Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT00002540
Collaborator
(none)
76,685
1
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Laboratory Biomarker Analysis
  • Procedure: Medical Examination
  • Other: Screening Questionnaire Administration
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. To assess screening variables, other than mortality, for each of the interventions including sensitivity, specificity, and positive predictive value.

  2. 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.

  3. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
76685 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Screening
Official Title:
Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
Actual Study Start Date :
Nov 16, 1993
Actual Primary Completion Date :
May 21, 2012

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

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

Active Comparator: 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. 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 Analysis
Correlative studies

Procedure: Medical Examination
Undergo DRE
Other Names:
  • Exam
  • Examination
  • Health Assessment
  • Medical Assessment
  • Medical Exam
  • Medical Inspection
  • Other: Screening Questionnaire Administration
    Undergo questionnaire assessments

    Outcome Measures

    Primary Outcome Measures

    1. Prostate Cancer Deaths [Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.]

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

    2. Prostate Cancer Death Rates [Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.]

      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.

    Secondary Outcome Measures

    1. Deaths From All Causes [Events through 13 years of follow-up or through December 31, 2009.]

      Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm.

    2. Death Rates From All Causes [Events through 13 years of follow-up or through December 31, 2009.]

      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.

    3. Prostate Cancer Incidence [Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.]

      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.

    4. Prostate Cancer Incidence Rates [Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.]

      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.

    5. Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test [One year from screening examination]

      Number of positive screens with complications

    6. T0 (Baseline) PSA Screening Results [T0 (at study entry)]

      Prostate-Specific Antigen (PSA) result.

    7. T0 (Baseline) DRE Screening Results [T0 (at study entry)]

      Digital Rectal Examination (DRE) result.

    8. T1 PSA Screening Results [T1 (one year after entry)]

      Prostate-Specific Antigen (PSA) result.

    9. T1 DRE Screening Results [T1 (one year after entry)]

      Digital Rectal Examination (DRE) result.

    10. T2 PSA Screening Results [T2 (two years after entry)]

      Prostate-Specific Antigen (PSA) result.

    11. T2 DRE Screening Results [T2 (two years after entry)]

      Digital Rectal Examination (DRE) results

    12. T3 PSA Screening Results [T3 (three years after entry)]

      Prostate-Specific Antigen (PSA) result

    13. T3 DRE Screening Results [T3 (three years after entry)]

      Digital Rectal examination (DRE) result

    14. T4 PSA Screening Result [T4 (four years after entry)]

      Prostate-Specific Antigen (PSA) result

    15. T5 PSA Screening Results [T5 (five years after entry)]

      Prostate-Specific Antigen (PSA) result.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 74 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Christine D Berg, National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00002540
    Other Study ID Numbers:
    • NCI-2012-01755
    • NCI-2012-01755
    • CDR0000078532
    • NCI-P93-0050
    • PLCO-1
    • PLCO-Prostate
    First Posted:
    Mar 26, 2004
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jun 1, 2021
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details 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).
    Pre-assignment Detail Participants signed a study informed consent prior to being randomized to a study arm.
    Arm/Group Title Control Prostate Screening
    Arm/Group Description Participants receive standard medical care. 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.
    Period Title: Overall Study
    STARTED 38345 38340
    COMPLETED 37544 35876
    NOT COMPLETED 801 2464

    Baseline Characteristics

    Arm/Group Title Control Prostate Screening Total
    Arm/Group Description Participants receive standard medical care. 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. Total of all reporting groups
    Overall Participants 38345 38340 76685
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    24390
    63.6%
    24400
    63.6%
    48790
    63.6%
    >=65 years
    13955
    36.4%
    13940
    36.4%
    27895
    36.4%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    62.7
    (5.3)
    62.7
    (5.3)
    62.7
    (5.3)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    Male
    38345
    100%
    38340
    100%
    76685
    100%
    Region of Enrollment (participants) [Number]
    United States
    38345
    100%
    38340
    100%
    76685
    100%

    Outcome Measures

    1. Primary Outcome
    Title Prostate Cancer Deaths
    Description Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
    Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.

    Outcome Measure Data

    Analysis Population Description
    All male participants randomized were analyzed. An intention-to-treat analysis was performed.
    Arm/Group Title Control Prostate Screening
    Arm/Group Description Participants receive standard medical care. 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.
    Measure Participants 38345 38340
    Number [Participants]
    145
    0.4%
    158
    0.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Control, Prostate Screening
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.09
    Confidence Interval (2-Sided) 95%
    0.87 to 1.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Deaths From All Causes
    Description Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm.
    Time Frame Events through 13 years of follow-up or through December 31, 2009.

    Outcome Measure Data

    Analysis Population Description
    All male participants were analyzed. An intention-to-treat analysis was performed.
    Arm/Group Title Control Prostate Screening
    Arm/Group Description Participants receive standard medical care. 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.
    Measure Participants 38345 38340
    Number [Participants]
    7089
    18.5%
    6855
    17.9%
    3. Secondary Outcome
    Title Death Rates From All Causes
    Description 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.
    Time Frame Events through 13 years of follow-up or through December 31, 2009.

    Outcome Measure Data

    Analysis Population Description
    All male participants were analyzed. An intention-to-treat analysis was performed.
    Arm/Group Title Control Prostate Screening
    Arm/Group Description Participants receive standard medical care. 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.
    Measure Participants 38345 38340
    Number [Deaths per 10,000 PY]
    166.6
    160.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Control, Prostate Screening
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.96
    Confidence Interval (2-Sided) 95%
    0.93 to 1.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Prostate Cancer Incidence
    Description 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.
    Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.

    Outcome Measure Data

    Analysis Population Description
    All male participants randomized were analyzed. An intention-to-treat analysis was performed.
    Arm/Group Title Control Prostate Screening
    Arm/Group Description Participants receive standard medical care. 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.
    Measure Participants 38345 38340
    Number [Participants]
    3815
    9.9%
    4250
    11.1%
    5. Secondary Outcome
    Title Prostate Cancer Incidence Rates
    Description 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.
    Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.

    Outcome Measure Data

    Analysis Population Description
    All male participants randomized were analyzed. An intention-to-treat analysis was performed.
    Arm/Group Title Control Prostate Screening
    Arm/Group Description Participants receive standard medical care. 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.
    Measure Participants 38345 38340
    Number [Diagnoses per 10,000 PY]
    97.1
    108.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Control, Prostate Screening
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.12
    Confidence Interval (2-Sided) 95%
    1.07 to 1.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
    Description Number of positive screens with complications
    Time Frame One year from screening examination

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Prostate Screening
    Arm/Group Description 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.
    Measure Participants 10642
    Measure Positive Screens with Follow-up 22269
    When DE Led to Prostate Cancer Diagnosis
    901
    When DE Did Not Lead to Prostate Cancer Diagnosis
    124
    7. Secondary Outcome
    Title T0 (Baseline) PSA Screening Results
    Description Prostate-Specific Antigen (PSA) result.
    Time Frame T0 (at study entry)

    Outcome Measure Data

    Analysis Population Description
    All males in the Prostate Screening arm who had a PSA screen at T0 were analyzed.
    Arm/Group Title Prostate Screening
    Arm/Group Description 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.
    Measure Participants 34247
    Negative (<=4 ng/mL)
    31507
    82.2%
    Positive (> 4 ng/mL)
    2718
    7.1%
    Inadequate screen
    22
    0.1%
    8. Secondary Outcome
    Title T0 (Baseline) DRE Screening Results
    Description Digital Rectal Examination (DRE) result.
    Time Frame T0 (at study entry)

    Outcome Measure Data

    Analysis Population Description
    All males in the Prostate Screening arm who had a DRE screen at T0 were analyzed.
    Arm/Group Title Prostate Screening
    Arm/Group Description 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.
    Measure Participants 34129
    Negative
    30456
    79.4%
    Positive
    2481
    6.5%
    Inadequate screen
    1192
    3.1%
    9. Secondary Outcome
    Title T1 PSA Screening Results
    Description Prostate-Specific Antigen (PSA) result.
    Time Frame T1 (one year after entry)

    Outcome Measure Data

    Analysis Population Description
    All males in the Prostate Screening arm who had a PSA screen at T1 were analyzed.
    Arm/Group Title Prostate Screening
    Arm/Group Description 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.
    Measure Participants 32688
    Negative (<=4 ng/mL)
    30159
    78.7%
    Positive (> 4 ng/mL)
    2502
    6.5%
    Inadequate screen
    27
    0.1%
    10. Secondary Outcome
    Title T1 DRE Screening Results
    Description Digital Rectal Examination (DRE) result.
    Time Frame T1 (one year after entry)

    Outcome Measure Data

    Analysis Population Description
    All males in the Prostate Screening arm who had a DRE screen at T1 were analyzed.
    Arm/Group Title Prostate Screening
    Arm/Group Description 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.
    Measure Participants 32448
    Negative
    29311
    76.4%
    Positive
    2237
    5.8%
    Inadequate screen
    900
    2.3%
    11. Secondary Outcome
    Title T2 PSA Screening Results
    Description Prostate-Specific Antigen (PSA) result.
    Time Frame T2 (two years after entry)

    Outcome Measure Data

    Analysis Population Description
    All males in the Prostate Screening arm who had a PSA screen at T2 were analyzed.
    Arm/Group Title Prostate Screening
    Arm/Group Description 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.
    Measure Participants 31691
    Negative
    29063
    75.8%
    Positive (> 4 ng/mL)
    2593
    6.8%
    Inadequate screen
    35
    0.1%
    12. Secondary Outcome
    Title T2 DRE Screening Results
    Description Digital Rectal Examination (DRE) results
    Time Frame T2 (two years after entry)

    Outcome Measure Data

    Analysis Population Description
    All males in the Prostate Screening arm who had a DRE screen at T2 were analyzed.
    Arm/Group Title Prostate Screening
    Arm/Group Description 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.
    Measure Participants 31451
    Negative
    28391
    74%
    Positive
    2327
    6.1%
    Inadequate screen
    733
    1.9%
    13. Secondary Outcome
    Title T3 PSA Screening Results
    Description Prostate-Specific Antigen (PSA) result
    Time Frame T3 (three years after entry)

    Outcome Measure Data

    Analysis Population Description
    All males in the Prostate Screening arm who had a PSA screen at T3 were analyzed.
    Arm/Group Title Prostate Screening
    Arm/Group Description 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.
    Measure Participants 30533
    Negative (<=4 ng/mL)
    27814
    72.5%
    Positive (> 4 ng/mL)
    2676
    7%
    Inadequate screen
    43
    0.1%
    14. Secondary Outcome
    Title T3 DRE Screening Results
    Description Digital Rectal examination (DRE) result
    Time Frame T3 (three years after entry)

    Outcome Measure Data

    Analysis Population Description
    All males in the Prostate Screening arm who had a DRE screen at T3 were analyzed.
    Arm/Group Title Prostate Screening
    Arm/Group Description 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.
    Measure Participants 30244
    Negative
    27179
    70.9%
    Positive
    2317
    6%
    Inadequate screen
    748
    2%
    15. Primary Outcome
    Title Prostate Cancer Death Rates
    Description 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.
    Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Control Prostate Screening
    Arm/Group Description Participants receive standard medical care. 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.
    Measure Participants 38345 38340
    Number [Deaths per 10,000 PY]
    3.4
    3.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Control, Prostate Screening
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.09
    Confidence Interval (2-Sided) 95%
    0.87 to 1.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title T4 PSA Screening Result
    Description Prostate-Specific Antigen (PSA) result
    Time Frame T4 (four years after entry)

    Outcome Measure Data

    Analysis Population Description
    All males in the Prostate Screening arm who had a PSA screen at T4 were analyzed.
    Arm/Group Title Prostate Screening
    Arm/Group Description 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.
    Measure Participants 22170
    Negative (<=4 ng/mL)
    20362
    53.1%
    Positive (> 4 ng/mL)
    1796
    4.7%
    Inadequate screen
    12
    0%
    17. Secondary Outcome
    Title T5 PSA Screening Results
    Description Prostate-Specific Antigen (PSA) result.
    Time Frame T5 (five years after entry)

    Outcome Measure Data

    Analysis Population Description
    All males in the Prostate Screening arm who had a PSA screen at T5 were analyzed.
    Arm/Group Title Prostate Screening
    Arm/Group Description 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.
    Measure Participants 25951
    Negative (<=4 ng/mL)
    23560
    61.4%
    Positive (> 4 ng/mL)
    2377
    6.2%
    Inadequate screen
    14
    0%

    Adverse Events

    Time Frame During each annual screening visit.
    Adverse Event Reporting Description These events are solely those prompted by the screening examination.
    Arm/Group Title Prostate Screening
    Arm/Group Description 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.
    All Cause Mortality
    Prostate Screening
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Prostate Screening
    Affected / at Risk (%) # Events
    Total 0/38340 (0%)
    Other (Not Including Serious) Adverse Events
    Prostate Screening
    Affected / at Risk (%) # Events
    Total 546/38340 (1.4%)
    General disorders
    Anxiety 1/38340 (0%) 1
    Bleeding 3/38340 (0%) 3
    Dizzy 101/38340 (0.3%) 108
    Fainted 58/38340 (0.2%) 59
    Inflammation 2/38340 (0%) 2
    Nausea 1/38340 (0%) 1
    Pain 11/38340 (0%) 11
    Bruising 182/38340 (0.5%) 183
    Hematoma 187/38340 (0.5%) 190

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Paul F. Pinsky, Ph.D.
    Organization Early Detection Research Group, NCI, NIH
    Phone 301-496-8544
    Email pinskyp@mail.nih.gov
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00002540
    Other Study ID Numbers:
    • NCI-2012-01755
    • NCI-2012-01755
    • CDR0000078532
    • NCI-P93-0050
    • PLCO-1
    • PLCO-Prostate
    First Posted:
    Mar 26, 2004
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jun 1, 2021