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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002540
Recruitment Status : Active, not recruiting
First Posted : March 26, 2004
Results First Posted : June 26, 2014
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE March 26, 2004
Results First Submitted Date  ICMJE August 30, 2013
Results First Posted Date  ICMJE June 26, 2014
Last Update Posted Date March 6, 2020
Actual Study Start Date  ICMJE November 16, 1993
Actual Primary Completion Date May 21, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
  • Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test [ Time Frame: One year from screening examination ]
    Number of positive screens with complications
  • T0 (Baseline) PSA Screening Results [ Time Frame: T0 (at study entry) ]
    Prostate-Specific Antigen (PSA) result.
  • T0 (Baseline) DRE Screening Results [ Time Frame: T0 (at study entry) ]
    Digital Rectal Examination (DRE) result.
  • T1 PSA Screening Results [ Time Frame: T1 (one year after entry) ]
    Prostate-Specific Antigen (PSA) result.
  • T1 DRE Screening Results [ Time Frame: T1 (one year after entry) ]
    Digital Rectal Examination (DRE) result.
  • T2 PSA Screening Results [ Time Frame: T2 (two years after entry) ]
    Prostate-Specific Antigen (PSA) result.
  • T2 DRE Screening Results [ Time Frame: T2 (two years after entry) ]
    Digital Rectal Examination (DRE) results
  • T3 PSA Screening Results [ Time Frame: T3 (three years after entry) ]
    Prostate-Specific Antigen (PSA) result
  • T3 DRE Screening Results [ Time Frame: T3 (three years after entry) ]
    Digital Rectal examination (DRE) result
  • T4 PSA Screening Result [ Time Frame: T4 (four years after entry) ]
    Prostate-Specific Antigen (PSA) result
  • T5 PSA Screening Results [ Time Frame: T5 (five years after entry) ]
    Prostate-Specific Antigen (PSA) result.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)
Official Title  ICMJE Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Condition  ICMJE Prostate Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Procedure: Medical Examination
    • Other: Screening Questionnaire Administration
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 19, 2014)
76685
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 21, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 55 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002540
Other Study ID Numbers  ICMJE NCI-2012-01755
NCI-2012-01755 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000078532
PLCO-1
PLCO-Prostate ( Other Identifier: National Institutes of Health Clinical Center )
NCI-P93-0050 ( Other Identifier: DCP )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christine D Berg National Institutes of Health Clinical Center (CC)
PRS Account National Cancer Institute (NCI)
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP