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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002540
First received: November 1, 1999
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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 Intervention
Prostate Cancer
Procedure: examination
Other: screening questionnaire administration
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening
Official Title: Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prostate Cancer Deaths [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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:
  • Deaths From All Causes [ Time Frame: Events through 13 years of follow-up or through December 31, 2009. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Number of positive screens with complications

  • T0 (Baseline) PSA Screening Results [ Time Frame: T0 (at study entry) ] [ Designated as safety issue: No ]
    Prostate-Specific Antigen (PSA) result.

  • T0 (Baseline) DRE Screening Results [ Time Frame: T0 (at study entry) ] [ Designated as safety issue: No ]
    Digital Rectal Examination (DRE) result.

  • T1 PSA Screening Results [ Time Frame: T1 (one year after entry) ] [ Designated as safety issue: No ]
    Prostate-Specific Antigen (PSA) result.

  • T1 DRE Screening Results [ Time Frame: T1 (one year after entry) ] [ Designated as safety issue: No ]
    Digital Rectal Examination (DRE) result.

  • T2 PSA Screening Results [ Time Frame: T2 (two years after entry) ] [ Designated as safety issue: No ]
    Prostate-Specific Antigen (PSA) result.

  • T2 DRE Screening Results [ Time Frame: T2 (two years after entry) ] [ Designated as safety issue: No ]
    Digital Rectal Examination (DRE) results

  • T3 PSA Screening Results [ Time Frame: T3 (three years after entry) ] [ Designated as safety issue: No ]
    Prostate-Specific Antigen (PSA) result

  • T3 DRE Screening Results [ Time Frame: T3 (three years after entry) ] [ Designated as safety issue: No ]
    Digital Rectal examination (DRE) result

  • T4 PSA Screening Result [ Time Frame: T4 (four years after entry) ] [ Designated as safety issue: No ]
    Prostate-Specific Antigen (PSA) result

  • T5 PSA Screening Results [ Time Frame: T5 (five years after entry) ] [ Designated as safety issue: No ]
    Prostate-Specific Antigen (PSA) result.


Enrollment: 76685
Study Start Date: November 1993
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: examination
Undergo DRE
Other Names:
  • Exam
  • Medical Assessment
  • Medical Exam
  • Medical Examination
  • Medical Inspection
Other: screening questionnaire administration
Undergo questionnaire assessments
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002540

Locations
United States, Maryland
Mark O Hatfield-Warren Grant Magnuson Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Christine Berg Mark O Hatfield-Warren Grant Magnuson Clinical Center
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002540     History of Changes
Other Study ID Numbers: NCI-2012-01755, NCI-2012-01755, PLCO-1, CDR0000078532, PLCO-Prostate, NCI-P93-0050
Study First Received: November 1, 1999
Results First Received: August 30, 2013
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014