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

March 9, 2024 updated by: National Cancer Institute (NCI)

Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

76685

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate Cancer Deaths
Time Frame: 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.
Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
Prostate Cancer Death Rates
Time Frame: 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.
Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deaths From All Causes
Time Frame: 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.
Events through 13 years of follow-up or through December 31, 2009.
Death Rates From All Causes
Time Frame: 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.
Events through 13 years of follow-up or through December 31, 2009.
Prostate Cancer Incidence
Time Frame: 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.
Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
Prostate Cancer Incidence Rates
Time Frame: 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.
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
Time Frame: One year from screening examination
Number of positive screens with complications
One year from screening examination
T0 (Baseline) PSA Screening Results
Time Frame: T0 (at study entry)
Prostate-Specific Antigen (PSA) result.
T0 (at study entry)
T0 (Baseline) DRE Screening Results
Time Frame: T0 (at study entry)
Digital Rectal Examination (DRE) result.
T0 (at study entry)
T1 PSA Screening Results
Time Frame: T1 (one year after entry)
Prostate-Specific Antigen (PSA) result.
T1 (one year after entry)
T1 DRE Screening Results
Time Frame: T1 (one year after entry)
Digital Rectal Examination (DRE) result.
T1 (one year after entry)
T2 PSA Screening Results
Time Frame: T2 (two years after entry)
Prostate-Specific Antigen (PSA) result.
T2 (two years after entry)
T2 DRE Screening Results
Time Frame: T2 (two years after entry)
Digital Rectal Examination (DRE) results
T2 (two years after entry)
T3 PSA Screening Results
Time Frame: T3 (three years after entry)
Prostate-Specific Antigen (PSA) result
T3 (three years after entry)
T3 DRE Screening Results
Time Frame: T3 (three years after entry)
Digital Rectal examination (DRE) result
T3 (three years after entry)
T4 PSA Screening Result
Time Frame: T4 (four years after entry)
Prostate-Specific Antigen (PSA) result
T4 (four years after entry)
T5 PSA Screening Results
Time Frame: T5 (five years after entry)
Prostate-Specific Antigen (PSA) result.
T5 (five years after entry)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 1993

Primary Completion (Actual)

May 21, 2012

Study Completion (Estimated)

March 11, 2025

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

March 25, 2004

First Posted (Estimated)

March 26, 2004

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

March 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-01755 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000078532
  • NCI-P93-0050
  • PLCO-1
  • PLCO-Prostate (Other Identifier: National Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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