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

National Cancer Institute (NCI)

Status: Active, not recruiting

Conditions: Prostate Carcinoma

Treatments: Other: Screening Questionnaire Administration; Other: Laboratory Biomarker Analysis; Procedure: Medical Examination Assessment

Study type: Interventional

Funder types: NIH

Identifiers

NCT00002540

PLCO-1

PLCO-Prostate (Other Identifier)

CDR0000078532

NCI-P93-0050

NCI-2012-01755 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76,685 patients

Sex: Male

Ages: 55 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76,685 participants in 2 patient groups

Control

No Intervention group

Description:

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

Prostate Screening

Active Comparator group

Description:

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.

Treatment:

Procedure: Medical Examination Assessment

Other: Laboratory Biomarker Analysis

Other: Screening Questionnaire Administration