocol UCLA CA-125, PSA Assays Biorepository Etiology & Early Marker Studies Whole Blood T3 (2)

  11. Specimens Available by Cancer Sites and Specimen Types 75,476 34,043 17,206 17,084 9,490 8,837 5,734 4,489 6,723 3,507 2,138 4,829 1,735 1,242 3,501 1,086 2,289 1,900 1,434 1,193

  12. TMAs with PLCO Tumors Supports multiple histologies per spot

  13. PLCO Trial Conclusions • PSA not a perfect test • Low mortality rates achieved at high rate of overdiagnosis • Important to have better biologic understanding of aggressive prostate cancer and means of differentiating from indolent disease • PLCO biospecimen repository useful • genetic and somatic risk assessment • development and validation of early markers of detection

  14. With appreciation • PLCO Research Colleagues • PLCO Site Coordinators and Staff • NCI Colleagues • The trial participants without whom these studies would not have been possible

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