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

Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002540
• Other study ID #: NCI-2012-01755
• Secondary ID: NCI-2012-01755CD
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 16, 1993
• Est. completion date: March 11, 2025

Study information

• Verified date: January 2024
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76685
• Est. completion date: March 11, 2025
• Est. primary completion date: May 21, 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Medical Examination
Undergo DRE

Other:
• Screening Questionnaire Administration
Undergo questionnaire assessments

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate Cancer Deaths	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.
Primary	Prostate Cancer Death Rates	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	Deaths From All Causes	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.
Secondary	Death Rates From All Causes	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.
Secondary	Prostate Cancer Incidence	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.
Secondary	Prostate Cancer Incidence Rates	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.
Secondary	Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test	Number of positive screens with complications	One year from screening examination
Secondary	T0 (Baseline) PSA Screening Results	Prostate-Specific Antigen (PSA) result.	T0 (at study entry)
Secondary	T0 (Baseline) DRE Screening Results	Digital Rectal Examination (DRE) result.	T0 (at study entry)
Secondary	T1 PSA Screening Results	Prostate-Specific Antigen (PSA) result.	T1 (one year after entry)
Secondary	T1 DRE Screening Results	Digital Rectal Examination (DRE) result.	T1 (one year after entry)
Secondary	T2 PSA Screening Results	Prostate-Specific Antigen (PSA) result.	T2 (two years after entry)
Secondary	T2 DRE Screening Results	Digital Rectal Examination (DRE) results	T2 (two years after entry)
Secondary	T3 PSA Screening Results	Prostate-Specific Antigen (PSA) result	T3 (three years after entry)
Secondary	T3 DRE Screening Results	Digital Rectal examination (DRE) result	T3 (three years after entry)
Secondary	T4 PSA Screening Result	Prostate-Specific Antigen (PSA) result	T4 (four years after entry)
Secondary	T5 PSA Screening Results	Prostate-Specific Antigen (PSA) result.	T5 (five years after entry)