NCT00002540

Brief Summary

This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for prostate cancer.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76,685

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Nov 1993

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Nov 1993Jun 2027

Study Start

First participant enrolled

November 16, 1993

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

March 26, 2004

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 26, 2014

Completed
13 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

April 28, 2026

Status Verified

January 1, 2026

Enrollment Period

18.5 years

First QC Date

November 1, 1999

Results QC Date

August 30, 2013

Last Update Submit

April 9, 2026

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Prostate Cancer Deaths

    Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.

    Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.

  • Prostate Cancer Death Rates

    Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.

    Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.

Secondary Outcomes (15)

  • Deaths From All Causes

    Events through 13 years of follow-up or through December 31, 2009.

  • Death Rates From All Causes

    Events through 13 years of follow-up or through December 31, 2009.

  • Prostate Cancer Incidence

    Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.

  • Prostate Cancer Incidence Rates

    Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.

  • Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test

    One year from screening examination

  • +10 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Participants receive standard medical care. Participants complete a DHQ at baseline.

Prostate Screening

ACTIVE COMPARATOR

Participants undergo blood sample collection for PSA analysis at baseline and annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo a DRE at baseline and annually for 3 years. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident prostate cancers as all deaths that occur among both screened and control subjects during the trial.

Other: Laboratory Biomarker AnalysisProcedure: Medical Examination AssessmentOther: Screening Questionnaire Administration

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Prostate Screening
Medical Examination AssessmentPROCEDURE

Undergo DRE

Also known as: Exam, Examination, Health Assessment, Health Examination, Health Status Assessment, Medical Assessment, Medical Exam, Medical Inspection
Prostate Screening
Screening Questionnaire AdministrationOTHER

Undergo questionnaire assessments

Prostate Screening

Eligibility Criteria

Age55 Years - 74 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Men who at the time of randomization are less than 55 or greater than or equal to 75 years of age
  • Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer
  • Individuals with known prior cancer of the colon, rectum, lung, prostate
  • This includes primary or metastatic PLCO cancers
  • Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate
  • Individuals who are participating in another cancer screening or cancer primary prevention trial
  • Males who have taken Proscar/Propecia/finasteride in the past 6 months
  • NOTE: Individuals who are already enrolled in the trial when their physician prescribes finasteride are not prevented from taking this medication. As a result, these participants will continue to be screened and followed just as those participants who are not on finasteride.
  • NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO Screening Trial.
  • Individuals who are unwilling or unable to sign the informed consent form
  • Males who have had more than one PSA blood test in the past three years
  • Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (29)

  • Malcomson FC, Shams-White MM, Reedy J, Huang WY, Moore SC, Loftfield E. Adherence to the 2018 World Cancer Research Fund/American Institute for Cancer Research Cancer Prevention Recommendations and risk of lifestyle-related cancers in the prostate, lung, colorectal, and ovarian cancer screening trial. BJC Rep. 2025 Nov 19;3(1):81. doi: 10.1038/s44276-025-00195-6.

    PMID: 41261199DERIVED

  • Fan Z, Zhang Y, Yao Q, Liu X, Duan H, Liu Y, Sheng C, Lyu Z, Yang L, Song F, Huang Y, Song F. Effects of joint screening for prostate, lung, colorectal, and ovarian cancer - results from a controlled trial. Front Oncol. 2024 Apr 29;14:1322044. doi: 10.3389/fonc.2024.1322044. eCollection 2024.

    PMID: 38741776DERIVED

  • Jiang Y, Xie Q, Chen R. Breast Cancer Incidence and Mortality in Relation to Hormone Replacement Therapy Use Among Postmenopausal Women: Results From a Prospective Cohort Study. Clin Breast Cancer. 2022 Feb;22(2):e206-e213. doi: 10.1016/j.clbc.2021.06.010. Epub 2021 Jun 26.

    PMID: 34548240DERIVED

  • Pinsky PF, Durham D, Strassels S. Opioid and Other Medication Use and General Health Status in a Cohort of Older Adults. Gerontology. 2021;67(5):554-562. doi: 10.1159/000513731. Epub 2021 Mar 10.

    PMID: 33691305DERIVED

  • Wang K, Wu Q, Li Z, Reger MK, Xiong Y, Zhong G, Li Q, Zhang X, Li H, Foukakis T, Xiang T, Zhang J, Ren G. Vitamin K intake and breast cancer incidence and death: results from a prospective cohort study. Clin Nutr. 2021 May;40(5):3370-3378. doi: 10.1016/j.clnu.2020.11.009. Epub 2020 Nov 16.

    PMID: 33277073DERIVED

  • Pinsky PF, Miller EA, Zhu CS, Prorok PC. Overall mortality in men and women in the randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. J Med Screen. 2019 Sep;26(3):127-134. doi: 10.1177/0969141319839097. Epub 2019 Apr 3. No abstract available.

    PMID: 30943843DERIVED

  • Pierre-Victor D, Pinsky PF. Association of Nonadherence to Cancer Screening Examinations With Mortality From Unrelated Causes: A Secondary Analysis of the PLCO Cancer Screening Trial. JAMA Intern Med. 2019 Feb 1;179(2):196-203. doi: 10.1001/jamainternmed.2018.5982.

    PMID: 30592477DERIVED

  • Miller EA, Pinsky PF, Schoen RE, Prorok PC, Church TR. Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: long-term follow-up of the randomised US PLCO cancer screening trial. Lancet Gastroenterol Hepatol. 2019 Feb;4(2):101-110. doi: 10.1016/S2468-1253(18)30358-3. Epub 2018 Nov 29.

    PMID: 30502933DERIVED

  • Click B, Pinsky PF, Hickey T, Doroudi M, Schoen RE. Association of Colonoscopy Adenoma Findings With Long-term Colorectal Cancer Incidence. JAMA. 2018 May 15;319(19):2021-2031. doi: 10.1001/jama.2018.5809.

    PMID: 29800214DERIVED

  • Schoen RE, Razzak A, Yu KJ, Berndt SI, Firl K, Riley TL, Pinsky PF. Incidence and mortality of colorectal cancer in individuals with a family history of colorectal cancer. Gastroenterology. 2015 Nov;149(6):1438-1445.e1. doi: 10.1053/j.gastro.2015.07.055. Epub 2015 Aug 5.

    PMID: 26255045DERIVED

  • Guertin KA, Loftfield E, Boca SM, Sampson JN, Moore SC, Xiao Q, Huang WY, Xiong X, Freedman ND, Cross AJ, Sinha R. Serum biomarkers of habitual coffee consumption may provide insight into the mechanism underlying the association between coffee consumption and colorectal cancer. Am J Clin Nutr. 2015 May;101(5):1000-11. doi: 10.3945/ajcn.114.096099. Epub 2015 Mar 11.

    PMID: 25762808DERIVED

  • Kvale PA, Johnson CC, Tammemagi M, Marcus PM, Zylak CJ, Spizarny DL, Hocking W, Oken M, Commins J, Ragard L, Hu P, Berg C, Prorok P. Interval lung cancers not detected on screening chest X-rays: How are they different? Lung Cancer. 2014 Oct;86(1):41-6. doi: 10.1016/j.lungcan.2014.07.013. Epub 2014 Jul 24.

    PMID: 25123333DERIVED

  • Guertin KA, Moore SC, Sampson JN, Huang WY, Xiao Q, Stolzenberg-Solomon RZ, Sinha R, Cross AJ. Metabolomics in nutritional epidemiology: identifying metabolites associated with diet and quantifying their potential to uncover diet-disease relations in populations. Am J Clin Nutr. 2014 Jul;100(1):208-17. doi: 10.3945/ajcn.113.078758. Epub 2014 Apr 16.

    PMID: 24740205DERIVED

  • Major JM, Yu K, Weinstein SJ, Berndt SI, Hyland PL, Yeager M, Chanock S, Albanes D. Genetic variants reflecting higher vitamin e status in men are associated with reduced risk of prostate cancer. J Nutr. 2014 May;144(5):729-33. doi: 10.3945/jn.113.189928. Epub 2014 Mar 12.

    PMID: 24623848DERIVED

  • Hocking WG, Tammemagi MC, Commins J, Oken MM, Kvale PA, Hu P, Ragard LR, Riley TL, Pinsky P, Beck TM, Prorok PC. Diagnostic evaluation following a positive lung screening chest radiograph in the Prostate, Lung, Colorectal, Ovarian (PLCO) Cancer Screening Trial. Lung Cancer. 2013 Nov;82(2):238-44. doi: 10.1016/j.lungcan.2013.07.017. Epub 2013 Aug 7.

    PMID: 23993734DERIVED

  • Rogal SS, Pinsky PF, Schoen RE. Relationship between detection of adenomas by flexible sigmoidoscopy and interval distal colorectal cancer. Clin Gastroenterol Hepatol. 2013 Jan;11(1):73-8. doi: 10.1016/j.cgh.2012.08.002. Epub 2012 Aug 16.

    PMID: 22902761DERIVED

  • Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, Bresalier R, Andriole GL, Buys SS, Crawford ED, Fouad MN, Isaacs C, Johnson CC, Reding DJ, O'Brien B, Carrick DM, Wright P, Riley TL, Purdue MP, Izmirlian G, Kramer BS, Miller AB, Gohagan JK, Prorok PC, Berg CD; PLCO Project Team. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. N Engl J Med. 2012 Jun 21;366(25):2345-57. doi: 10.1056/NEJMoa1114635. Epub 2012 May 21.

    PMID: 22612596DERIVED

  • Oken MM, Hocking WG, Kvale PA, Andriole GL, Buys SS, Church TR, Crawford ED, Fouad MN, Isaacs C, Reding DJ, Weissfeld JL, Yokochi LA, O'Brien B, Ragard LR, Rathmell JM, Riley TL, Wright P, Caparaso N, Hu P, Izmirlian G, Pinsky PF, Prorok PC, Kramer BS, Miller AB, Gohagan JK, Berg CD; PLCO Project Team. Screening by chest radiograph and lung cancer mortality: the Prostate, Lung, Colorectal, and Ovarian (PLCO) randomized trial. JAMA. 2011 Nov 2;306(17):1865-73. doi: 10.1001/jama.2011.1591. Epub 2011 Oct 26.

    PMID: 22031728DERIVED

  • Buys SS, Partridge E, Black A, Johnson CC, Lamerato L, Isaacs C, Reding DJ, Greenlee RT, Yokochi LA, Kessel B, Crawford ED, Church TR, Andriole GL, Weissfeld JL, Fouad MN, Chia D, O'Brien B, Ragard LR, Clapp JD, Rathmell JM, Riley TL, Hartge P, Pinsky PF, Zhu CS, Izmirlian G, Kramer BS, Miller AB, Xu JL, Prorok PC, Gohagan JK, Berg CD; PLCO Project Team. Effect of screening on ovarian cancer mortality: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial. JAMA. 2011 Jun 8;305(22):2295-303. doi: 10.1001/jama.2011.766.

    PMID: 21642681DERIVED

  • Berg CD. The Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial: the prostate cancer screening results in context. Acta Oncol. 2011 Jun;50 Suppl 1:12-7. doi: 10.3109/0284186X.2010.531283.

    PMID: 21604935DERIVED

  • Pinsky PF, Blacka A, Kramer BS, Miller A, Prorok PC, Berg C. Assessing contamination and compliance in the prostate component of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. Clin Trials. 2010 Aug;7(4):303-11. doi: 10.1177/1740774510374091. Epub 2010 Jun 22.

    PMID: 20571134DERIVED

  • Troy JD, Hartge P, Weissfeld JL, Oken MM, Colditz GA, Mechanic LE, Morton LM. Associations between anthropometry, cigarette smoking, alcohol consumption, and non-Hodgkin lymphoma in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Am J Epidemiol. 2010 Jun 15;171(12):1270-81. doi: 10.1093/aje/kwq085. Epub 2010 May 21.

    PMID: 20494998DERIVED

  • Croswell JM, Kramer BS, Kreimer AR, Prorok PC, Xu JL, Baker SG, Fagerstrom R, Riley TL, Clapp JD, Berg CD, Gohagan JK, Andriole GL, Chia D, Church TR, Crawford ED, Fouad MN, Gelmann EP, Lamerato L, Reding DJ, Schoen RE. Cumulative incidence of false-positive results in repeated, multimodal cancer screening. Ann Fam Med. 2009 May-Jun;7(3):212-22. doi: 10.1370/afm.942.

    PMID: 19433838DERIVED

  • Tammemagi MC, Freedman MT, Pinsky PF, Oken MM, Hu P, Riley TL, Ragard LR, Berg CD, Prorok PC. Prediction of true positive lung cancers in individuals with abnormal suspicious chest radiographs: a prostate, lung, colorectal, and ovarian cancer screening trial study. J Thorac Oncol. 2009 Jun;4(6):710-21. doi: 10.1097/JTO.0b013e31819e77ce.

    PMID: 19404219DERIVED

  • Partridge E, Kreimer AR, Greenlee RT, Williams C, Xu JL, Church TR, Kessel B, Johnson CC, Weissfeld JL, Isaacs C, Andriole GL, Ogden S, Ragard LR, Buys SS; PLCO Project Team. Results from four rounds of ovarian cancer screening in a randomized trial. Obstet Gynecol. 2009 Apr;113(4):775-782. doi: 10.1097/AOG.0b013e31819cda77.

    PMID: 19305319DERIVED

  • Andriole GL, Crawford ED, Grubb RL 3rd, Buys SS, Chia D, Church TR, Fouad MN, Gelmann EP, Kvale PA, Reding DJ, Weissfeld JL, Yokochi LA, O'Brien B, Clapp JD, Rathmell JM, Riley TL, Hayes RB, Kramer BS, Izmirlian G, Miller AB, Pinsky PF, Prorok PC, Gohagan JK, Berg CD; PLCO Project Team. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009 Mar 26;360(13):1310-9. doi: 10.1056/NEJMoa0810696. Epub 2009 Mar 18.

    PMID: 19297565DERIVED

  • Lacey JV Jr, Kreimer AR, Buys SS, Marcus PM, Chang SC, Leitzmann MF, Hoover RN, Prorok PC, Berg CD, Hartge P; Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial Project Team. Breast cancer epidemiology according to recognized breast cancer risk factors in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial Cohort. BMC Cancer. 2009 Mar 17;9:84. doi: 10.1186/1471-2407-9-84.

    PMID: 19292893DERIVED

  • Tammemagi CM, Freedman MT, Church TR, Oken MM, Hocking WG, Kvale PA, Hu P, Riley TL, Ragard LR, Prorok PC, Berg CD. Factors associated with human small aggressive non small cell lung cancer. Cancer Epidemiol Biomarkers Prev. 2007 Oct;16(10):2082-9. doi: 10.1158/1055-9965.EPI-07-0251.

    PMID: 17932357DERIVED

  • Lacey JV Jr, Greene MH, Buys SS, Reding D, Riley TL, Berg CD, Fagerstrom RM, Hartge P. Ovarian cancer screening in women with a family history of breast or ovarian cancer. Obstet Gynecol. 2006 Nov;108(5):1176-84. doi: 10.1097/01.AOG.0000239105.39149.d8.

    PMID: 17077240DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Restraint, PhysicalNutrition SurveysIndependent Medical Evaluation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative TechniquesSurveys and QuestionnairesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Paul F. Pinsky, Ph.D.
Organization
Early Detection Research Group, NCI, NIH
pinskyp@mail.nih.gov
301-496-8544

Study Officials

  • Christine D Berg

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 26, 2004

Study Start

November 16, 1993

Primary Completion

May 21, 2012

Study Completion (Estimated)

June 30, 2027

Last Updated

April 28, 2026

Results First Posted

June 26, 2014

Record last verified: 2026-01

Locations

US(1)