Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01755 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000078532 | |||
| NCI-P93-0050 | |||
| PLCO-1 | |||
| PLCO-Prostate | Other Identifier | National Cancer Institute |
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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.
PRIMARY OBJECTIVES:
I. To determine whether screening with digital rectal examination (DRE) plus serum prostate-specific antigen (PSA) can reduce mortality from prostate cancer in men aged 55-74 at entry.
SECONDARY OBJECTIVES:
I. To assess screening variables, other than mortality, for each of the interventions including sensitivity, specificity, and positive predictive value.
II. To assess the incidence, stage, and survival of cancer cases. III. To investigate the mortality predictive value of biologic and/or prognostic characterizations of tumor tissue as intermediate endpoints.
IV. To conduct biomolecular and genetic research into factors associated with cancer carcinogenesis and promotion, as well as the early detection of these factors.
OUTLINE: Participants in the overall PLCO study are stratified by screening center, gender, and age (55-59 vs 60-64 vs 65-69 vs 70-74). Participants are randomized to 1 of 2 arms (control vs screening).
ARM I (Control): Participants receive standard medical care. Participants complete a Diet History Questionnaire (DHQ) at baseline.
ARM II (Prostate Screening): 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. A scheduling and tracking procedure is implemented to ensure regular attendance at repeat screens for participants screened negative or for those who are designated suspicious or positive at screening but for whom subsequent diagnostic procedures do not reveal prostate cancer (follow-up diagnostic procedures are through their own medical care environment). Participants diagnosed with prostate cancer via a screening test are referred for treatment in accordance with current accepted practice for appropriate stage of disease, patient age, and medical condition; a procedure is provided for contact with qualified medical personnel to insure appropriate therapy.
Participants complete a Dietary Questionnaire (DQX) at baseline and DHQ at year 3. An Annual Study Update (ADU) (previously referred to as the Periodic Survey of Health [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.
After completion of screening, participants are followed up for at least 13 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Deaths From All Causes | Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm. | Events through 13 years of follow-up or through December 31, 2009. |
| Death Rates From All Causes |
Not provided
Exclusion Criteria:
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
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Christine D Berg | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41261199 | Derived | 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. | |
| 38741776 |
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Participants signed a study informed consent prior to being randomized to a study arm.
Participants were enrolled between November 1993 and July 2001 at 10 study centers. Recruitment was done for all four outcomes of the study (prostate, lung, colorectal and ovarian).
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants receive standard medical care. |
| FG001 | Prostate Screening | Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants receive standard medical care. |
| BG001 | Prostate Screening | Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prostate Cancer Deaths | Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. | All male participants randomized were analyzed. An intention-to-treat analysis was performed. | Posted | Number | Participants | Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. |
|
During each annual screening visit.
These events are solely those prompted by the screening examination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prostate Screening | Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul F. Pinsky, Ph.D. | Early Detection Research Group, NCI, NIH | 301-496-8544 | pinskyp@mail.nih.gov |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| D009749 | Nutrition Surveys |
| D000070536 | Independent Medical Evaluation |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
Not provided
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| Medical Examination Assessment |
| Procedure |
Undergo DRE |
|
|
| Screening Questionnaire Administration | Other | Undergo questionnaire assessments |
|
Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm. 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. |
| Prostate Cancer Incidence | Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer. | Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. |
| Prostate Cancer Incidence Rates | Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer. | 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 | Number of positive screens with complications | One year from screening examination |
| T0 (Baseline) PSA Screening Results | Prostate-Specific Antigen (PSA) result. | T0 (at study entry) |
| T0 (Baseline) DRE Screening Results | Digital Rectal Examination (DRE) result. | T0 (at study entry) |
| T1 PSA Screening Results | Prostate-Specific Antigen (PSA) result. | T1 (one year after entry) |
| T1 DRE Screening Results | Digital Rectal Examination (DRE) result. | T1 (one year after entry) |
| T2 PSA Screening Results | Prostate-Specific Antigen (PSA) result. | T2 (two years after entry) |
| T2 DRE Screening Results | Digital Rectal Examination (DRE) results | T2 (two years after entry) |
| T3 PSA Screening Results | Prostate-Specific Antigen (PSA) result | T3 (three years after entry) |
| T3 DRE Screening Results | Digital Rectal examination (DRE) result | T3 (three years after entry) |
| T4 PSA Screening Result | Prostate-Specific Antigen (PSA) result | T4 (four years after entry) |
| T5 PSA Screening Results | Prostate-Specific Antigen (PSA) result. | T5 (five years after entry) |
| 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. |
| 34548240 | Derived | 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. |
| 33691305 | Derived | 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. |
| 33277073 | Derived | 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. |
| 30943843 | Derived | 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. |
| 30592477 | Derived | 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. |
| 30502933 | Derived | 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. |
| 29800214 | Derived | 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. |
| 26255045 | Derived | 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. |
| 25762808 | Derived | 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. |
| 25123333 | Derived | 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. |
| 24740205 | Derived | 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. |
| 24623848 | Derived | 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. |
| 23993734 | Derived | 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. |
| 22902761 | Derived | 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. |
| 22612596 | Derived | 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. |
| 22031728 | Derived | 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. |
| 21642681 | Derived | 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. |
| 21604935 | Derived | 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. |
| 20571134 | Derived | 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. |
| 20494998 | Derived | 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. |
| 19433838 | Derived | 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. |
| 19404219 | Derived | 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. |
| 19305319 | Derived | 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. |
| 19297565 | Derived | 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. |
| 19292893 | Derived | 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. |
| 17932357 | Derived | 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. |
| 17077240 | Derived | 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. |
| Died Before ASU (Control) |
|
| Refused ASU (Control) |
|
| Refused Screen (Prostate Screening) |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Deaths From All Causes | Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm. | All male participants were analyzed. An intention-to-treat analysis was performed. | Posted | Number | Participants | Events through 13 years of follow-up or through December 31, 2009. |
|
|
|
| Secondary | Death Rates From All Causes | Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study. | All male participants were analyzed. An intention-to-treat analysis was performed. | Posted | Number | Deaths per 10,000 PY | Events through 13 years of follow-up or through December 31, 2009. |
|
|
|
|
| Secondary | Prostate Cancer Incidence | Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer. | All male participants randomized were analyzed. An intention-to-treat analysis was performed. | Posted | Number | Participants | Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. |
|
|
|
| Secondary | Prostate Cancer Incidence Rates | Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer. | All male participants randomized were analyzed. An intention-to-treat analysis was performed. | Posted | Number | Diagnoses per 10,000 PY | Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. |
|
|
|
|
| Secondary | Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test | Number of positive screens with complications | The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed. | Posted | Number | Positive screens w/ complications | One year from screening examination | Positive Screens with Follow-up | Positive Screens with Follow-up |
|
|
|
| Secondary | T0 (Baseline) PSA Screening Results | Prostate-Specific Antigen (PSA) result. | All males in the Prostate Screening arm who had a PSA screen at T0 were analyzed. | Posted | Number | Participants | T0 (at study entry) |
|
|
|
| Secondary | T0 (Baseline) DRE Screening Results | Digital Rectal Examination (DRE) result. | All males in the Prostate Screening arm who had a DRE screen at T0 were analyzed. | Posted | Number | Participants | T0 (at study entry) |
|
|
|
| Secondary | T1 PSA Screening Results | Prostate-Specific Antigen (PSA) result. | All males in the Prostate Screening arm who had a PSA screen at T1 were analyzed. | Posted | Number | Participants | T1 (one year after entry) |
|
|
|
| Secondary | T1 DRE Screening Results | Digital Rectal Examination (DRE) result. | All males in the Prostate Screening arm who had a DRE screen at T1 were analyzed. | Posted | Number | Participants | T1 (one year after entry) |
|
|
|
| Secondary | T2 PSA Screening Results | Prostate-Specific Antigen (PSA) result. | All males in the Prostate Screening arm who had a PSA screen at T2 were analyzed. | Posted | Number | Participants | T2 (two years after entry) |
|
|
|
| Secondary | T2 DRE Screening Results | Digital Rectal Examination (DRE) results | All males in the Prostate Screening arm who had a DRE screen at T2 were analyzed. | Posted | Number | Participants | T2 (two years after entry) |
|
|
|
| Secondary | T3 PSA Screening Results | Prostate-Specific Antigen (PSA) result | All males in the Prostate Screening arm who had a PSA screen at T3 were analyzed. | Posted | Number | Participants | T3 (three years after entry) |
|
|
|
| Secondary | T3 DRE Screening Results | Digital Rectal examination (DRE) result | All males in the Prostate Screening arm who had a DRE screen at T3 were analyzed. | Posted | Number | Participants | T3 (three years after entry) |
|
|
|
| Primary | 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. | Posted | Number | Deaths per 10,000 PY | Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. |
|
|
|
|
| Secondary | T4 PSA Screening Result | Prostate-Specific Antigen (PSA) result | All males in the Prostate Screening arm who had a PSA screen at T4 were analyzed. | Posted | Number | Participants | T4 (four years after entry) |
|
|
|
| Secondary | T5 PSA Screening Results | Prostate-Specific Antigen (PSA) result. | All males in the Prostate Screening arm who had a PSA screen at T5 were analyzed. | Posted | Number | Participants | T5 (five years after entry) |
|
|
|
| 0 |
| 38,340 |
| 546 |
| 38,340 |
| Bleeding | General disorders | Non-systematic Assessment |
|
| Dizzy | General disorders | Non-systematic Assessment |
|
| Fainted | General disorders | Non-systematic Assessment |
|
| Inflammation | General disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Bruising | General disorders | Non-systematic Assessment |
|
| Hematoma | General disorders | Non-systematic Assessment |
|
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011795 |
| Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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