Clinical trial NCT00002540: Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)
Official title: Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-03-26
Enrollment: 76685
Sex: MALE
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Prostate Cancer Deaths
timeFrame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
measure: Prostate Cancer Death Rates
timeFrame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
Secondary outcomes:
measure: Deaths From All Causes
timeFrame: Events through 13 years of follow-up or through December 31, 2009.
measure: Death Rates From All Causes
timeFrame: Events through 13 years of follow-up or through December 31, 2009.
measure: Prostate Cancer Incidence
timeFrame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
measure: Prostate Cancer Incidence Rates
timeFrame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
measure: Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
timeFrame: One year from screening examination
measure: T0 (Baseline) PSA Screening Results
timeFrame: T0 (at study entry)
measure: T0 (Baseline) DRE Screening Results
timeFrame: T0 (at study entry)
measure: T1 PSA Screening Results
timeFrame: T1 (one year after entry)
measure: T1 DRE Screening Results
timeFrame: T1 (one year after entry)
measure: T2 PSA Screening Results
timeFrame: T2 (two years after entry)
measure: T2 DRE Screening Results
timeFrame: T2 (two years after entry)
measure: T3 PSA Screening Results
timeFrame: T3 (three years after entry)
measure: T3 DRE Screening Results
timeFrame: T3 (three years after entry)
measure: T4 PSA Screening Result
timeFrame: T4 (four years after entry)
measure: T5 PSA Screening Results
timeFrame: T5 (five years after entry)
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Christine D Berg
role: PRINCIPAL_INVESTIGATOR
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